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Medicare puts Aduhelm on the back bench
Access restricted: Medicare is proposing to only cover the new, pricey Alzheimer’s drug for patients enrolled in certain clinical trials, a condition that would severely limit its use.
That's a sigh of relief for health insurers and critics who have worried the drug is ineffective and would skyrocket premiums for seniors. But don't expect a harmonious reaction to yesterday's draft decision. There's still a deep divide among health experts, patient advocates and the drug industry — just as both camps were split over the Food and Drug Administration’s controversial approval of the drug this summer.
Why the decision has been so fraught boils down to this: It’s the first aimed at changing the course of a devastating disease afflicting more than 6 million Americans, while other drugs just target its symptoms. But some health experts remain concerned about its safety.
The quick reactions to CMS’s proposal highlighted the firestorm Aduhelm has ignited — and foreshadow the comments the agency will soon receive.
- Rachel Sachs, a professor at Washington University in St. Louis School of Law: “I think CMS made the right decision. … It was important for them to make this decision because this reasserts the authority of Medicare to make its independent judgments.”
- Major insurer lobby AHIP: “We agree with CMS that there is a need to obtain more clinical data on efficacy,” which is “essential” to get before broadening access.
- Joseph Ross, with the Yale School of Medicine who sits on CMS’ coverage advisory committee: “I think the decision by CMS to require CED is in the best interests of patients and clinicians, allowing rigorous collection of data.”
Bioethicist Zeke Emanuel:
There are medical orgs/hospitals already refusing to cover Aduhelm b/c not effective in the key clinical outcome of reversing or stabilizing cognitive decline. Medicare should not pay for a totally unproven drug —that is the definition of a waste of money.https://t.co/Su3HLEVEz0— Zeke Emanuel (@ZekeEmanuel) January 11, 2022
Democrats on the House Oversight Committee:
We intend to get to the bottom of how this drug made its way through FDA’s approval process despite concerns raised by experts, and what role Aduhelm’s manufacturer, Biogen, played in that process.— Oversight Committee (@OversightDems) January 12, 2022
- Drugmaker Biogen: “This draft coverage determination denies the daily burden of people living with Alzheimer’s disease.”
- The Alzheimer’s Association: The group called it a “shocking discrimination” where “access to treatment would now only be available to a privileged few.”
- Major drug lobby PhrMA: “With this proposal, CMS is writing off an entire class of medicines before multiple products have even been reviewed by FDA.”
The move is a fascinating case study on the interplay between two key federal agencies. Both the FDA and the Centers for Medicare and Medicaid Services (CMS) faced difficult decisions over how to handle a drug when the evidence isn’t clear that it works.
- CMS rarely launches a months-long review to decide whether Medicare will pay for a drug the FDA has signed off on.
- And as our colleagues Laurie McGinley and Amy Goldstein note: “CMS almost never demands such [clinical] trials for a drug already approved by the Food and Drug Administration.”
- Key quote: “While there may be the potential for promise with this treatment, there is also the potential for serious harm to patients,” Lee Fleisher, CMS’s chief medical officer, told reporters yesterday.
Nicholas Florko, Stat:
We are officially living in crazy town. This is a quote from CMS' chief medical officer on the Aduhelm NCD.— Nicholas Florko (@NicholasFlorko) January 11, 2022
For context: CMS typically decides to pay for drugs based on things "being reasonable and necessary," the FDA is the one who decides if a drug is safe and effective. pic.twitter.com/rubdWf4XOE
The Medicare agency had a key decision to make: Should it cover Aduhelm, the first drug cleared for Alzheimer’s in nearly 20 years, and other similar drugs on the horizon? Should it restrict or deny coverage — or kick the decision to local contractors?
CMS proposed a path called “coverage with evidence development.” But it also chose one of the most restrictive ways of setting up such a program. Medicare will only pay for the drug for patients enrolled in studies approved by CMS or supported by the National Institutes of Health.
- “The number of patients who will be able to enroll in these trials over the next five years is a small fraction of the patients who would have potentially been eligible for the drug,” said Sean Tunis, a former CMS official who helped set up the models for coverage with evidence.
The decision appears to track with the majority of the feedback the agency received. CMS netted 131 comments during a period for public input ahead of the proposal. Roughly 77 comments opposed covering the treatment or recommended the coverage with evidence development pathway. Twenty-six comments didn’t give a clear position, the agency wrote in its proposed decision.
- “People sort of got seduced in this idea that CMS was just the checkwriter for FDA’s decisions about the marketplace. It's never been like that,” said Peter Bach, the chairman of the committee advising Medicare on some coverage decisions.
What’s next: The agency is opening another 30-day comment period, and will issue a final decision by April 11.
Peter Bach, chief medical officer at Delfi Diagnostics:
On the Hill
Biden health officials face tough questions over the administration’s pandemic response
Four federal health officials testified before Congress the day the country hit record levels of hospitalizations — a stark reminder that the pandemic is far from over. The nearly-four-hour-affair yesterday marked their first appearance on Capitol Hill since omicron took off in the United States, The Post’s Felicia Sonmez, Lena H. Sun, Salvador Rizzo and your host report.
Here are some of the key takeaways:
1. Lawmakers from both parties delivered critiques of the nation’s pandemic response. While Republicans have repeatedly criticized the Biden administration’s response, the hearing was notable for the Democrats who also expressed frustration.
- “People back in my home state of Washington and across the country are frustrated and worried about the course of this pandemic and its persistent challenges, like how hard it still is to get a test,” said Sen. Patty Murray (D-Wash.), the chair of the Senate HELP Committee.
2. A top health official delivered a stark assessment on the state of the pandemic: “Most people are going to get covid,” Janet Woodcock, FDA’s acting commissioner, told lawmakers.
- Woodcock said the emphasis now needs to be on averting the worst of the pandemic, making sure hospitals and essential services can still function. “I think after that will be a good time to reassess how we’re approaching this pandemic,” she said.
3. A shortage of tests and confusing guidelines around isolation came up again and again. The Biden administration is planning to deliver 500 million free, at-home rapid tests to Americans starting at the end of this month. But in the meantime, even as coronavirus cases hit record levels, at-home coronavirus tests are hard to come by.
- Sen. Susan Collins (R-Maine) said the testing difficulties were “entirely preventable,” adding that it appeared “the administration simply failed to anticipate our testing needs.”
Lawmakers also expressed frustration over recent guidance from the Centers for Disease Control and Prevention on how long infected people need to isolate, calling the government’s communications around the guidance confusing.
4. Top infectious-disease expert Anthony S. Fauci had a heated exchange with Sen. Rand Paul (R-Ky.). Fauci accused Paul of raising campaign funds off of making false accusations against him. Fauci cited the arrest of a California man in Iowa last month who police said was traveling to Washington, D.C., with an assault rifle and a “hit list” that included his name.
- Fauci’s comments came after Paul falsely accused him of orchestrating a smear campaign against three conservative academics who opposed shutdown measures in 2020.
5. Fauci and Sen. Roger Marshall (R-Kan.) also sparred.
- Marshall falsely claimed Fauci is not making available his annual financial disclosure form as a member of the federal government, accusing “the Big Tech giants” of “doing an incredible job of keeping it from being public.”
- An incredulous Fauci replied: “All you have to do is ask for it. You’re so misinformed, it’s extraordinary.”
- Moments later, Fauci could be heard muttering near an open microphone, “What a moron. Jesus Christ.”
The White House is promising schools 10M free coronavirus tests per month
The push for tests comes as President Biden has urged schools to remain open amid surging coronavirus cases, The Post’s Laura Meckler and Dan Diamond report.
- The administration said it will distribute 5 million free rapid tests to K-12 schools each month, which can be used to screen students on a regular basis. They can also be used to create test-to-stay programs, where students exposed to the virus can stay in school as long as they periodically test negative.
- The White House also said it will make lab capacity available each month to process 5 million PCR tests.
Districts have been slow to embrace coronavirus testing.
- In September, a Washington Post survey found just four of the nation’s 20 largest school districts were screening asymptomatic students.
- The opening days of school in 2022 have been chaotic. But the data firm Burbio found that on Monday and Tuesday about 2,700 public schools had in-person learning disrupted, a small slice of some 100,000 K-12 schools in the country.
Pfizer will manufacture up to 100M doses of omicron-specific vaccine by the spring
Pfizer is racing ahead with plans to manufacture 50 million to 100 million new doses of an omicron-specific version of its coronavirus vaccine by late March or early April.
The company is testing hybrid combinations of vaccine that could target multiple forms of the coronavirus, as well as larger doses, The Post’s Christopher Rowland reports. Pfizer said that if the omicron-specific shots aren’t needed, it’ll absorb the costs.
Meanwhile, Moderna said it hopes to have an omicron-specific vaccine by the fall. The company is also working on developing a single-dose, annual vaccine that can protect against multiple respiratory viruses.
Key context: Last month, Fauci said that a variant-targeting vaccine wasn’t necessary, since the booster shot offers additional protection. But the moves reflect growing concerns that vaccine formulations may need to be tweaked.
Here's what else you need to know:
- Congress’s attending physician, Brian P. Monahan, is offering at-home coronavirus testing kits to House members and essential staffers in response to rising cases, The Post’s Eugene Scott reports.
- Those rising cases have also led lawmakers to postpone the House Democratic Caucus Issues Conference, which was scheduled for early February, Eugene writes.
- A new lawmaker is coming to the Hill after working as a health-care CEO. Democrat Sheila Cherfilus-McCormick easily won a special election to fill Florida’s vacant 20th Congressional District. She ran as a supporter for Medicare-for-all and has spent more than a decade as CEO of Trinity Health Care Services, a company providing in-home care.
Calendar check: The Senate HELP Committee has rescheduled its vote on the nomination of Robert Califf for FDA commissioner. It’s now set for tomorrow. The switch was due to schedule changes, per a Democratic committee aide.
Thanks for reading! See y'all tomorrow.