| | | |   | Hi again, D.C. Diagnosis readers. For any reporter who has dealt with a 4:15 Medicare rule, it’s your time to shine. I’m speaking, of course, about CMS’ coverage decision for Aduhelm, which is expected any day now. I’m at nicholas.florko@statnews.com. | | | How a couple confronting ALS built one of the nation’s most effective patient advocacy organizations In a new story for STAT, my colleague Lev Facher takes you inside Brian Wallach and his wife Sandra Abrevaya’s all-in effort to found I Am ALS, the advocacy organization that has played an outsized role in dramatically increasing federal funding for research into the disease. Since the group’s founding in 2019, following Wallach’s diagnosis with the terminal illness, the group has successfully quadrupled the Pentagon’s funding for ALS research, made it easier for patients to receive disability benefits, and spearheaded a new law that will fund $100 million worth of ALS initiatives each year. As Lev writes, “[Wallach] and Abrevaya have galvanized what is likely the most successful patient advocacy campaign of the 21st century.” The story is also a truly moving account of what it means to live with a terminal illness, and the toll caretaking can take on a family. Seriously, I know we plug a lot of STAT stories in D.C. Diagnosis, but I can’t recommend this one enough. Check it out here. | It’s a make-or-break week for Aduhelm. Here’s what Wall Street is expecting CMS is expected to release a policy this week outlining when it will pay for the controversial new Alzehimer’s drug, Aduhelm — a decision that could, in theory, deal the biggest blow yet to Biogen’s catastrophic rollout of the drug: denying to cover it entirely. The decision could also have massive implications for the state Medicaid agencies, which are struggling with how to pay for the drug and some major hospitals, which are looking to CMS before deciding whether to even offer the drug. But Wall Street analysts, by and large, aren’t expecting CMS to deal Biogen a bad break. “Generally speaking, [Wall] Street has thought about it like this: non-coverage is the bad bad outcome, but no one [is] really expecting that,” wrote Evercore ISI analyst Umer Raffat in a recent presentation. Instead, many analysts are betting on CMS issuing some form of a coverage with evidence development decision, a rare regulatory move that would require patients to enroll in some form of clinical research before accessing the drug. The big question, if investors are right, will be how many hoops such a policy requires patients and their doctors to jump through in order to access the drug. The agency could make patients enroll in randomized placebo-control trials, for example, or simply cap how long they can access Aduhelm. Raffat surveyed 150 investors and roughly 60% said they expected CMS to issue a coverage decision that is more restrictive than the FDA-approved label, but not “way more restrictive.” ICYMI: Monday was a big day for Biogen, too. HHS Secretary Xavier Becerra announced yesterday that he was ordering CMS to reconsider its earlier decision to hike Medicare premiums, after Biogen slashed the price of Aduhelm in half last month. The announcement came just moments before the company’s CEO Michel Vounatsos addressed investors at the annual JP Morgan confab – where he pitched the company’s decision to cut the price of Aduhelm as “courageous.” | Decision-makers need to account for patient differences to ensure equitable care Every patient is unique — but research shows that health care decisions made at the population level, rather than the individual level, can lead to inequities and disparities in treatment. Learn more about making health care more patient-centered in the National Pharmaceutical Council’s updated Myth of Average report. | Hey lawmakers, read this The nation’s top health officials will testify today at 10 a.m. before the Senate HELP committee. It’s the first time experts like NIH’s Anthony Fauci and the CDC’s Rochelle Walensky will be forced to answer lawmakers’ questions since the rapidly spreading Omicron variant catapulted the United States into a new stage of the pandemic. The new variant has left Americans grasping for answers to basic questions, like whether Covid-19 tests actually work. To mark the occasion — and hopefully encourage a hearing full of insightful questions rather than partisan bickering — my colleagues Drew Joseph, Helen Branswell, Lev Facher, and I compiled the 13 most burning questions we hope lawmakers will ask the officials this morning. You can check those out here. | | | Thanks for reading! More next week,  | | | |
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