Medicare has placed restrictions on which Alzheimer’s drugs will be covered under Part “B” of the program. This means that seniors who are diagnosed with Alzheimer’s may have to pay more for their medications. The good news is that there are still a number of drugs that will be covered, and you may be able to get a discount on your Part “B” premium if you fall into one of the categories outlined by Medicare.
This case has far-reaching consequences for Biogen and its competitors because the FDA’s exclusivity decision affects all therapies in the class, including future treatments. The decision also has implications for the entire health care system, which is struggling to find ways to pay for new, high-cost drugs.
However, in a significant departure from the initial concept, Medicare officials created a sort of shortcut route for medicines that, unlike Aduhelm, provide evidence of clinical benefit to patients before they are approved. This means that they can skip certain testing phases and be covered by Medicare for a larger group of people.
Since the Food and Drug Administration approved Aduhelm last summer, doctors and scientists have raised questions about whether it actually works, government watchdogs have begun investigating whether the FDA followed proper procedure to approve it, and policy experts have questioned whether it is effective enough to justify its hefty price tag.
Aduhelm is the first new Alzheimer’s disease drug to reach the market in nearly 20 years, and it is also one of the most expensive drugs ever. The list price is $56,000 a year, but Medicare officials have said that the real cost to patients and taxpayers will be much higher because of discounts and rebates.
The FDA’s decision to give Biogen an exclusive license for Aduhelm was based on the fact that the drug appeared to slow the decline of patients in early clinical trials. But some experts have said that the evidence is not strong enough to justify such a high price tag, and that other drugs might be more effective.
The Medicare program is increasing its premiums in order to cover the high costs of a new, expensive drug. However, the new restrictions on who can take the drug will mean that the Medicare program will spend less money on it. Health secretary Xavier Becerra said he plans to decide whether to lower Medicare premiums for older adults after Medicare’s decision on the new drug.“We will be looking at this to see if there is a way that we can give some relief to our seniors,” Becerra said. “This is something that we’re going to have to take a look at.”
Aduhelm’s restricted coverage policy is unique, as Medicare frequently pays for medications if the FDA approves them. Because the agency gave approval for the therapy without a promise that patients would experience slower cognitive deterioration, Aduhelm has been unique. Many questions have been raised about Biogen’s arrangement with the FDA, which STAT revealed in its reporting that Biogen has an extensive back-channel connection with the FDA. The decision highlights a stark power struggle between Medicare and the FDA over Americans’ access to Aduhelm, but Medicare officials did give the FDA a significant win.
Medicare will limit who can obtain the drug to people with mild forms of cognitive impairment or dementia that have amyloid plaques in their brain, as opposed to the FDA-approved population. Because the FDA didn’t require proof of amyloid plaques, patients with other medical issues such as Down syndrome are now permitted to take part in clinical trials.
The controversial tool that Medicare used to cover Aduhelm is called a “Coverage with Evidence Development.” It’s possible that Biogen or other drug makers could sue Medicare over the decision by arguing Medicare doesn’t have the legal authority to require more studies to prove companies’ drugs benefit patients, said Sean Tunis, a principal at Rubix Health who helped develop the CED process during his tenure at the Centers for Medicare and Medicaid Services.
“The CED process hasn’t been challenged in any way before because it wasn’t to anyone’s advantage,” Tunis said. In the past, CED systems have been utilized to regulate coverage of new drug or device indications that would not have been covered otherwise.
While many persons with Alzheimer’s disease are Medicare beneficiaries, the choice could have ramifications that go beyond the Medicare population, since most major insurers follow the federal government’s example when formulating their own drug policies.
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Rolando Arellano J.D. is the founder of YourMedicare by AYA and Associates.
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