Following the Centers for Medicare & Medicaid Services’ (CMS) announcement of draft guidance on its highly anticipated reimbursement decision regarding Aduhelm (aducanumab) and other future anti-amyloid monoclonal antibody (mAb) products in Alzheimer’s disease (AD);
Rose Joachim, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:
“CMS’s decision to limit Medicare reimbursement of anti-amyloid mAb products to AD patients participating in randomized controlled trials (RCTs) will significantly delay and limit patient access to these products in the near term, with Biogen’s Aduhelm likely bearing the brunt of these troubles.
“Despite Aduhelm’s first-to-market advantage, the months of controversy following the drug’s approval were a major setback. While CMS’s preliminary decision is yet another blow for the drug, the guidance can still potentially change, with a final decision expected in April. Based on Aduhelm’s delayed uptake trajectory, as well as its recently slashed price at nearly 50% of the original, GlobalData estimates that 2028 will see the product reach sales of $906.1 million—only a quarter of the sales GlobalData had previously forecast for that year.
“The three other anti-amyloid mAb products in Phase III trials—Eisai and Biogen’s lecanemab; Roche/Genentech’s gantenerumab; and Eli Lilly’s donanemab—could either improve or worsen Aduhelm’s prospects. All three products are in Phase III trials with expected readouts in H2 2022 and H1 2023, which will help to confirm or deny the clinical relevance of amyloid reduction in the treatment of AD.
“Further, while positive competitor data supporting the clinical benefit of amyloid clearance could give Aduhelm’s sales a small boost, Aduhelm will likely no longer be the only anti-amyloid therapy on the market by the time this data is released. Eisai and Biogen and Eli Lilly are expected to pursue accelerated approval for lecanemab and donanemab, respectively, based on the surrogate endpoint of amyloid reduction, with both entering the AD market in Q3 2022.
“Another complicating factor is the uncertainty regarding how quickly positive clinical data from other anti-amyloid mAb products could persuade CMS to end the CED requirement on this class of products. The recent draft guidance suggests CMS may want to see further long-term data on anti-amyloid mAb efficacy and safety before expanding access, which could spell trouble for all anti-amyloid mAbs—not just Aduhelm.”