CMS on July 12 began its review of whether it will standardize coverage of Biogen's much-debated Alzheimer's drug Aduhelm.
Medicare will analyze clinical studies on the drug and medical society guidelines. Two public hearings assessing the drug's benefits, slated to take place later in July, will also be part of the evaluation process.
The evaluation seeks to determine if Aduhelm is a "reasonable and necessary" drug, because if it is, Medicare is required by law to cover it. CMS could still restrict which patients receive the drug, though, as it could limit coverage to only those who match the FDA's criteria.
"We want to consider Medicare coverage of new treatments very carefully in light of the evidence available," CMS Administrator Chiquita Brooks-LaSure said in a statement. "That’s why our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease."
CMS said it expects to make a proposed decision within six months, and a final one within nine months. The public will have 30 days to submit comments after the proposed decision is announced.
Biogen lists Aduhelm's annual price as $56,000. The drugmaker based this price on the three vials required to treat a patient who weighs 163 pounds.
Aduhelm and other infused drugs are administered based on a patient's weight, meaning heavier patients need higher doses than lighter patients. The annual price rises to $68,430 for patients weighing 200 pounds.