A controversial new Alzheimer’s drug is officially only covered for a select few patients under Medicare, as a modified version of a January proposal became reality earlier this week.
Medicare will only cover Aduhelm, the expensive IV treatment approved for use in the United States last summer, for patients participating in eligible clinical trials, the U.S. Centers for Medicare and Medicaid Services announced Thursday. The new National Coverage Determination follows a proposal earlier this year that had even tighter restrictions on coverage. The Alzheimer’s Association, a nonprofit that funds Alzheimer’s research, harshly criticized the earlier proposal as well as the final decision.
Medicare will only cover Aduhelm, the expensive IV treatment approved for use in the United States last summer, for patients participating in eligible clinical trials.
Aduhelm, produced by Massachusetts-based Biogen and also known generically as aducanumab, is the first new drug approved for the treatment of Alzheimer’s by the U.S. Food and Drug Administration since 2003, but has faced significant backlash and controversy throughout its existence. It’s marketed as a first-of-its-kind drug that attacks the pathology of Alzheimer’s instead of just the symptoms, but its high price tag, potential side effects and questions about its effectiveness have made it a target for criticism.
When the FDA first approved Aduhelm in July 2021, it did so using its accelerated approval pathway, requiring more future research into the drug’s effectiveness, which is set to begin this year. Aduhelm has been proven to reduce the amount of amyloid plaque in the brain, a hallmark of Alzheimer’s, but the FDA may revoke its approval if the trials do not produce evidence the drug improves memory or mitigates other symptoms of Alzheimer’s.
When Medicare premiums increased by record percentages for 2022, CMS specifically cited Aduhelm and uncertainty around its coverage plan as part of the reason for the price hike. Originally priced at more than $50,000 per year for treatment, Biogen cut the drug’s price in half shortly after 2022 premiums were announced. Medicare will likely be a major purchaser of the drug going forward.
The criteria for approved trials is broader in the final CMS coverage decision than it was in the January proposal, but the fact remains only patients participating in Aduhelm’s continuing trials will be eligible to have the drug covered by Medicare. Right now, Aduhelm is only approved for treatment of patients with mild cognitive impairment or mild dementia as a result of Alzheimer’s, although the Medicare Coverage Database notes its coverage could change if the FDA widens the approved use of the drug.
In the statement announcing the National Coverage Determination, CMS chief Chiquita Brooks-LaSure said the final plan was a result of feedback the organization received on the proposed policy.
“CMS has a responsibility to ensure that people with Medicare have equitable and appropriate access to therapies that are reasonable and necessary for use in the Medicare population,” said Brooks-LaSure in the statement. “Through this decision, we are creating a pathway for people with Medicare to quickly access drugs the FDA determines have shown a clinical benefit and encourages manufacturers and trial administrators to ensure that the clinical trials recruit racially diverse participants.”
Racial diversity was a key part of the Alzheimer’s Association’s criticism of the earlier proposal, which the Association called “shocking discrimination” in a release at the time. For the final NCD, the organization said in a statement that it is “deeply disappointed,” and the association’s CEO, Harry Johns, said more patients should have access to the treatment.
“CMS has created unnecessary barriers for individuals with Alzheimer’s disease,” Johns said in the statement. “Patients with Alzheimer’s, a fatal disease, should have FDA-approved treatments covered by Medicare just as those facing other diseases do.”
CMS notes in its release on the NCD that more than 6 million Americans live with Alzheimer’s, and that number is expected to more than double in the next 40 years.
More than 6 million Americans live with Alzheimer’s, and that number is expected to more than double in the next 40 years.
“Effective treatments are needed, and because of the early but promising evidence and the immense burden of this devastating disease on the Medicare population, CMS is finalizing Medicare coverage under CED to support rigorous studies approved by the FDA and NIH to help answer whether this class of drugs improves health outcomes for patients,” reads the release.