As Aduhelm forecasts plunge, all eyes turn to coverage decision

The FDA’s verdict on Biogen’s Aduhelm was the biggest biopharma event of 2021, and next year the controversial Alzheimer’s drug will once again dominate sector catalyst trackers. The CMS’s National Coverage Decision, which will set out how Medicare will reimburse the drug, is due in the opening months of 2022. The meagre $300,000 in third-quarter sales that Biogen reported for the product yesterday amply illustrates the importance of the NCD; many physicians are waiting for it before prescribing, the company claims. That third-quarter figure substantially missed sellside consensus and prompted a wave of downgrades, although until CMS decides who is eligible for Aduhelm future demand is hard to gauge. The extent to which the medical community will actually use the antibody is also a big unknown, but most analysts assume that Aduhelm will become a blockbuster eventually. Still, a number of crucial readouts and regulatory moves are nearing for competitor projects; while three months ago Roche rubbished the idea of an early gantenerumab filing yesterday its stance shifted, and it would not rule out applying for accelerated approval. In reality Aduhelm’s long-term outlook remains just as hard to predict as near-term demand.