Just over 51% of older hypertensive adults regularly check their own blood pressure, compared with 48% of those with blood pressure–related health conditions (BPHCs), based on a 2021 survey of individuals aged 50-80 years.

“Guidelines recommend that patients use self-measured blood pressure monitoring (SBPM) outside the clinic to diagnose and manage hypertension,” but just 61% of respondents with a BPHC and 68% of those with hypertension said that they had received such a recommendation from a physician, nurse, or other health care professional, Melanie V. Springer, MD, and associates said in JAMA Network Open.

The prevalence of regular monitoring among those with hypertension, 51.2%, does, however, compare favorably with an earlier study showing that 43% of adults aged 18 and older regularly monitored their BP in 2005 and 2008, “which is perhaps associated with our sample’s older age,” said Dr. Springer and associates of the University of Michigan, Ann Arbor.

The current study, they noted, is the first to report “SBPM prevalence in adults ages 50 to 80 years with hypertension or BPHCs, who have a higher risk of adverse outcomes from uncontrolled BP than younger adults.” The analysis is based on data from the National Poll on Healthy Aging, conducted by the University of Michigan in January 2021 and completed by 2,023 individuals.

The frequency of home monitoring varied among adults with BPHCs, as just under 15% reported daily checks and the largest proportion, about 28%, used their device one to three times per month. The results of home monitoring were shared with health care professionals by 50.2% of respondents with a BPHC and by 51.5% of those with hypertension, they said in the research letter.

Home monitoring’s less-than-universal recommendation by providers and use by patients “suggest that protocols should be developed to educate patients about the importance of SBPM and sharing readings with clinicians and the frequency that SBPM should be performed,” Dr. Springer and associates wrote.

The study was funded by AARP, Michigan Medicine, the National Institute of Neurological Disorders and Stroke, and the Department of Veterans Affairs. One investigator has received consulting fees or honoraria from SeeChange Health, HealthMine, the Kaiser Permanente Washington Health Research Institute, the Robert Wood Johnson Foundation, AbilTo, Kansas City Area Life Sciences Institute, American Diabetes Association, Donaghue Foundation, and Luxembourg National Research Fund.

Just over 51% of older hypertensive adults regularly check their own blood pressure, compared with 48% of those with blood pressure–related health conditions (BPHCs), based on a 2021 survey of individuals aged 50-80 years.

“Guidelines recommend that patients use self-measured blood pressure monitoring (SBPM) outside the clinic to diagnose and manage hypertension,” but just 61% of respondents with a BPHC and 68% of those with hypertension said that they had received such a recommendation from a physician, nurse, or other health care professional, Melanie V. Springer, MD, and associates said in JAMA Network Open.

The prevalence of regular monitoring among those with hypertension, 51.2%, does, however, compare favorably with an earlier study showing that 43% of adults aged 18 and older regularly monitored their BP in 2005 and 2008, “which is perhaps associated with our sample’s older age,” said Dr. Springer and associates of the University of Michigan, Ann Arbor.

The current study, they noted, is the first to report “SBPM prevalence in adults ages 50 to 80 years with hypertension or BPHCs, who have a higher risk of adverse outcomes from uncontrolled BP than younger adults.” The analysis is based on data from the National Poll on Healthy Aging, conducted by the University of Michigan in January 2021 and completed by 2,023 individuals.

The frequency of home monitoring varied among adults with BPHCs, as just under 15% reported daily checks and the largest proportion, about 28%, used their device one to three times per month. The results of home monitoring were shared with health care professionals by 50.2% of respondents with a BPHC and by 51.5% of those with hypertension, they said in the research letter.

Home monitoring’s less-than-universal recommendation by providers and use by patients “suggest that protocols should be developed to educate patients about the importance of SBPM and sharing readings with clinicians and the frequency that SBPM should be performed,” Dr. Springer and associates wrote.

The study was funded by AARP, Michigan Medicine, the National Institute of Neurological Disorders and Stroke, and the Department of Veterans Affairs. One investigator has received consulting fees or honoraria from SeeChange Health, HealthMine, the Kaiser Permanente Washington Health Research Institute, the Robert Wood Johnson Foundation, AbilTo, Kansas City Area Life Sciences Institute, American Diabetes Association, Donaghue Foundation, and Luxembourg National Research Fund.

Just over 51% of older hypertensive adults regularly check their own blood pressure, compared with 48% of those with blood pressure–related health conditions (BPHCs), based on a 2021 survey of individuals aged 50-80 years.

“Guidelines recommend that patients use self-measured blood pressure monitoring (SBPM) outside the clinic to diagnose and manage hypertension,” but just 61% of respondents with a BPHC and 68% of those with hypertension said that they had received such a recommendation from a physician, nurse, or other health care professional, Melanie V. Springer, MD, and associates said in JAMA Network Open.

The prevalence of regular monitoring among those with hypertension, 51.2%, does, however, compare favorably with an earlier study showing that 43% of adults aged 18 and older regularly monitored their BP in 2005 and 2008, “which is perhaps associated with our sample’s older age,” said Dr. Springer and associates of the University of Michigan, Ann Arbor.

The current study, they noted, is the first to report “SBPM prevalence in adults ages 50 to 80 years with hypertension or BPHCs, who have a higher risk of adverse outcomes from uncontrolled BP than younger adults.” The analysis is based on data from the National Poll on Healthy Aging, conducted by the University of Michigan in January 2021 and completed by 2,023 individuals.

The frequency of home monitoring varied among adults with BPHCs, as just under 15% reported daily checks and the largest proportion, about 28%, used their device one to three times per month. The results of home monitoring were shared with health care professionals by 50.2% of respondents with a BPHC and by 51.5% of those with hypertension, they said in the research letter.

Home monitoring’s less-than-universal recommendation by providers and use by patients “suggest that protocols should be developed to educate patients about the importance of SBPM and sharing readings with clinicians and the frequency that SBPM should be performed,” Dr. Springer and associates wrote.

The study was funded by AARP, Michigan Medicine, the National Institute of Neurological Disorders and Stroke, and the Department of Veterans Affairs. One investigator has received consulting fees or honoraria from SeeChange Health, HealthMine, the Kaiser Permanente Washington Health Research Institute, the Robert Wood Johnson Foundation, AbilTo, Kansas City Area Life Sciences Institute, American Diabetes Association, Donaghue Foundation, and Luxembourg National Research Fund.

Key clinical point: Once-daily 75 mg vibegron was not associated with a clinically significant improvement in irritable bowel syndrome (IBS)-associated abdominal pain in women with diarrhea-predominant IBS (IBS-D) or mixed diarrhea/constipation IBS (IBS-M).

Major finding: At week 12, the percentage of women with IBS-D (40.9% vs 42.9%; P = .8222) or IBS-M (28.9% vs 24.4%; P = .6151) experiencing ≥30% improvement in IBS-associated abdominal pain was not significantly different with vibegron vs placebo. The incidence of treatment-emergent adverse events was comparable between the treatment groups.

Study details: The data come from a phase 2 randomized controlled trial including 222 adult women with IBS-D or IBS-M who were randomly assigned to receive 75 mg vibegron (n = 111) or placebo (n = 111).

Disclosures: This study was funded by Urovant Sciences. J King, D Shortino, C Schaumburg, and C Haag-Molkenteller declared being former employees of Urovant Sciences. Some authors declared receiving research grants or serving as consultants or on scientific advisory boards for various sources, including Urovant Sciences.

Source: Lacy BE et al. Efficacy and safety of vibegron for the treatment of irritable bowel syndrome in women: Results of a randomized, double-blind, placebo-controlled phase 2 trial. Neurogastroenterol Motil. 2022;e14448 (Aug 16). Doi: 10.1111/nmo.14448

Key clinical point: Once-daily 75 mg vibegron was not associated with a clinically significant improvement in irritable bowel syndrome (IBS)-associated abdominal pain in women with diarrhea-predominant IBS (IBS-D) or mixed diarrhea/constipation IBS (IBS-M).

Major finding: At week 12, the percentage of women with IBS-D (40.9% vs 42.9%; P = .8222) or IBS-M (28.9% vs 24.4%; P = .6151) experiencing ≥30% improvement in IBS-associated abdominal pain was not significantly different with vibegron vs placebo. The incidence of treatment-emergent adverse events was comparable between the treatment groups.

Study details: The data come from a phase 2 randomized controlled trial including 222 adult women with IBS-D or IBS-M who were randomly assigned to receive 75 mg vibegron (n = 111) or placebo (n = 111).

Disclosures: This study was funded by Urovant Sciences. J King, D Shortino, C Schaumburg, and C Haag-Molkenteller declared being former employees of Urovant Sciences. Some authors declared receiving research grants or serving as consultants or on scientific advisory boards for various sources, including Urovant Sciences.

Source: Lacy BE et al. Efficacy and safety of vibegron for the treatment of irritable bowel syndrome in women: Results of a randomized, double-blind, placebo-controlled phase 2 trial. Neurogastroenterol Motil. 2022;e14448 (Aug 16). Doi: 10.1111/nmo.14448

Key clinical point: Once-daily 75 mg vibegron was not associated with a clinically significant improvement in irritable bowel syndrome (IBS)-associated abdominal pain in women with diarrhea-predominant IBS (IBS-D) or mixed diarrhea/constipation IBS (IBS-M).

Major finding: At week 12, the percentage of women with IBS-D (40.9% vs 42.9%; P = .8222) or IBS-M (28.9% vs 24.4%; P = .6151) experiencing ≥30% improvement in IBS-associated abdominal pain was not significantly different with vibegron vs placebo. The incidence of treatment-emergent adverse events was comparable between the treatment groups.

Study details: The data come from a phase 2 randomized controlled trial including 222 adult women with IBS-D or IBS-M who were randomly assigned to receive 75 mg vibegron (n = 111) or placebo (n = 111).

Disclosures: This study was funded by Urovant Sciences. J King, D Shortino, C Schaumburg, and C Haag-Molkenteller declared being former employees of Urovant Sciences. Some authors declared receiving research grants or serving as consultants or on scientific advisory boards for various sources, including Urovant Sciences.

Source: Lacy BE et al. Efficacy and safety of vibegron for the treatment of irritable bowel syndrome in women: Results of a randomized, double-blind, placebo-controlled phase 2 trial. Neurogastroenterol Motil. 2022;e14448 (Aug 16). Doi: 10.1111/nmo.14448

Key clinical point: An 8-week treatment with mesalazine offered no clear benefits over placebo for global improvement of irritable bowel syndrome (IBS) symptoms.

Major finding: A similar proportion of patients receiving mesalazine vs placebo reported satisfactory relief of IBS symptoms during ≥50% of the treatment weeks (36% vs 30%; P = .40); however, the improvement in abdominal bloating was significantly greater in the mesalazine vs placebo group (P = .02).

Study details: The data come from a randomized controlled trial including 181 patients with IBS who were assigned to an 8-week treatment with 2400 mg mesalazine orally or placebo once daily.

Disclosures: This study was funded by Eurostars project grant from Tillotts Pharma AB and by the Swedish state. Some authors declared receiving research grants or serving as consultants or on advisory boards for various sources, including Tillotts Pharma.

Source: Tejera VC et al. Randomised clinical trial and meta-analysis: Mesalazine treatment in irritable bowel syndrome—Effects on gastrointestinal symptoms and rectal biomarkers of immune activity. Aliment Pharmacol Ther. 2022;56(6):968-979 (Aug 8). Doi: 10.1111/apt.17182

Key clinical point: An 8-week treatment with mesalazine offered no clear benefits over placebo for global improvement of irritable bowel syndrome (IBS) symptoms.

Major finding: A similar proportion of patients receiving mesalazine vs placebo reported satisfactory relief of IBS symptoms during ≥50% of the treatment weeks (36% vs 30%; P = .40); however, the improvement in abdominal bloating was significantly greater in the mesalazine vs placebo group (P = .02).

Study details: The data come from a randomized controlled trial including 181 patients with IBS who were assigned to an 8-week treatment with 2400 mg mesalazine orally or placebo once daily.

Disclosures: This study was funded by Eurostars project grant from Tillotts Pharma AB and by the Swedish state. Some authors declared receiving research grants or serving as consultants or on advisory boards for various sources, including Tillotts Pharma.

Source: Tejera VC et al. Randomised clinical trial and meta-analysis: Mesalazine treatment in irritable bowel syndrome—Effects on gastrointestinal symptoms and rectal biomarkers of immune activity. Aliment Pharmacol Ther. 2022;56(6):968-979 (Aug 8). Doi: 10.1111/apt.17182

Key clinical point: An 8-week treatment with mesalazine offered no clear benefits over placebo for global improvement of irritable bowel syndrome (IBS) symptoms.

Major finding: A similar proportion of patients receiving mesalazine vs placebo reported satisfactory relief of IBS symptoms during ≥50% of the treatment weeks (36% vs 30%; P = .40); however, the improvement in abdominal bloating was significantly greater in the mesalazine vs placebo group (P = .02).

Study details: The data come from a randomized controlled trial including 181 patients with IBS who were assigned to an 8-week treatment with 2400 mg mesalazine orally or placebo once daily.

Disclosures: This study was funded by Eurostars project grant from Tillotts Pharma AB and by the Swedish state. Some authors declared receiving research grants or serving as consultants or on advisory boards for various sources, including Tillotts Pharma.

Source: Tejera VC et al. Randomised clinical trial and meta-analysis: Mesalazine treatment in irritable bowel syndrome—Effects on gastrointestinal symptoms and rectal biomarkers of immune activity. Aliment Pharmacol Ther. 2022;56(6):968-979 (Aug 8). Doi: 10.1111/apt.17182

Wearing a cuffless device on the wrist to continuously monitor blood pressure was associated with a significantly lower systolic BP at 6 months among hypertensive adults, real-world results from Europe show.

“We don’t know what they did to reduce their blood pressure,” Jay Shah, MD, Division of Cardiology, Mayo Clinic Arizona, Phoenix, told this news organization.

“The idea is that because they were exposed to their data on a continual basis, that may have prompted them to do something that led to an improvement in their blood pressure, whether it be exercise more, go to their doctor, or change their medication,” said Dr. Shah, who is also chief medical officer for Aktiia.

Dr. Shah presented the study at the Hypertension Scientific Sessions, San Diego.
 

Empowering data

The study used the Aktiia 24/7 BP monitor; Atkiia funded the trial. The monitor passively and continually monitors BP values from photoplethysmography signals collected via optical sensors at the wrist.

After initial individualized calibration using a cuff-based reference, BP measurements are displayed on a smartphone app, allowing users to consistently monitor their own BP for long periods of time.

Aktiia received CE mark in Europe in January 2021 and is currently under review by the U.S. Food and Drug Administration.

Dr. Shah and colleagues analyzed systolic BP (SBP) trends among 838 real-world Aktiia users in Europe (age 57 ± 11 years; 14% women) who consistently used the monitor for 6 months.

Altogether, they had data on 375 (± 287) app interactions, 3,646 (± 1,417) cuffless readings per user, and 9 (± 7) cuff readings per user.

Traditional cuff SBP averages were calculated monthly and compared with the SBP average of the first month. A t-test analysis was used to detect the difference in SBP between the first and successive months.

On the basis of the mean SBP calculated over 6 months, 136 participants were hypertensive (SBP > 140 mm Hg) and the rest had SBP less than 140 mm Hg.

Hypertensive users saw a statistically significant reduction in SBP of –3.2 mm Hg (95% CI, –0.70 to –5.59; P < .02), beginning at 3 months of continual cuffless BP monitoring, which was sustained through 6 months.

Among users with SBP less than 140 mm Hg, the mean SBP remained unchanged.

“The magnitude of improvement might look modest, but even a 5 mm Hg reduction in systolic BP correlates to a 10% decrease in cardiovascular risk,” Dr. Shah told this news organization.

He noted that “one of the major hurdles is that people may not be aware they have high blood pressure because they don’t feel it. And with a regular cuff, they’ll only see that number when they actually check their blood pressure, which is extremely rare, even for people who have hypertension.”

“Having the ability to show someone their continual blood pressure picture really empowers them to do something to make changes and to be aware, [as well as] to be a more active participant in their health,” Dr. Shah said.

He said that a good analogy is diabetes management, which has transitioned from single finger-stick glucose monitoring to continuous glucose monitoring that provides a complete 24/7 picture of glucose levels.

Transforming technology

Offering perspective on the study, Harlan Krumholz, MD, SM, with Yale New Haven Hospital and Yale School of Medicine, New Haven, Conn., said that having an accurate, affordable, unobtrusive cuffless continuous BP monitor would “transform” BP management.

Courtesy Yale University

“This could unlock an era of precision BP management with empowerment of patients to view and act on their numbers,” Dr. Krumholz said in an interview.

“We need data to be confident in the devices – and then research to best leverage the streams of information – and strategies to optimize its use in practice,” Dr. Krumholz added.

“Like any new innovation, we need to mitigate risks and monitor for unintended adverse consequences, but I am bullish on the future of cuffless continuous BP monitors,” Dr. Krumholz said.

Dr. Krumholz said that he “applauds Aktiia for doing studies that assess the effect of the information they are producing on BP over time. We need to know that new approaches not only generate valid information but that they can improve health.”
 

Ready for prime time?

In June, the European Society of Hypertension issued a statement noting that cuffless BP measurement is a fast-growing and promising field with considerable potential for improving hypertension awareness, management, and control, but because the accuracy of these new devices has not yet been validated, they are not yet suitable for clinical use.

Also providing perspective, Stephen Juraschek, MD, PhD, research director, Hypertension Center of Excellence at Healthcare Associates, Beth Israel Deaconess Medical Center, Boston, said that “there is a lot of interest in cuffless BP monitors due to their ease of measurement, comfort, and ability to obtain BP measurements in multiple settings and environments, and this study showed that the monitoring improved BP over time.”

“It is believed that the increased awareness and feedback may promote healthier behaviors aimed at lowering BP. However, this result should not be conflated with the accuracy of these monitors,” Dr. Juraschek cautioned.

He also noted that there is still no formally approved validation protocol by the Association for the Advancement of Medical Instrumentation.

“While a number of cuffless devices are cleared by the FDA through its 510k mechanism (that is, demonstration of device equivalence), there is no formal stamp of approval or attestation that the measurements are accurate,” Dr. Juraschek said in an interview.

In his view, “more work is needed to understand the validity of these devices. For now, validated, cuff-based home devices are recommended for BP measurement at home, while further work is done to determine the accuracy of these cuffless technologies.”

The study was funded by Aktiia. Dr. Shah is an employee of the company. Dr. Krumholz has no relevant disclosures. Dr. Juraschek is a member of the Validate BP review committee and the AAMI sphygmomanometer committee.

A version of this article first appeared on Medscape.com.

Wearing a cuffless device on the wrist to continuously monitor blood pressure was associated with a significantly lower systolic BP at 6 months among hypertensive adults, real-world results from Europe show.

“We don’t know what they did to reduce their blood pressure,” Jay Shah, MD, Division of Cardiology, Mayo Clinic Arizona, Phoenix, told this news organization.

“The idea is that because they were exposed to their data on a continual basis, that may have prompted them to do something that led to an improvement in their blood pressure, whether it be exercise more, go to their doctor, or change their medication,” said Dr. Shah, who is also chief medical officer for Aktiia.

Dr. Shah presented the study at the Hypertension Scientific Sessions, San Diego.
 

Empowering data

The study used the Aktiia 24/7 BP monitor; Atkiia funded the trial. The monitor passively and continually monitors BP values from photoplethysmography signals collected via optical sensors at the wrist.

After initial individualized calibration using a cuff-based reference, BP measurements are displayed on a smartphone app, allowing users to consistently monitor their own BP for long periods of time.

Aktiia received CE mark in Europe in January 2021 and is currently under review by the U.S. Food and Drug Administration.

Dr. Shah and colleagues analyzed systolic BP (SBP) trends among 838 real-world Aktiia users in Europe (age 57 ± 11 years; 14% women) who consistently used the monitor for 6 months.

Altogether, they had data on 375 (± 287) app interactions, 3,646 (± 1,417) cuffless readings per user, and 9 (± 7) cuff readings per user.

Traditional cuff SBP averages were calculated monthly and compared with the SBP average of the first month. A t-test analysis was used to detect the difference in SBP between the first and successive months.

On the basis of the mean SBP calculated over 6 months, 136 participants were hypertensive (SBP > 140 mm Hg) and the rest had SBP less than 140 mm Hg.

Hypertensive users saw a statistically significant reduction in SBP of –3.2 mm Hg (95% CI, –0.70 to –5.59; P < .02), beginning at 3 months of continual cuffless BP monitoring, which was sustained through 6 months.

Among users with SBP less than 140 mm Hg, the mean SBP remained unchanged.

“The magnitude of improvement might look modest, but even a 5 mm Hg reduction in systolic BP correlates to a 10% decrease in cardiovascular risk,” Dr. Shah told this news organization.

He noted that “one of the major hurdles is that people may not be aware they have high blood pressure because they don’t feel it. And with a regular cuff, they’ll only see that number when they actually check their blood pressure, which is extremely rare, even for people who have hypertension.”

“Having the ability to show someone their continual blood pressure picture really empowers them to do something to make changes and to be aware, [as well as] to be a more active participant in their health,” Dr. Shah said.

He said that a good analogy is diabetes management, which has transitioned from single finger-stick glucose monitoring to continuous glucose monitoring that provides a complete 24/7 picture of glucose levels.

Transforming technology

Offering perspective on the study, Harlan Krumholz, MD, SM, with Yale New Haven Hospital and Yale School of Medicine, New Haven, Conn., said that having an accurate, affordable, unobtrusive cuffless continuous BP monitor would “transform” BP management.

Courtesy Yale University

“This could unlock an era of precision BP management with empowerment of patients to view and act on their numbers,” Dr. Krumholz said in an interview.

“We need data to be confident in the devices – and then research to best leverage the streams of information – and strategies to optimize its use in practice,” Dr. Krumholz added.

“Like any new innovation, we need to mitigate risks and monitor for unintended adverse consequences, but I am bullish on the future of cuffless continuous BP monitors,” Dr. Krumholz said.

Dr. Krumholz said that he “applauds Aktiia for doing studies that assess the effect of the information they are producing on BP over time. We need to know that new approaches not only generate valid information but that they can improve health.”
 

Ready for prime time?

In June, the European Society of Hypertension issued a statement noting that cuffless BP measurement is a fast-growing and promising field with considerable potential for improving hypertension awareness, management, and control, but because the accuracy of these new devices has not yet been validated, they are not yet suitable for clinical use.

Also providing perspective, Stephen Juraschek, MD, PhD, research director, Hypertension Center of Excellence at Healthcare Associates, Beth Israel Deaconess Medical Center, Boston, said that “there is a lot of interest in cuffless BP monitors due to their ease of measurement, comfort, and ability to obtain BP measurements in multiple settings and environments, and this study showed that the monitoring improved BP over time.”

“It is believed that the increased awareness and feedback may promote healthier behaviors aimed at lowering BP. However, this result should not be conflated with the accuracy of these monitors,” Dr. Juraschek cautioned.

He also noted that there is still no formally approved validation protocol by the Association for the Advancement of Medical Instrumentation.

“While a number of cuffless devices are cleared by the FDA through its 510k mechanism (that is, demonstration of device equivalence), there is no formal stamp of approval or attestation that the measurements are accurate,” Dr. Juraschek said in an interview.

In his view, “more work is needed to understand the validity of these devices. For now, validated, cuff-based home devices are recommended for BP measurement at home, while further work is done to determine the accuracy of these cuffless technologies.”

The study was funded by Aktiia. Dr. Shah is an employee of the company. Dr. Krumholz has no relevant disclosures. Dr. Juraschek is a member of the Validate BP review committee and the AAMI sphygmomanometer committee.

A version of this article first appeared on Medscape.com.

Wearing a cuffless device on the wrist to continuously monitor blood pressure was associated with a significantly lower systolic BP at 6 months among hypertensive adults, real-world results from Europe show.

“We don’t know what they did to reduce their blood pressure,” Jay Shah, MD, Division of Cardiology, Mayo Clinic Arizona, Phoenix, told this news organization.

“The idea is that because they were exposed to their data on a continual basis, that may have prompted them to do something that led to an improvement in their blood pressure, whether it be exercise more, go to their doctor, or change their medication,” said Dr. Shah, who is also chief medical officer for Aktiia.

Dr. Shah presented the study at the Hypertension Scientific Sessions, San Diego.
 

Empowering data

The study used the Aktiia 24/7 BP monitor; Atkiia funded the trial. The monitor passively and continually monitors BP values from photoplethysmography signals collected via optical sensors at the wrist.

After initial individualized calibration using a cuff-based reference, BP measurements are displayed on a smartphone app, allowing users to consistently monitor their own BP for long periods of time.

Aktiia received CE mark in Europe in January 2021 and is currently under review by the U.S. Food and Drug Administration.

Dr. Shah and colleagues analyzed systolic BP (SBP) trends among 838 real-world Aktiia users in Europe (age 57 ± 11 years; 14% women) who consistently used the monitor for 6 months.

Altogether, they had data on 375 (± 287) app interactions, 3,646 (± 1,417) cuffless readings per user, and 9 (± 7) cuff readings per user.

Traditional cuff SBP averages were calculated monthly and compared with the SBP average of the first month. A t-test analysis was used to detect the difference in SBP between the first and successive months.

On the basis of the mean SBP calculated over 6 months, 136 participants were hypertensive (SBP > 140 mm Hg) and the rest had SBP less than 140 mm Hg.

Hypertensive users saw a statistically significant reduction in SBP of –3.2 mm Hg (95% CI, –0.70 to –5.59; P < .02), beginning at 3 months of continual cuffless BP monitoring, which was sustained through 6 months.

Among users with SBP less than 140 mm Hg, the mean SBP remained unchanged.

“The magnitude of improvement might look modest, but even a 5 mm Hg reduction in systolic BP correlates to a 10% decrease in cardiovascular risk,” Dr. Shah told this news organization.

He noted that “one of the major hurdles is that people may not be aware they have high blood pressure because they don’t feel it. And with a regular cuff, they’ll only see that number when they actually check their blood pressure, which is extremely rare, even for people who have hypertension.”

“Having the ability to show someone their continual blood pressure picture really empowers them to do something to make changes and to be aware, [as well as] to be a more active participant in their health,” Dr. Shah said.

He said that a good analogy is diabetes management, which has transitioned from single finger-stick glucose monitoring to continuous glucose monitoring that provides a complete 24/7 picture of glucose levels.

Transforming technology

Offering perspective on the study, Harlan Krumholz, MD, SM, with Yale New Haven Hospital and Yale School of Medicine, New Haven, Conn., said that having an accurate, affordable, unobtrusive cuffless continuous BP monitor would “transform” BP management.

Courtesy Yale University

“This could unlock an era of precision BP management with empowerment of patients to view and act on their numbers,” Dr. Krumholz said in an interview.

“We need data to be confident in the devices – and then research to best leverage the streams of information – and strategies to optimize its use in practice,” Dr. Krumholz added.

“Like any new innovation, we need to mitigate risks and monitor for unintended adverse consequences, but I am bullish on the future of cuffless continuous BP monitors,” Dr. Krumholz said.

Dr. Krumholz said that he “applauds Aktiia for doing studies that assess the effect of the information they are producing on BP over time. We need to know that new approaches not only generate valid information but that they can improve health.”
 

Ready for prime time?

In June, the European Society of Hypertension issued a statement noting that cuffless BP measurement is a fast-growing and promising field with considerable potential for improving hypertension awareness, management, and control, but because the accuracy of these new devices has not yet been validated, they are not yet suitable for clinical use.

Also providing perspective, Stephen Juraschek, MD, PhD, research director, Hypertension Center of Excellence at Healthcare Associates, Beth Israel Deaconess Medical Center, Boston, said that “there is a lot of interest in cuffless BP monitors due to their ease of measurement, comfort, and ability to obtain BP measurements in multiple settings and environments, and this study showed that the monitoring improved BP over time.”

“It is believed that the increased awareness and feedback may promote healthier behaviors aimed at lowering BP. However, this result should not be conflated with the accuracy of these monitors,” Dr. Juraschek cautioned.

He also noted that there is still no formally approved validation protocol by the Association for the Advancement of Medical Instrumentation.

“While a number of cuffless devices are cleared by the FDA through its 510k mechanism (that is, demonstration of device equivalence), there is no formal stamp of approval or attestation that the measurements are accurate,” Dr. Juraschek said in an interview.

In his view, “more work is needed to understand the validity of these devices. For now, validated, cuff-based home devices are recommended for BP measurement at home, while further work is done to determine the accuracy of these cuffless technologies.”

The study was funded by Aktiia. Dr. Shah is an employee of the company. Dr. Krumholz has no relevant disclosures. Dr. Juraschek is a member of the Validate BP review committee and the AAMI sphygmomanometer committee.

A version of this article first appeared on Medscape.com.

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

A version of this article first appeared on Medscape.com.

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

A version of this article first appeared on Medscape.com.

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

A version of this article first appeared on Medscape.com.

A World Health Organization (WHO) consultation workshop on global disparities in Parkinson’s disease has suggested six avenues for action to address the needs of these patients.

Since 2000, Parkinson’s disease has increased 81% and related deaths have increased 100% globally. In addition, many patients affected by Parkinson’s disease live in low- and middle-income countries and experience large inequalities in access to neurologic care and essential medicines.

To address these issues, the Brain Health Unit at the WHO developed six “action steps” it says are urgently required to combat global disparities in Parkinson’s disease.

The need for action is great, said lead author Nicoline Schiess, MD, MPH, a neurologist and technical officer in the WHO’s Brain Health Unit in Geneva.

“In adults, disorders of the nervous system are the leading cause of disability adjusted life years, or DALYs, and the second leading cause of death globally, accounting for 9 million deaths per year,” Dr. Schiess said.

The WHO’s recommendations were published online recently as a “Special Communication” in JAMA Neurology.
 

Serious public health challenge

Parkinson’s disease is the fastest growing disorder in terms of death and disability, and it is estimated that it caused 329,000 deaths in 2019 – an increase of more than 100% since 2000.

“The rise in cases is thought to be multifactorial and is likely affected by factors such as aging populations and environmental exposures, such as certain pesticides. With these rapidly increasing numbers, compounded by a lack of specialists and medicines in low- and middle-income countries, Parkinson’s disease presents a serious public health challenge,” Dr. Schiess  said.

The publication of the six action steps is targeted toward clinicians and researchers who work in Parkinson’s disease, she added. The steps address the following areas:

• 1. Disease burden
• 2. Advocacy and awareness
• 3. Prevention and risk reduction
• 4. Diagnosis, treatment, and care
• 5. Caregiver support
• 6. Research

Dr. Schiess noted that data on disease burden are lacking in certain areas of the world, such as low- and middle-income countries, and information “based on race and ethnicity are inconsistent. Studies are needed to establish more representative epidemiological data.”

She said that advocacy and awareness are particularly important since young people may not be aware they can also develop Parkinson’s disease, and sex and race differences can factor in to the potential for delays in diagnosis and care. “This is often due to the incorrect perception that Parkinson’s disease only affects older people,” she noted.

In addition, “a substantial need exists to identify risks for Parkinson’s disease – in particular the risks we can mitigate,” said Dr. Schiess, citing pesticide exposure as one example. “The evidence linking pesticide exposure, for example paraquat and chlorpyrifos, with the risk of developing Parkinson’s disease is substantial. And yet in many countries, these products are still being used.”

Under the heading of diagnosis, treatment, and care, Dr. Schiess noted that patients with Parkinson’s disease in “low resource settings” and low- to middle-income countries are unable to obtain “even the most basic medications” to treat Parkinson’s disease.

“Strengthening health and social systems, and building capacity to improve medical care, including rehabilitation and palliative care and medication access, are vital. Also, education and training of primary health care professionals, growing the neurological workforce, and increasing the use of digital technology such as telemedicine, are key mechanisms to improving diagnosis and sustainability of care,” she said.

For caregiver support, Dr. Schiess pointed out that the progressive nature of the disease and timing of onset are contributors to increased caregiver burden. Other contributors, as the disease advances in a patient, include the development of cognitive impairment, psychiatric manifestations, and sleep disruption.

“Solutions that could decrease the burden on caregivers include providing an accurate and timely diagnosis and training and education to caregivers, such as the WHO iSUPPORT program, as well as psychosocial, financial, and community-based support,” said Dr. Schiess.

For research, she noted that the amount of studies in the field of Parkinson’s disease has grown because of increased funding and a greater number of initiatives over the past 2 decades.

“Continuing to build on this momentum is important in order to generate new treatment options, better care, and research capacity, especially in low- and middle-income countries,” she said.

Dr. Schiess emphasized the urgency for adopting these measures as cases of Parkinson’s disease continue to rise.

“The take-away message for clinicians is that Parkinson disease is a growing global public health issue. There is a pressing need for a global public health response to address health and social requirements for people with Parkinson’s disease,” she said.

Dr. Schiess reports having received grants from the Edmond J. Safra Foundation paid to her institution during the conduct of the study.

A version of this article first appeared on Medscape.com.

A World Health Organization (WHO) consultation workshop on global disparities in Parkinson’s disease has suggested six avenues for action to address the needs of these patients.

Since 2000, Parkinson’s disease has increased 81% and related deaths have increased 100% globally. In addition, many patients affected by Parkinson’s disease live in low- and middle-income countries and experience large inequalities in access to neurologic care and essential medicines.

To address these issues, the Brain Health Unit at the WHO developed six “action steps” it says are urgently required to combat global disparities in Parkinson’s disease.

The need for action is great, said lead author Nicoline Schiess, MD, MPH, a neurologist and technical officer in the WHO’s Brain Health Unit in Geneva.

“In adults, disorders of the nervous system are the leading cause of disability adjusted life years, or DALYs, and the second leading cause of death globally, accounting for 9 million deaths per year,” Dr. Schiess said.

The WHO’s recommendations were published online recently as a “Special Communication” in JAMA Neurology.
 

Serious public health challenge

Parkinson’s disease is the fastest growing disorder in terms of death and disability, and it is estimated that it caused 329,000 deaths in 2019 – an increase of more than 100% since 2000.

“The rise in cases is thought to be multifactorial and is likely affected by factors such as aging populations and environmental exposures, such as certain pesticides. With these rapidly increasing numbers, compounded by a lack of specialists and medicines in low- and middle-income countries, Parkinson’s disease presents a serious public health challenge,” Dr. Schiess  said.

The publication of the six action steps is targeted toward clinicians and researchers who work in Parkinson’s disease, she added. The steps address the following areas:

• 1. Disease burden
• 2. Advocacy and awareness
• 3. Prevention and risk reduction
• 4. Diagnosis, treatment, and care
• 5. Caregiver support
• 6. Research

Dr. Schiess noted that data on disease burden are lacking in certain areas of the world, such as low- and middle-income countries, and information “based on race and ethnicity are inconsistent. Studies are needed to establish more representative epidemiological data.”

She said that advocacy and awareness are particularly important since young people may not be aware they can also develop Parkinson’s disease, and sex and race differences can factor in to the potential for delays in diagnosis and care. “This is often due to the incorrect perception that Parkinson’s disease only affects older people,” she noted.

In addition, “a substantial need exists to identify risks for Parkinson’s disease – in particular the risks we can mitigate,” said Dr. Schiess, citing pesticide exposure as one example. “The evidence linking pesticide exposure, for example paraquat and chlorpyrifos, with the risk of developing Parkinson’s disease is substantial. And yet in many countries, these products are still being used.”

Under the heading of diagnosis, treatment, and care, Dr. Schiess noted that patients with Parkinson’s disease in “low resource settings” and low- to middle-income countries are unable to obtain “even the most basic medications” to treat Parkinson’s disease.

“Strengthening health and social systems, and building capacity to improve medical care, including rehabilitation and palliative care and medication access, are vital. Also, education and training of primary health care professionals, growing the neurological workforce, and increasing the use of digital technology such as telemedicine, are key mechanisms to improving diagnosis and sustainability of care,” she said.

For caregiver support, Dr. Schiess pointed out that the progressive nature of the disease and timing of onset are contributors to increased caregiver burden. Other contributors, as the disease advances in a patient, include the development of cognitive impairment, psychiatric manifestations, and sleep disruption.

“Solutions that could decrease the burden on caregivers include providing an accurate and timely diagnosis and training and education to caregivers, such as the WHO iSUPPORT program, as well as psychosocial, financial, and community-based support,” said Dr. Schiess.

For research, she noted that the amount of studies in the field of Parkinson’s disease has grown because of increased funding and a greater number of initiatives over the past 2 decades.

“Continuing to build on this momentum is important in order to generate new treatment options, better care, and research capacity, especially in low- and middle-income countries,” she said.

Dr. Schiess emphasized the urgency for adopting these measures as cases of Parkinson’s disease continue to rise.

“The take-away message for clinicians is that Parkinson disease is a growing global public health issue. There is a pressing need for a global public health response to address health and social requirements for people with Parkinson’s disease,” she said.

Dr. Schiess reports having received grants from the Edmond J. Safra Foundation paid to her institution during the conduct of the study.

A version of this article first appeared on Medscape.com.

A World Health Organization (WHO) consultation workshop on global disparities in Parkinson’s disease has suggested six avenues for action to address the needs of these patients.

Since 2000, Parkinson’s disease has increased 81% and related deaths have increased 100% globally. In addition, many patients affected by Parkinson’s disease live in low- and middle-income countries and experience large inequalities in access to neurologic care and essential medicines.

To address these issues, the Brain Health Unit at the WHO developed six “action steps” it says are urgently required to combat global disparities in Parkinson’s disease.

The need for action is great, said lead author Nicoline Schiess, MD, MPH, a neurologist and technical officer in the WHO’s Brain Health Unit in Geneva.

“In adults, disorders of the nervous system are the leading cause of disability adjusted life years, or DALYs, and the second leading cause of death globally, accounting for 9 million deaths per year,” Dr. Schiess said.

The WHO’s recommendations were published online recently as a “Special Communication” in JAMA Neurology.
 

Serious public health challenge

Parkinson’s disease is the fastest growing disorder in terms of death and disability, and it is estimated that it caused 329,000 deaths in 2019 – an increase of more than 100% since 2000.

“The rise in cases is thought to be multifactorial and is likely affected by factors such as aging populations and environmental exposures, such as certain pesticides. With these rapidly increasing numbers, compounded by a lack of specialists and medicines in low- and middle-income countries, Parkinson’s disease presents a serious public health challenge,” Dr. Schiess  said.

The publication of the six action steps is targeted toward clinicians and researchers who work in Parkinson’s disease, she added. The steps address the following areas:

• 1. Disease burden
• 2. Advocacy and awareness
• 3. Prevention and risk reduction
• 4. Diagnosis, treatment, and care
• 5. Caregiver support
• 6. Research

Dr. Schiess noted that data on disease burden are lacking in certain areas of the world, such as low- and middle-income countries, and information “based on race and ethnicity are inconsistent. Studies are needed to establish more representative epidemiological data.”

She said that advocacy and awareness are particularly important since young people may not be aware they can also develop Parkinson’s disease, and sex and race differences can factor in to the potential for delays in diagnosis and care. “This is often due to the incorrect perception that Parkinson’s disease only affects older people,” she noted.

In addition, “a substantial need exists to identify risks for Parkinson’s disease – in particular the risks we can mitigate,” said Dr. Schiess, citing pesticide exposure as one example. “The evidence linking pesticide exposure, for example paraquat and chlorpyrifos, with the risk of developing Parkinson’s disease is substantial. And yet in many countries, these products are still being used.”

Under the heading of diagnosis, treatment, and care, Dr. Schiess noted that patients with Parkinson’s disease in “low resource settings” and low- to middle-income countries are unable to obtain “even the most basic medications” to treat Parkinson’s disease.

“Strengthening health and social systems, and building capacity to improve medical care, including rehabilitation and palliative care and medication access, are vital. Also, education and training of primary health care professionals, growing the neurological workforce, and increasing the use of digital technology such as telemedicine, are key mechanisms to improving diagnosis and sustainability of care,” she said.

For caregiver support, Dr. Schiess pointed out that the progressive nature of the disease and timing of onset are contributors to increased caregiver burden. Other contributors, as the disease advances in a patient, include the development of cognitive impairment, psychiatric manifestations, and sleep disruption.

“Solutions that could decrease the burden on caregivers include providing an accurate and timely diagnosis and training and education to caregivers, such as the WHO iSUPPORT program, as well as psychosocial, financial, and community-based support,” said Dr. Schiess.

For research, she noted that the amount of studies in the field of Parkinson’s disease has grown because of increased funding and a greater number of initiatives over the past 2 decades.

“Continuing to build on this momentum is important in order to generate new treatment options, better care, and research capacity, especially in low- and middle-income countries,” she said.

Dr. Schiess emphasized the urgency for adopting these measures as cases of Parkinson’s disease continue to rise.

“The take-away message for clinicians is that Parkinson disease is a growing global public health issue. There is a pressing need for a global public health response to address health and social requirements for people with Parkinson’s disease,” she said.

Dr. Schiess reports having received grants from the Edmond J. Safra Foundation paid to her institution during the conduct of the study.

A version of this article first appeared on Medscape.com.

Systolic blood pressure went down safely and consistently 2 months after renal denervation achieved by ultrasound ablation in patients with uncontrolled, mild to moderate hypertension (HTN) in a key sham-controlled test of the balloon-equipped catheter.

The BP reductions were significant almost regardless of how they were measured – at home, in the office, during the day, at night, or over 24 hours – and weren’t dependent on baseline BP levels.

The 224-patient RADIANCE II Pivotal Study follows two earlier successful sham-controlled trials that used the same renal denervation catheter in other types of patients with HTN. They were RADIANCE-HTN SOLO, which entered patients with mild to moderate HTN not taking medication,  and RADIANCE-HTN TRIO, which included patients with HTN despite fixed-dose, single-pill, triple-antihypertensive therapy.

Courtesy American College of Cardiology

The consistent results of all three trials suggest that the ultrasound renal denervation (uRDN) technique “lowers blood pressure across the spectrum of hypertension,” concluded co–principal investigator Ajay J. Kirtane, MD, SM, Columbia University Irving Medical Center, New York–Presbyterian Hospital, when presenting RADIANCE II at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

RADIANCE II, the largest of the three studies, met its prespecified primary efficacy endpoint of change in daytime ambulatory systolic BP at 2 months by showing a significant 6.3–mm Hg greater reduction in the uRDN group, compared with the sham-control group. There were no major adverse events at 30 days in either group.

The trial was similarly successful for the secondary endpoints of change in systolic BP measured in various other settings, including over 24 hours. Reductions after uRDN averaged 5-7 mm Hg greater than in the control group.

Sparse top-line results of the RADIANCE II pivotal trial were announced in July by the study’s sponsor, ReCor Medical.

Dr. Kirtane stressed in an interview that uRDN and likely any form of HTN renal denervation therapy is not a substitute for standard management. “This is really for patients in whom you’ve made best efforts to do the traditional things – lifestyle modification, medications, all of that – and yet they’re still uncontrolled.” At that point, assuming denervation therapy is available in practice, “it would be something to potentially consider.”

As a panelist after Dr. Kirtane’s formal presentation of RADIANCE II at the conference, Naomi D. Fisher, MD, who was a RADIANCE-HTN TRIO investigator, described how the treatment’s perceived intended patient population evolved over time.

“We all began with the idea that we were going to treat patients with resistant hypertension, that was going to be the first target. We have learned that those patients are far fewer than we thought,” said Dr. Fisher, who directs the hypertension service at Brigham and Women’s Hospital, Boston.

Initial estimates were that such patients with the resistant form, “meaning they require more than three drugs to control their blood pressure,” would represent 15%-20% of patients with HTN.

“We learned from our TRIO data that if you give these patients one single combined pill, lo and behold, many of them become controlled,” she said. “There is so much nonadherence out there in the world, about 50% of our patients aren’t taking their pills. It’s a hard and true fact.”

Exclude patients who aren’t adherent and “our true resistance population becomes minuscule. So, I don’t think that’s going to be the main population” for renal denervation therapy.

More likely, she said, it would be “patients who are uncontrolled and unable to take their medications. So that is going to include nonadherence, intolerance. It’s a very large category of patients. And the priorities can be stacked in favor of those who have higher cardiovascular risk.”

RADIANCE II can show the persistence of uRDN’s BP-lowering effect only out to 2 months so far, but the effect’s durability based on the RADIANCE program’s combined experience appears to be at least 2 years, Dr. Kirtane said in an interview.

“The RADIANCE II pivotal trial is a powerful, well-designed study attesting to the efficacy of renal denervation in BP lowering,” Franz H. Messerli, MD, Swiss Cardiovascular Center, University Hospital Bern, said in an interview.

The trial “shows the well-known unpredictability of antihypertensive response. We cannot predict who responds to renal denervation and who does not, and who even has a paradoxical increase in BP,” Dr. Messerli, an international hypertension expert not associated with the trial, said in an interview.  

“As long as we cannot predict the antihypertensive response to renal denervation therapy, potential synergism/antagonism with drug therapy remains an educated guess,” he said.

“Hypertension is a disease that lasts years and decades. As impressive as RADIANCE II’s 2-month snapshot is, I look forward to similar or better BP data 12 and 24 months after renal denervation,” Dr. Messerli added.

RADIANCE II entered patients with mild to moderate uncontrolled HTN, that is, a systolic BP at least 140/90 mm Hg and less than 180/120 mm Hg, who were receiving no more than two antihypertensive medications. They could have no history of cardiovascular or cerebrovascular events or uncontrolled diabetes, and their estimated glomerular filtration rate (eGFR) had to be at least 40 mL/min per 1.73 m².

After a 4-week drug washout period, patients who were clinically stable with an ambulatory BP of at least 135/85 mm Hg and less than 170/105 mm Hg underwent CT and renal angiography. Then, the 224 patients still anatomically eligible for the procedure were randomly assigned 2:1 to uRDN or a sham-control procedure: 150 and 74 patients, respectively.

At 2 months, daytime ambulatory systolic BP on average fell 7.9 mm Hg in the uRDN group and 1.8 mm Hg in the sham-control group, for a drop that was steeper by 6.3 mm Hg (P < .0001) after uRDN.

Also in the uRDN group, there was a 6.2–mm Hg larger decrease in 24-hour ambulatory systolic BP (P < .0001), a 5.8–mm Hg greater decline in nighttime ambulatory systolic BP (P < .0004), a 7.6–mm Hg steeper drop in mean home systolic BP (P < .0001), and 5.4 mm Hg more of a decrease in office-based systolic BP (P = .0035).

No significant differences were seen in subgroup analyses by sex, age, higher versus lower baseline systolic pressures, high versus low baseline eGFR, degree of abdominal obesity, U.S. versus European site, or whether patients entered before or during the COVID pandemic

Regulators have been accepting change in systolic BP as a surrogate for clinical endpoints in trials of antihypertensive therapy, whether pharmacologic or interventional, under consideration for approval. “That’s why safety endpoints are important to investigate” in these clinical trials, especially for invasive therapies like renal denervation, Dr. Kirtane observed.

That said, “in the longer-term follow-ups of the renal denervation therapies that are out there, including this one, there does not appear to be an appreciable decline in glomerular filtration rate, or any adverse safety signals that we see to date,” Dr. Kirtane said in an interview. “But we know that these are low-frequency events, so we have to be very vigilant, and we can’t get complacent about it.”

In RADIANCE II, there were zero adverse events within 30 days in both groups; the endpoint included death, new myocardial infarction, renal artery complications requiring invasive intervention, and hospitalization for major cardiovascular or hemodynamic-related events. Nor were there instances of new-onset renal artery stenosis greater than 70% documented by imaging at 6 months.

The ReCor uRDN catheter uses ultrasound energy to disrupt renal nerve signaling, a technology thought to deliver safer “burns,” compared with other renal denervation catheter technologies. It features an axially stabilizing balloon that transmits ultrasound energy – two to three sonications, each lasting 7 seconds, Dr. Kirtane said – outward through the arterial wall. The design is intended to ensure consistently circumferential ablation. Circulating saline within the balloon, Kirtane noted, directly cools the adjacent vessel wall to help it avoid thermal damage.

Dr. Kirtane reported receiving institutional funding from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck; consulting for IMDS; and receiving travel and meal expenses from Medtronic, Boston Scientific, Abbott Vascular, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr. Fisher disclosed receiving honoraria or fees for consulting or serving on a speaker’s bureau for Medtronic, ReCor Medical, and Aktiia and receiving grant support or holding research contracts for Recor Medical and Aktiia. Dr. Messerli disclosed receiving honoraria from Medtronic, Menarini, Krka, and Ipca.

A version of this article first appeared on Medscape.com.

Systolic blood pressure went down safely and consistently 2 months after renal denervation achieved by ultrasound ablation in patients with uncontrolled, mild to moderate hypertension (HTN) in a key sham-controlled test of the balloon-equipped catheter.

The BP reductions were significant almost regardless of how they were measured – at home, in the office, during the day, at night, or over 24 hours – and weren’t dependent on baseline BP levels.

The 224-patient RADIANCE II Pivotal Study follows two earlier successful sham-controlled trials that used the same renal denervation catheter in other types of patients with HTN. They were RADIANCE-HTN SOLO, which entered patients with mild to moderate HTN not taking medication,  and RADIANCE-HTN TRIO, which included patients with HTN despite fixed-dose, single-pill, triple-antihypertensive therapy.

Courtesy American College of Cardiology

The consistent results of all three trials suggest that the ultrasound renal denervation (uRDN) technique “lowers blood pressure across the spectrum of hypertension,” concluded co–principal investigator Ajay J. Kirtane, MD, SM, Columbia University Irving Medical Center, New York–Presbyterian Hospital, when presenting RADIANCE II at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

RADIANCE II, the largest of the three studies, met its prespecified primary efficacy endpoint of change in daytime ambulatory systolic BP at 2 months by showing a significant 6.3–mm Hg greater reduction in the uRDN group, compared with the sham-control group. There were no major adverse events at 30 days in either group.

The trial was similarly successful for the secondary endpoints of change in systolic BP measured in various other settings, including over 24 hours. Reductions after uRDN averaged 5-7 mm Hg greater than in the control group.

Sparse top-line results of the RADIANCE II pivotal trial were announced in July by the study’s sponsor, ReCor Medical.

Dr. Kirtane stressed in an interview that uRDN and likely any form of HTN renal denervation therapy is not a substitute for standard management. “This is really for patients in whom you’ve made best efforts to do the traditional things – lifestyle modification, medications, all of that – and yet they’re still uncontrolled.” At that point, assuming denervation therapy is available in practice, “it would be something to potentially consider.”

As a panelist after Dr. Kirtane’s formal presentation of RADIANCE II at the conference, Naomi D. Fisher, MD, who was a RADIANCE-HTN TRIO investigator, described how the treatment’s perceived intended patient population evolved over time.

“We all began with the idea that we were going to treat patients with resistant hypertension, that was going to be the first target. We have learned that those patients are far fewer than we thought,” said Dr. Fisher, who directs the hypertension service at Brigham and Women’s Hospital, Boston.

Initial estimates were that such patients with the resistant form, “meaning they require more than three drugs to control their blood pressure,” would represent 15%-20% of patients with HTN.

“We learned from our TRIO data that if you give these patients one single combined pill, lo and behold, many of them become controlled,” she said. “There is so much nonadherence out there in the world, about 50% of our patients aren’t taking their pills. It’s a hard and true fact.”

Exclude patients who aren’t adherent and “our true resistance population becomes minuscule. So, I don’t think that’s going to be the main population” for renal denervation therapy.

More likely, she said, it would be “patients who are uncontrolled and unable to take their medications. So that is going to include nonadherence, intolerance. It’s a very large category of patients. And the priorities can be stacked in favor of those who have higher cardiovascular risk.”

RADIANCE II can show the persistence of uRDN’s BP-lowering effect only out to 2 months so far, but the effect’s durability based on the RADIANCE program’s combined experience appears to be at least 2 years, Dr. Kirtane said in an interview.

“The RADIANCE II pivotal trial is a powerful, well-designed study attesting to the efficacy of renal denervation in BP lowering,” Franz H. Messerli, MD, Swiss Cardiovascular Center, University Hospital Bern, said in an interview.

The trial “shows the well-known unpredictability of antihypertensive response. We cannot predict who responds to renal denervation and who does not, and who even has a paradoxical increase in BP,” Dr. Messerli, an international hypertension expert not associated with the trial, said in an interview.  

“As long as we cannot predict the antihypertensive response to renal denervation therapy, potential synergism/antagonism with drug therapy remains an educated guess,” he said.

“Hypertension is a disease that lasts years and decades. As impressive as RADIANCE II’s 2-month snapshot is, I look forward to similar or better BP data 12 and 24 months after renal denervation,” Dr. Messerli added.

RADIANCE II entered patients with mild to moderate uncontrolled HTN, that is, a systolic BP at least 140/90 mm Hg and less than 180/120 mm Hg, who were receiving no more than two antihypertensive medications. They could have no history of cardiovascular or cerebrovascular events or uncontrolled diabetes, and their estimated glomerular filtration rate (eGFR) had to be at least 40 mL/min per 1.73 m².

After a 4-week drug washout period, patients who were clinically stable with an ambulatory BP of at least 135/85 mm Hg and less than 170/105 mm Hg underwent CT and renal angiography. Then, the 224 patients still anatomically eligible for the procedure were randomly assigned 2:1 to uRDN or a sham-control procedure: 150 and 74 patients, respectively.

At 2 months, daytime ambulatory systolic BP on average fell 7.9 mm Hg in the uRDN group and 1.8 mm Hg in the sham-control group, for a drop that was steeper by 6.3 mm Hg (P < .0001) after uRDN.

Also in the uRDN group, there was a 6.2–mm Hg larger decrease in 24-hour ambulatory systolic BP (P < .0001), a 5.8–mm Hg greater decline in nighttime ambulatory systolic BP (P < .0004), a 7.6–mm Hg steeper drop in mean home systolic BP (P < .0001), and 5.4 mm Hg more of a decrease in office-based systolic BP (P = .0035).

No significant differences were seen in subgroup analyses by sex, age, higher versus lower baseline systolic pressures, high versus low baseline eGFR, degree of abdominal obesity, U.S. versus European site, or whether patients entered before or during the COVID pandemic

Regulators have been accepting change in systolic BP as a surrogate for clinical endpoints in trials of antihypertensive therapy, whether pharmacologic or interventional, under consideration for approval. “That’s why safety endpoints are important to investigate” in these clinical trials, especially for invasive therapies like renal denervation, Dr. Kirtane observed.

That said, “in the longer-term follow-ups of the renal denervation therapies that are out there, including this one, there does not appear to be an appreciable decline in glomerular filtration rate, or any adverse safety signals that we see to date,” Dr. Kirtane said in an interview. “But we know that these are low-frequency events, so we have to be very vigilant, and we can’t get complacent about it.”

In RADIANCE II, there were zero adverse events within 30 days in both groups; the endpoint included death, new myocardial infarction, renal artery complications requiring invasive intervention, and hospitalization for major cardiovascular or hemodynamic-related events. Nor were there instances of new-onset renal artery stenosis greater than 70% documented by imaging at 6 months.

The ReCor uRDN catheter uses ultrasound energy to disrupt renal nerve signaling, a technology thought to deliver safer “burns,” compared with other renal denervation catheter technologies. It features an axially stabilizing balloon that transmits ultrasound energy – two to three sonications, each lasting 7 seconds, Dr. Kirtane said – outward through the arterial wall. The design is intended to ensure consistently circumferential ablation. Circulating saline within the balloon, Kirtane noted, directly cools the adjacent vessel wall to help it avoid thermal damage.

Dr. Kirtane reported receiving institutional funding from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck; consulting for IMDS; and receiving travel and meal expenses from Medtronic, Boston Scientific, Abbott Vascular, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr. Fisher disclosed receiving honoraria or fees for consulting or serving on a speaker’s bureau for Medtronic, ReCor Medical, and Aktiia and receiving grant support or holding research contracts for Recor Medical and Aktiia. Dr. Messerli disclosed receiving honoraria from Medtronic, Menarini, Krka, and Ipca.

A version of this article first appeared on Medscape.com.

Systolic blood pressure went down safely and consistently 2 months after renal denervation achieved by ultrasound ablation in patients with uncontrolled, mild to moderate hypertension (HTN) in a key sham-controlled test of the balloon-equipped catheter.

The BP reductions were significant almost regardless of how they were measured – at home, in the office, during the day, at night, or over 24 hours – and weren’t dependent on baseline BP levels.

The 224-patient RADIANCE II Pivotal Study follows two earlier successful sham-controlled trials that used the same renal denervation catheter in other types of patients with HTN. They were RADIANCE-HTN SOLO, which entered patients with mild to moderate HTN not taking medication,  and RADIANCE-HTN TRIO, which included patients with HTN despite fixed-dose, single-pill, triple-antihypertensive therapy.

Courtesy American College of Cardiology

The consistent results of all three trials suggest that the ultrasound renal denervation (uRDN) technique “lowers blood pressure across the spectrum of hypertension,” concluded co–principal investigator Ajay J. Kirtane, MD, SM, Columbia University Irving Medical Center, New York–Presbyterian Hospital, when presenting RADIANCE II at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

RADIANCE II, the largest of the three studies, met its prespecified primary efficacy endpoint of change in daytime ambulatory systolic BP at 2 months by showing a significant 6.3–mm Hg greater reduction in the uRDN group, compared with the sham-control group. There were no major adverse events at 30 days in either group.

The trial was similarly successful for the secondary endpoints of change in systolic BP measured in various other settings, including over 24 hours. Reductions after uRDN averaged 5-7 mm Hg greater than in the control group.

Sparse top-line results of the RADIANCE II pivotal trial were announced in July by the study’s sponsor, ReCor Medical.

Dr. Kirtane stressed in an interview that uRDN and likely any form of HTN renal denervation therapy is not a substitute for standard management. “This is really for patients in whom you’ve made best efforts to do the traditional things – lifestyle modification, medications, all of that – and yet they’re still uncontrolled.” At that point, assuming denervation therapy is available in practice, “it would be something to potentially consider.”

As a panelist after Dr. Kirtane’s formal presentation of RADIANCE II at the conference, Naomi D. Fisher, MD, who was a RADIANCE-HTN TRIO investigator, described how the treatment’s perceived intended patient population evolved over time.

“We all began with the idea that we were going to treat patients with resistant hypertension, that was going to be the first target. We have learned that those patients are far fewer than we thought,” said Dr. Fisher, who directs the hypertension service at Brigham and Women’s Hospital, Boston.

Initial estimates were that such patients with the resistant form, “meaning they require more than three drugs to control their blood pressure,” would represent 15%-20% of patients with HTN.

“We learned from our TRIO data that if you give these patients one single combined pill, lo and behold, many of them become controlled,” she said. “There is so much nonadherence out there in the world, about 50% of our patients aren’t taking their pills. It’s a hard and true fact.”

Exclude patients who aren’t adherent and “our true resistance population becomes minuscule. So, I don’t think that’s going to be the main population” for renal denervation therapy.

More likely, she said, it would be “patients who are uncontrolled and unable to take their medications. So that is going to include nonadherence, intolerance. It’s a very large category of patients. And the priorities can be stacked in favor of those who have higher cardiovascular risk.”

RADIANCE II can show the persistence of uRDN’s BP-lowering effect only out to 2 months so far, but the effect’s durability based on the RADIANCE program’s combined experience appears to be at least 2 years, Dr. Kirtane said in an interview.

“The RADIANCE II pivotal trial is a powerful, well-designed study attesting to the efficacy of renal denervation in BP lowering,” Franz H. Messerli, MD, Swiss Cardiovascular Center, University Hospital Bern, said in an interview.

The trial “shows the well-known unpredictability of antihypertensive response. We cannot predict who responds to renal denervation and who does not, and who even has a paradoxical increase in BP,” Dr. Messerli, an international hypertension expert not associated with the trial, said in an interview.  

“As long as we cannot predict the antihypertensive response to renal denervation therapy, potential synergism/antagonism with drug therapy remains an educated guess,” he said.

“Hypertension is a disease that lasts years and decades. As impressive as RADIANCE II’s 2-month snapshot is, I look forward to similar or better BP data 12 and 24 months after renal denervation,” Dr. Messerli added.

RADIANCE II entered patients with mild to moderate uncontrolled HTN, that is, a systolic BP at least 140/90 mm Hg and less than 180/120 mm Hg, who were receiving no more than two antihypertensive medications. They could have no history of cardiovascular or cerebrovascular events or uncontrolled diabetes, and their estimated glomerular filtration rate (eGFR) had to be at least 40 mL/min per 1.73 m².

After a 4-week drug washout period, patients who were clinically stable with an ambulatory BP of at least 135/85 mm Hg and less than 170/105 mm Hg underwent CT and renal angiography. Then, the 224 patients still anatomically eligible for the procedure were randomly assigned 2:1 to uRDN or a sham-control procedure: 150 and 74 patients, respectively.

At 2 months, daytime ambulatory systolic BP on average fell 7.9 mm Hg in the uRDN group and 1.8 mm Hg in the sham-control group, for a drop that was steeper by 6.3 mm Hg (P < .0001) after uRDN.

Also in the uRDN group, there was a 6.2–mm Hg larger decrease in 24-hour ambulatory systolic BP (P < .0001), a 5.8–mm Hg greater decline in nighttime ambulatory systolic BP (P < .0004), a 7.6–mm Hg steeper drop in mean home systolic BP (P < .0001), and 5.4 mm Hg more of a decrease in office-based systolic BP (P = .0035).

No significant differences were seen in subgroup analyses by sex, age, higher versus lower baseline systolic pressures, high versus low baseline eGFR, degree of abdominal obesity, U.S. versus European site, or whether patients entered before or during the COVID pandemic

Regulators have been accepting change in systolic BP as a surrogate for clinical endpoints in trials of antihypertensive therapy, whether pharmacologic or interventional, under consideration for approval. “That’s why safety endpoints are important to investigate” in these clinical trials, especially for invasive therapies like renal denervation, Dr. Kirtane observed.

That said, “in the longer-term follow-ups of the renal denervation therapies that are out there, including this one, there does not appear to be an appreciable decline in glomerular filtration rate, or any adverse safety signals that we see to date,” Dr. Kirtane said in an interview. “But we know that these are low-frequency events, so we have to be very vigilant, and we can’t get complacent about it.”

In RADIANCE II, there were zero adverse events within 30 days in both groups; the endpoint included death, new myocardial infarction, renal artery complications requiring invasive intervention, and hospitalization for major cardiovascular or hemodynamic-related events. Nor were there instances of new-onset renal artery stenosis greater than 70% documented by imaging at 6 months.

The ReCor uRDN catheter uses ultrasound energy to disrupt renal nerve signaling, a technology thought to deliver safer “burns,” compared with other renal denervation catheter technologies. It features an axially stabilizing balloon that transmits ultrasound energy – two to three sonications, each lasting 7 seconds, Dr. Kirtane said – outward through the arterial wall. The design is intended to ensure consistently circumferential ablation. Circulating saline within the balloon, Kirtane noted, directly cools the adjacent vessel wall to help it avoid thermal damage.

Dr. Kirtane reported receiving institutional funding from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck; consulting for IMDS; and receiving travel and meal expenses from Medtronic, Boston Scientific, Abbott Vascular, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr. Fisher disclosed receiving honoraria or fees for consulting or serving on a speaker’s bureau for Medtronic, ReCor Medical, and Aktiia and receiving grant support or holding research contracts for Recor Medical and Aktiia. Dr. Messerli disclosed receiving honoraria from Medtronic, Menarini, Krka, and Ipca.

A version of this article first appeared on Medscape.com.

European royal families may be enormously rich, but being a blueblood doesn’t always mean your blood is pristine. Queen Victoria’s DNA is famously believed to have silently bequeathed hemophilia to many of her descendants, including a great-grandson whose severe illness played a tragic role in spurring the Russian Revolution.

And that’s not all. Some have suspected that the British royal family DNA harbors porphyria, another genetic blood disease.

There’s plenty of skepticism about this theory, which seeks to explain the “madness” of King George III. But one thing is clear. If porphyria does indeed haunt the imperial bloodline that stretches to a new generation – the late Queen Elizabeth II’s great-grandchildren – any royal who’s afflicted going forward is likely to benefit mightily from modern treatment. While this disease may require lifelong vigilance, experts said in interviews that porphyria can often be controlled.

“If patients know they have the diagnosis, and they do the right things and avoid alcohol and risky drugs, most people will have few acute attacks,” said gastroenterologist Herbert Lloyd Bonkovsky, MD, of Wake Forest University, Winston-Salem, N.C., a leading porphyria specialist.

Heme infusions can also be helpful, he added, and the revolutionary new drug givosiran is available for those who suffer recurrent attacks. And “if all else fails, a successful liver transplant is curative” – as long as the transplanted liver doesn’t have porphyria, as happened in at least one case.

But, Dr. Bonkovsky cautioned, the diagnosis is often missed, in some cases for 15 years or more.

Diagnosing porphyria: Awareness and tests are crucial

Porphyria is caused when porphyins – essential components of hemoglobin – build up in the body, disrupting systems such as the nerves, skin, and gut. The urine can turn purplish, hence the condition’s name. (Porphyrus is the Greek word for purple.)

According to hematologist Danielle Nance, MD, of Banner MD Anderson Cancer Center in Gilbert, Ariz., acute intermittent porphyria “should be suspected in persons who have recurrent severe attacks of abdominal pain requiring strong pain medication to control symptoms, and there is no obvious physical cause.”

In such cases, practitioners should send out blood and urine for porphobilinogen (PBG) and delta-aminolevulinic acid (dALA or Delta-ALA) testing, Dr. Nance said. “These are almost always elevated, even between attacks, in persons with diagnoses of acute intermittent porphyria. Other types of porphyria, such as erythropoietic porphyria, may require additional testing. Genetic testing should be offered when a patient is suspected of having porphyria, as this can speed the diagnosis.”

The typical patient is a woman from age 18 to 55, often a young woman with recurrent abdominal pain that may occur during the second half of the menstrual cycle, Wake Forest’s Dr. Bonkovsky said. Constipation is common.

“She keeps coming to the clinic or emergency department, and no one knows what’s going on. Eventually, she tends to undergo an appendectomy, often a cholecystectomy, or sometimes gynecologic procedures without cure of the disease. Only after this long and arduous road of misdiagnosis does someone think it’s porphyria and do the correct tests.”

Dr. Bonkovsky led a 2014 study of 108 subjects (81% female) with acute porphyrias and found that the average time to a correct diagnosis was a whopping 15 years. Pain in the abdomen was the most common symptom (74%), followed by nausea/vomiting (73%), weakness (63%), and constipation (60%).

While underdiagnosis is common, porphyrias can also be overdiagnosed. According to Dr. Bonkovsky, a mild increase in urinary porphyrins is often misdiagnosed as porphyria when it may be a sign of liver disease or alcohol use, instead.

Hematologist Kleber Y. Fertrin, MD, PhD, of the University of Washington, Seattle, emphasized the importance of ordering the correct tests. “Urinary porphyrins are often inappropriately ordered because of their name. They are not diagnostic for acute hepatic porphyrias and may be nonspecifically elevated. It is paramount to get the labs from a reliable lab test experienced at performing diagnostic testing for porphyrias and make sure the urine sample needed is correctly obtained and preserved.”

New drug can control attacks, but it’s costly

Treatment should begin right away if porphyria is suspected, without waiting for confirmation, Dr. Nance said. “There are porphyria experts in the U.S. and in many other countries who can help practitioners interpret symptoms and testing results if there is uncertainty or if treatment options are unclear.”

Patients are counseled to avoid attack triggers and eat healthy diets, she said. “Persons with porphyria are encouraged to have a plan for home management of an attack and when to come to the hospital for symptoms that don’t respond to home therapy,” she said.

Dr. Fertrin said “the typical treatment for an acute porphyric attack is the use of intravenous glucose, as well as intravenous hemin infusions, along with pain medications and fluids as needed. Some patients may need medication for high blood pressure. For patients with recurrent attacks, prophylactic doses of hemin can be used.”

Another option is givosiran (Givlaari), the biggest recent advance in porphyria treatment. It was approved by the Food and Drug Administration for acute hepatic porphyria in 2019. “It’s an inhibitory mRNA that shuts down heme synthesis by downregulating aminolevulinic acid synthase,” said hematologist Thomas DeLoughery, MD, of Oregon Health & Science University, Portland.

A 2020 study coauthored by Dr. Bonkovsky found that the drug reduced the mean annualized attack rate in acute intermittent porphyria by 74%, compared with placebo (P < .001). “Givosiran led to lower levels of urinary ALA and porphobilinogen, fewer days of hemin use, and better daily scores for pain than placebo,” the study authors write. “Key adverse events that were observed more frequently in the givosiran group were elevations in serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions.”

Dr. Bonkovsky said the drug is appropriate in patients whose disease is not controlled by lifestyle interventions regarding alcohol, smoking, and substance use. However, while givosiran is helpful, “it’s not a cure,” he said. “Probably about 40% of patients have found the side effects such as nausea, fatigue, headaches, and liver injury to be too adverse and have not decided to take it in the long term.”

In addition, the drug costs about $500,000 a year, and insurers may balk at the expense. Still, specialists say it can be a good option. “Before givosiran, the standard therapy was hematin, which decreased the activity of the ALA synthase,” Dr. DeLoughery said. “This is a nasty drug that can inflame the blood vessels and is not all that effective.”

The royal family may be able to breathe easy

There are other forms of porphyria besides the acute type. Cutaneous porphryias can cause blistering from sunlight exposure, and treatment is avoidance of such triggers, Dr. Fertin said. “For a rare form called erythropoietic protoporphyria, there is a subcutaneous implant with a medication called afamelanotide that increases tolerance to sunlight.”

There’s another type: variegate porphyria, which UpToDate says is “characterized by cutaneous blistering and/or acute neurovisceral attacks.” In 1966, a mother-and-son psychiatrist team theorized that Britain’s King George III suffered from this type of porphyria.

However, researchers have sharply criticized the porphyria theory with regard to that king, and a recent theory now suggests that he actually had bipolar disorder. Dr. Fertin is among the skeptics, noting the high prevalence of porphyria in affected families.

“Since King George III would now have a living number of relatives of about 900 people, we would expect around 180 cases of variegate porphyria to be connected to him, and those are nowhere to be found,” he said. “The idea that it could cause progressive psychosis and dementia is also a misconception. We do not find that porphyria is the underlying cause of psychiatric conditions on their own. Many atypical symptoms of the king were attributed to variegate porphyria, and the few more typical symptoms he reportedly had, of abdominal pain and urine discoloration, can be more easily explained by common diseases, such as kidney stones or gallstones. Finally, attempts at obtaining genetic or biochemical evidence of porphyria from relatives of King George III have been negative or inconclusive.”

That’s good news for the royals, who have many other concerns these days.

Dr. Nance discloses research study funding from Alnylam (maker of Givlaari) and payments to participate in educational activities for patients and practitioners. Dr. Bonkovsky discloses relationships with drugmakers who have developed products to treat porphyria including Alnylam, Mitsubishi Tanabe, Recordati, and Disc. Dr. Fertin is subinvestigator in a clinical trial for a novel treatment for erythropoietic protoporphyria sponsored by Mitsubishi Tanabe. Dr. DeLoughery reports no disclosures.

European royal families may be enormously rich, but being a blueblood doesn’t always mean your blood is pristine. Queen Victoria’s DNA is famously believed to have silently bequeathed hemophilia to many of her descendants, including a great-grandson whose severe illness played a tragic role in spurring the Russian Revolution.

And that’s not all. Some have suspected that the British royal family DNA harbors porphyria, another genetic blood disease.

There’s plenty of skepticism about this theory, which seeks to explain the “madness” of King George III. But one thing is clear. If porphyria does indeed haunt the imperial bloodline that stretches to a new generation – the late Queen Elizabeth II’s great-grandchildren – any royal who’s afflicted going forward is likely to benefit mightily from modern treatment. While this disease may require lifelong vigilance, experts said in interviews that porphyria can often be controlled.

“If patients know they have the diagnosis, and they do the right things and avoid alcohol and risky drugs, most people will have few acute attacks,” said gastroenterologist Herbert Lloyd Bonkovsky, MD, of Wake Forest University, Winston-Salem, N.C., a leading porphyria specialist.

Heme infusions can also be helpful, he added, and the revolutionary new drug givosiran is available for those who suffer recurrent attacks. And “if all else fails, a successful liver transplant is curative” – as long as the transplanted liver doesn’t have porphyria, as happened in at least one case.

But, Dr. Bonkovsky cautioned, the diagnosis is often missed, in some cases for 15 years or more.

Diagnosing porphyria: Awareness and tests are crucial

Porphyria is caused when porphyins – essential components of hemoglobin – build up in the body, disrupting systems such as the nerves, skin, and gut. The urine can turn purplish, hence the condition’s name. (Porphyrus is the Greek word for purple.)

According to hematologist Danielle Nance, MD, of Banner MD Anderson Cancer Center in Gilbert, Ariz., acute intermittent porphyria “should be suspected in persons who have recurrent severe attacks of abdominal pain requiring strong pain medication to control symptoms, and there is no obvious physical cause.”

In such cases, practitioners should send out blood and urine for porphobilinogen (PBG) and delta-aminolevulinic acid (dALA or Delta-ALA) testing, Dr. Nance said. “These are almost always elevated, even between attacks, in persons with diagnoses of acute intermittent porphyria. Other types of porphyria, such as erythropoietic porphyria, may require additional testing. Genetic testing should be offered when a patient is suspected of having porphyria, as this can speed the diagnosis.”

The typical patient is a woman from age 18 to 55, often a young woman with recurrent abdominal pain that may occur during the second half of the menstrual cycle, Wake Forest’s Dr. Bonkovsky said. Constipation is common.

“She keeps coming to the clinic or emergency department, and no one knows what’s going on. Eventually, she tends to undergo an appendectomy, often a cholecystectomy, or sometimes gynecologic procedures without cure of the disease. Only after this long and arduous road of misdiagnosis does someone think it’s porphyria and do the correct tests.”

Dr. Bonkovsky led a 2014 study of 108 subjects (81% female) with acute porphyrias and found that the average time to a correct diagnosis was a whopping 15 years. Pain in the abdomen was the most common symptom (74%), followed by nausea/vomiting (73%), weakness (63%), and constipation (60%).

While underdiagnosis is common, porphyrias can also be overdiagnosed. According to Dr. Bonkovsky, a mild increase in urinary porphyrins is often misdiagnosed as porphyria when it may be a sign of liver disease or alcohol use, instead.

Hematologist Kleber Y. Fertrin, MD, PhD, of the University of Washington, Seattle, emphasized the importance of ordering the correct tests. “Urinary porphyrins are often inappropriately ordered because of their name. They are not diagnostic for acute hepatic porphyrias and may be nonspecifically elevated. It is paramount to get the labs from a reliable lab test experienced at performing diagnostic testing for porphyrias and make sure the urine sample needed is correctly obtained and preserved.”

New drug can control attacks, but it’s costly

Treatment should begin right away if porphyria is suspected, without waiting for confirmation, Dr. Nance said. “There are porphyria experts in the U.S. and in many other countries who can help practitioners interpret symptoms and testing results if there is uncertainty or if treatment options are unclear.”

Patients are counseled to avoid attack triggers and eat healthy diets, she said. “Persons with porphyria are encouraged to have a plan for home management of an attack and when to come to the hospital for symptoms that don’t respond to home therapy,” she said.

Dr. Fertrin said “the typical treatment for an acute porphyric attack is the use of intravenous glucose, as well as intravenous hemin infusions, along with pain medications and fluids as needed. Some patients may need medication for high blood pressure. For patients with recurrent attacks, prophylactic doses of hemin can be used.”

Another option is givosiran (Givlaari), the biggest recent advance in porphyria treatment. It was approved by the Food and Drug Administration for acute hepatic porphyria in 2019. “It’s an inhibitory mRNA that shuts down heme synthesis by downregulating aminolevulinic acid synthase,” said hematologist Thomas DeLoughery, MD, of Oregon Health & Science University, Portland.

A 2020 study coauthored by Dr. Bonkovsky found that the drug reduced the mean annualized attack rate in acute intermittent porphyria by 74%, compared with placebo (P < .001). “Givosiran led to lower levels of urinary ALA and porphobilinogen, fewer days of hemin use, and better daily scores for pain than placebo,” the study authors write. “Key adverse events that were observed more frequently in the givosiran group were elevations in serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions.”

Dr. Bonkovsky said the drug is appropriate in patients whose disease is not controlled by lifestyle interventions regarding alcohol, smoking, and substance use. However, while givosiran is helpful, “it’s not a cure,” he said. “Probably about 40% of patients have found the side effects such as nausea, fatigue, headaches, and liver injury to be too adverse and have not decided to take it in the long term.”

In addition, the drug costs about $500,000 a year, and insurers may balk at the expense. Still, specialists say it can be a good option. “Before givosiran, the standard therapy was hematin, which decreased the activity of the ALA synthase,” Dr. DeLoughery said. “This is a nasty drug that can inflame the blood vessels and is not all that effective.”

The royal family may be able to breathe easy

There are other forms of porphyria besides the acute type. Cutaneous porphryias can cause blistering from sunlight exposure, and treatment is avoidance of such triggers, Dr. Fertin said. “For a rare form called erythropoietic protoporphyria, there is a subcutaneous implant with a medication called afamelanotide that increases tolerance to sunlight.”

There’s another type: variegate porphyria, which UpToDate says is “characterized by cutaneous blistering and/or acute neurovisceral attacks.” In 1966, a mother-and-son psychiatrist team theorized that Britain’s King George III suffered from this type of porphyria.

However, researchers have sharply criticized the porphyria theory with regard to that king, and a recent theory now suggests that he actually had bipolar disorder. Dr. Fertin is among the skeptics, noting the high prevalence of porphyria in affected families.

“Since King George III would now have a living number of relatives of about 900 people, we would expect around 180 cases of variegate porphyria to be connected to him, and those are nowhere to be found,” he said. “The idea that it could cause progressive psychosis and dementia is also a misconception. We do not find that porphyria is the underlying cause of psychiatric conditions on their own. Many atypical symptoms of the king were attributed to variegate porphyria, and the few more typical symptoms he reportedly had, of abdominal pain and urine discoloration, can be more easily explained by common diseases, such as kidney stones or gallstones. Finally, attempts at obtaining genetic or biochemical evidence of porphyria from relatives of King George III have been negative or inconclusive.”

That’s good news for the royals, who have many other concerns these days.

Dr. Nance discloses research study funding from Alnylam (maker of Givlaari) and payments to participate in educational activities for patients and practitioners. Dr. Bonkovsky discloses relationships with drugmakers who have developed products to treat porphyria including Alnylam, Mitsubishi Tanabe, Recordati, and Disc. Dr. Fertin is subinvestigator in a clinical trial for a novel treatment for erythropoietic protoporphyria sponsored by Mitsubishi Tanabe. Dr. DeLoughery reports no disclosures.

European royal families may be enormously rich, but being a blueblood doesn’t always mean your blood is pristine. Queen Victoria’s DNA is famously believed to have silently bequeathed hemophilia to many of her descendants, including a great-grandson whose severe illness played a tragic role in spurring the Russian Revolution.

And that’s not all. Some have suspected that the British royal family DNA harbors porphyria, another genetic blood disease.

There’s plenty of skepticism about this theory, which seeks to explain the “madness” of King George III. But one thing is clear. If porphyria does indeed haunt the imperial bloodline that stretches to a new generation – the late Queen Elizabeth II’s great-grandchildren – any royal who’s afflicted going forward is likely to benefit mightily from modern treatment. While this disease may require lifelong vigilance, experts said in interviews that porphyria can often be controlled.

“If patients know they have the diagnosis, and they do the right things and avoid alcohol and risky drugs, most people will have few acute attacks,” said gastroenterologist Herbert Lloyd Bonkovsky, MD, of Wake Forest University, Winston-Salem, N.C., a leading porphyria specialist.

Heme infusions can also be helpful, he added, and the revolutionary new drug givosiran is available for those who suffer recurrent attacks. And “if all else fails, a successful liver transplant is curative” – as long as the transplanted liver doesn’t have porphyria, as happened in at least one case.

But, Dr. Bonkovsky cautioned, the diagnosis is often missed, in some cases for 15 years or more.

Diagnosing porphyria: Awareness and tests are crucial

Porphyria is caused when porphyins – essential components of hemoglobin – build up in the body, disrupting systems such as the nerves, skin, and gut. The urine can turn purplish, hence the condition’s name. (Porphyrus is the Greek word for purple.)

According to hematologist Danielle Nance, MD, of Banner MD Anderson Cancer Center in Gilbert, Ariz., acute intermittent porphyria “should be suspected in persons who have recurrent severe attacks of abdominal pain requiring strong pain medication to control symptoms, and there is no obvious physical cause.”

In such cases, practitioners should send out blood and urine for porphobilinogen (PBG) and delta-aminolevulinic acid (dALA or Delta-ALA) testing, Dr. Nance said. “These are almost always elevated, even between attacks, in persons with diagnoses of acute intermittent porphyria. Other types of porphyria, such as erythropoietic porphyria, may require additional testing. Genetic testing should be offered when a patient is suspected of having porphyria, as this can speed the diagnosis.”

The typical patient is a woman from age 18 to 55, often a young woman with recurrent abdominal pain that may occur during the second half of the menstrual cycle, Wake Forest’s Dr. Bonkovsky said. Constipation is common.

“She keeps coming to the clinic or emergency department, and no one knows what’s going on. Eventually, she tends to undergo an appendectomy, often a cholecystectomy, or sometimes gynecologic procedures without cure of the disease. Only after this long and arduous road of misdiagnosis does someone think it’s porphyria and do the correct tests.”

Dr. Bonkovsky led a 2014 study of 108 subjects (81% female) with acute porphyrias and found that the average time to a correct diagnosis was a whopping 15 years. Pain in the abdomen was the most common symptom (74%), followed by nausea/vomiting (73%), weakness (63%), and constipation (60%).

While underdiagnosis is common, porphyrias can also be overdiagnosed. According to Dr. Bonkovsky, a mild increase in urinary porphyrins is often misdiagnosed as porphyria when it may be a sign of liver disease or alcohol use, instead.

Hematologist Kleber Y. Fertrin, MD, PhD, of the University of Washington, Seattle, emphasized the importance of ordering the correct tests. “Urinary porphyrins are often inappropriately ordered because of their name. They are not diagnostic for acute hepatic porphyrias and may be nonspecifically elevated. It is paramount to get the labs from a reliable lab test experienced at performing diagnostic testing for porphyrias and make sure the urine sample needed is correctly obtained and preserved.”

New drug can control attacks, but it’s costly

Treatment should begin right away if porphyria is suspected, without waiting for confirmation, Dr. Nance said. “There are porphyria experts in the U.S. and in many other countries who can help practitioners interpret symptoms and testing results if there is uncertainty or if treatment options are unclear.”

Patients are counseled to avoid attack triggers and eat healthy diets, she said. “Persons with porphyria are encouraged to have a plan for home management of an attack and when to come to the hospital for symptoms that don’t respond to home therapy,” she said.

Dr. Fertrin said “the typical treatment for an acute porphyric attack is the use of intravenous glucose, as well as intravenous hemin infusions, along with pain medications and fluids as needed. Some patients may need medication for high blood pressure. For patients with recurrent attacks, prophylactic doses of hemin can be used.”

Another option is givosiran (Givlaari), the biggest recent advance in porphyria treatment. It was approved by the Food and Drug Administration for acute hepatic porphyria in 2019. “It’s an inhibitory mRNA that shuts down heme synthesis by downregulating aminolevulinic acid synthase,” said hematologist Thomas DeLoughery, MD, of Oregon Health & Science University, Portland.

A 2020 study coauthored by Dr. Bonkovsky found that the drug reduced the mean annualized attack rate in acute intermittent porphyria by 74%, compared with placebo (P < .001). “Givosiran led to lower levels of urinary ALA and porphobilinogen, fewer days of hemin use, and better daily scores for pain than placebo,” the study authors write. “Key adverse events that were observed more frequently in the givosiran group were elevations in serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions.”

Dr. Bonkovsky said the drug is appropriate in patients whose disease is not controlled by lifestyle interventions regarding alcohol, smoking, and substance use. However, while givosiran is helpful, “it’s not a cure,” he said. “Probably about 40% of patients have found the side effects such as nausea, fatigue, headaches, and liver injury to be too adverse and have not decided to take it in the long term.”

In addition, the drug costs about $500,000 a year, and insurers may balk at the expense. Still, specialists say it can be a good option. “Before givosiran, the standard therapy was hematin, which decreased the activity of the ALA synthase,” Dr. DeLoughery said. “This is a nasty drug that can inflame the blood vessels and is not all that effective.”

The royal family may be able to breathe easy

There are other forms of porphyria besides the acute type. Cutaneous porphryias can cause blistering from sunlight exposure, and treatment is avoidance of such triggers, Dr. Fertin said. “For a rare form called erythropoietic protoporphyria, there is a subcutaneous implant with a medication called afamelanotide that increases tolerance to sunlight.”

There’s another type: variegate porphyria, which UpToDate says is “characterized by cutaneous blistering and/or acute neurovisceral attacks.” In 1966, a mother-and-son psychiatrist team theorized that Britain’s King George III suffered from this type of porphyria.

However, researchers have sharply criticized the porphyria theory with regard to that king, and a recent theory now suggests that he actually had bipolar disorder. Dr. Fertin is among the skeptics, noting the high prevalence of porphyria in affected families.

“Since King George III would now have a living number of relatives of about 900 people, we would expect around 180 cases of variegate porphyria to be connected to him, and those are nowhere to be found,” he said. “The idea that it could cause progressive psychosis and dementia is also a misconception. We do not find that porphyria is the underlying cause of psychiatric conditions on their own. Many atypical symptoms of the king were attributed to variegate porphyria, and the few more typical symptoms he reportedly had, of abdominal pain and urine discoloration, can be more easily explained by common diseases, such as kidney stones or gallstones. Finally, attempts at obtaining genetic or biochemical evidence of porphyria from relatives of King George III have been negative or inconclusive.”

That’s good news for the royals, who have many other concerns these days.

Dr. Nance discloses research study funding from Alnylam (maker of Givlaari) and payments to participate in educational activities for patients and practitioners. Dr. Bonkovsky discloses relationships with drugmakers who have developed products to treat porphyria including Alnylam, Mitsubishi Tanabe, Recordati, and Disc. Dr. Fertin is subinvestigator in a clinical trial for a novel treatment for erythropoietic protoporphyria sponsored by Mitsubishi Tanabe. Dr. DeLoughery reports no disclosures.

He’s 24 years younger than I am, recently married, no kids. Just starting out as a neurologist. He also has a full head of hair, something I’m admittedly jealous of.

He’s always in a sweater, something that seems oddly out of place in Phoenix, Arizona.

He’s the picture on my hospital ID.

I don’t go to the hospital much anymore, but he still sits in my car, greeting me whenever I open the center console to get my sunglasses or phone charger. He looks very enthusiastic about starting his career. I clearly remember the day I had the picture taken, as a newly-minted attending getting his first hospital privileges.

Sometimes I talk to him. Usually it’s just silly advice (“bet on the ’16 Cubs”). Other times I wonder what he’d do in certain situations, with all his youthful enthusiasm. I’m sure he wonders the same about me, with my 24 years of experience.

To a large extent we are the same people we started out as, but time changes us, in ways besides the obvious (like my hairs jumping off like lemmings). We learn from experience, both good and bad.

Looking back at him (or even the older pic on my medical school application) I have no complaints about where life and my career have taken me. Would there be a few things I might have changed if I could go back?

Realistically, maybe one or two, both involving my father, but neither of them would likely change where I am.

But as far as medicine goes? Not really. The things I liked then, that got me into the field? I still enjoy them. The horse hockey? Yeah, it’s always there, probably has gotten worse over time, and it still bothers me. But there isn’t a job that doesn’t have its share of cow patties. It’s just a matter of trying not to step in them more than necessary as you do the parts you enjoy.

Sometimes I look at my younger self, and wonder what I’d really say to him if we actually met.

Probably just “good luck, enjoy the ride, and ditch the sweater.”
 

We measure our gains out in luck and coincidence

Lanterns to turn back the night.

And put our defeats down to chance or experience

And try once again for the light.

– Al Stewart

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

He’s 24 years younger than I am, recently married, no kids. Just starting out as a neurologist. He also has a full head of hair, something I’m admittedly jealous of.

He’s always in a sweater, something that seems oddly out of place in Phoenix, Arizona.

He’s the picture on my hospital ID.

I don’t go to the hospital much anymore, but he still sits in my car, greeting me whenever I open the center console to get my sunglasses or phone charger. He looks very enthusiastic about starting his career. I clearly remember the day I had the picture taken, as a newly-minted attending getting his first hospital privileges.

Sometimes I talk to him. Usually it’s just silly advice (“bet on the ’16 Cubs”). Other times I wonder what he’d do in certain situations, with all his youthful enthusiasm. I’m sure he wonders the same about me, with my 24 years of experience.

To a large extent we are the same people we started out as, but time changes us, in ways besides the obvious (like my hairs jumping off like lemmings). We learn from experience, both good and bad.

Looking back at him (or even the older pic on my medical school application) I have no complaints about where life and my career have taken me. Would there be a few things I might have changed if I could go back?

Realistically, maybe one or two, both involving my father, but neither of them would likely change where I am.

But as far as medicine goes? Not really. The things I liked then, that got me into the field? I still enjoy them. The horse hockey? Yeah, it’s always there, probably has gotten worse over time, and it still bothers me. But there isn’t a job that doesn’t have its share of cow patties. It’s just a matter of trying not to step in them more than necessary as you do the parts you enjoy.

Sometimes I look at my younger self, and wonder what I’d really say to him if we actually met.

Probably just “good luck, enjoy the ride, and ditch the sweater.”
 

We measure our gains out in luck and coincidence

Lanterns to turn back the night.

And put our defeats down to chance or experience

And try once again for the light.

– Al Stewart

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

He’s 24 years younger than I am, recently married, no kids. Just starting out as a neurologist. He also has a full head of hair, something I’m admittedly jealous of.

He’s always in a sweater, something that seems oddly out of place in Phoenix, Arizona.

He’s the picture on my hospital ID.

I don’t go to the hospital much anymore, but he still sits in my car, greeting me whenever I open the center console to get my sunglasses or phone charger. He looks very enthusiastic about starting his career. I clearly remember the day I had the picture taken, as a newly-minted attending getting his first hospital privileges.

Sometimes I talk to him. Usually it’s just silly advice (“bet on the ’16 Cubs”). Other times I wonder what he’d do in certain situations, with all his youthful enthusiasm. I’m sure he wonders the same about me, with my 24 years of experience.

To a large extent we are the same people we started out as, but time changes us, in ways besides the obvious (like my hairs jumping off like lemmings). We learn from experience, both good and bad.

Looking back at him (or even the older pic on my medical school application) I have no complaints about where life and my career have taken me. Would there be a few things I might have changed if I could go back?

Realistically, maybe one or two, both involving my father, but neither of them would likely change where I am.

But as far as medicine goes? Not really. The things I liked then, that got me into the field? I still enjoy them. The horse hockey? Yeah, it’s always there, probably has gotten worse over time, and it still bothers me. But there isn’t a job that doesn’t have its share of cow patties. It’s just a matter of trying not to step in them more than necessary as you do the parts you enjoy.

Sometimes I look at my younger self, and wonder what I’d really say to him if we actually met.

Probably just “good luck, enjoy the ride, and ditch the sweater.”
 

We measure our gains out in luck and coincidence

Lanterns to turn back the night.

And put our defeats down to chance or experience

And try once again for the light.

– Al Stewart

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

More than two dozen patient advocacy organizations have raised alarms about a recent court ruling that could threaten patient access to no-cost preventive screenings, including cancer screenings.

In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”

The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).

Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.

The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.

But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.

After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.

In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.

Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”

In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.

“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.

For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.

“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”

A version of this article first appeared on Medscape.com.

More than two dozen patient advocacy organizations have raised alarms about a recent court ruling that could threaten patient access to no-cost preventive screenings, including cancer screenings.

In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”

The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).

Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.

The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.

But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.

After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.

In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.

Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”

In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.

“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.

For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.

“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”

A version of this article first appeared on Medscape.com.

More than two dozen patient advocacy organizations have raised alarms about a recent court ruling that could threaten patient access to no-cost preventive screenings, including cancer screenings.

In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”

The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).

Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.

The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.

But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.

After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.

In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.

Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”

In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.

“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.

For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.

“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”

A version of this article first appeared on Medscape.com.