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), AIS Health reported.

Controversial approval:

  • Aduhelm’s two Phase III trials showed contradictory results regarding efficacy. Moreover, patients reported temporary swelling in areas of the brain that caused symptoms such as headache, confusion and nausea, and an adverse reaction. The Institute for Clinical and Economic Review in a draft evidence report concluded that the evidence was “insufficient” to determine the net health benefit of Aduhelm.

Medical benefit coverage:

  • Aduhelm 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.

Implications for Medicare:

  • “New generations of drugs are increasingly tied to diagnostic monitoring. In this case, patients may be required to undergo Magnetic Resonance Imaging (MRI) to determine disease progression,” observes Jay Jackson, a principal at Avalere Health. And MRI is a currently covered diagnostic for Alzheimer’s patients, he notes. “While most Medicare beneficiaries have some form of secondary insurance…out-of-pocket expenses for both for those patients without such secondary coverage could create barriers to access.”
  • For MCOs, the drug and related imaging presents a “major incremental cost” to Medicare and could trigger the “significant cost” threshold in Medicare, suggested analysts from Evercore ISI in a June 7 research note.
  • Since MA plan bids were due on June 7, it’s too late for Aduhelm’s approval to be factored into their 2022 capitation rates and it’s unclear at this time what CMS will do for the 2023 capitation rates, suggests Brad Piper, a principal and consulting actuary with Milliman.

by Lauren Flynn Kelly