| | | Hello, D.C. Diagnosis readers. It was great seeing some of you last week at STAT’s Breakthrough Science Summit. If you weren’t there, may I suggest you check out my dispatch from FDA Commissioner Robert Califf’s first public interview? Got some questions we didn’t ask? Send them my way, and I’ll find a way to ask them the next time we are in the same room. I’m at nicholas.florko@statnews.com. | | The pressure on Medicare just keeps ramping up Medicare is set to decide this month whether to finalize its plan to only pay for Biogen’s controversial Alzheimer’s drug, Aduhelm, when patients are enrolled in clinical trials. And advocates who oppose the idea are in the middle of a massive lobbying blitz to get them to change their minds. The Alzheimer’s Association, UsAgainstAlzheimer’s, the Alliance for Aging Research and the Global Alzheimer's Platform (GAP) Foundation – four of the nation’s biggest Alzheimer’s advocacy groups – met with HHS Deputy Secretary Andrea Palm on Friday, according to John Dwyer, the president of the GAP Foundation. The group also met separately with HHS Secretary Xavier Becerra last month, though Becerra surprised the group when he got on the call and declined to participate in the meeting, citing the advice of his lawyers, Dwyer explained. Advocates also have met with two of the White House's senior policy advisors: Christen Linke Young and Bruce Reed. Dwyer also estimates advocates have spoken to roughly 150 lawmakers’ offices. The activism seems to be paying off. A bipartisan coalition of more than 40 House lawmakers urged the administration in a Thursday letter to abandon the plan, too. The letter is especially notable because it includes both progressives like Rep. Barbara Lee (D-Calif.) and Nanette Diaz Barragán (D-Calif.), as well as a number of the Republican party’s most influential health care advocates, including Rep. Brett Guthrie (Ky.) and Michael Burgess (Texas). “We are very concerned about the impact that this proposed rule would have on Alzheimer’s patients – including patients of color and patients with a higher risk of Alzheimer’s such as people with Down Syndrome – and their families who have waited far too long for a new Alzheimer’s therapeutic,” they write. “As thousands of patients per day progress to later stages of the disease and become ineligible for these therapeutics, Americans cannot wait while [Medicare] further delays access.” Medicare officials are expected to finalize their coverage policy for Aduhelm and other similar Alzheimer’s drugs by next Monday. | Califf’s massive challenge Robert Califf, the newly minted FDA commissioner, has unofficially embarked on a speaking tour outlining his priorities for his second term as the head of the agency – and he’s not aiming small. In two public appearances over the last week Califf has repeatedly emphasized that he’s focused on fixing the root causes of America's ailing health. “We’re the greatest inventors in the world … And yet we’re living on average almost five years shorter than the average of high income countries,” Califf told my colleague Matt Herper on Thursday. “We’re in last place. I’m used to being on the winning team.” In his remarks yesterday at the annual Health Datapalooza confab, Califf raised this concern again. He even argued that if the United States was a soccer team competing on the TV show Ted Lasso, they should be relegated to the lower league. The question for me, however, is how Califf will actually tackle this massive issue. To date he’s mostly spoken in generalities about developing better medical evidence and combating misinformation. During yesterday’s speech, Califf tried to lay out steps he thought would help reverse this problem, but even those steps – like improving America’s system for generating medical evidence – are massive undertakings. And Califf has had this problem before: He spent much of this first term at the FDA talking up the same ideas, but he never was able to work the levers of Washington during his short tenure to actually turn those thoughts into policy. | Unpacking California’s skyrocketing hospital prices Looking for a cheap hospital? California might not be your best bet. A new study in Health Affairs finds that 11 of the 19 most expensive regions, in terms of the hospital prices paid by private insurers, were located in California – and 8 of those were clustered in the northern part of the state. STAT’s new expert on all things hospitals and insurance, Tara Bannow, unpacked the root causes of those quickly soaring prices in a new piece for STAT that touches on everything from good old fashioned monopolies to mandatory earthquake standards. Check out Tara’s new story here. | Manufacturers paid more in discounts in 2021 than the NFL made over Tom Brady’s 22-year career If drug manufacturers continue to give money back to payors in the form of discounts and rebates, why aren’t patients’ costs going down? Adam Gluck, Head of U.S. and Specialty Care Corporate Affairs at Sanofi, shares how health insurance plans and pharmaceutical benefit managers prevent discounts from reaching patients, and what policy solutions can help. Read more here. | Yikes … Faced with high drug prices, seniors are abandoning cancer drugs at the pharmacy A new study scrutinizing more than 17,000 Medicare prescription records found that a sizable portion of seniors did not go get a high-cost specialty medicine they were prescribed for a serious condition, like Hepatitis C or dangerously high cholesterol. In fact, the study found that one in three seniors did not even fill their prescriptions for cancer drugs. Why wouldn’t a senior get a drug that could potentially save their life? The study’s lead author Stacie Dusetzina, a health policy professor at Vanderbilt University who also sits on Congress’ board of Medicare advisors, says it’s the high out-of-pocket costs seniors face at the pharmacy counter. After all, when seniors got to pay less, they took their drugs. Dusetzina’s study found that seniors who received a so-called “low income subsidy,” which allows seniors to pick up prescriptions at the pharmacy for only a few dollars regardless of how much they cost, were nearly twice as likely to pick up their prescriptions. Check out the new study here. | STAT stories you may have missed Biden’s high-stakes biomedical science agency ARPA-H will be part of the NIH — but there’s a twist. The Biden administration is funneling one of the largest-ever pay increases to Medicare Advantage insurers. Key senators eye new, more ambitious legislation to lower insulin prices. Hospitals, including some flush with cash, scramble to grab last scraps of federal Covid dollars. NIH’s cancer chief, Ned Sharpless, to step down. UnitedHealth’s deal with LHC highlights broader interest in the home health industry. HHS seeks to penalize another drugmaker amid legal clash over 340B. CVS, Teva, and Allergan reach massive deal with Florida over the opioid crisis. With pharma still struggling in Alzheimer’s, health tech companies want a swing. Even as medicine becomes more diverse, main authors in elite journals remain mostly white and male. By a narrow margin, an FDA advisory panel concludes Amylyx ALS drug hasn’t proven effectiveness. | Thanks for reading! More next week, | | |
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