BRIEF—Biogen comes out aggressive over Aduhelm

US biotech Biogen held a virtual analyst day where the focus was not surprisingly on the recent draft National Coverage Determination (NCD) for Aduhelm (aducanumab) and the Anti-Abeta MAb class.

Management reiterated its disappointment with Centers for Medicare and Medicaid Services’ (CMS) “dramatic” draft decision of Coverage with Evidence Development (CED) and thinks that the CED would limit the number of patients on therapy to the hundreds, commented SVB Leerink Research analyst Marc Goodman.

Management adopted an aggressive tone regarding the decision, citing this as a “non-coverage type of position,” and it believes that this CMS decision would slow down innovation in the risky Alzheimer’s disease (AD) space.

It was surprising to hear that other than one conversation with the Commissioner, Biogen management has had no dialogue with senior people at CMS for the NCD process yet.

Biogen is working on a formal response to be submitted during the 30-day open comment period, which would be followed by a 30-day period for CMS meetings before the final NCD in April.

And management reiterated that coverage with restrictions (ie, open access to patients consistent with the inclusion criteria in Aduhelm’s clinical trials) is the desired outcome for the final NCD.

Most importantly, said Mr Goodman, if the final NCD in April does not change from the current draft, management indicated that it would remain flexible and would take additional measures with respect to necessary cost-cutting (on top of the recently announced $500 million restructuring plan) as well as to business development.