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Presented by Express Scripts by Evernorth: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Katherine Ellen Foley and Lauren Gardner | | | With Carmen Paun
| | |  The FDA has reviewed data from a nonprofit that seeks to conduct a late-stage clinical trial to study the use of a hormone for gender-affirming care. | Manuel Balce Ceneta/AP | FDA SIGNALS INTEREST — The FDA has indicated interest in seeing data on the use of a feminizing hormone as a part of gender-affirming care in its response to a request for a late-stage clinical trial. This week, the Research Institute for Gender Therapeutics, a new nonprofit group dedicated to improving access to gender-affirming care, said the FDA had provided feedback on its proposal for a late-stage clinical trial studying the use of estradiol, a form of the hormone estrogen, for some individuals receiving gender-affirming care. The FDA response is significant because conducting a Phase III trial would pave the way for the agency to approve the hormone for its use in gender-affirming care. At the moment, health care providers who care for transgender patients must prescribe the hormone off-label. FDA approval for estradiol for gender-affirming care likely wouldn’t change how providers prescribe the treatment, Dr. Meredithe McNamara, assistant professor of pediatrics at Yale School of Medicine, told Prescription Pulse. It might increase the likelihood of insurance covering the treatment for patients, and major medical associations — including the American Medical Association, the American Academy of Pediatrics and the American Psychological Association — support gender-affirming care for trans individuals. But FDA approval could have massive implications outside of the doctor’s office. “Currently, access to gender-affirming care is under examination in the court of law and the court of public opinion,” Dr. Madeline Deutsch, medical director of the University of California, San Francisco’s Gender Affirming Health Program, told Prescription Pulse. Twenty-two states have banned gender-affirming care for minors, and at least three have considered barring gender-affirming care for those younger than 26, according to the Human Rights Campaign. McNamara and Deutsch said FDA approval for estradiol for gender incongruence would be a legal argument against those bans. The Alliance Defending Freedom, a conservative legal advocacy group that has helped lawmakers draft trans-focused legislation, did not respond to a request for comment. RIGT initially proposed studying estradiol in adults with a randomized trial. The agency suggested the company broaden its study to include children as young as 13 and that it doesn’t have a group receiving a placebo, Brad Sippy, founder and president of RIGT, told Prescription Pulse. “Now [that] we have this first initial feedback, our next stop will be to select a formulation,” he said, adding that he anticipated trials would begin in 2025. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Now we’re in the final lap of 2023, we want to know: Who was your top-played artist on Spotify? Send news, tips and superior music takes to Lauren Gardner (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Katherine Ellen Foley talks with POLITICO White House correspondent Adam Cancryn about former President Donald Trump's call to repeal the Affordable Care Act — a move the Biden administration views as a political gift ahead of the 2024 election — and the potential political implications of Trump's comments.
| | | | | | | A message from Express Scripts by Evernorth: With drug prices on the rise, Express Scripts by Evernorth is redefining and reimagining what's possible for the pharmacy benefit. Prescriptions come with an easy-to-understand savings statement, detailing the cost of the drug, the price the consumer pays, and the value generated by Express Scripts. It’s all made simple with one clear fee. And if we don’t reach our client’s goals, they pay less – guaranteed. Simplicity, savings, and trust – that’s our pharmacy benefit. | | | | | | | 
The birth control pill, Opill, is expected to be available over the counter next year, but how much consumers will have to pay out of pocket for it is up in the air. | Perrigo via AP | HOW TO COVER OTC BIRTH CONTROL? Monday is the deadline for comments to the so-called tri-departments — HHS, Labor and Treasury — on the potential benefits and costs of certain free over-the-counter preventive items like contraception and tobacco-cessation products. Opill, the OTC birth control pill the FDA approved in July as the first of its kind in the U.S., is expected to become available early next year. Contraception advocates and congressional Democrats have urged the Biden administration to encourage access to the drug by requiring insurers to cover it with no cost-sharing — and without requiring a prescription, standard practice for most OTC items eligible for insurance coverage. Payers and pharmacy groups aren’t necessarily opposed. But plenty of unknowns linger about how consumers would access Opill at no cost without a provider’s intervention. Insurance claim logistics on the part of pharmacists and customers is an open question. Plus, the suggested retail price for Opill has yet to be announced, raising concerns about how the OTC drug’s cost might compare with similar medications available by prescription. Lauren has more on the questions being raised by the myriad parties interested in a potential coverage mandate. CALIFF: LIFE EXPECTANCY DECLINES ‘CATASTROPHIC’ — FDA Commissioner Robert Califf said the U.S. is “facing extraordinary headwinds in our public health with a major decline in life expectancy” on Thursday in a post on X, formerly Twitter. Califf’s words came after the CDC published the latest data on U.S. life expectancy earlier this week. In 2022, the average life expectancy was 77.5 — up more than a year from 2021. The agency cited fewer deaths related to Covid, heart disease, cancer, homicides and unintentional injuries as reasons for the increase. It also noted that life expectancy would have been higher if not for more deaths associated with pneumonia and the flu, nutritional deficits, perinatal disease and kidney disease. But life expectancy remains lower than it was in 2019 when it was 78.8. Life expectancy fell 2.7 years between 2019 and 2021, a decline that Califf referred to as “catastrophic” online after Prescription Pulse asked for comment.
| | | | GET A BACKSTAGE PASS TO COP28 WITH GLOBAL PLAYBOOK: Get insider access to the conference that sets the tone of the global climate agenda with POLITICO's Global Playbook newsletter. Authored by Suzanne Lynch, Global Playbook delivers exclusive, daily insights and comprehensive coverage that will keep you informed about the most crucial climate summit of the year. Dive deep into the critical discussions and developments at COP28 from Nov. 30 to Dec. 12. SUBSCRIBE NOW. | | | | | | | | | A RING AGAINST HIV — A vaginal ring that releases an antiretroviral drug to prevent HIV infection has been approved in 11 countries in Eastern and Southern Africa. The ring, to be produced by a South African company with the aim of expanding access for women most at risk of HIV infection, is available in Eswatini, Kenya, Lesotho, South Africa, Uganda and Zimbabwe through implementation and pilot studies, according to the Population Council, a nonprofit that owns the intellectual property for the so-called PreP ring. The ring is the first long-acting, HIV-prevention method designed for women and has been approved for use in adult women. Made of flexible silicone, the ring slowly releases the antiretroviral drug dapivirine in the vagina over one month. Why it matters: Girls and young women in Sub-Saharan Africa are among those most at risk for HIV infection, at levels three times those of boys and young men in the region, according to the World Health Organization, which recommended the ring in 2021 as an additional prevention choice for women at high risk.
| | | | A message from Express Scripts by Evernorth:   | | | | | ABBVIE TO ACQUIRE CANCER-DRUG MAKER — Drugmaker AbbVie said Thursday it plans to buy biotech ImmunoGen and its bellwether ovarian cancer therapy Elahere. The transaction is valued at $10.1 billion.
| | The FDA’s chief scientist, Dr. Namandjé Bumpus, will step into the agency’s principal deputy commissioner role following Dr. Janet Woodcock’s retirement in early 2024. Dr. Camille Bedrosian will become chief medical officer at Amylyx Pharmaceuticals. She held the same position at Ultragenyx.
| | | | JOIN WOMEN RULE ON 12/12: For centuries, women were left out of the rooms that shaped policy, built companies and led countries. Now, society needs the creativity and entrepreneurship of women more than ever. How can we make sure that women are given the space and opportunity to shape the world’s future for the better? Join POLITICO's Women Rule on Dec. 12 for Leading with Purpose: How Women Are Reinventing the World to explore this and more. REGISTER HERE. | | | | | | | | | The Biden Justice Department is appealing a court opinion striking down a Trump-era rule allowing insurers to collect co-pay assistance while not counting the coupons toward a beneficiary’s out-of-pocket costs, STAT reports.
| | | The FDA on Wednesday posted modified-risk tobacco product renewal applications from General Snus smokeless tobacco from Swedish Match USA for scientific review.
| | | | A message from Express Scripts by Evernorth: With drug prices on the rise, Express Scripts by Evernorth is redefining and reimagining what's possible for the pharmacy benefit.
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