BIOGEN: Aduhelm "borra" también las expectativas y previsiones de ventas

 

Biogen readies fight to reverse preliminary CMS coverage decision for Aduhelm

Biogen executives on Thursday pledged to try to reverse a draft decision by the US Centers for Medicare and Medicaid Services (CMS) that would sharply limit Medicare coverage of its Alzheimer's disease drug Aduhelm (aducanumab). 

The "coverage with evidence development" proposal would only cover Alzheimer's amyloid antibody treatments for patients who are enrolled in approved clinical trials, a decision that threatens to further erode Aduhelm's already struggling sales.

Biogen had expected roughly 50,000 patients would begin treatment with Aduhelm in 2022. However, CEO Michel Vounatsos estimates that only a small number, possibly in the hundreds, who have the resources and time to travel to major hospitals conducting the trials, would now get access to the drug under the CMS rule

Stakeholders urged to voice disapproval

The draft proposal is currently in a 30-day public comment period, with Alisha Alaimo, president of Biogen's US business, saying it is "really, really important" for stakeholders to express their view about the policy. Vounatsos also urged patients to "make their voice heard" during the period to allow for a "broader and more equitable access" to the therapy. After that period closes, Biogen executives said there is likely to be a 30-day period when CMS officials will meet with interested companies and advocacy groups.

Vounatsos indicated that he has had no dialogue with CMS during an initial Medicare coverage review process last year, other than a call with the administrator at the review's outset. In the near future, the CEO hopes that he and his team can meet with CMS officials to share the company's perspective. He also anticipates the final decision, due by April 12, will look different than the "dramatic" CMS proposal that was issued this week.

Most cost-cutting on the way? Meanwhile, the drugmaker recently announced plans for $500 million in cost-reduction measures in 2022, and company officials suggested Thursday that more could be on the horizon if Medicare's final decision does not go its way. "We are engaging very closely with our board on tactical shorter measures, but also strategic options," remarked Vounatsos, although he did not provide specifics.

Biogen previously said that the healthcare system has been "a major bottleneck" to uptake of Aduhelm, which was awarded an accelerated approval by the FDA in June despite doubts over its safety and efficacy .

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Todo sobre Aduhelm en PHARMACOSERIAS

The drug's original annual cost of $56,000 per patient also raised concerns over the toll it might take on the Medicare programme. Last month, the company slashed Aduhelm's list price by about half to $28,200 per year . Biogen has indicated that it was banking on the pending Medicare decision to provide "clarity on reimbursement" to help drive sales.

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