Patient access to new Alzheimer’s drugs will depend on diagnostic innovation and payment reform

With Biogen’s Alzheimer’s therapy up for approval this year, there’s an urgency to solve market access

If Biogen’s Alzheimer’s disease therapy aducanumab gets approved this year, it will set off a payment time bomb given the huge patient population, and the fact it almost exclusively falls in the Medicare age group. As things stand, who gets the therapy will depend on whether progress can be made on diagnostics, data collection and new payment models.

If those issues aren’t sorted out, it’s possible that only patients with the resources to pay out of pocket for the required screening tests -- and maybe even for the drug itself -- will have access to the therapy.

Until very recently, drug developers haven’t had to solidify commercial plans in Alzheimer’s disease (AD) because nothing new has worked or come close to gaining approval.

That changed last October when Biogen Inc. (NASDAQ:BIIB) made the unexpected announcement that aducanumab, its anti-amyloid mAb, met the primary endpoint in a Phase III study. The announcement came seven months after the company said it was discontinuing development of the mAb due to a failed interim futility analysis (see “If Approved, Aducanumab Will Still Have Hills to Climb”).

Biogen plans to submit a BLA to FDA this year. With an accelerated review, the therapy could reach the market before year-end. That possibility has increased the urgency to figure out how to deliver the first biologic therapy for the disease, and how to pay for it.

“Approval of a biological like aducanumab will stimulate the kind of infrastructure changes needed to create better care and access to care. It will come, but there are things we can be doing now to prepare,” Howard Fillit, founding executive director and CSO at the

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