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Fewer than half of health care providers offer routine contraception along with emergency contraception
Key clinical point: In 2019, 41% of health care providers prescribed regular contraception at the same time as emergency contraception; this percentage was an increase from 2013-2014, but falls short of the US Selected Practice Recommendations for Contraceptive Use, first released in 2013.
Major finding: Health care providers in 2019 were more likely than health care providers in 2013 and 2014 to prescribe or provide contraception when providing emergency contraception (adjusted prevalence ratio 1.26) and to provide a copper intrauterine device (adjusted prevalence ratio 3.87). A total of 41% frequently provided or prescribed regular contraception at the time of providing emergency contraceptive pills (ECP), 16% of providers in 2019 frequently provided an advance prescription for ECPs, 8% provided a copper intrauterine device as emergency contraception, and 7% provided an advance supply of ECPs.
Study details: The data come from two cross-sectional surveys mailed to office-based physicians and public-sector health care providers in the United States in 2013-14 (2,060 respondents) and 2019 (1,420 respondents).
Disclosures: The study was published on behalf of the Jacobs Institute of Women’s Health. The researchers had no financial conflicts to disclose.
Source: Pagano HP et al. Womens Health Issues. 2021 Sep 9. doi: 10.1016/j.whi.2021.07.006.
Key clinical point: In 2019, 41% of health care providers prescribed regular contraception at the same time as emergency contraception; this percentage was an increase from 2013-2014, but falls short of the US Selected Practice Recommendations for Contraceptive Use, first released in 2013.
Major finding: Health care providers in 2019 were more likely than health care providers in 2013 and 2014 to prescribe or provide contraception when providing emergency contraception (adjusted prevalence ratio 1.26) and to provide a copper intrauterine device (adjusted prevalence ratio 3.87). A total of 41% frequently provided or prescribed regular contraception at the time of providing emergency contraceptive pills (ECP), 16% of providers in 2019 frequently provided an advance prescription for ECPs, 8% provided a copper intrauterine device as emergency contraception, and 7% provided an advance supply of ECPs.
Study details: The data come from two cross-sectional surveys mailed to office-based physicians and public-sector health care providers in the United States in 2013-14 (2,060 respondents) and 2019 (1,420 respondents).
Disclosures: The study was published on behalf of the Jacobs Institute of Women’s Health. The researchers had no financial conflicts to disclose.
Source: Pagano HP et al. Womens Health Issues. 2021 Sep 9. doi: 10.1016/j.whi.2021.07.006.
Key clinical point: In 2019, 41% of health care providers prescribed regular contraception at the same time as emergency contraception; this percentage was an increase from 2013-2014, but falls short of the US Selected Practice Recommendations for Contraceptive Use, first released in 2013.
Major finding: Health care providers in 2019 were more likely than health care providers in 2013 and 2014 to prescribe or provide contraception when providing emergency contraception (adjusted prevalence ratio 1.26) and to provide a copper intrauterine device (adjusted prevalence ratio 3.87). A total of 41% frequently provided or prescribed regular contraception at the time of providing emergency contraceptive pills (ECP), 16% of providers in 2019 frequently provided an advance prescription for ECPs, 8% provided a copper intrauterine device as emergency contraception, and 7% provided an advance supply of ECPs.
Study details: The data come from two cross-sectional surveys mailed to office-based physicians and public-sector health care providers in the United States in 2013-14 (2,060 respondents) and 2019 (1,420 respondents).
Disclosures: The study was published on behalf of the Jacobs Institute of Women’s Health. The researchers had no financial conflicts to disclose.
Source: Pagano HP et al. Womens Health Issues. 2021 Sep 9. doi: 10.1016/j.whi.2021.07.006.
LARCs prompt increase in body mass index among adolescents
Key clinical point: Use of progestin-releasing long-acting reversible contraceptives (LARC) was linked to weight gain in nulliparous adolescents aged 14-19 years; 25% of the study population was obese, and significant interaction effect (P = .017) showed a greater increase in BMI in this subset of participants who used an LARC compared to a copper intrauterine device (IUD).
Major finding: The mean change in body mass index among teen girls who used LARC was an increase of 0.73 kg/m2; BMI increases averaged 0.92 kg/m2 for those who used an etornogestrel subdermal implant plus levonorgestrel intrauterine device (LNG-IUD) and 0.37 kg/m2 in those who used a copper IUD.
Study details: The data come from a retrospective cohort study of 196 adolescents aged 14-19 years who underwent placement of long-acting reversible contraceptive devices.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Scott N et al. J Pediatr Adolesc Gynecol. 2021 Aug 10. doi: 10.1016/j.jpag.2021.08.004.
Key clinical point: Use of progestin-releasing long-acting reversible contraceptives (LARC) was linked to weight gain in nulliparous adolescents aged 14-19 years; 25% of the study population was obese, and significant interaction effect (P = .017) showed a greater increase in BMI in this subset of participants who used an LARC compared to a copper intrauterine device (IUD).
Major finding: The mean change in body mass index among teen girls who used LARC was an increase of 0.73 kg/m2; BMI increases averaged 0.92 kg/m2 for those who used an etornogestrel subdermal implant plus levonorgestrel intrauterine device (LNG-IUD) and 0.37 kg/m2 in those who used a copper IUD.
Study details: The data come from a retrospective cohort study of 196 adolescents aged 14-19 years who underwent placement of long-acting reversible contraceptive devices.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Scott N et al. J Pediatr Adolesc Gynecol. 2021 Aug 10. doi: 10.1016/j.jpag.2021.08.004.
Key clinical point: Use of progestin-releasing long-acting reversible contraceptives (LARC) was linked to weight gain in nulliparous adolescents aged 14-19 years; 25% of the study population was obese, and significant interaction effect (P = .017) showed a greater increase in BMI in this subset of participants who used an LARC compared to a copper intrauterine device (IUD).
Major finding: The mean change in body mass index among teen girls who used LARC was an increase of 0.73 kg/m2; BMI increases averaged 0.92 kg/m2 for those who used an etornogestrel subdermal implant plus levonorgestrel intrauterine device (LNG-IUD) and 0.37 kg/m2 in those who used a copper IUD.
Study details: The data come from a retrospective cohort study of 196 adolescents aged 14-19 years who underwent placement of long-acting reversible contraceptive devices.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Scott N et al. J Pediatr Adolesc Gynecol. 2021 Aug 10. doi: 10.1016/j.jpag.2021.08.004.
Millions of women view YouTube videos on self-removal of long-acting contraception
Key clinical point: A review of 58 YouTube videos on removal of long-acting reversible contraception showed more than 4 million views overall; reasons for removal included negative side effects, fear of side effects, and desire for pregnancy.
Major finding: Most of the women who created the 58 videos were white (53%), 31% were Black, and 14% were Latina. Of these, 56 of 58 successfully removed their device and described the experience as positive in terms of ease of removal.
Study details: The data come from a review of 58 videos on self-removal of long-acting reversible contraception based on YouTube keyword searches. The videos included 48 individuals removing an intrauterine device and 10 removing an implant.
Disclosures: The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and by the National Science Foundation Graduate Research Fellowship Program. The researchers had no financial conflicts to disclose.
Source: Broussard K and Becker A. Contraception. 2021 Aug 13. doi: 10.1016/j.contraception.2021.08.002.
Key clinical point: A review of 58 YouTube videos on removal of long-acting reversible contraception showed more than 4 million views overall; reasons for removal included negative side effects, fear of side effects, and desire for pregnancy.
Major finding: Most of the women who created the 58 videos were white (53%), 31% were Black, and 14% were Latina. Of these, 56 of 58 successfully removed their device and described the experience as positive in terms of ease of removal.
Study details: The data come from a review of 58 videos on self-removal of long-acting reversible contraception based on YouTube keyword searches. The videos included 48 individuals removing an intrauterine device and 10 removing an implant.
Disclosures: The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and by the National Science Foundation Graduate Research Fellowship Program. The researchers had no financial conflicts to disclose.
Source: Broussard K and Becker A. Contraception. 2021 Aug 13. doi: 10.1016/j.contraception.2021.08.002.
Key clinical point: A review of 58 YouTube videos on removal of long-acting reversible contraception showed more than 4 million views overall; reasons for removal included negative side effects, fear of side effects, and desire for pregnancy.
Major finding: Most of the women who created the 58 videos were white (53%), 31% were Black, and 14% were Latina. Of these, 56 of 58 successfully removed their device and described the experience as positive in terms of ease of removal.
Study details: The data come from a review of 58 videos on self-removal of long-acting reversible contraception based on YouTube keyword searches. The videos included 48 individuals removing an intrauterine device and 10 removing an implant.
Disclosures: The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and by the National Science Foundation Graduate Research Fellowship Program. The researchers had no financial conflicts to disclose.
Source: Broussard K and Becker A. Contraception. 2021 Aug 13. doi: 10.1016/j.contraception.2021.08.002.
Counseling promotes contraception in hospitalized adolescents
Key clinical point: Among young women, the average Pregnancy Risk Index (PRI) was 4.75; individuals using teratogenic medication had the lowest PRI (0.32); 88% of these individuals used reversible contraception and 31% used long-acting reversible contraception.
Major finding: Approximately 73% of sexually active young women received contraceptive counseling, which was associated with a significantly increased use of reversible and dual contraception, but not long-acting reversible contraception. At last reported vaginal sex, 65% reported using condoms, 49% reported using reversible contraception, and 12% reported using long-acting reversible contraception.
Study details: The data come from a cross-sectional survey of 177 hospitalized females aged 14 to 21 years at two academic medical centers; the surveys assessed sexual health behaviors, contraceptive use, contraceptive counseling, and pregnancy complications. Researchers calculated the Pregnancy Risk Index (the number per 100 individuals who will become pregnant in the next year).
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Hunt JA et al. Hosp Pediatr. 2021 Sep 13. doi: 10.1542/hpeds.2021-005810.
Key clinical point: Among young women, the average Pregnancy Risk Index (PRI) was 4.75; individuals using teratogenic medication had the lowest PRI (0.32); 88% of these individuals used reversible contraception and 31% used long-acting reversible contraception.
Major finding: Approximately 73% of sexually active young women received contraceptive counseling, which was associated with a significantly increased use of reversible and dual contraception, but not long-acting reversible contraception. At last reported vaginal sex, 65% reported using condoms, 49% reported using reversible contraception, and 12% reported using long-acting reversible contraception.
Study details: The data come from a cross-sectional survey of 177 hospitalized females aged 14 to 21 years at two academic medical centers; the surveys assessed sexual health behaviors, contraceptive use, contraceptive counseling, and pregnancy complications. Researchers calculated the Pregnancy Risk Index (the number per 100 individuals who will become pregnant in the next year).
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Hunt JA et al. Hosp Pediatr. 2021 Sep 13. doi: 10.1542/hpeds.2021-005810.
Key clinical point: Among young women, the average Pregnancy Risk Index (PRI) was 4.75; individuals using teratogenic medication had the lowest PRI (0.32); 88% of these individuals used reversible contraception and 31% used long-acting reversible contraception.
Major finding: Approximately 73% of sexually active young women received contraceptive counseling, which was associated with a significantly increased use of reversible and dual contraception, but not long-acting reversible contraception. At last reported vaginal sex, 65% reported using condoms, 49% reported using reversible contraception, and 12% reported using long-acting reversible contraception.
Study details: The data come from a cross-sectional survey of 177 hospitalized females aged 14 to 21 years at two academic medical centers; the surveys assessed sexual health behaviors, contraceptive use, contraceptive counseling, and pregnancy complications. Researchers calculated the Pregnancy Risk Index (the number per 100 individuals who will become pregnant in the next year).
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Hunt JA et al. Hosp Pediatr. 2021 Sep 13. doi: 10.1542/hpeds.2021-005810.
Contraindication to estrogen drives contraception choices
Key clinical point: Women with potential contraindications to estrogen were significantly more likely than those without contraindication to use permanent contraception or no contraception
Major finding: A total of 15% of women with potential contraindications to estrogen reported using the pill, patch, or ring, compared to 20% of women with no potential contraindications to estrogen. Women with contraindications to estrogen also were significantly more likely than those without contraindications to use permanent contraception (odds ratio vs. patch, pill, or ring 1.48) or no contraception (OR vs. patch, pill, or ring 1.37).
Study details: The data come from surveys of 32,098 women aged 18-44 years who participated in the 2017 Behavioral Risk Factor Surveillance System, 16% of whom had at least one potential contraindication to estrogen.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Erly SJ et al. J Womens Health. 2021 Sep 1. doi: 10.1089/jwh.2020.8905.
Key clinical point: Women with potential contraindications to estrogen were significantly more likely than those without contraindication to use permanent contraception or no contraception
Major finding: A total of 15% of women with potential contraindications to estrogen reported using the pill, patch, or ring, compared to 20% of women with no potential contraindications to estrogen. Women with contraindications to estrogen also were significantly more likely than those without contraindications to use permanent contraception (odds ratio vs. patch, pill, or ring 1.48) or no contraception (OR vs. patch, pill, or ring 1.37).
Study details: The data come from surveys of 32,098 women aged 18-44 years who participated in the 2017 Behavioral Risk Factor Surveillance System, 16% of whom had at least one potential contraindication to estrogen.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Erly SJ et al. J Womens Health. 2021 Sep 1. doi: 10.1089/jwh.2020.8905.
Key clinical point: Women with potential contraindications to estrogen were significantly more likely than those without contraindication to use permanent contraception or no contraception
Major finding: A total of 15% of women with potential contraindications to estrogen reported using the pill, patch, or ring, compared to 20% of women with no potential contraindications to estrogen. Women with contraindications to estrogen also were significantly more likely than those without contraindications to use permanent contraception (odds ratio vs. patch, pill, or ring 1.48) or no contraception (OR vs. patch, pill, or ring 1.37).
Study details: The data come from surveys of 32,098 women aged 18-44 years who participated in the 2017 Behavioral Risk Factor Surveillance System, 16% of whom had at least one potential contraindication to estrogen.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Erly SJ et al. J Womens Health. 2021 Sep 1. doi: 10.1089/jwh.2020.8905.
Levonorgestrel expulsion rates are similar for contraception or heavy bleeding
Key clinical point: Expulsion rates were similar for women using a 52 mg levonorgestrel intrauterine system for heavy menstrual bleeding and those who used it for contraception; a history of cesarean delivery increased the risk of expulsion in both groups.
Major finding: Expulsion of the device occurred in 548 of the women with heavy menstrual bleeding (5.6%) and 315 of the women using the device for contraception (5.6%). The odds ratio for expulsion for women with a history of cesarean delivery in either group was 1.93.
Study details: The data come from an audit of 548 women who used a 52 mg levonorgestrel intrauterine system to manage heavy menstrual bleeding and 5,655 who used it for contraception.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Furlan RM et al. Contraception. 2021 Sep 5. doi: 10.1016/j.contraception.2021.09.001.
Key clinical point: Expulsion rates were similar for women using a 52 mg levonorgestrel intrauterine system for heavy menstrual bleeding and those who used it for contraception; a history of cesarean delivery increased the risk of expulsion in both groups.
Major finding: Expulsion of the device occurred in 548 of the women with heavy menstrual bleeding (5.6%) and 315 of the women using the device for contraception (5.6%). The odds ratio for expulsion for women with a history of cesarean delivery in either group was 1.93.
Study details: The data come from an audit of 548 women who used a 52 mg levonorgestrel intrauterine system to manage heavy menstrual bleeding and 5,655 who used it for contraception.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Furlan RM et al. Contraception. 2021 Sep 5. doi: 10.1016/j.contraception.2021.09.001.
Key clinical point: Expulsion rates were similar for women using a 52 mg levonorgestrel intrauterine system for heavy menstrual bleeding and those who used it for contraception; a history of cesarean delivery increased the risk of expulsion in both groups.
Major finding: Expulsion of the device occurred in 548 of the women with heavy menstrual bleeding (5.6%) and 315 of the women using the device for contraception (5.6%). The odds ratio for expulsion for women with a history of cesarean delivery in either group was 1.93.
Study details: The data come from an audit of 548 women who used a 52 mg levonorgestrel intrauterine system to manage heavy menstrual bleeding and 5,655 who used it for contraception.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Furlan RM et al. Contraception. 2021 Sep 5. doi: 10.1016/j.contraception.2021.09.001.
Progestogen-only pill shows promise as non-prescription contraception
Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women
Major finding: Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.
Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.
Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.
Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.
Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women
Major finding: Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.
Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.
Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.
Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.
Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women
Major finding: Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.
Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.
Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.
Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.
Contraception prescription patterns vary by specialty and geography
Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.
Major finding: Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.
Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring.
Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.
Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.
Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.
Major finding: Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.
Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring.
Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.
Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.
Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.
Major finding: Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.
Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring.
Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.
Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.
FDA panel backs Pfizer's COVID booster for 65 and older, those at high risk
An expert panel that advises the Food and Drug Administration on its regulatory decisions voted Sept. 17 against recommending third doses of Pfizer’s COVID-19 vaccine for younger Americans.
But they didn’t kill the idea of booster shots completely.
In a dramatic, last-minute pivot, the 18 members of the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend the FDA make boosters available for seniors and others at high risk of severe outcomes from COVID-19, including health care workers.
The 16-2 vote was a rebuttal to Pfizer’s initial request. The company had asked the FDA to allow it to offer third doses to all Americans over the age of 16 at least six months after their second shot.
The company requested an amendment to the full approval the FDA granted in August. That is the typical way boosters are authorized in the U.S., but it requires a higher bar of evidence and more regulatory scrutiny than the agency had been able to give since Pfizer filed for the change just days after its vaccine was granted full approval.
The committee’s actions were also a rebuff to the Biden administration, which announced before the FDA approved them that boosters would be rolled out to the general public Sept. 20. The announcement triggered the resignations of two of the agency’s top vaccine reviewers, who both participated in the Sept. 17 meeting.
After initially voting against Pfizer’s request to amend its license, the committee then worked on the fly with FDA officials to craft a strategy that would allow third doses to be offered under an emergency use authorization (EUA).
An EUA requires a lower standard of evidence and is more specific. It will restrict third doses to a more defined population than a change to the license would. It will also require Pfizer to continue to monitor the safety of third doses as they begin to be administered.
“This should demonstrate to the public that the members of this committee are independent of the FDA and that we do, in fact, bring our voices to the table when we are asked to serve on this committee,” said Archana Chattergee, MD, a pediatric infectious disease specialist who is dean of the Chicago Medical School at Rosalind Franklin University in Illinois.
The FDA doesn’t have to follow the committee’s recommendation, but almost certainly will, though regulators said they may still make some changes.
“We are not bound at FDA by your vote, we can tweak this,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA. Dr. Marks participated in the meeting and helped to draft the revised proposal.
If the FDA issues the recommended EUA, a council of independent advisors to the CDC will make specific recommendations about how the third doses should be given. After the CDC director weighs in, boosters will begin rolling out to the public.
Moderna submitted data to the FDA on Sept. 1 in support of adding a booster dose to its regimen. The agency has not yet scheduled a public review of that data.
The Biden administration is prepared to administer shots as soon as they get the green light, Surgeon General Vivek Murthy, MD, said at a White House briefing earlier Sept. 17.
"This process is consistent with what we outlined in August where our goals were to stay ahead of the virus," Dr. Murthy said. "Our goal then and now is to protect the health and well-being of the public. As soon as the FDA and CDC complete their evaluations, we will be ready to move forward accordingly."
He added, "We've used this time since our August announcement to communicate and coordinate with pharmacy partners, nursing homes, states, and localities."
White House COVID-19 Response Coordinator Jeff Zients said vaccine supply is "in good shape for all Americans to get boosters as recommended."
Taking cues from Israel
In considering Pfizer’s original request, the committee overwhelmingly felt that they didn’t have enough information to say that the benefits of an additional dose of vaccine in 16- and 17-year-olds would outweigh its risk. Teens have the highest risk of rare heart inflammation after vaccination, a side effect known as myocarditis. It is not known how the vaccines are causing these cases of heart swelling. Most who have been diagnosed with the condition have recovered, though some have needed hospital care.
Pfizer didn’t include 16- and 17-year-olds in its studies of boosters, which included about 300 people between the ages of 18 and 55. The company acknowledged that gap in its data but pointed to FDA guidance that said evidence from adults could be extrapolated to teens.
“We don’t know that much about risks,” said committee member Eric Rubin, MD, who is editor-in-chief of the New England Journal of Medicine.
Much of the data on the potential benefits and harms of third Pfizer doses comes from Israel, which first began rolling out boosters to older adults in July.
In a highly anticipated presentation, Sharon Alroy-Preis, Israel’s director of public health services, joined the meeting to describe Israel’s experience with boosters.
Israel began to see a third surge of COVID-19 cases in December.
“This was after having two waves and two lockdowns,” Ms. Alroy-Preis said. By the third surge, she said, Israelis were tired.
“We decided on a lockdown, but the compliance of the public wasn’t as it was in the previous two waves,” she said.
Then the vaccine arrived. Israel started vaccinations as soon as the FDA approved it, and they quickly vaccinated a high percentage of their population, about 3 months faster than the rest of the world.
All vaccinations are reported and tracked by the Ministry of Health, so the country is able to keep close tabs on how well the shots are working.
As vaccines rolled out, cases fell dramatically. The pandemic seemed to be behind them. Delta arrived in March. By June, their cases were doubling every 10 days, despite about 80% of their most vulnerable adults being fully vaccinated, she said.
Most concerning was that about 60% of severe cases were breakthrough cases in fully vaccinated individuals.
“We had to stop and figure out, was this a Delta issue,” she said. “Or was this a waning immunity issue.”
“We had some clue that it might not be the Delta variant, at least not alone,” she said.
People who had originally been first in line for the vaccines, seniors and health care workers, were having the highest rates of breakthrough infections. People further away from their second dose were more likely to get a breakthrough infection.
Ms. Alroy-Preis said that if they had not started booster doses in July, their hospitals would have been overwhelmed. They had projected that they would have 2,000 cases in the hospital each day.
Boosters have helped to flatten the curve, though they are still seeing a significant number of infections.
Data from Israel presented at the meeting show boosters are largely safe and effective at reducing severe outcomes in seniors. Israeli experience also showed that third doses, which generate very high levels of neutralizing antibodies—the first and fastest line of the body’s immune defense - -may also slow transmission of the virus.
Key differences in the U.S.
The benefit of slowing down the explosive spread of a highly contagious virus was tantalizing, but many members noted that circumstances in Israel are very different than in the United States. Israel went into its current Delta surge already having high levels of vaccination in its population. They also relied on the Pfizer vaccine almost exclusively for their campaign.
The United States used a different mix of vaccines – Pfizer, Moderna, and Johnson & Johnson -- and doesn’t have the same high level of vaccination coverage of its population.
In the United States, transmission is mainly being driven by unvaccinated people, Dr. Rubin noted.
“That really means the primary benefit is going to be in reducing disease,” he said, “And we know the people who are going to benefit from that … and those are the kinds of people the FDA has already approved a third dose for,” he said, referring to those with underlying health conditions.
But Israel only began vaccinating younger people a few weeks ago. Most are still within a window where rare risks like myocarditis could appear, Rubin noted.
He and other members of the committee said they wished they had more information about the safety of third doses in younger adults.
“We don’t have that right now, and I don’t think I would be comfortable giving it to a 16-year-old,” he said.
At the same time, the primary benefit for third doses would be in preventing severe disease, and overall, data from the United States and other countries show that two doses of the vaccines remain highly effective at preventing hospitalization and death.
Asked why Israel began to see more severe cases in fully vaccinated people, the CDC’s Sara Oliver, MD, a disease detective with the CDC, said it was probably due to a mix of factors including the fact that Israel defines severe cases a little differently.
In the United States, a severe case is generally a person who has to be hospitalized or who has died from the infection. In Israel, a person with a severe case is someone who has an elevated respiratory rate and someone who has a blood oxygen level less than 94%. In the United States, that kind of patient wouldn’t necessarily be hospitalized.
In the end, one of the two committee members who wanted full approval for Pfizer’s third doses said he was satisfied with the outcome.
Mark Sawyer, MD, a professor of pediatrics and infectious disease at the University of California at San Diego, said he voted yes on the first question because he thought full approval was the best way to give doctors the flexibility to prescribe the shots to vulnerable individuals.
“I’m really glad we authorized a vaccine for a third dose, and I plan to go out and get my vaccine this afternoon,” Dr. Sawyer said, noting that he was at high risk as a health care provider.
This article was updated 9/19/21.
A version of this article first appeared on Medscape.com.
An expert panel that advises the Food and Drug Administration on its regulatory decisions voted Sept. 17 against recommending third doses of Pfizer’s COVID-19 vaccine for younger Americans.
But they didn’t kill the idea of booster shots completely.
In a dramatic, last-minute pivot, the 18 members of the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend the FDA make boosters available for seniors and others at high risk of severe outcomes from COVID-19, including health care workers.
The 16-2 vote was a rebuttal to Pfizer’s initial request. The company had asked the FDA to allow it to offer third doses to all Americans over the age of 16 at least six months after their second shot.
The company requested an amendment to the full approval the FDA granted in August. That is the typical way boosters are authorized in the U.S., but it requires a higher bar of evidence and more regulatory scrutiny than the agency had been able to give since Pfizer filed for the change just days after its vaccine was granted full approval.
The committee’s actions were also a rebuff to the Biden administration, which announced before the FDA approved them that boosters would be rolled out to the general public Sept. 20. The announcement triggered the resignations of two of the agency’s top vaccine reviewers, who both participated in the Sept. 17 meeting.
After initially voting against Pfizer’s request to amend its license, the committee then worked on the fly with FDA officials to craft a strategy that would allow third doses to be offered under an emergency use authorization (EUA).
An EUA requires a lower standard of evidence and is more specific. It will restrict third doses to a more defined population than a change to the license would. It will also require Pfizer to continue to monitor the safety of third doses as they begin to be administered.
“This should demonstrate to the public that the members of this committee are independent of the FDA and that we do, in fact, bring our voices to the table when we are asked to serve on this committee,” said Archana Chattergee, MD, a pediatric infectious disease specialist who is dean of the Chicago Medical School at Rosalind Franklin University in Illinois.
The FDA doesn’t have to follow the committee’s recommendation, but almost certainly will, though regulators said they may still make some changes.
“We are not bound at FDA by your vote, we can tweak this,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA. Dr. Marks participated in the meeting and helped to draft the revised proposal.
If the FDA issues the recommended EUA, a council of independent advisors to the CDC will make specific recommendations about how the third doses should be given. After the CDC director weighs in, boosters will begin rolling out to the public.
Moderna submitted data to the FDA on Sept. 1 in support of adding a booster dose to its regimen. The agency has not yet scheduled a public review of that data.
The Biden administration is prepared to administer shots as soon as they get the green light, Surgeon General Vivek Murthy, MD, said at a White House briefing earlier Sept. 17.
"This process is consistent with what we outlined in August where our goals were to stay ahead of the virus," Dr. Murthy said. "Our goal then and now is to protect the health and well-being of the public. As soon as the FDA and CDC complete their evaluations, we will be ready to move forward accordingly."
He added, "We've used this time since our August announcement to communicate and coordinate with pharmacy partners, nursing homes, states, and localities."
White House COVID-19 Response Coordinator Jeff Zients said vaccine supply is "in good shape for all Americans to get boosters as recommended."
Taking cues from Israel
In considering Pfizer’s original request, the committee overwhelmingly felt that they didn’t have enough information to say that the benefits of an additional dose of vaccine in 16- and 17-year-olds would outweigh its risk. Teens have the highest risk of rare heart inflammation after vaccination, a side effect known as myocarditis. It is not known how the vaccines are causing these cases of heart swelling. Most who have been diagnosed with the condition have recovered, though some have needed hospital care.
Pfizer didn’t include 16- and 17-year-olds in its studies of boosters, which included about 300 people between the ages of 18 and 55. The company acknowledged that gap in its data but pointed to FDA guidance that said evidence from adults could be extrapolated to teens.
“We don’t know that much about risks,” said committee member Eric Rubin, MD, who is editor-in-chief of the New England Journal of Medicine.
Much of the data on the potential benefits and harms of third Pfizer doses comes from Israel, which first began rolling out boosters to older adults in July.
In a highly anticipated presentation, Sharon Alroy-Preis, Israel’s director of public health services, joined the meeting to describe Israel’s experience with boosters.
Israel began to see a third surge of COVID-19 cases in December.
“This was after having two waves and two lockdowns,” Ms. Alroy-Preis said. By the third surge, she said, Israelis were tired.
“We decided on a lockdown, but the compliance of the public wasn’t as it was in the previous two waves,” she said.
Then the vaccine arrived. Israel started vaccinations as soon as the FDA approved it, and they quickly vaccinated a high percentage of their population, about 3 months faster than the rest of the world.
All vaccinations are reported and tracked by the Ministry of Health, so the country is able to keep close tabs on how well the shots are working.
As vaccines rolled out, cases fell dramatically. The pandemic seemed to be behind them. Delta arrived in March. By June, their cases were doubling every 10 days, despite about 80% of their most vulnerable adults being fully vaccinated, she said.
Most concerning was that about 60% of severe cases were breakthrough cases in fully vaccinated individuals.
“We had to stop and figure out, was this a Delta issue,” she said. “Or was this a waning immunity issue.”
“We had some clue that it might not be the Delta variant, at least not alone,” she said.
People who had originally been first in line for the vaccines, seniors and health care workers, were having the highest rates of breakthrough infections. People further away from their second dose were more likely to get a breakthrough infection.
Ms. Alroy-Preis said that if they had not started booster doses in July, their hospitals would have been overwhelmed. They had projected that they would have 2,000 cases in the hospital each day.
Boosters have helped to flatten the curve, though they are still seeing a significant number of infections.
Data from Israel presented at the meeting show boosters are largely safe and effective at reducing severe outcomes in seniors. Israeli experience also showed that third doses, which generate very high levels of neutralizing antibodies—the first and fastest line of the body’s immune defense - -may also slow transmission of the virus.
Key differences in the U.S.
The benefit of slowing down the explosive spread of a highly contagious virus was tantalizing, but many members noted that circumstances in Israel are very different than in the United States. Israel went into its current Delta surge already having high levels of vaccination in its population. They also relied on the Pfizer vaccine almost exclusively for their campaign.
The United States used a different mix of vaccines – Pfizer, Moderna, and Johnson & Johnson -- and doesn’t have the same high level of vaccination coverage of its population.
In the United States, transmission is mainly being driven by unvaccinated people, Dr. Rubin noted.
“That really means the primary benefit is going to be in reducing disease,” he said, “And we know the people who are going to benefit from that … and those are the kinds of people the FDA has already approved a third dose for,” he said, referring to those with underlying health conditions.
But Israel only began vaccinating younger people a few weeks ago. Most are still within a window where rare risks like myocarditis could appear, Rubin noted.
He and other members of the committee said they wished they had more information about the safety of third doses in younger adults.
“We don’t have that right now, and I don’t think I would be comfortable giving it to a 16-year-old,” he said.
At the same time, the primary benefit for third doses would be in preventing severe disease, and overall, data from the United States and other countries show that two doses of the vaccines remain highly effective at preventing hospitalization and death.
Asked why Israel began to see more severe cases in fully vaccinated people, the CDC’s Sara Oliver, MD, a disease detective with the CDC, said it was probably due to a mix of factors including the fact that Israel defines severe cases a little differently.
In the United States, a severe case is generally a person who has to be hospitalized or who has died from the infection. In Israel, a person with a severe case is someone who has an elevated respiratory rate and someone who has a blood oxygen level less than 94%. In the United States, that kind of patient wouldn’t necessarily be hospitalized.
In the end, one of the two committee members who wanted full approval for Pfizer’s third doses said he was satisfied with the outcome.
Mark Sawyer, MD, a professor of pediatrics and infectious disease at the University of California at San Diego, said he voted yes on the first question because he thought full approval was the best way to give doctors the flexibility to prescribe the shots to vulnerable individuals.
“I’m really glad we authorized a vaccine for a third dose, and I plan to go out and get my vaccine this afternoon,” Dr. Sawyer said, noting that he was at high risk as a health care provider.
This article was updated 9/19/21.
A version of this article first appeared on Medscape.com.
An expert panel that advises the Food and Drug Administration on its regulatory decisions voted Sept. 17 against recommending third doses of Pfizer’s COVID-19 vaccine for younger Americans.
But they didn’t kill the idea of booster shots completely.
In a dramatic, last-minute pivot, the 18 members of the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend the FDA make boosters available for seniors and others at high risk of severe outcomes from COVID-19, including health care workers.
The 16-2 vote was a rebuttal to Pfizer’s initial request. The company had asked the FDA to allow it to offer third doses to all Americans over the age of 16 at least six months after their second shot.
The company requested an amendment to the full approval the FDA granted in August. That is the typical way boosters are authorized in the U.S., but it requires a higher bar of evidence and more regulatory scrutiny than the agency had been able to give since Pfizer filed for the change just days after its vaccine was granted full approval.
The committee’s actions were also a rebuff to the Biden administration, which announced before the FDA approved them that boosters would be rolled out to the general public Sept. 20. The announcement triggered the resignations of two of the agency’s top vaccine reviewers, who both participated in the Sept. 17 meeting.
After initially voting against Pfizer’s request to amend its license, the committee then worked on the fly with FDA officials to craft a strategy that would allow third doses to be offered under an emergency use authorization (EUA).
An EUA requires a lower standard of evidence and is more specific. It will restrict third doses to a more defined population than a change to the license would. It will also require Pfizer to continue to monitor the safety of third doses as they begin to be administered.
“This should demonstrate to the public that the members of this committee are independent of the FDA and that we do, in fact, bring our voices to the table when we are asked to serve on this committee,” said Archana Chattergee, MD, a pediatric infectious disease specialist who is dean of the Chicago Medical School at Rosalind Franklin University in Illinois.
The FDA doesn’t have to follow the committee’s recommendation, but almost certainly will, though regulators said they may still make some changes.
“We are not bound at FDA by your vote, we can tweak this,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA. Dr. Marks participated in the meeting and helped to draft the revised proposal.
If the FDA issues the recommended EUA, a council of independent advisors to the CDC will make specific recommendations about how the third doses should be given. After the CDC director weighs in, boosters will begin rolling out to the public.
Moderna submitted data to the FDA on Sept. 1 in support of adding a booster dose to its regimen. The agency has not yet scheduled a public review of that data.
The Biden administration is prepared to administer shots as soon as they get the green light, Surgeon General Vivek Murthy, MD, said at a White House briefing earlier Sept. 17.
"This process is consistent with what we outlined in August where our goals were to stay ahead of the virus," Dr. Murthy said. "Our goal then and now is to protect the health and well-being of the public. As soon as the FDA and CDC complete their evaluations, we will be ready to move forward accordingly."
He added, "We've used this time since our August announcement to communicate and coordinate with pharmacy partners, nursing homes, states, and localities."
White House COVID-19 Response Coordinator Jeff Zients said vaccine supply is "in good shape for all Americans to get boosters as recommended."
Taking cues from Israel
In considering Pfizer’s original request, the committee overwhelmingly felt that they didn’t have enough information to say that the benefits of an additional dose of vaccine in 16- and 17-year-olds would outweigh its risk. Teens have the highest risk of rare heart inflammation after vaccination, a side effect known as myocarditis. It is not known how the vaccines are causing these cases of heart swelling. Most who have been diagnosed with the condition have recovered, though some have needed hospital care.
Pfizer didn’t include 16- and 17-year-olds in its studies of boosters, which included about 300 people between the ages of 18 and 55. The company acknowledged that gap in its data but pointed to FDA guidance that said evidence from adults could be extrapolated to teens.
“We don’t know that much about risks,” said committee member Eric Rubin, MD, who is editor-in-chief of the New England Journal of Medicine.
Much of the data on the potential benefits and harms of third Pfizer doses comes from Israel, which first began rolling out boosters to older adults in July.
In a highly anticipated presentation, Sharon Alroy-Preis, Israel’s director of public health services, joined the meeting to describe Israel’s experience with boosters.
Israel began to see a third surge of COVID-19 cases in December.
“This was after having two waves and two lockdowns,” Ms. Alroy-Preis said. By the third surge, she said, Israelis were tired.
“We decided on a lockdown, but the compliance of the public wasn’t as it was in the previous two waves,” she said.
Then the vaccine arrived. Israel started vaccinations as soon as the FDA approved it, and they quickly vaccinated a high percentage of their population, about 3 months faster than the rest of the world.
All vaccinations are reported and tracked by the Ministry of Health, so the country is able to keep close tabs on how well the shots are working.
As vaccines rolled out, cases fell dramatically. The pandemic seemed to be behind them. Delta arrived in March. By June, their cases were doubling every 10 days, despite about 80% of their most vulnerable adults being fully vaccinated, she said.
Most concerning was that about 60% of severe cases were breakthrough cases in fully vaccinated individuals.
“We had to stop and figure out, was this a Delta issue,” she said. “Or was this a waning immunity issue.”
“We had some clue that it might not be the Delta variant, at least not alone,” she said.
People who had originally been first in line for the vaccines, seniors and health care workers, were having the highest rates of breakthrough infections. People further away from their second dose were more likely to get a breakthrough infection.
Ms. Alroy-Preis said that if they had not started booster doses in July, their hospitals would have been overwhelmed. They had projected that they would have 2,000 cases in the hospital each day.
Boosters have helped to flatten the curve, though they are still seeing a significant number of infections.
Data from Israel presented at the meeting show boosters are largely safe and effective at reducing severe outcomes in seniors. Israeli experience also showed that third doses, which generate very high levels of neutralizing antibodies—the first and fastest line of the body’s immune defense - -may also slow transmission of the virus.
Key differences in the U.S.
The benefit of slowing down the explosive spread of a highly contagious virus was tantalizing, but many members noted that circumstances in Israel are very different than in the United States. Israel went into its current Delta surge already having high levels of vaccination in its population. They also relied on the Pfizer vaccine almost exclusively for their campaign.
The United States used a different mix of vaccines – Pfizer, Moderna, and Johnson & Johnson -- and doesn’t have the same high level of vaccination coverage of its population.
In the United States, transmission is mainly being driven by unvaccinated people, Dr. Rubin noted.
“That really means the primary benefit is going to be in reducing disease,” he said, “And we know the people who are going to benefit from that … and those are the kinds of people the FDA has already approved a third dose for,” he said, referring to those with underlying health conditions.
But Israel only began vaccinating younger people a few weeks ago. Most are still within a window where rare risks like myocarditis could appear, Rubin noted.
He and other members of the committee said they wished they had more information about the safety of third doses in younger adults.
“We don’t have that right now, and I don’t think I would be comfortable giving it to a 16-year-old,” he said.
At the same time, the primary benefit for third doses would be in preventing severe disease, and overall, data from the United States and other countries show that two doses of the vaccines remain highly effective at preventing hospitalization and death.
Asked why Israel began to see more severe cases in fully vaccinated people, the CDC’s Sara Oliver, MD, a disease detective with the CDC, said it was probably due to a mix of factors including the fact that Israel defines severe cases a little differently.
In the United States, a severe case is generally a person who has to be hospitalized or who has died from the infection. In Israel, a person with a severe case is someone who has an elevated respiratory rate and someone who has a blood oxygen level less than 94%. In the United States, that kind of patient wouldn’t necessarily be hospitalized.
In the end, one of the two committee members who wanted full approval for Pfizer’s third doses said he was satisfied with the outcome.
Mark Sawyer, MD, a professor of pediatrics and infectious disease at the University of California at San Diego, said he voted yes on the first question because he thought full approval was the best way to give doctors the flexibility to prescribe the shots to vulnerable individuals.
“I’m really glad we authorized a vaccine for a third dose, and I plan to go out and get my vaccine this afternoon,” Dr. Sawyer said, noting that he was at high risk as a health care provider.
This article was updated 9/19/21.
A version of this article first appeared on Medscape.com.
Step-wise medical therapy is cost effective for endometriosis
For patients with endometriosis-related dysmenorrhea, it is cost effective to use medical therapy before surgery, according to investigators.
A stepwise strategy involving two medications, then surgery, was associated with the lowest cost per quality-adjusted life-years (QALYs), reported lead author, Jacqueline A. Bohn, MD, of Oregon Health & Science University, Portland, and colleagues.
“In 2009, the medical costs associated with endometriosis in the United States were estimated at $69.4 billion annually,” the investigators wrote in Obstetrics and Gynecology. “Despite the recognized cost burden of this disease, cost-effectiveness data on the various treatment strategies is limited. Previous studies have investigated the direct and indirect costs regarding endometriosis; however, there are no prior studies that evaluate the cost-effectiveness of a stepwise regimen to guide management.”
To fill this knowledge gap, Dr. Bohn and colleagues created a cost-effectiveness model comparing four treatment strategies:
NSAIDs, then surgery
NSAIDs, then short-acting reversible contraceptives or long-acting reversible contraceptives (LARCs), then surgery
NSAIDs, then a short-acting reversible contraceptive or a LARC, then a LARC or gonadotropin-releasing hormone (GnRH) modulator, then surgery
Surgery alone
The analysis, which compared costs, QALYs, and incremental cost-effectiveness ratios, involved a theoretical cohort of 4,817,894 women aged 18-45 years, representing the estimated number of reproductive-age women in the United States with endometriosis-related dysmenorrhea. Costs were determined from published literature and inflated to 2019 dollars. Medical treatments were theoretically given for 6 months each, and the cost of laparoscopic surgery incorporated 12 months of postoperative care.
Of the four strategies, the two-medication approach was most cost effective, with a cost per QALY of $1,158. This was followed closely by the three-medication regimen, at $1,158, the single-medication regimen, at $2,108, and finally, surgery alone, at $4,338.
“We found that, although cost effective, requiring trial of a third medication offered little comparative advantage before proceeding directly to surgery after the second therapy fails,” the investigators wrote. “Yet, for the woman who is anxious about surgical intervention, or when a prolonged wait for a surgical specialist occurs, trial of a GnRH modulator may be worthwhile.”
Compared with surgery alone, each regimen starting with medical therapy remained below the standard willingness-to-pay threshold of $100,000 per QALY; however, the investigators recommend against trying more than three medications.
“Delaying surgical management in a woman with pain refractory to more than three medications may decrease quality of life and further increase cost,” they wrote.
To make surgery alone the most cost-effective option, surgery success would need to exceed 83%, Dr. Bohn and colleagues concluded.
According to Hugh Taylor, MD, of Yale University, New Haven, Conn., it’s unlikely that this surgery success threshold will be met, since surgery alone typically leads to recurrence.
“We know there’s a very high relapse rate after surgery,” Dr. Taylor said in an interview. “Even if the surgery may be initially successful, there’s roughly a 50% recurrence rate after about 2 years. So, finding the right medical therapy will give you more chance for long-term success.”
Dr. Taylor said it’s “really nice” that Dr. Bohn and colleagues conducted a sequential analysis because the findings support the most common approach in real-world practice.
“It confirms that starting with a medical therapy prior to surgery is an appropriate, successful treatment for endometriosis, which is something that many, many people in the community do, but we haven’t had a real trial to show that,” he said.
Dr. Taylor offered two areas of improvement for similar studies in the future: First, he suggested separating LARCs from oral contraceptives because LARCs may be less effective for some patients with endometriosis; and second, he suggested that limiting the third medication to a GnRH antagonist would be more applicable to real-world practice than using the broader category of GnRH modulators.
Although the three-medication approach involving a GnRH modulator was slightly more expensive than the two-medication approach, Dr. Taylor said the costs were so similar that a three-medication approach is “still reasonable,” particularly because it could spare patients from surgery.
Dr. Taylor also speculated that trying a GnRH antagonist could become more cost effective soon. Although only one GnRH antagonist is currently on the market, he noted that a second agent is poised for Food and Drug Administration approval, while a third is in the pipeline, and this competition may decrease drug prices.
The investigators disclosed support from the National Institutes of Health, Arnold Ventures, the World Health Organization, Merck, and others. Dr. Taylor reported that Yale University receives funding for endometriosis biomarker research from AbbVie.
For patients with endometriosis-related dysmenorrhea, it is cost effective to use medical therapy before surgery, according to investigators.
A stepwise strategy involving two medications, then surgery, was associated with the lowest cost per quality-adjusted life-years (QALYs), reported lead author, Jacqueline A. Bohn, MD, of Oregon Health & Science University, Portland, and colleagues.
“In 2009, the medical costs associated with endometriosis in the United States were estimated at $69.4 billion annually,” the investigators wrote in Obstetrics and Gynecology. “Despite the recognized cost burden of this disease, cost-effectiveness data on the various treatment strategies is limited. Previous studies have investigated the direct and indirect costs regarding endometriosis; however, there are no prior studies that evaluate the cost-effectiveness of a stepwise regimen to guide management.”
To fill this knowledge gap, Dr. Bohn and colleagues created a cost-effectiveness model comparing four treatment strategies:
NSAIDs, then surgery
NSAIDs, then short-acting reversible contraceptives or long-acting reversible contraceptives (LARCs), then surgery
NSAIDs, then a short-acting reversible contraceptive or a LARC, then a LARC or gonadotropin-releasing hormone (GnRH) modulator, then surgery
Surgery alone
The analysis, which compared costs, QALYs, and incremental cost-effectiveness ratios, involved a theoretical cohort of 4,817,894 women aged 18-45 years, representing the estimated number of reproductive-age women in the United States with endometriosis-related dysmenorrhea. Costs were determined from published literature and inflated to 2019 dollars. Medical treatments were theoretically given for 6 months each, and the cost of laparoscopic surgery incorporated 12 months of postoperative care.
Of the four strategies, the two-medication approach was most cost effective, with a cost per QALY of $1,158. This was followed closely by the three-medication regimen, at $1,158, the single-medication regimen, at $2,108, and finally, surgery alone, at $4,338.
“We found that, although cost effective, requiring trial of a third medication offered little comparative advantage before proceeding directly to surgery after the second therapy fails,” the investigators wrote. “Yet, for the woman who is anxious about surgical intervention, or when a prolonged wait for a surgical specialist occurs, trial of a GnRH modulator may be worthwhile.”
Compared with surgery alone, each regimen starting with medical therapy remained below the standard willingness-to-pay threshold of $100,000 per QALY; however, the investigators recommend against trying more than three medications.
“Delaying surgical management in a woman with pain refractory to more than three medications may decrease quality of life and further increase cost,” they wrote.
To make surgery alone the most cost-effective option, surgery success would need to exceed 83%, Dr. Bohn and colleagues concluded.
According to Hugh Taylor, MD, of Yale University, New Haven, Conn., it’s unlikely that this surgery success threshold will be met, since surgery alone typically leads to recurrence.
“We know there’s a very high relapse rate after surgery,” Dr. Taylor said in an interview. “Even if the surgery may be initially successful, there’s roughly a 50% recurrence rate after about 2 years. So, finding the right medical therapy will give you more chance for long-term success.”
Dr. Taylor said it’s “really nice” that Dr. Bohn and colleagues conducted a sequential analysis because the findings support the most common approach in real-world practice.
“It confirms that starting with a medical therapy prior to surgery is an appropriate, successful treatment for endometriosis, which is something that many, many people in the community do, but we haven’t had a real trial to show that,” he said.
Dr. Taylor offered two areas of improvement for similar studies in the future: First, he suggested separating LARCs from oral contraceptives because LARCs may be less effective for some patients with endometriosis; and second, he suggested that limiting the third medication to a GnRH antagonist would be more applicable to real-world practice than using the broader category of GnRH modulators.
Although the three-medication approach involving a GnRH modulator was slightly more expensive than the two-medication approach, Dr. Taylor said the costs were so similar that a three-medication approach is “still reasonable,” particularly because it could spare patients from surgery.
Dr. Taylor also speculated that trying a GnRH antagonist could become more cost effective soon. Although only one GnRH antagonist is currently on the market, he noted that a second agent is poised for Food and Drug Administration approval, while a third is in the pipeline, and this competition may decrease drug prices.
The investigators disclosed support from the National Institutes of Health, Arnold Ventures, the World Health Organization, Merck, and others. Dr. Taylor reported that Yale University receives funding for endometriosis biomarker research from AbbVie.
For patients with endometriosis-related dysmenorrhea, it is cost effective to use medical therapy before surgery, according to investigators.
A stepwise strategy involving two medications, then surgery, was associated with the lowest cost per quality-adjusted life-years (QALYs), reported lead author, Jacqueline A. Bohn, MD, of Oregon Health & Science University, Portland, and colleagues.
“In 2009, the medical costs associated with endometriosis in the United States were estimated at $69.4 billion annually,” the investigators wrote in Obstetrics and Gynecology. “Despite the recognized cost burden of this disease, cost-effectiveness data on the various treatment strategies is limited. Previous studies have investigated the direct and indirect costs regarding endometriosis; however, there are no prior studies that evaluate the cost-effectiveness of a stepwise regimen to guide management.”
To fill this knowledge gap, Dr. Bohn and colleagues created a cost-effectiveness model comparing four treatment strategies:
NSAIDs, then surgery
NSAIDs, then short-acting reversible contraceptives or long-acting reversible contraceptives (LARCs), then surgery
NSAIDs, then a short-acting reversible contraceptive or a LARC, then a LARC or gonadotropin-releasing hormone (GnRH) modulator, then surgery
Surgery alone
The analysis, which compared costs, QALYs, and incremental cost-effectiveness ratios, involved a theoretical cohort of 4,817,894 women aged 18-45 years, representing the estimated number of reproductive-age women in the United States with endometriosis-related dysmenorrhea. Costs were determined from published literature and inflated to 2019 dollars. Medical treatments were theoretically given for 6 months each, and the cost of laparoscopic surgery incorporated 12 months of postoperative care.
Of the four strategies, the two-medication approach was most cost effective, with a cost per QALY of $1,158. This was followed closely by the three-medication regimen, at $1,158, the single-medication regimen, at $2,108, and finally, surgery alone, at $4,338.
“We found that, although cost effective, requiring trial of a third medication offered little comparative advantage before proceeding directly to surgery after the second therapy fails,” the investigators wrote. “Yet, for the woman who is anxious about surgical intervention, or when a prolonged wait for a surgical specialist occurs, trial of a GnRH modulator may be worthwhile.”
Compared with surgery alone, each regimen starting with medical therapy remained below the standard willingness-to-pay threshold of $100,000 per QALY; however, the investigators recommend against trying more than three medications.
“Delaying surgical management in a woman with pain refractory to more than three medications may decrease quality of life and further increase cost,” they wrote.
To make surgery alone the most cost-effective option, surgery success would need to exceed 83%, Dr. Bohn and colleagues concluded.
According to Hugh Taylor, MD, of Yale University, New Haven, Conn., it’s unlikely that this surgery success threshold will be met, since surgery alone typically leads to recurrence.
“We know there’s a very high relapse rate after surgery,” Dr. Taylor said in an interview. “Even if the surgery may be initially successful, there’s roughly a 50% recurrence rate after about 2 years. So, finding the right medical therapy will give you more chance for long-term success.”
Dr. Taylor said it’s “really nice” that Dr. Bohn and colleagues conducted a sequential analysis because the findings support the most common approach in real-world practice.
“It confirms that starting with a medical therapy prior to surgery is an appropriate, successful treatment for endometriosis, which is something that many, many people in the community do, but we haven’t had a real trial to show that,” he said.
Dr. Taylor offered two areas of improvement for similar studies in the future: First, he suggested separating LARCs from oral contraceptives because LARCs may be less effective for some patients with endometriosis; and second, he suggested that limiting the third medication to a GnRH antagonist would be more applicable to real-world practice than using the broader category of GnRH modulators.
Although the three-medication approach involving a GnRH modulator was slightly more expensive than the two-medication approach, Dr. Taylor said the costs were so similar that a three-medication approach is “still reasonable,” particularly because it could spare patients from surgery.
Dr. Taylor also speculated that trying a GnRH antagonist could become more cost effective soon. Although only one GnRH antagonist is currently on the market, he noted that a second agent is poised for Food and Drug Administration approval, while a third is in the pipeline, and this competition may decrease drug prices.
The investigators disclosed support from the National Institutes of Health, Arnold Ventures, the World Health Organization, Merck, and others. Dr. Taylor reported that Yale University receives funding for endometriosis biomarker research from AbbVie.
FROM OBSTETRICS & GYNECOLOGY