Axios Vitals: IVF quandary

Plus: Skinny labels save Medicare $1.5B | Tuesday, November 29, 2022

Open in app View in browser   Presented By PhRMA   Axios Vitals By Tina Reed · Nov 29, 2022 Good morning, Vitals readers. Today's newsletter is 907 words or a 3.5-minute read. 📆 Mark your calendars: Join Axios' Caitlin Owens and me in Washington, D.C., at 8:00 am ET on Wednesday, Dec. 7, for an event looking at the top priorities, issues and challenges shaping the post-midterm health care policy landscape. Register here to attend in person or virtually.      1 big thing: Republicans' thorny path ahead on fertility policy Illustration: Aïda Amer/Axios   Former Vice President Mike Pence's recent support for fertility treatments like in vitro fertilization as well as a national abortion ban surfaced what could become a dilemma for 2024 Republican hopefuls staking out reproductive health platforms, Axios' Caitlin Owens and Oriana Gonzalez write. The big picture: Republicans have largely insisted that fertility treatments aren't at risk from the proliferation of new state abortion restrictions. But anti-abortion groups remain deeply concerned with the use of embryos in IVF and back tighter regulations on providers. The divisions may create a thorny path for 2024 hopefuls intent on bolstering their anti-abortion bona fides while still hoping to differentiate themselves from the rest of the field. Driving the news: "I fully support fertility treatments and I think they deserve the protection of the law," Pence recently said on CBS' Face the Nation, citing his and his wife Karen's struggles with infertility. She underwent IVF several times, he said. At the same time, the likely 2024 presidential contender was unambiguous on abortion, saying he would support Sen. Lindsey Graham's 15-week federal ban if he was in Congress "as a beginning" — and adding he'll keep working to "restore the sanctity of life to the center of American law in all 50 states." State of play: Legal experts say that the language of red-state "trigger laws" banning abortion may, in some cases, be interpreted to apply to IVF as well, since embryos are fertilized before they're stored. There hasn't been a large-scale push to interpret the laws that way — in fact, some Republican attorneys general have issued guidance saying that they're not applicable to embryos made outside of a woman's body. But the pro-life movement, like the GOP, is still finding its footing in the post-Roe world, and IVF and other assisted reproductive technologies are still opposed by some groups, according to their websites. Between the lines: Some Republican politicians have quietly expressed openness to more stringent IVF regulations. Go deeper.     2. Seniors push for standalone drug plans Illustration: Natalie Peeples/Axios   Patient advocates are pressing Congress to use the lame-duck session to give standalone Medicare drug coverage to some senior citizens who qualify for nursing-level care, Axios' Arielle Dreher writes. Why it matters: The "fix" would make up for how the Inflation Reduction Act's drug price controls stopped short of applying to the PACE Program, a comprehensive care alternative to nursing homes. The IRA capped out-of-pocket spending at $2,000 annually for seniors using Medicare Part D, but in PACE, all costs are built into one set premium with no copays or deductibles. Driving the news: A plan from Sens. Thomas Carper (D-Del.) and Bill Cassidy (R-La.) would enable Medicare beneficiaries enrolled in PACE to access the Part D drug plans and benefit from the price controls in the IRA. Be smart: The vast majority of PACE participants are eligible for both Medicare and Medicaid, and an October Bipartisan Policy Center report estimates that just 1% of the nearly 62,000 participants in programs around the country are Medicare-only beneficiaries. Yes, but: The proposed bipartisan fix joins a long list of health care policy changes that are in play during the lame duck and may test lawmakers' willingness to tinker with Medicare law.     3. Medicare saves on biosimilar "skinny labels" FDA approvals of so-called "skinny labels" on biosimilars saved Medicare an estimated $1.5 billion between 2015 and 2020, according to a research letter published Monday in JAMA Internal Medicine. Why it matters: While biologics make up fewer than 5% of prescription drugs used, they account for 40% of drug spending. Companies that make biologics are often able to maintain market exclusivity for years by getting supplemental patents beyond their product's original indication. But the FDA's skinny label specifies a use for a biosimilar, allowing it to reach the market sooner with less of a threat of patent litigation. By the numbers: The researchers, from Brigham and Women's Hospital and Harvard Medical School, found 33 biosimilars based on 11 biologics were approved by the FDA between 2015 and 2021. Two-thirds had a skinny label. The researchers estimate competition from skinny-label biosimilars saved Medicare $1.5 billion from 2015 to 2020 due to years of earlier competition. That is nearly 5% of the $30.2 billion Medicare spent on the five biologics during that period. That number will "likely grow substantially" after biosimilars for Abbvie's Humira become available in 2023, the authors write.     A message from PhRMA Data shows insurers and their PBMs shift costs to patients     Costly OOP expenses tied to deductible and coinsurance requirements are a leading concern for patients with commercial insurance. These harmful practices put in place by insurers and pharmacy benefit managers (PBMs) are even causing patients to abandon their medicines. Learn more.     4. Data du jour: Most COVID deaths among elderly Data: CDC ; Chart: Tory Lysik/Axios Visuals Nine out of 10 COVID deaths in the U.S. are in people 65 and older, the Washington Post reported. Why it matters: The data from the Centers for Disease Control and Prevention shows the ongoing vulnerabilities America has largely decided to live with as it returns to pre-pandemic norms, per the Post. Between the lines: It's also a reversal from earlier trends, showing how pandemic risks have evolved over time. A study out Monday in the Annals of Internal Medicine showed that while overall COVID deaths dropped in the second year of the pandemic, the average years of life lost increased as those deaths shifted to younger populations. That study found deaths among older adults were higher in the beginning of the pandemic, but that the numbers improved compared to younger populations due to a relatively higher uptake of vaccines and other pandemic precautions by older adults.     5. Catch up quick 🗣️ HHS moves to overhaul privacy rules for substance abuse patients. (Axios) 🏍 Organ donations rise around motorcycle rallies, study finds. (New York Times) 🧠 Poor countries are developing a new paradigm of mental health care. (Vox) 👉 WHO has renamed monkeypox as mpox. (Axios)     A message from PhRMA Patients are frustrated     New data from IQVIA reveal patients with deductibles and coinsurance are more likely to abandon their medicines than patients with copays. The reason: Insurers and their PBMs shift the costs of covered medicines onto their patients. That's not fair. Learn more.   👋 Thanks for reading, and thanks to senior editor Adriel Bettelheim and copy editor Nick Aspinwall for the edits. 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