Look for an announcement on Aduhelm this week
It’s a massive week for the pricey, new Alzheimer’s drug.
Medicare officials are bumping up against a critical Wednesday deadline to issue a proposal on whether — and how — to cover Aduhelm. Controversy has swirled over the medicine ever since the Food and Drug Administration approved it in June despite unclear evidence the treatment works.
The FDA’s decision this summer sparked fierce backlash and has already affected how much seniors pay for Medicare. For instance:
- Three of the agency’s outside advisers quit over the decision.
- A government watchdog is investigating how Aduhelm was approved.
- Seniors saw a surprising 14.5 percent hike in their monthly premiums for outpatient care this year, partly due to Aduhelm. (That decision was made before drugmaker Biogen nearly halved the price to $28,200 this year, which is still higher than some critics say is necessary.)
The complex dynamics at play have put the Centers for Medicare and Medicaid Services (CMS) in a tricky position. Back in July, the agency launched a rare months-long review of how Medicare should cover the drug, which could create clinical guidelines narrowing who can access the treatment.
- Time’s up: The deadline to release a proposed decision is Wednesday, and the agency then has another three months to finalize it. CMS didn’t say when a proposal will be unveiled, but a spokesperson said the agency expects to release more information on the coverage determination by mid-January.
The agency’s decision has broader implications. Aduhelm was the first drug cleared for Alzheimer’s in nearly 20 years, and more are in the pipeline. The treatment is designed to reduce a hallmark of the disease — toxic clumps of amyloid beta in the brain.
CMS is deciding whether to cover future Alzheimer’s drugs that function similar to Aduhelm. This comes amid a long-simmering debate among researchers about whether targeting amyloid clumps in the brain actually helps patients, our colleague Laurie McGinley reported this summer.
Afflicting over 6 million Americans, Alzheimer’s is a devastating disease — and one that’s immensely difficult for the patient’s family and friends. That’s one reason why the decisions over Aduhelm have been so fraught.
What Medicare is deciding boils down to this: Is the drug “reasonable and necessary” for treating the disease? The answer to that question determines whether Medicare pays for the expensive drug.
There are multiple paths the agency can take. CMS could simply decide not to cover the drug. Or it could cover Aduhelm in full. It could cover the drug for a specific patient population or let local Medicare contractors decide.
- Another possible path is known as coverage with evidence development. That means Medicare will cover the product if a patient participates in a clinical study or a patient registry that collects data.
- “We might see CMS start to push back here to say that just because the FDA decides the drug meets their standard of ‘safe and effective’ doesn't mean it meets the Medicare standard of ‘reasonable and necessary,’” said Rachel Sachs, a professor at Washington University in St. Louis School of Law.
CMS received more than 130 comments as it began weighing its decision last year. The varying opinions have also been reflected on Twitter, in op-eds and in conversations with The Health 202.
For instance: The Alzheimer’s Association, a patient advocacy group, is advocating for full coverage of drugs in this class, said Robert Egge, the group’s chief public policy officer. (The association receives funding from drug companies, including Biogen, but its website says contributions don’t impact the group’s positions.)
But not all are convinced. Joseph Ross, a pharmaceutical policy expert at the Yale School of Medicine who sits on a committee advising Medicare on some coverage decisions, remains concerned about the drug’s safety. He predicts coverage with evidence is the most likely route.
- “I'm on the edge of my seat, kind of like everybody else,” Ross said.
On the Hill
Another Build Back Better breakdown?
Talks between Sen. Joe Manchin (D-W.Va.) and the White House are on ice, calling into question whether Democrats will be able to deliver on key health-care objectives.
The West Virginia senator sent a $1.8 trillion counteroffer to Biden’s economic package the week before Christmas. But even that offer — which included permanent funding for universal prekindergarten, climate spending and an expansion of Obamacare — may be off the table following a breakdown in negotiations between Manchin and the White House, The Post’s Jeff Stein reports.
Manchin said publicly this week that he is no longer involved in talks with the White House over the legislation. Senior Democrats told The Post that at this point, they don’t even believe Manchin would support his own offer even if the White House adopted it in full.
First in The Health 202: Democrats detail testing asks. A group of roughly 50 congressional Democrats sent a letter yesterday to President Biden calling for additional measures to expand rapid coronavirus tests, citing concerns about the tests’ availability. This comes as the administration has come under fire for a shortage of these tests.
The lawmakers say the administration is taking steps like setting up federal testing sites and crafting plans to send 500 million free at-home tests to Americans.
- “But as the Omicron variant spreads and we enter an ominous and unprecedented next phase of this pandemic, it is critical that we ensure these efforts meet the severity of the moment,” the lawmakers wrote in a letter led by Rep. Adam Schiff (D-Calif.), along with Rep. Ro Khanna (D-Calif) and Sen. Bernie Sanders (I-Vt.).
The lawmakers’ asks include measures like manufacturing enough rapid tests so every American can take at least one per week and ensuring Americans without Internet access can sign up to get the free rapid tests, such as through a national hotline.
- The group is also advocating for free tests in places like grocery stores, along with ensuring Americans with private insurance can easily get reimbursed for at-home tests.
The view from the administration: A White House official said the administration is in “full agreement” about the importance of rapid tests, “which is why we’ve taken action on all of the mentioned areas.” The official pointed to measures like the administration’s use of the Defense Production Act and efforts to send 50 million rapid tests to health centers and rural clinics.
And some news: The administration is planning to set up a phone line for its delivery of at-home tests for those who can’t order them online, per the White House official.
In the latest coronavirus news …
House lawmakers are getting upgrades to their masks, The Post’s Dan Diamond reports.
The U.S. is shipping treatments that may not work against omicron
The federal government has resumed shipping all three monoclonal antibodies authorized to treat early-stage covid-19 to states. But there’s evidence that two of the treatments may be ineffective against the omicron variant, our colleagues Lenny Bernstein, Laurie McGinley and Katie Shepherd report.
The move has received mixed reactions. There’s a severe shortage of sotrovimab, the monoclonal antibody that appears to work best against omicron in laboratory studies.
Some doctors say that they’d rather have access to some treatments than none, especially since some patients may be infected by the delta variant. Others worry about the ethics of giving patients costly treatments that may not work.
- When should the other two treatments be used? Only if a substantial proportion of infections in a region are from the delta variant and if a facility has the testing to show a patient doesn’t have omicron, per David Kessler, the chief scientific officer for the administration’s covid response.
Yet, most hospitals don’t have the capacity to do real-time genetic sequencing to differentiate between omicron or delta infections.
Here's what else you need to know:
- Early data: Information from some of the cities hit earliest by omicron show deaths following cases at a slightly reduced scale compared with previous peaks. But even if a slightly lower proportion of infections result in deaths, the sheer number of cases could be devastating, The New York Times’s Lauren Leatherby and Eleanor Lutz report.
- A silver lining? Some experts say the massive wave of omicron infections could help boost immunity as it rips through the population, meaning that once this wave ebbs, the pandemic could be less dangerous. But it’s far from assured, our colleagues Joel Achenbach and Carolyn Y. Johnson write.
In the courts
In case you missed it: The Supreme Court on Friday heard oral arguments over the Biden administration’s vaccine rules. Conservative justices appeared skeptical that the federal government had the authority to compel large employers to require vaccinations or regular coronavirus testing. But some of the same justices appeared more open to the administration’s vaccine mandate for health-care, The Post’s Robert Barnes and Ann E. Marimow report.
Tomorrow the Senate HELP Committee will hear testimony from top administration officials on the government’s response to new coronavirus variants.
On Wednesday, the same panel will consider the nomination of Robert Califf to lead the FDA.
On Thursday, Biden will deliver an update on the administration's response to the latest coronavirus surge.
Saturday is the deadline the administration set to provide guidance on private insurance reimbursement for at-home coronavirus tests.
Thanks for reading! See y'all tomorrow.