Biogen’s aducanumab in AD unlikely to be well-covered by payers, with FDA approval prospects mixed

Following a controversial FDA Advisory Committee meeting for Biogen’s aducanumab for mild Alzheimer’s disease, where the panel members sharply recommended against approval, the therapy will likely face significant barriers to coverage if it gains an agency nod in March, according to reporting from William Newton, Pharma Writer for the Investigative News team at GlobalData, a leading data and analytics company.

Both Medicare and private insurance will likely be concerned by aducanumab’s questionable efficacy, high cost of USD 50,000 a year that could be incurred for more than a decade, and safety concerns.

Newton states: “High coinsurance requirements and stringent prior authorization, including expensive testing to determine eligibility, could mean far less than 10% of eligible patients take aducanumab if it gains FDA approval.”

Despite support for aducanumab in official FDA documents released prior to the FDA Advisory Committee hearing on the treatment, panelists were extremely critical of aducanumab and voted that it did not demonstrate efficacy in clinical trials. Given this contradictory signaling, experts Newton interviewed had no clear consensus over the likelihood of FDA approval.

The likely payer response to aducanumab, however, is clearer. Newton reports: “Even if the FDA contradicts the advisory committee in its approval decision, the Center for Medicare Services officials are likely to pay close attention to panel member objections in making coverage decisions, including their questions regarding aducanumab’s efficacy.”

Additionally, Medicare and private insurance will likely be concerned with the adverse event of amyloid-related imaging abnormalities seen in prior aducanumab studies. Newton states: “Payers are likely to strongly weigh this well-established safety concern against the more unclear efficacy benefit when determining coverage plans.”

There is a potential way forward for aducanumab, even if the FDA does reject the application. Newton states: “The FDA could require Biogen to complete a one-year study confirming aducanumab’s effect on reducing amyloid count. The FDA could then approve aducanumab while requiring an additional postmarket study to confirm the surrogate marker of reduced amyloid count is clinically meaningful.”

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