How much patient autonomy is too much – especially when you or a family member is the patient? In this episode of the Psychcast, Dr. Lorenzo Norris sits down with Dr. Jeffrey Strawn, director of the Anxiety Disorders Research Program at the University of Cincinnati College of Medicine. They discuss the challenges of respecting patient autonomy and providing clear guidance to patients.

How much patient autonomy is too much – especially when you or a family member is the patient? In this episode of the Psychcast, Dr. Lorenzo Norris sits down with Dr. Jeffrey Strawn, director of the Anxiety Disorders Research Program at the University of Cincinnati College of Medicine. They discuss the challenges of respecting patient autonomy and providing clear guidance to patients.

How much patient autonomy is too much – especially when you or a family member is the patient? In this episode of the Psychcast, Dr. Lorenzo Norris sits down with Dr. Jeffrey Strawn, director of the Anxiety Disorders Research Program at the University of Cincinnati College of Medicine. They discuss the challenges of respecting patient autonomy and providing clear guidance to patients.

Black children aged 5 to 12 years are roughly twice as likely as white children to commit suicide, according to a study funded by the National Institute of Mental Health. But that trend reverses in adolescence: From ages 13 to 17 years, the suicide rates for white children are double those of black children.

The researchers used the CDC’s web-based Injury Statistics Query and Reporting System, analyzing data from 2001-2015 separately for each age group. The data were limited, the researchers say, and did not include information on contributing factors. They add that their findings highlight the need for a greater understanding of age-related racial disparities in youth suicide.

The disturbing findings are part of an overall rise in suicide nationwide. Suicide is the tenth leading cause of death in the US, according to the latest figures from the CDC. In 2016, nearly 45,000 Americans aged ≥ 10 years died by suicide.

In 2017, the CDC released Preventing Suicide: A Technical Package of Policy, Programs, and Practices, with evidence-based strategies (https://www.cdc.gov/media/releases/2018/p0607-suicide-prevention.html). The strategies include creating protective environments by reducing access to lethal means among at-risk individuals and intervening at “suicide hotspots” by, for example, putting barriers on tall structures. “Like most public health problems,” the guide says, “suicide is preventable.”

Black children aged 5 to 12 years are roughly twice as likely as white children to commit suicide, according to a study funded by the National Institute of Mental Health. But that trend reverses in adolescence: From ages 13 to 17 years, the suicide rates for white children are double those of black children.

The researchers used the CDC’s web-based Injury Statistics Query and Reporting System, analyzing data from 2001-2015 separately for each age group. The data were limited, the researchers say, and did not include information on contributing factors. They add that their findings highlight the need for a greater understanding of age-related racial disparities in youth suicide.

The disturbing findings are part of an overall rise in suicide nationwide. Suicide is the tenth leading cause of death in the US, according to the latest figures from the CDC. In 2016, nearly 45,000 Americans aged ≥ 10 years died by suicide.

In 2017, the CDC released Preventing Suicide: A Technical Package of Policy, Programs, and Practices, with evidence-based strategies (https://www.cdc.gov/media/releases/2018/p0607-suicide-prevention.html). The strategies include creating protective environments by reducing access to lethal means among at-risk individuals and intervening at “suicide hotspots” by, for example, putting barriers on tall structures. “Like most public health problems,” the guide says, “suicide is preventable.”

Black children aged 5 to 12 years are roughly twice as likely as white children to commit suicide, according to a study funded by the National Institute of Mental Health. But that trend reverses in adolescence: From ages 13 to 17 years, the suicide rates for white children are double those of black children.

The researchers used the CDC’s web-based Injury Statistics Query and Reporting System, analyzing data from 2001-2015 separately for each age group. The data were limited, the researchers say, and did not include information on contributing factors. They add that their findings highlight the need for a greater understanding of age-related racial disparities in youth suicide.

The disturbing findings are part of an overall rise in suicide nationwide. Suicide is the tenth leading cause of death in the US, according to the latest figures from the CDC. In 2016, nearly 45,000 Americans aged ≥ 10 years died by suicide.

In 2017, the CDC released Preventing Suicide: A Technical Package of Policy, Programs, and Practices, with evidence-based strategies (https://www.cdc.gov/media/releases/2018/p0607-suicide-prevention.html). The strategies include creating protective environments by reducing access to lethal means among at-risk individuals and intervening at “suicide hotspots” by, for example, putting barriers on tall structures. “Like most public health problems,” the guide says, “suicide is preventable.”

According to the VA, 8,744,000 veterans served in the Armed Forces in the time between the Gulf of Tonkin incident and the signing of the Paris Peace Accords.1 Of those, 3,403,000 were deployed to Southeast Asia. Those who served during this period often were exposed to unique environmental hazards, such as commonly used pesticides and herbicides, as well as diseases attributed to the tropical environment, such as fungal infections, and there were more than 40,000 reported cases of malaria. Upon returning home, these veterans faced a tough readjustment that often magnified the stress associated with combat.

Click here to continue reading.

According to the VA, 8,744,000 veterans served in the Armed Forces in the time between the Gulf of Tonkin incident and the signing of the Paris Peace Accords.1 Of those, 3,403,000 were deployed to Southeast Asia. Those who served during this period often were exposed to unique environmental hazards, such as commonly used pesticides and herbicides, as well as diseases attributed to the tropical environment, such as fungal infections, and there were more than 40,000 reported cases of malaria. Upon returning home, these veterans faced a tough readjustment that often magnified the stress associated with combat.

Click here to continue reading.

According to the VA, 8,744,000 veterans served in the Armed Forces in the time between the Gulf of Tonkin incident and the signing of the Paris Peace Accords.1 Of those, 3,403,000 were deployed to Southeast Asia. Those who served during this period often were exposed to unique environmental hazards, such as commonly used pesticides and herbicides, as well as diseases attributed to the tropical environment, such as fungal infections, and there were more than 40,000 reported cases of malaria. Upon returning home, these veterans faced a tough readjustment that often magnified the stress associated with combat.

Click here to continue reading.

Clinical question: What physician characteristics are associated with CT pulmonary angiogram (CTPA) diagnostic yield?

Background: Overuse of CTPAs for pulmonary embolism evaluation exposes patients to unnecessary testing and harmful ionizing radiation. Physician characteristics influence ordering practice. Identifying specific characteristics can provide an intervention for reducing overutilization.

Study design: Retrospective analysis.

Setting: Academic teaching hospital in Montreal, Canada.

Synopsis: Investigators reviewed 1,394 CTPAs ordered by 182 physicians at an academic teaching hospital during 2014-2016, with 199 (14.3%) positive studies and 1,195 (85.7%) negative studies. Physician years of experience, physician sex, and emergency medicine specialty were not associated with diagnostic yield. However, the diagnostic yield decreased with the total number of scans ordered per physician. For every 10 additional scans ordered, the odds of a positive test were reduced (odds ratio, 0.76; 95% confidence interval, 0.73-0.79). For physicians who ordered more than 50 studies, the percentage of positive studies was only 5%.

This study’s results show that overuse of CTPA is associated with decreased diagnostic yield. A limitation of the study was that pretest probabilities for pulmonary embolism could not be calculated because of inadequate charting, which would have determined whether CTPA was the appropriate test (as opposed to D-dimer).

Bottom line: Physicians who order higher numbers of CTPAs have lower diagnostic yields.

Citation: Chong J et al. Association of lower diagnostic yield with high users of CT pulmonary angiogram. JAMA Intern Med. 2018 Mar 1;178(3):412-3.

Dr. Komsoukaniants is a hospitalist at UC San Diego Health and an assistant clinical professor at the University of California, San Diego.

Clinical question: What physician characteristics are associated with CT pulmonary angiogram (CTPA) diagnostic yield?

Background: Overuse of CTPAs for pulmonary embolism evaluation exposes patients to unnecessary testing and harmful ionizing radiation. Physician characteristics influence ordering practice. Identifying specific characteristics can provide an intervention for reducing overutilization.

Study design: Retrospective analysis.

Setting: Academic teaching hospital in Montreal, Canada.

Synopsis: Investigators reviewed 1,394 CTPAs ordered by 182 physicians at an academic teaching hospital during 2014-2016, with 199 (14.3%) positive studies and 1,195 (85.7%) negative studies. Physician years of experience, physician sex, and emergency medicine specialty were not associated with diagnostic yield. However, the diagnostic yield decreased with the total number of scans ordered per physician. For every 10 additional scans ordered, the odds of a positive test were reduced (odds ratio, 0.76; 95% confidence interval, 0.73-0.79). For physicians who ordered more than 50 studies, the percentage of positive studies was only 5%.

This study’s results show that overuse of CTPA is associated with decreased diagnostic yield. A limitation of the study was that pretest probabilities for pulmonary embolism could not be calculated because of inadequate charting, which would have determined whether CTPA was the appropriate test (as opposed to D-dimer).

Bottom line: Physicians who order higher numbers of CTPAs have lower diagnostic yields.

Citation: Chong J et al. Association of lower diagnostic yield with high users of CT pulmonary angiogram. JAMA Intern Med. 2018 Mar 1;178(3):412-3.

Dr. Komsoukaniants is a hospitalist at UC San Diego Health and an assistant clinical professor at the University of California, San Diego.

Clinical question: What physician characteristics are associated with CT pulmonary angiogram (CTPA) diagnostic yield?

Background: Overuse of CTPAs for pulmonary embolism evaluation exposes patients to unnecessary testing and harmful ionizing radiation. Physician characteristics influence ordering practice. Identifying specific characteristics can provide an intervention for reducing overutilization.

Study design: Retrospective analysis.

Setting: Academic teaching hospital in Montreal, Canada.

Synopsis: Investigators reviewed 1,394 CTPAs ordered by 182 physicians at an academic teaching hospital during 2014-2016, with 199 (14.3%) positive studies and 1,195 (85.7%) negative studies. Physician years of experience, physician sex, and emergency medicine specialty were not associated with diagnostic yield. However, the diagnostic yield decreased with the total number of scans ordered per physician. For every 10 additional scans ordered, the odds of a positive test were reduced (odds ratio, 0.76; 95% confidence interval, 0.73-0.79). For physicians who ordered more than 50 studies, the percentage of positive studies was only 5%.

This study’s results show that overuse of CTPA is associated with decreased diagnostic yield. A limitation of the study was that pretest probabilities for pulmonary embolism could not be calculated because of inadequate charting, which would have determined whether CTPA was the appropriate test (as opposed to D-dimer).

Bottom line: Physicians who order higher numbers of CTPAs have lower diagnostic yields.

Citation: Chong J et al. Association of lower diagnostic yield with high users of CT pulmonary angiogram. JAMA Intern Med. 2018 Mar 1;178(3):412-3.

Dr. Komsoukaniants is a hospitalist at UC San Diego Health and an assistant clinical professor at the University of California, San Diego.

Public health officials are expanding efforts to get the HIV prevention pill into the hands of those at risk, in a nationwide effort to curb infections. But the officials are hitting roadblocks – the drug’s price tag, which has surged in recent years, and changes in insurance coverage that put a heftier financial burden on patients.

Since brand-name Truvada was approved for HIV prevention six years ago, its average wholesale price has increased by about 45 percent. Now, the drug – which rakes in billions of dollars in annual global revenue for its manufacturer, Gilead Sciences – carries a list price of close to $2,000 for a 30-day supply.

Most insurers cover the pill, also known as pre-exposure prophylaxis, or PrEP. It has been shown to be more than 90 percent effective in HIV prevention when taken daily.

But patients can get stuck with out-of-pocket costs that make it unaffordable.

“If there is any example of the dysfunction in the American pharmaceutical system, it is this case,” said James Krellenstein, a member of the AIDS advocacy group ACT UP New York. “We have the most effective tool for ending the HIV epidemic, and one reason we’re unable to scale up is because it costs so [much] unnecessarily.”

As policymakers and the health system debate how to control ever-climbing drug prices, experts say this case underscores how patients are left holding the bag.

Private health plans are making patients responsible for a larger share of drug costs. And more are restricting use of the “copay coupons” pharmaceutical companies have used to shield patients from out-of-pocket expenses. Insurers say the drug companies use coupons to steer consumers toward pricier meds. One way health plans are limiting their use is by no longer allowing them to count toward patients’ deductibles.

“This is one more thing that is going to push people off their medications,” said Jim Pickett, a senior director at the AIDS Foundation of Chicago.

Jared Wile, who lives in Chicago, started taking PrEP about three years ago, when he was dating someone with HIV. Wile, who has a $2,750 deductible, used a coupon to obtain the drug. He never paid anything out-of-pocket, he said.

Gilead waives up to $4,800 in out-of-pocket expenses for commercially insured patients.

That changed for Wile this past May, when Wile learned the coupon no longer counted toward his deductible and that he would have to pay the full cost of the prescription – $1,600 per month – until he hit his deductible. Wile said he felt “blindsided” and stopped taking the medication.

Gilead spokesman Ryan McKeel said the company has made extra efforts to help patients overcome financial barriers. He cited assistance programs for uninsured and underinsured people.

“We have designed our assistance programs with the intent that people can benefit from their full value, and we cannot control the actions or decisions of health insurers,” McKeel said in an emailed statement.

The federal Centers for Disease Control and Prevention estimates that more than 1 million people are at high risk of contracting HIV, but Gilead says only about 167,000 people currently take PrEP.
 

Beyond the money crunch

Price is one of many barriers – alongside patients’ lack of awareness and doctors’ hesitation to prescribe – that threaten to exacerbate the already stark disparities in PrEP use and HIV infection rates.

One major disparity is along geographic lines. The South, for example, accounts for over half of new HIV diagnoses but only about 30 percent of new PrEP users, according to data from AIDSVu, which maps HIV disease and PrEP use. HIV rates and PrEP use also vary by race and ethnicity.

“We are not necessarily seeing that those most at risk are the ones starting PrEP,” said Kristin Keglovitz Baker, chief operating officer of Howard Brown Health, a Chicago health center.

Gilead has recently gone all-in with advertising to reach people at risk, including print campaigns and TV ads that will air through the summer. Since 2012, it has spent $28 million to fund U.S. organizations that seek to raise awareness of HIV, McKeel, the company spokesman, said.

“We recognize that many people who are at high risk for HIV infection still face challenges in accessing Truvada for PrEP, and we are in regular dialogue with public health officials, advocates and physicians to better understand and, where possible, help to address these challenges,” he added.

But price is also an impediment for publicly funded programs, which have limited budgets and are now shelling out more cash for the prevention effort.

“If it was only pennies ... we would be throwing it around,” said Joey Mattingly, an assistant professor at the University of Maryland School of Pharmacy. “Because of how costly it is, we have to control it.”

Some states – California and Florida among them – have launched PrEP assistance programs that can help patients cover the cost of the medication, along with required lab work and medical visits.

Beyond these state-based programs, some public health departments and HIV service organizations are hiring PrEP navigators to help patients navigate the maze of copays and deductibles, and to improve recruitment and retention of new PrEP users.

Washington, D.C.’s health department has doubled down on prevention, and Truvada is key in that effort, said Michael Kharfen, the department’s senior deputy director for HIV/AIDS, Hepatitis, STD and TB Administration.

Insurance usually covers PrEP, and patient assistance programs should fill any financial gaps, he said. But when that isn’t feasible, the department steps in, distributing free Truvada starter packs to at-risk patients.

Kharfen said the city has in the past three years spent almost a million dollars just on Truvada pills, which it purchases at a discounted rate through the federal 340B program, which benefits certain health care providers that treat low-income people. And because of new publicity efforts, he expects the department will need to buy and distribute more pills – posing a conundrum.

Treating more people is net positive, he said. But “how do we sustain this?”

Medicaid programs generally cover PrEP, so they confront a similar situation. Outreach efforts lead to more beneficiaries who take the drug, but that, in turn, could subject the states’ Medicaid budgets to financial hardship.

States are spending millions of dollars on the drug. California’s Medicaid program, for example, spent about $50 million in 2017 and expects the costs to continue climbing. But officials said the expense is offset by long-term savings in preventing new HIV cases.

Massachusetts’ Medicaid program spent about $22 million on Truvada that same year – about $18,000 per beneficiary, according to a spokeswoman for the agency’s Executive Office of Health and Human Services. Those figures don’t account for rebates the state receives from Gilead, which are undisclosed and considered proprietary information.
 

A complex solution, and no competition

PrEP is only one part of HIV prevention, so help paying for the pill is only one piece of the puzzle.

Patients also need regular HIV testing and medical care, which add to the cost borne both by patients and the health system. Some experts warn that Truvada’s high price point could financially undermine such broad prevention efforts.

Competition could help.

A generic version of the drug, manufactured by Teva Pharmaceuticals, is available abroad and gained approval for use last year from the federal Food and Drug Administration. When it becomes available in the United States, it could bring down prices, though it’s unclear when that will happen. Gilead’s own forecasts reflect that expectation, showing declines in future revenue from Truvada.

“When generics enter, brands lose market share,” said David Howard, a health economist and professor at Emory University, who previously worked in the pharmaceutical industry.

For now, though, Truvada is the only PrEP option available in the U.S., he said. “From a company standpoint ... their best strategy is to make as much money as they can.”
 

KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Blue Shield of California Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Public health officials are expanding efforts to get the HIV prevention pill into the hands of those at risk, in a nationwide effort to curb infections. But the officials are hitting roadblocks – the drug’s price tag, which has surged in recent years, and changes in insurance coverage that put a heftier financial burden on patients.

Since brand-name Truvada was approved for HIV prevention six years ago, its average wholesale price has increased by about 45 percent. Now, the drug – which rakes in billions of dollars in annual global revenue for its manufacturer, Gilead Sciences – carries a list price of close to $2,000 for a 30-day supply.

Most insurers cover the pill, also known as pre-exposure prophylaxis, or PrEP. It has been shown to be more than 90 percent effective in HIV prevention when taken daily.

But patients can get stuck with out-of-pocket costs that make it unaffordable.

“If there is any example of the dysfunction in the American pharmaceutical system, it is this case,” said James Krellenstein, a member of the AIDS advocacy group ACT UP New York. “We have the most effective tool for ending the HIV epidemic, and one reason we’re unable to scale up is because it costs so [much] unnecessarily.”

As policymakers and the health system debate how to control ever-climbing drug prices, experts say this case underscores how patients are left holding the bag.

Private health plans are making patients responsible for a larger share of drug costs. And more are restricting use of the “copay coupons” pharmaceutical companies have used to shield patients from out-of-pocket expenses. Insurers say the drug companies use coupons to steer consumers toward pricier meds. One way health plans are limiting their use is by no longer allowing them to count toward patients’ deductibles.

“This is one more thing that is going to push people off their medications,” said Jim Pickett, a senior director at the AIDS Foundation of Chicago.

Jared Wile, who lives in Chicago, started taking PrEP about three years ago, when he was dating someone with HIV. Wile, who has a $2,750 deductible, used a coupon to obtain the drug. He never paid anything out-of-pocket, he said.

Gilead waives up to $4,800 in out-of-pocket expenses for commercially insured patients.

That changed for Wile this past May, when Wile learned the coupon no longer counted toward his deductible and that he would have to pay the full cost of the prescription – $1,600 per month – until he hit his deductible. Wile said he felt “blindsided” and stopped taking the medication.

Gilead spokesman Ryan McKeel said the company has made extra efforts to help patients overcome financial barriers. He cited assistance programs for uninsured and underinsured people.

“We have designed our assistance programs with the intent that people can benefit from their full value, and we cannot control the actions or decisions of health insurers,” McKeel said in an emailed statement.

The federal Centers for Disease Control and Prevention estimates that more than 1 million people are at high risk of contracting HIV, but Gilead says only about 167,000 people currently take PrEP.
 

Beyond the money crunch

Price is one of many barriers – alongside patients’ lack of awareness and doctors’ hesitation to prescribe – that threaten to exacerbate the already stark disparities in PrEP use and HIV infection rates.

One major disparity is along geographic lines. The South, for example, accounts for over half of new HIV diagnoses but only about 30 percent of new PrEP users, according to data from AIDSVu, which maps HIV disease and PrEP use. HIV rates and PrEP use also vary by race and ethnicity.

“We are not necessarily seeing that those most at risk are the ones starting PrEP,” said Kristin Keglovitz Baker, chief operating officer of Howard Brown Health, a Chicago health center.

Gilead has recently gone all-in with advertising to reach people at risk, including print campaigns and TV ads that will air through the summer. Since 2012, it has spent $28 million to fund U.S. organizations that seek to raise awareness of HIV, McKeel, the company spokesman, said.

“We recognize that many people who are at high risk for HIV infection still face challenges in accessing Truvada for PrEP, and we are in regular dialogue with public health officials, advocates and physicians to better understand and, where possible, help to address these challenges,” he added.

But price is also an impediment for publicly funded programs, which have limited budgets and are now shelling out more cash for the prevention effort.

“If it was only pennies ... we would be throwing it around,” said Joey Mattingly, an assistant professor at the University of Maryland School of Pharmacy. “Because of how costly it is, we have to control it.”

Some states – California and Florida among them – have launched PrEP assistance programs that can help patients cover the cost of the medication, along with required lab work and medical visits.

Beyond these state-based programs, some public health departments and HIV service organizations are hiring PrEP navigators to help patients navigate the maze of copays and deductibles, and to improve recruitment and retention of new PrEP users.

Washington, D.C.’s health department has doubled down on prevention, and Truvada is key in that effort, said Michael Kharfen, the department’s senior deputy director for HIV/AIDS, Hepatitis, STD and TB Administration.

Insurance usually covers PrEP, and patient assistance programs should fill any financial gaps, he said. But when that isn’t feasible, the department steps in, distributing free Truvada starter packs to at-risk patients.

Kharfen said the city has in the past three years spent almost a million dollars just on Truvada pills, which it purchases at a discounted rate through the federal 340B program, which benefits certain health care providers that treat low-income people. And because of new publicity efforts, he expects the department will need to buy and distribute more pills – posing a conundrum.

Treating more people is net positive, he said. But “how do we sustain this?”

Medicaid programs generally cover PrEP, so they confront a similar situation. Outreach efforts lead to more beneficiaries who take the drug, but that, in turn, could subject the states’ Medicaid budgets to financial hardship.

States are spending millions of dollars on the drug. California’s Medicaid program, for example, spent about $50 million in 2017 and expects the costs to continue climbing. But officials said the expense is offset by long-term savings in preventing new HIV cases.

Massachusetts’ Medicaid program spent about $22 million on Truvada that same year – about $18,000 per beneficiary, according to a spokeswoman for the agency’s Executive Office of Health and Human Services. Those figures don’t account for rebates the state receives from Gilead, which are undisclosed and considered proprietary information.
 

A complex solution, and no competition

PrEP is only one part of HIV prevention, so help paying for the pill is only one piece of the puzzle.

Patients also need regular HIV testing and medical care, which add to the cost borne both by patients and the health system. Some experts warn that Truvada’s high price point could financially undermine such broad prevention efforts.

Competition could help.

A generic version of the drug, manufactured by Teva Pharmaceuticals, is available abroad and gained approval for use last year from the federal Food and Drug Administration. When it becomes available in the United States, it could bring down prices, though it’s unclear when that will happen. Gilead’s own forecasts reflect that expectation, showing declines in future revenue from Truvada.

“When generics enter, brands lose market share,” said David Howard, a health economist and professor at Emory University, who previously worked in the pharmaceutical industry.

For now, though, Truvada is the only PrEP option available in the U.S., he said. “From a company standpoint ... their best strategy is to make as much money as they can.”
 

KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Blue Shield of California Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Public health officials are expanding efforts to get the HIV prevention pill into the hands of those at risk, in a nationwide effort to curb infections. But the officials are hitting roadblocks – the drug’s price tag, which has surged in recent years, and changes in insurance coverage that put a heftier financial burden on patients.

Since brand-name Truvada was approved for HIV prevention six years ago, its average wholesale price has increased by about 45 percent. Now, the drug – which rakes in billions of dollars in annual global revenue for its manufacturer, Gilead Sciences – carries a list price of close to $2,000 for a 30-day supply.

Most insurers cover the pill, also known as pre-exposure prophylaxis, or PrEP. It has been shown to be more than 90 percent effective in HIV prevention when taken daily.

But patients can get stuck with out-of-pocket costs that make it unaffordable.

“If there is any example of the dysfunction in the American pharmaceutical system, it is this case,” said James Krellenstein, a member of the AIDS advocacy group ACT UP New York. “We have the most effective tool for ending the HIV epidemic, and one reason we’re unable to scale up is because it costs so [much] unnecessarily.”

As policymakers and the health system debate how to control ever-climbing drug prices, experts say this case underscores how patients are left holding the bag.

Private health plans are making patients responsible for a larger share of drug costs. And more are restricting use of the “copay coupons” pharmaceutical companies have used to shield patients from out-of-pocket expenses. Insurers say the drug companies use coupons to steer consumers toward pricier meds. One way health plans are limiting their use is by no longer allowing them to count toward patients’ deductibles.

“This is one more thing that is going to push people off their medications,” said Jim Pickett, a senior director at the AIDS Foundation of Chicago.

Jared Wile, who lives in Chicago, started taking PrEP about three years ago, when he was dating someone with HIV. Wile, who has a $2,750 deductible, used a coupon to obtain the drug. He never paid anything out-of-pocket, he said.

Gilead waives up to $4,800 in out-of-pocket expenses for commercially insured patients.

That changed for Wile this past May, when Wile learned the coupon no longer counted toward his deductible and that he would have to pay the full cost of the prescription – $1,600 per month – until he hit his deductible. Wile said he felt “blindsided” and stopped taking the medication.

Gilead spokesman Ryan McKeel said the company has made extra efforts to help patients overcome financial barriers. He cited assistance programs for uninsured and underinsured people.

“We have designed our assistance programs with the intent that people can benefit from their full value, and we cannot control the actions or decisions of health insurers,” McKeel said in an emailed statement.

The federal Centers for Disease Control and Prevention estimates that more than 1 million people are at high risk of contracting HIV, but Gilead says only about 167,000 people currently take PrEP.
 

Beyond the money crunch

Price is one of many barriers – alongside patients’ lack of awareness and doctors’ hesitation to prescribe – that threaten to exacerbate the already stark disparities in PrEP use and HIV infection rates.

One major disparity is along geographic lines. The South, for example, accounts for over half of new HIV diagnoses but only about 30 percent of new PrEP users, according to data from AIDSVu, which maps HIV disease and PrEP use. HIV rates and PrEP use also vary by race and ethnicity.

“We are not necessarily seeing that those most at risk are the ones starting PrEP,” said Kristin Keglovitz Baker, chief operating officer of Howard Brown Health, a Chicago health center.

Gilead has recently gone all-in with advertising to reach people at risk, including print campaigns and TV ads that will air through the summer. Since 2012, it has spent $28 million to fund U.S. organizations that seek to raise awareness of HIV, McKeel, the company spokesman, said.

“We recognize that many people who are at high risk for HIV infection still face challenges in accessing Truvada for PrEP, and we are in regular dialogue with public health officials, advocates and physicians to better understand and, where possible, help to address these challenges,” he added.

But price is also an impediment for publicly funded programs, which have limited budgets and are now shelling out more cash for the prevention effort.

“If it was only pennies ... we would be throwing it around,” said Joey Mattingly, an assistant professor at the University of Maryland School of Pharmacy. “Because of how costly it is, we have to control it.”

Some states – California and Florida among them – have launched PrEP assistance programs that can help patients cover the cost of the medication, along with required lab work and medical visits.

Beyond these state-based programs, some public health departments and HIV service organizations are hiring PrEP navigators to help patients navigate the maze of copays and deductibles, and to improve recruitment and retention of new PrEP users.

Washington, D.C.’s health department has doubled down on prevention, and Truvada is key in that effort, said Michael Kharfen, the department’s senior deputy director for HIV/AIDS, Hepatitis, STD and TB Administration.

Insurance usually covers PrEP, and patient assistance programs should fill any financial gaps, he said. But when that isn’t feasible, the department steps in, distributing free Truvada starter packs to at-risk patients.

Kharfen said the city has in the past three years spent almost a million dollars just on Truvada pills, which it purchases at a discounted rate through the federal 340B program, which benefits certain health care providers that treat low-income people. And because of new publicity efforts, he expects the department will need to buy and distribute more pills – posing a conundrum.

Treating more people is net positive, he said. But “how do we sustain this?”

Medicaid programs generally cover PrEP, so they confront a similar situation. Outreach efforts lead to more beneficiaries who take the drug, but that, in turn, could subject the states’ Medicaid budgets to financial hardship.

States are spending millions of dollars on the drug. California’s Medicaid program, for example, spent about $50 million in 2017 and expects the costs to continue climbing. But officials said the expense is offset by long-term savings in preventing new HIV cases.

Massachusetts’ Medicaid program spent about $22 million on Truvada that same year – about $18,000 per beneficiary, according to a spokeswoman for the agency’s Executive Office of Health and Human Services. Those figures don’t account for rebates the state receives from Gilead, which are undisclosed and considered proprietary information.
 

A complex solution, and no competition

PrEP is only one part of HIV prevention, so help paying for the pill is only one piece of the puzzle.

Patients also need regular HIV testing and medical care, which add to the cost borne both by patients and the health system. Some experts warn that Truvada’s high price point could financially undermine such broad prevention efforts.

Competition could help.

A generic version of the drug, manufactured by Teva Pharmaceuticals, is available abroad and gained approval for use last year from the federal Food and Drug Administration. When it becomes available in the United States, it could bring down prices, though it’s unclear when that will happen. Gilead’s own forecasts reflect that expectation, showing declines in future revenue from Truvada.

“When generics enter, brands lose market share,” said David Howard, a health economist and professor at Emory University, who previously worked in the pharmaceutical industry.

For now, though, Truvada is the only PrEP option available in the U.S., he said. “From a company standpoint ... their best strategy is to make as much money as they can.”
 

KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Blue Shield of California Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The fallout from the federal court ruling June 29 that struck down the Medicaid work requirement in Kentucky was swift.

The decision by Judge James Boasberg immediately blocked Kentucky from enacting the provision in Campbell County, which had been set to start Sunday and roll out statewide later this year. Within 36 hours, Kentucky Gov. Matt Bevin, a Republican, eliminated vision and dental benefits to nearly 500,000 Medicaid enrollees, saying the state could no longer afford it.

Meanwhile, Arkansas, New Hampshire and Indiana are moving ahead with the implementation of their versions of a Medicaid work requirement. It is not clear how or if Boasberg’s ruling invalidating the Trump administration’s approval of Kentucky’s plan affects these states.

Arkansas is implementing its requirement this summer while New Hampshire and Indiana plan to phase in their rules beginning In January.

Virginia health officials say they still plan to seek federal permission to enact a work requirement but it isn’t needed in order to expand Medicaid eligibility on Jan.1.

Virginia lawmakers approved Medicaid expansion in June with the condition the state apply for federal permission to include the new mandate.

“We remain focused on the work necessary to ensure that new health coverage for Virginia adults is available beginning on January 1, 2019,” Dr. Jennifer Lee, director of the Virginia Department of Medical Assistance Services, said in a statement. “Developing a waiver is a separate and ongoing process, as described in the final state budget.”

Virginia Medicaid is in discussions with the U.S. Centers for Medicare & Medicaid Services about its waiver, which has not yet been submitted.

Many Republican lawmakers in Virginia voted to expand Medicaid only after it was assured new enrollees would have to work or do volunteer service.

Dr. Scott Garrett, a Virginia House member from Lynchburg, Va., said he was under the impression the bill signed in June by Virginia Gov. Ralph Northam, a Democrat, meant the Medicaid expansion would begin only with a work requirement in place.

“The intent of the General Assembly ... was that you could not do one absent the other,” he said.

Garrett, a Republican, said he long opposed plans to add 400,000 adults to Medicaid because of cost concerns. He said requiring these enrollees to work or do volunteer service would make them healthier and improve their well-being.

Patricia Boozang, senior managing director for Manatt Health, a consulting firm, said she is not surprised states are moving ahead with work requirement plans regardless of the court ruling, which was specific to Kentucky.

She said the decision would cause the Trump administration to review the pending applications more closely so they could withstand a judicial review.

The federal court said Health and Human Services Secretary Alex Azar did not adequately take into account how many people would lose coverage for the work requirement and did not prove such a provision would improve enrollees’ health.

“It’s going to be challenging for them to make the case that health and well-being is going to be improved by the [work requirement] waiver,” she said.

In Arkansas, some Medicaid enrollees face a Thursday deadline to register their status – that they worked, did volunteer service in June or meet one of the state’s many exemptions.

“The ruling does not have an immediate effect on Arkansas’ work requirement,” said spokeswoman Marci Manley.

Advocates for low-income people are weighing whether to file lawsuits to stop the work requirement in other states that have won federal approval.

“We have ... partnerships with state legal advocates in these states and are exploring enforcement and litigation options with them,” said Jane Perkins, legal director of the National Health Law Program, which filed the suit on behalf of Medicaid enrollees in Kentucky to block the work requirements.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The fallout from the federal court ruling June 29 that struck down the Medicaid work requirement in Kentucky was swift.

The decision by Judge James Boasberg immediately blocked Kentucky from enacting the provision in Campbell County, which had been set to start Sunday and roll out statewide later this year. Within 36 hours, Kentucky Gov. Matt Bevin, a Republican, eliminated vision and dental benefits to nearly 500,000 Medicaid enrollees, saying the state could no longer afford it.

Meanwhile, Arkansas, New Hampshire and Indiana are moving ahead with the implementation of their versions of a Medicaid work requirement. It is not clear how or if Boasberg’s ruling invalidating the Trump administration’s approval of Kentucky’s plan affects these states.

Arkansas is implementing its requirement this summer while New Hampshire and Indiana plan to phase in their rules beginning In January.

Virginia health officials say they still plan to seek federal permission to enact a work requirement but it isn’t needed in order to expand Medicaid eligibility on Jan.1.

Virginia lawmakers approved Medicaid expansion in June with the condition the state apply for federal permission to include the new mandate.

“We remain focused on the work necessary to ensure that new health coverage for Virginia adults is available beginning on January 1, 2019,” Dr. Jennifer Lee, director of the Virginia Department of Medical Assistance Services, said in a statement. “Developing a waiver is a separate and ongoing process, as described in the final state budget.”

Virginia Medicaid is in discussions with the U.S. Centers for Medicare & Medicaid Services about its waiver, which has not yet been submitted.

Many Republican lawmakers in Virginia voted to expand Medicaid only after it was assured new enrollees would have to work or do volunteer service.

Dr. Scott Garrett, a Virginia House member from Lynchburg, Va., said he was under the impression the bill signed in June by Virginia Gov. Ralph Northam, a Democrat, meant the Medicaid expansion would begin only with a work requirement in place.

“The intent of the General Assembly ... was that you could not do one absent the other,” he said.

Garrett, a Republican, said he long opposed plans to add 400,000 adults to Medicaid because of cost concerns. He said requiring these enrollees to work or do volunteer service would make them healthier and improve their well-being.

Patricia Boozang, senior managing director for Manatt Health, a consulting firm, said she is not surprised states are moving ahead with work requirement plans regardless of the court ruling, which was specific to Kentucky.

She said the decision would cause the Trump administration to review the pending applications more closely so they could withstand a judicial review.

The federal court said Health and Human Services Secretary Alex Azar did not adequately take into account how many people would lose coverage for the work requirement and did not prove such a provision would improve enrollees’ health.

“It’s going to be challenging for them to make the case that health and well-being is going to be improved by the [work requirement] waiver,” she said.

In Arkansas, some Medicaid enrollees face a Thursday deadline to register their status – that they worked, did volunteer service in June or meet one of the state’s many exemptions.

“The ruling does not have an immediate effect on Arkansas’ work requirement,” said spokeswoman Marci Manley.

Advocates for low-income people are weighing whether to file lawsuits to stop the work requirement in other states that have won federal approval.

“We have ... partnerships with state legal advocates in these states and are exploring enforcement and litigation options with them,” said Jane Perkins, legal director of the National Health Law Program, which filed the suit on behalf of Medicaid enrollees in Kentucky to block the work requirements.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The fallout from the federal court ruling June 29 that struck down the Medicaid work requirement in Kentucky was swift.

The decision by Judge James Boasberg immediately blocked Kentucky from enacting the provision in Campbell County, which had been set to start Sunday and roll out statewide later this year. Within 36 hours, Kentucky Gov. Matt Bevin, a Republican, eliminated vision and dental benefits to nearly 500,000 Medicaid enrollees, saying the state could no longer afford it.

Meanwhile, Arkansas, New Hampshire and Indiana are moving ahead with the implementation of their versions of a Medicaid work requirement. It is not clear how or if Boasberg’s ruling invalidating the Trump administration’s approval of Kentucky’s plan affects these states.

Arkansas is implementing its requirement this summer while New Hampshire and Indiana plan to phase in their rules beginning In January.

Virginia health officials say they still plan to seek federal permission to enact a work requirement but it isn’t needed in order to expand Medicaid eligibility on Jan.1.

Virginia lawmakers approved Medicaid expansion in June with the condition the state apply for federal permission to include the new mandate.

“We remain focused on the work necessary to ensure that new health coverage for Virginia adults is available beginning on January 1, 2019,” Dr. Jennifer Lee, director of the Virginia Department of Medical Assistance Services, said in a statement. “Developing a waiver is a separate and ongoing process, as described in the final state budget.”

Virginia Medicaid is in discussions with the U.S. Centers for Medicare & Medicaid Services about its waiver, which has not yet been submitted.

Many Republican lawmakers in Virginia voted to expand Medicaid only after it was assured new enrollees would have to work or do volunteer service.

Dr. Scott Garrett, a Virginia House member from Lynchburg, Va., said he was under the impression the bill signed in June by Virginia Gov. Ralph Northam, a Democrat, meant the Medicaid expansion would begin only with a work requirement in place.

“The intent of the General Assembly ... was that you could not do one absent the other,” he said.

Garrett, a Republican, said he long opposed plans to add 400,000 adults to Medicaid because of cost concerns. He said requiring these enrollees to work or do volunteer service would make them healthier and improve their well-being.

Patricia Boozang, senior managing director for Manatt Health, a consulting firm, said she is not surprised states are moving ahead with work requirement plans regardless of the court ruling, which was specific to Kentucky.

She said the decision would cause the Trump administration to review the pending applications more closely so they could withstand a judicial review.

The federal court said Health and Human Services Secretary Alex Azar did not adequately take into account how many people would lose coverage for the work requirement and did not prove such a provision would improve enrollees’ health.

“It’s going to be challenging for them to make the case that health and well-being is going to be improved by the [work requirement] waiver,” she said.

In Arkansas, some Medicaid enrollees face a Thursday deadline to register their status – that they worked, did volunteer service in June or meet one of the state’s many exemptions.

“The ruling does not have an immediate effect on Arkansas’ work requirement,” said spokeswoman Marci Manley.

Advocates for low-income people are weighing whether to file lawsuits to stop the work requirement in other states that have won federal approval.

“We have ... partnerships with state legal advocates in these states and are exploring enforcement and litigation options with them,” said Jane Perkins, legal director of the National Health Law Program, which filed the suit on behalf of Medicaid enrollees in Kentucky to block the work requirements.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Women who received only a primary human papillomavirus test were 58% less likely to develop grade 3 or worse cervical intraepithelial neoplasia (CIN3+) by 48 months than women who had the traditional Pap cytology screen.

The primary HPV test also reduced the 2-year risk of CIN2+ neoplasia, compared with Pap smear alone, Gina Suzanne Ogilvie, MD, and her colleagues reported in JAMA.

“These results have demonstrated that primary HPV testing detects cervical neoplasia earlier and more accurately than cytology,” wrote Dr. Ogilvie of the University of British Columbia, Vancouver, and her colleagues.

HPV FOCAL (the Human Papilloma Virus For Cervical Cancers Screening trial) enrolled 19,009 Canadian women aged 25-65 years and randomized them to two cervical cancer screening paradigms: Pap liquid-based cytology (LBC) or primary HPV testing.

The intervention group (9,552) had cervical cancer screening with a high-risk HPV DNA test that detects types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. If either test was positive, they were referred for colposcopy. If both tests were negative, they returned for their final screen with both tests at 48 months.

The control group underwent primary LBC testing, followed by HPV testing for women with atypical squamous cells of unknown significance (ASCUS). If these tests were both positive, they were referred for colposcopy. Women who were positive for ASCUS and HPV negative returned in 12 months and were referred for colposcopy if they had ASCUS or any higher-grade abnormality. At 48 months, they also returned and underwent both screening tests.

The primary outcome was the rate of CIN3+ at 48 months. Secondary endpoints included the 48-month rate of CIN2+, the threshold for colposcopy referral, and the effect of primary HPV testing on colposcopy.

In the first round of screening, HPV testing detected significantly more cases of CIN3+ than did LBC (risk ratio, 1.61). This was an absolute difference of 2.67 more cases per 1,000 screened women.

At 48 months, the rate of CIN3+ was significantly lower in the intervention group than in the control group (2.3 vs. 5.5 per 1,000; RR, 0.42). This represents an absolute difference of 3.2 fewer cases per 1,000, the investigators said.

Overall, however, the two methods detected about the same number of cases by 48 months, the investigators said.

“Cumulative CIN3+ incidence curves show no significantly different disease detection across trial groups in the intervention group. The cumulative incidence was higher earlier in the trial at 18 months and 42 months, compared with the control group. ... By the end of trial follow-up (72 months), incidence was similar across both groups.”

Women who were HPV negative at baseline reaped the biggest benefit. The 48-month HPV incidence rate among them was 1.4 per 1,000, compared with 5.4 per 1,000 in the control group. This 75% risk reduction (RR, 0.25) represents an absolute reduction of 4 cases per 1,000 women.

The intervention group was 61% more likely to have a CIN2+ result by 12 months (RR, 1.61), but 53% less likely to have it at 48 months (RR, 0.47).

“By 48 months, significantly fewer CIN2+ cases were detected overall and across all age groups in the intervention group, compared with the control group,” the team said. At 48 months, the CIN2+ rate was 5 per 1,000 vs. 10.6 per 1,000 – a 53% reduced risk (RR, 0.47) and an absolute reduction of 5.6 cases per 1,000.

Again, the benefit accrued early and mostly in women who were negative by HPV or cytology at baseline. Among these, the CIN2+ risk for the intervention, compared with the control group, was 64% lower (RR, 0.36), and the absolute difference in incidence was 6.38 per 1,000.

This early detection came at a cost, however. Colposcopies were significantly more common in the intervention group in the first screening round (57 vs. 30.8). However, by 48 months, colposcopy rates were lower in the intervention group, compared with the control group (49.2 vs. 70.5). By the end of the study, cumulative colposcopy referral rates were similar (106.2 vs. 101.5).

Dr. Ogilvie and her colleagues suggested that this ultimate similarity in colposcopy rate shows that fears about overdiagnosis with HPV testing are unfounded.

“One of the concerns for adopting HPV-based screening is the lower CIN2+ specificity of HPV testing, compared with cytology, leading to higher screen positive rates and the resulting need for more colposcopies and biopsies. Unnecessary colposcopies potentially cause unintended harm for women and increased costs to health care systems. In this trial, round 1 colposcopy rates in the HPV-tested group were significantly higher than the cytology-tested group. However, by 48 months, the colposcopy rate in the intervention group was reduced while the control group rate increased.

“This increase is partly a result of HPV and cytology co-testing at trial end. Of the 513 control-group women referred for colposcopy at exit, 304 (59%) were cytology negative and HPV positive. In the HPV-tested group, the colposcopy rate decreased in the second round of screening, which more accurately reflects the ongoing impact of HPV-based screening on a colposcopy program. The baseline colposcopy referral rate reflects what happens when HPV-based screening is first implemented, when both prevalent and incident infections will be detected,” the investigators said.

The Canadian Institute of Health Research funded the study. Dr. Ogilvie was a coinvestigator on adjunct studies funded by Hologic and Roche, designed to compare the performance of different HPV assays. Funding for the adjunct studies was not applied to the main HPV FOCAL trial.
 

[email protected]

SOURCE: Ogilvie GS et al. JAMA. 2018;320:43-52.

Women who received only a primary human papillomavirus test were 58% less likely to develop grade 3 or worse cervical intraepithelial neoplasia (CIN3+) by 48 months than women who had the traditional Pap cytology screen.

The primary HPV test also reduced the 2-year risk of CIN2+ neoplasia, compared with Pap smear alone, Gina Suzanne Ogilvie, MD, and her colleagues reported in JAMA.

“These results have demonstrated that primary HPV testing detects cervical neoplasia earlier and more accurately than cytology,” wrote Dr. Ogilvie of the University of British Columbia, Vancouver, and her colleagues.

HPV FOCAL (the Human Papilloma Virus For Cervical Cancers Screening trial) enrolled 19,009 Canadian women aged 25-65 years and randomized them to two cervical cancer screening paradigms: Pap liquid-based cytology (LBC) or primary HPV testing.

The intervention group (9,552) had cervical cancer screening with a high-risk HPV DNA test that detects types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. If either test was positive, they were referred for colposcopy. If both tests were negative, they returned for their final screen with both tests at 48 months.

The control group underwent primary LBC testing, followed by HPV testing for women with atypical squamous cells of unknown significance (ASCUS). If these tests were both positive, they were referred for colposcopy. Women who were positive for ASCUS and HPV negative returned in 12 months and were referred for colposcopy if they had ASCUS or any higher-grade abnormality. At 48 months, they also returned and underwent both screening tests.

The primary outcome was the rate of CIN3+ at 48 months. Secondary endpoints included the 48-month rate of CIN2+, the threshold for colposcopy referral, and the effect of primary HPV testing on colposcopy.

In the first round of screening, HPV testing detected significantly more cases of CIN3+ than did LBC (risk ratio, 1.61). This was an absolute difference of 2.67 more cases per 1,000 screened women.

At 48 months, the rate of CIN3+ was significantly lower in the intervention group than in the control group (2.3 vs. 5.5 per 1,000; RR, 0.42). This represents an absolute difference of 3.2 fewer cases per 1,000, the investigators said.

Overall, however, the two methods detected about the same number of cases by 48 months, the investigators said.

“Cumulative CIN3+ incidence curves show no significantly different disease detection across trial groups in the intervention group. The cumulative incidence was higher earlier in the trial at 18 months and 42 months, compared with the control group. ... By the end of trial follow-up (72 months), incidence was similar across both groups.”

Women who were HPV negative at baseline reaped the biggest benefit. The 48-month HPV incidence rate among them was 1.4 per 1,000, compared with 5.4 per 1,000 in the control group. This 75% risk reduction (RR, 0.25) represents an absolute reduction of 4 cases per 1,000 women.

The intervention group was 61% more likely to have a CIN2+ result by 12 months (RR, 1.61), but 53% less likely to have it at 48 months (RR, 0.47).

“By 48 months, significantly fewer CIN2+ cases were detected overall and across all age groups in the intervention group, compared with the control group,” the team said. At 48 months, the CIN2+ rate was 5 per 1,000 vs. 10.6 per 1,000 – a 53% reduced risk (RR, 0.47) and an absolute reduction of 5.6 cases per 1,000.

Again, the benefit accrued early and mostly in women who were negative by HPV or cytology at baseline. Among these, the CIN2+ risk for the intervention, compared with the control group, was 64% lower (RR, 0.36), and the absolute difference in incidence was 6.38 per 1,000.

This early detection came at a cost, however. Colposcopies were significantly more common in the intervention group in the first screening round (57 vs. 30.8). However, by 48 months, colposcopy rates were lower in the intervention group, compared with the control group (49.2 vs. 70.5). By the end of the study, cumulative colposcopy referral rates were similar (106.2 vs. 101.5).

Dr. Ogilvie and her colleagues suggested that this ultimate similarity in colposcopy rate shows that fears about overdiagnosis with HPV testing are unfounded.

“One of the concerns for adopting HPV-based screening is the lower CIN2+ specificity of HPV testing, compared with cytology, leading to higher screen positive rates and the resulting need for more colposcopies and biopsies. Unnecessary colposcopies potentially cause unintended harm for women and increased costs to health care systems. In this trial, round 1 colposcopy rates in the HPV-tested group were significantly higher than the cytology-tested group. However, by 48 months, the colposcopy rate in the intervention group was reduced while the control group rate increased.

“This increase is partly a result of HPV and cytology co-testing at trial end. Of the 513 control-group women referred for colposcopy at exit, 304 (59%) were cytology negative and HPV positive. In the HPV-tested group, the colposcopy rate decreased in the second round of screening, which more accurately reflects the ongoing impact of HPV-based screening on a colposcopy program. The baseline colposcopy referral rate reflects what happens when HPV-based screening is first implemented, when both prevalent and incident infections will be detected,” the investigators said.

The Canadian Institute of Health Research funded the study. Dr. Ogilvie was a coinvestigator on adjunct studies funded by Hologic and Roche, designed to compare the performance of different HPV assays. Funding for the adjunct studies was not applied to the main HPV FOCAL trial.
 

[email protected]

SOURCE: Ogilvie GS et al. JAMA. 2018;320:43-52.

Women who received only a primary human papillomavirus test were 58% less likely to develop grade 3 or worse cervical intraepithelial neoplasia (CIN3+) by 48 months than women who had the traditional Pap cytology screen.

The primary HPV test also reduced the 2-year risk of CIN2+ neoplasia, compared with Pap smear alone, Gina Suzanne Ogilvie, MD, and her colleagues reported in JAMA.

“These results have demonstrated that primary HPV testing detects cervical neoplasia earlier and more accurately than cytology,” wrote Dr. Ogilvie of the University of British Columbia, Vancouver, and her colleagues.

HPV FOCAL (the Human Papilloma Virus For Cervical Cancers Screening trial) enrolled 19,009 Canadian women aged 25-65 years and randomized them to two cervical cancer screening paradigms: Pap liquid-based cytology (LBC) or primary HPV testing.

The intervention group (9,552) had cervical cancer screening with a high-risk HPV DNA test that detects types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. If either test was positive, they were referred for colposcopy. If both tests were negative, they returned for their final screen with both tests at 48 months.

The control group underwent primary LBC testing, followed by HPV testing for women with atypical squamous cells of unknown significance (ASCUS). If these tests were both positive, they were referred for colposcopy. Women who were positive for ASCUS and HPV negative returned in 12 months and were referred for colposcopy if they had ASCUS or any higher-grade abnormality. At 48 months, they also returned and underwent both screening tests.

The primary outcome was the rate of CIN3+ at 48 months. Secondary endpoints included the 48-month rate of CIN2+, the threshold for colposcopy referral, and the effect of primary HPV testing on colposcopy.

In the first round of screening, HPV testing detected significantly more cases of CIN3+ than did LBC (risk ratio, 1.61). This was an absolute difference of 2.67 more cases per 1,000 screened women.

At 48 months, the rate of CIN3+ was significantly lower in the intervention group than in the control group (2.3 vs. 5.5 per 1,000; RR, 0.42). This represents an absolute difference of 3.2 fewer cases per 1,000, the investigators said.

Overall, however, the two methods detected about the same number of cases by 48 months, the investigators said.

“Cumulative CIN3+ incidence curves show no significantly different disease detection across trial groups in the intervention group. The cumulative incidence was higher earlier in the trial at 18 months and 42 months, compared with the control group. ... By the end of trial follow-up (72 months), incidence was similar across both groups.”

Women who were HPV negative at baseline reaped the biggest benefit. The 48-month HPV incidence rate among them was 1.4 per 1,000, compared with 5.4 per 1,000 in the control group. This 75% risk reduction (RR, 0.25) represents an absolute reduction of 4 cases per 1,000 women.

The intervention group was 61% more likely to have a CIN2+ result by 12 months (RR, 1.61), but 53% less likely to have it at 48 months (RR, 0.47).

“By 48 months, significantly fewer CIN2+ cases were detected overall and across all age groups in the intervention group, compared with the control group,” the team said. At 48 months, the CIN2+ rate was 5 per 1,000 vs. 10.6 per 1,000 – a 53% reduced risk (RR, 0.47) and an absolute reduction of 5.6 cases per 1,000.

Again, the benefit accrued early and mostly in women who were negative by HPV or cytology at baseline. Among these, the CIN2+ risk for the intervention, compared with the control group, was 64% lower (RR, 0.36), and the absolute difference in incidence was 6.38 per 1,000.

This early detection came at a cost, however. Colposcopies were significantly more common in the intervention group in the first screening round (57 vs. 30.8). However, by 48 months, colposcopy rates were lower in the intervention group, compared with the control group (49.2 vs. 70.5). By the end of the study, cumulative colposcopy referral rates were similar (106.2 vs. 101.5).

Dr. Ogilvie and her colleagues suggested that this ultimate similarity in colposcopy rate shows that fears about overdiagnosis with HPV testing are unfounded.

“One of the concerns for adopting HPV-based screening is the lower CIN2+ specificity of HPV testing, compared with cytology, leading to higher screen positive rates and the resulting need for more colposcopies and biopsies. Unnecessary colposcopies potentially cause unintended harm for women and increased costs to health care systems. In this trial, round 1 colposcopy rates in the HPV-tested group were significantly higher than the cytology-tested group. However, by 48 months, the colposcopy rate in the intervention group was reduced while the control group rate increased.

“This increase is partly a result of HPV and cytology co-testing at trial end. Of the 513 control-group women referred for colposcopy at exit, 304 (59%) were cytology negative and HPV positive. In the HPV-tested group, the colposcopy rate decreased in the second round of screening, which more accurately reflects the ongoing impact of HPV-based screening on a colposcopy program. The baseline colposcopy referral rate reflects what happens when HPV-based screening is first implemented, when both prevalent and incident infections will be detected,” the investigators said.

The Canadian Institute of Health Research funded the study. Dr. Ogilvie was a coinvestigator on adjunct studies funded by Hologic and Roche, designed to compare the performance of different HPV assays. Funding for the adjunct studies was not applied to the main HPV FOCAL trial.
 

[email protected]

SOURCE: Ogilvie GS et al. JAMA. 2018;320:43-52.

BALTIMORE—A new algorithm may be key to optimizing alertness with caffeine, a study suggests. Caffeine is the most widely used stimulant to counter the effects of sleep loss on neurobehavioral performance, but no tools exist to guide the timing and amount of caffeine consumption to optimize its benefits, said Jaques Reifman, PhD, and colleagues. “By using our algorithm, which determines when and how much caffeine a subject should consume, we can improve alertness by up to 64% while consuming the same total amount of caffeine” as in previous studies of caffeine use during chronic sleep restriction, said Dr. Reifman. “Alternatively, a subject can reduce caffeine consumption by up to 65% and still achieve equivalent improvements in alertness.”

Suggested Reading

Vital-Lopez FG, Ramakrishnan S, Doty TJ, et al. Caffeine dosing strategies to optimize alertness during sleep loss. J Sleep Res. 2018 May 28 [Epub ahead of print].

BALTIMORE—A new algorithm may be key to optimizing alertness with caffeine, a study suggests. Caffeine is the most widely used stimulant to counter the effects of sleep loss on neurobehavioral performance, but no tools exist to guide the timing and amount of caffeine consumption to optimize its benefits, said Jaques Reifman, PhD, and colleagues. “By using our algorithm, which determines when and how much caffeine a subject should consume, we can improve alertness by up to 64% while consuming the same total amount of caffeine” as in previous studies of caffeine use during chronic sleep restriction, said Dr. Reifman. “Alternatively, a subject can reduce caffeine consumption by up to 65% and still achieve equivalent improvements in alertness.”

Suggested Reading

Vital-Lopez FG, Ramakrishnan S, Doty TJ, et al. Caffeine dosing strategies to optimize alertness during sleep loss. J Sleep Res. 2018 May 28 [Epub ahead of print].

BALTIMORE—A new algorithm may be key to optimizing alertness with caffeine, a study suggests. Caffeine is the most widely used stimulant to counter the effects of sleep loss on neurobehavioral performance, but no tools exist to guide the timing and amount of caffeine consumption to optimize its benefits, said Jaques Reifman, PhD, and colleagues. “By using our algorithm, which determines when and how much caffeine a subject should consume, we can improve alertness by up to 64% while consuming the same total amount of caffeine” as in previous studies of caffeine use during chronic sleep restriction, said Dr. Reifman. “Alternatively, a subject can reduce caffeine consumption by up to 65% and still achieve equivalent improvements in alertness.”

Suggested Reading

Vital-Lopez FG, Ramakrishnan S, Doty TJ, et al. Caffeine dosing strategies to optimize alertness during sleep loss. J Sleep Res. 2018 May 28 [Epub ahead of print].

SAN DIEGO – The transition from noninjecting to injecting drug use can be a reversible process, results from a long-term study suggest.

“There’s a common stereotype in popular culture and in academic research that once people start injecting drugs, that will be their dominant route of administration for the rest of their lives,” lead study author Don C. Des Jarlais, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “We found that people who started injecting injected for several years, but then went back to noninjecting drug use. That so-called ‘reverse transition’ leads to a very big difference in infection with hepatitis C virus as well as reduced risk of overdose and reduced risk of other bacterial infections. Even though these people continued to use drugs, they were doing it in a way that was much safer.”

In an effort to examine the prevalence and characteristics of reverse transitions, Dr. Des Jarlais and his associates recruited injecting and noninjecting drug users aged 18 years and older from the Mount Sinai Beth Israel detoxification and methadone maintenance programs in New York City from 2000 to 2017. The researchers obtained informed consent and conducted a structured interview that included questions on why former injectors had ceased injecting drugs, along with testing for HIV and HCV.

Doug Brunk/MDEdge News

[email protected]

SAN DIEGO – The transition from noninjecting to injecting drug use can be a reversible process, results from a long-term study suggest.

“There’s a common stereotype in popular culture and in academic research that once people start injecting drugs, that will be their dominant route of administration for the rest of their lives,” lead study author Don C. Des Jarlais, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “We found that people who started injecting injected for several years, but then went back to noninjecting drug use. That so-called ‘reverse transition’ leads to a very big difference in infection with hepatitis C virus as well as reduced risk of overdose and reduced risk of other bacterial infections. Even though these people continued to use drugs, they were doing it in a way that was much safer.”

In an effort to examine the prevalence and characteristics of reverse transitions, Dr. Des Jarlais and his associates recruited injecting and noninjecting drug users aged 18 years and older from the Mount Sinai Beth Israel detoxification and methadone maintenance programs in New York City from 2000 to 2017. The researchers obtained informed consent and conducted a structured interview that included questions on why former injectors had ceased injecting drugs, along with testing for HIV and HCV.

Doug Brunk/MDEdge News

[email protected]

SAN DIEGO – The transition from noninjecting to injecting drug use can be a reversible process, results from a long-term study suggest.

“There’s a common stereotype in popular culture and in academic research that once people start injecting drugs, that will be their dominant route of administration for the rest of their lives,” lead study author Don C. Des Jarlais, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “We found that people who started injecting injected for several years, but then went back to noninjecting drug use. That so-called ‘reverse transition’ leads to a very big difference in infection with hepatitis C virus as well as reduced risk of overdose and reduced risk of other bacterial infections. Even though these people continued to use drugs, they were doing it in a way that was much safer.”

In an effort to examine the prevalence and characteristics of reverse transitions, Dr. Des Jarlais and his associates recruited injecting and noninjecting drug users aged 18 years and older from the Mount Sinai Beth Israel detoxification and methadone maintenance programs in New York City from 2000 to 2017. The researchers obtained informed consent and conducted a structured interview that included questions on why former injectors had ceased injecting drugs, along with testing for HIV and HCV.

Doug Brunk/MDEdge News

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The use of ultrasound is often overlooked when it could very well aid in the diagnosis of a critical illness in a shorter amount of time, while eliminating potential risks that come with many of the usually administered tests.

In 2013, Seth Koenig, MD, FCCP, of Hofstra School of Medicine in New Hyde Park, New York, noticed the need to educate providers about the use of ultrasound in the ICU. Dr. Koenig approached Richard Irwin, MD, Master FCCP, and Editor in Chief of the journal CHEST, with an idea for a new section in the journal. So began “Ultrasound Corner,” an online, video-based series in the journal that provides readers with real cases where ultrasound has played a large role in diagnostic patient care.

Each month, the journal receives two to four submissions from chest medicine clinicians who want to share their critical care ultrasound patient stories. One to two stories are selected and published monthly with real video images that are explained in the manuscript and in a narration done by Dr. Koenig.

“This creates a section where clinicians worldwide can share their experiences so that others may incorporate different methods of diagnosis into their practice,” said Dr. Koenig. “This method of learning challenges the readers to interpret images and integrate the results into a patient management plan.”

Dr. Koenig recommends that clinicians who have experienced benefit using ultrasound in critical care situations submit their cases so that viewers can learn from each other. Share the knowledge you’ve gained from your patient cases. Visit https://mc.manuscriptcentral.com/chest, log in to your account, and click “Start a New Submission” under the “Author” section.  

More importantly, Dr. Koenig encourages the journal readership to explore Ultrasound Corner (https://journal.chestnet.org/ultrasound) every month in CHEST to learn of different courses of diagnosis and treatment being used to strengthen patient diagnostic and management plans in new, evolving ways.

The use of ultrasound is often overlooked when it could very well aid in the diagnosis of a critical illness in a shorter amount of time, while eliminating potential risks that come with many of the usually administered tests.

In 2013, Seth Koenig, MD, FCCP, of Hofstra School of Medicine in New Hyde Park, New York, noticed the need to educate providers about the use of ultrasound in the ICU. Dr. Koenig approached Richard Irwin, MD, Master FCCP, and Editor in Chief of the journal CHEST, with an idea for a new section in the journal. So began “Ultrasound Corner,” an online, video-based series in the journal that provides readers with real cases where ultrasound has played a large role in diagnostic patient care.

Each month, the journal receives two to four submissions from chest medicine clinicians who want to share their critical care ultrasound patient stories. One to two stories are selected and published monthly with real video images that are explained in the manuscript and in a narration done by Dr. Koenig.

“This creates a section where clinicians worldwide can share their experiences so that others may incorporate different methods of diagnosis into their practice,” said Dr. Koenig. “This method of learning challenges the readers to interpret images and integrate the results into a patient management plan.”

Dr. Koenig recommends that clinicians who have experienced benefit using ultrasound in critical care situations submit their cases so that viewers can learn from each other. Share the knowledge you’ve gained from your patient cases. Visit https://mc.manuscriptcentral.com/chest, log in to your account, and click “Start a New Submission” under the “Author” section.  

More importantly, Dr. Koenig encourages the journal readership to explore Ultrasound Corner (https://journal.chestnet.org/ultrasound) every month in CHEST to learn of different courses of diagnosis and treatment being used to strengthen patient diagnostic and management plans in new, evolving ways.

The use of ultrasound is often overlooked when it could very well aid in the diagnosis of a critical illness in a shorter amount of time, while eliminating potential risks that come with many of the usually administered tests.

In 2013, Seth Koenig, MD, FCCP, of Hofstra School of Medicine in New Hyde Park, New York, noticed the need to educate providers about the use of ultrasound in the ICU. Dr. Koenig approached Richard Irwin, MD, Master FCCP, and Editor in Chief of the journal CHEST, with an idea for a new section in the journal. So began “Ultrasound Corner,” an online, video-based series in the journal that provides readers with real cases where ultrasound has played a large role in diagnostic patient care.

Each month, the journal receives two to four submissions from chest medicine clinicians who want to share their critical care ultrasound patient stories. One to two stories are selected and published monthly with real video images that are explained in the manuscript and in a narration done by Dr. Koenig.

“This creates a section where clinicians worldwide can share their experiences so that others may incorporate different methods of diagnosis into their practice,” said Dr. Koenig. “This method of learning challenges the readers to interpret images and integrate the results into a patient management plan.”

Dr. Koenig recommends that clinicians who have experienced benefit using ultrasound in critical care situations submit their cases so that viewers can learn from each other. Share the knowledge you’ve gained from your patient cases. Visit https://mc.manuscriptcentral.com/chest, log in to your account, and click “Start a New Submission” under the “Author” section.  

More importantly, Dr. Koenig encourages the journal readership to explore Ultrasound Corner (https://journal.chestnet.org/ultrasound) every month in CHEST to learn of different courses of diagnosis and treatment being used to strengthen patient diagnostic and management plans in new, evolving ways.