Marking the first FDA approval of an Alzheimer’s disease treatment in nearly 20 years, the federal agency on June 7 gave accelerated approval to Biogen Inc. and Eisai Co., Ltd.’s Aduhelm (aducanumab-avwa). While its approval was met with controversy over conflicting trial data and the drug’s $56,000 price tag, it was viewed as a turning point by some Alzheimer’s advocacy groups in the long road to finding a treatment that may slow the debilitating disease’s progression. The ultimate cost to the Medicare program and to Medicare Advantage insurers, meanwhile, will largely depend on whether neurologists are willing to prescribe it, what kind of national coverage policy CMS gives it and whether it could generate any medical cost offsets over the long term.
There are a host of other Alzheimer’s medications that are approved to treat the disease’s symptoms, and they are all covered under the pharmacy benefit, with varying degrees of prior authorization, step therapy, etc. (see chart, p. 3). Aduhelm, which is expected to slow the progression of Alzheimer’s by reducing the amount of beta-amyloid plaque in the brain, is infused once every four weeks and therefore likely to be covered under the medical benefit. Biogen has said it expects about 80% of potential Aduhelm patients to be covered through Medicare Part B, which would easily double the $37 billion Medicare already spends on Part B drugs annually if Biogen’s estimates are correct that roughly 1 to 2 million Americans would qualify for treatment.
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