Medicare proposes covering controversial Alzheimer's drug, with restrictions
Why it matters: Medicare is sending a signal to the pharmaceutical industry that Aduhelm — an IV medication with unproven clinical benefit, serious side effects and a $28,000 annual price tag — and other Alzheimer's drugs must show they work to gain Medicare's full coverage and payment.
Details: Under the proposal, the Centers for Medicare & Medicaid Services would oversee the clinical trials, under what's called a "coverage with evidence development."
- Patients could only have mild Alzheimer's, not later stages of the brain disease, and the study's population would have to be diverse and representative of the general population.
- Medicare does not cover "beta amyloid" PET scans, a test that measures a brain plaque that these drugs target and eliminate, but Medicare would cover one of these tests for enrolling patients.
The bottom line: Through this pathway, CMS is trying to answer whether Aduhelm and other similar drugs lead to a "statistically significant and clinically meaningful difference in decline in cognition and function" and determine how severe the side effects of the drugs are.
- Flashback: Biogen actively did not conduct another clinical trial that could have answered these questions, and the FDA did not push Biogen to conduct it, so now taxpayers will be covering the tab.
Keep in mind: This is the preliminary decision, and the drug's price, by law, had no bearing on the outcome.
- The final decision on Aduhelm will be published by April 11, and it could differ greatly from this decision.
- For example, in 2019, CMS initially said the cancer treatment CAR-T would only be covered in an "approved clinical study."
- The agency then switched gears in the final decision and decided to cover CAR-T fully without those parameters.