Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News
On Tuesday the Centers for Medicare & Medicaid Services (CMS) announced that it will provide coverage for Aduhelm, a high cost, controversial medication that treats Alzheimer’s disease created by Biogen. However, the ruling has a catch, as coverage will be limited to Medicare recipients that enroll in clinical trials.
CMS generally covers services that are considered reasonable and necessary under specific criteria, but in some cases the law allows for limiting coverage for certain items or treatments. This provision allows for a treatment to be approved while collecting data from trials that could confirm the need for a more comprehensive coverage decision.
The current ruling is preliminary and is currently open to a 30-day public comment period that will allow members of the public to provide feedback to CMS. The agency is expected to reach a final determination on the drug in early April.
In a statement, CMS Administrator Chiquita Brooks-LaSure said, “Throughout this National Coverage Determination process, CMS has been and remains committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
Beneficiaries would be expected to pay a 20% co-pay for the treatment, which costs $28,200 a year. Due to the high price and demand for the treatment, as well as other contributing factors, CMS announced in November that monthly premiums would increase by 15% starting in 2022.
Aduhelm is the first drug approved to treat Alzheimer’s disease, which impacts more than 6 million Americans, by slowing progressive cognitive decline. The drug is a monthly infusion of monoclonal antibodies that target beta-amyloids, which are the main components found in amyloid plaques of individuals with Alzheimer’s. However, many physicians are hesitant to prescribe the medication, citing a lack of clear evidence that it works.
Biogen stopped two clinical trials after an analysis showed that it was likely the drug would not work as expected. However, after reanalyzing the data, Biogen said that the studies did in fact indicate that the medication worked, though at higher doses.
The medication was approved through an accelerated pathway but was required to continue clinical trials to gather more data. This approval came despite the fact that an independent panel of experts found that the evidence provided by Biogen did not adequately show that the medication slowed the disease process. The Phase 3 portion of the clinical trials which was analyzed produced mixed results about how well the drug worked.
The drug also comes with the risk of complications such as vision changes, confusion, hallucinations, delusions, and changes in speech. Some complications could be fatal, with 41% of patients in the trial reporting brain swelling or bleeding according to a study from JAMA Neurology.
The conditional FDA approval means that Biogen will need to conduct post-market surveillance studies to prove that the drug works. This will be a global, placebo-controlled trial that will enroll approximately 1,300 early Alzheimer’s disease patients with a completion date of 4 years after the study begins.
If the drug were to show promise it would be a game changer for the millions of Americans that suffer from debilitating memory loss and behavioral changes from the disease.