Last week, Biogen announced that effective January 1, 2022, it will reduce the wholesale cost of its controversial new Alzheimer’s disease treatment, Aduhelm, in the U.S. by approximately 50% as an important Medicare decision looms.
For months, the U.S. Centers for Medicare and Medicaid Services (CMS) have been evaluating whether the drug should be covered, analyzing published clinical studies and medical society guidelines, as well as conducting public hearings. CMS is expected to release a proposed decision about Aduhelm's coverage on Jan. 12, with a final decision expected three months later.
Approved by the U.S. FDA back in June, part of the debate surrounding Aduhelm was focused on the mismatched results from the drug’s two phase 3 trials — one showed a benefit, while the other did not. Although Biogen presented data suggesting that a discrepancy in dose exposure between patients in the two studies explained the diverging results, not everyone was convinced – including payers, who have been unsure of Aduhelm’s benefit-risk profile. The initial price tag of $56,000 posed a huge potential financial burden for Medicare, commercial insurers and patients.
Now, with the yearly cost lowered to $28,200, Biogen hopes to enable access for more patients — and convince CMS to cover the drug. According to Biogen CEO Michel Vounatsos, “Too many patients are not being offered the choice of Aduhelm due to financial considerations and are thus progressing beyond the point of benefitting from the first treatment to address an underlying pathology of Alzheimer’s disease."
Biogen has also announced a plan to implement a series of cost-reduction measures in 2022, which are estimated to yield approximately $500 million in annualized savings.
In October, Biogen released its third-quarter financial report, which stated that the drug had brought in $300,000 in revenue — falling short of the forecasted $12 million expected by Biogen and analysts.
But if insurance coverage and access to diagnostics and specialized centers come together, Biogen believes that approximately 50,000 patients may start Aduhelm treatment in 2022.