Biogen's take on the Centers for Medicare & Medicaid Services' (CMS') stifling coverage proposal for Alzheimer's disease drug Aduhelm? "Strong disagreement," CEO Michel Vounatsos said at the top of a Thursday Q&A call with investors.
If finalized in its current form, Biogen thinks the coverage decision will "deny nearly all Medicare beneficiaries the right to access Aduhelm," which the CEO noted is the first FDA-approved Alzheimer's treatment since 2003.
Warning that the move could also hamstring future Alzheimer's innovation and put current patients at risk, Vounatsos asked supporters of Aduhelm, also known as aducanumab, to make their disagreement heard before the CMS issues its final verdict this spring.
During a 30-day open commenting period on the CMS decision, "we encourage others to make their voice heard so that this final decision expected in April will allow for broader and more equitable access," Vounatsos said.
“Why should Alzheimer’s disease patients be treated differently than those suffering from cancer, HIV or other illnesses,” the CEO asked. Biogen believes it’s “more fair and appropriate” for Medicare to align coverage of anti-amyloid therapies like Aduhelm consistently with the criteria used in respective clinical trials, he said.
Earlier this week at the 2022 J.P. Morgan Healthcare Conference, the CEO said that “anything that starts to provide access in this country—the No. 1 market in the world—is very good news." But after CMS unveiled its proposal, SVB Leerink analyst Marc Goodman wrote to clients that the "disappointing" Medicare decision “barely opens the door for access.”
Biogen hopes the final decision in April yields "coverage with restrictions," Mizuho Securities Salim Syed noted in an email to clients after Biogen's call. As for whether Biogen might pull Aduhelm from the market, Syed said the company is considering all possibilities.
Other analysts are hedging their bets, too. RBC Capital Markets Brian Abrahams said Thursday, before Biogen's call, that his team is removing "any meaningful go-forward revenue from Aduhelm."
The analyst said it's tough to imagine how any stakeholders other than Biogen itself could convincingly advocate for the drug without more data. If Biogen chooses to keep the drug on the market, Aduhelm would likely enjoy minimal adoption among commercial and self-pay patients, Abrahams said.
Nevertheless, the CMS decision could provide "somewhat of a clearing event" for Biogen's stock, dispelling any "lingering hope about Alzheimer's upside," the analyst added.
Before Thursday's call, Syed wrote to clients that his team is also "removing nearly all Aduhelm sales" from his estimates. The requirement of a clinical trial as a condition for reimbursement—known as coverage with evidence development (CED)—"essentially means that access to the drug will be significantly limited," he added.
The coverage framework, which focuses not just on Aduhelm, but also other amyloid-targeting drugs, could “block access” to those future therapies for the “indefinite future,” Vounatsos warned.
The “likely result,” according to Vounatsos, is that the number on patients on therapy for the foreseeable future will only be in the “hundreds,” despite the millions of patients affected by Alzheimer’s, the CEO said.
It’s also likely to “promote inequality,” since eligible patients would need to live close to or be able to travel to treatment centers involved in registered studies, even if they would otherwise meet clinical trial criteria. Biogen has been advocating for coverage with restrictions that mirror the enrollment criteria for Aduhelm’s phase 3 clinical trials.
The CMS’ decision appears to be based “on an incomplete and in some cases, inaccurate, assessment of the body of evidence for this class of antibodies,” Vounatsos continued.
The CEO also voiced concern that the decision could “discourage investment” and produce a “chilling effect” on future Alzheimer’s development.