April 8, 2022 — Federal officers have made their ultimate choice: Medicare will solely pay for sufferers to get the brand new Alzheimer’s drug aducanumab (Aduhelm) if the sufferers are collaborating in scientific trials.
On Thursday, the Facilities for Medicare & Medicaid Providers (CMS) launched its nationwide protection willpower for aducanumab and different comparable medication that focus on beta-amyloid within the mind, which is taken into account an indicator of Alzheimer’s illness.
In a press launch, the CMS stated its choice is a two-part coverage primarily based on the at present out there proof for anti-amyloid brokers.
Final yr, the FDA permitted aducanumab for Alzheimer’s illness utilizing the accelerated approval pathway, as a result of trials had proven the drug eliminated beta-amyloid from the mind, nevertheless it wasn’t clear the drug had improved the signs of individuals with Alzheimer’s.
The choice sparked controversy and led to the resignation of three members of the FDA’s advisory panel that had voted in opposition to approving the drug.
CMS set far much less restrictive situations for potential protection of anti-amyloid medication that will get full FDA approval sooner or later. In such instances, protection could be pegged to participation in CMS-approved research, similar to a knowledge assortment via routine scientific apply or registries, not solely scientific trials.
Howard Fillit, MD, co-founder and Chief Science Officer of the Alzheimer’s Drug Discovery Basis, supported the choice.
“Medicare will now present protection for sufferers enrolled in any FDA- or NIH-approved trial,” Fillit stated. “This is a vital change that can increase entry for extra sufferers to entry the drug in further settings.”
“Though that is an enchancment, it will have been preferable for CMS to incorporate affected person registries, which gather real-world proof that extra intently displays the precise inhabitants residing with Alzheimer’s, in comparison with the restricted populations that enroll in scientific trials,” he added. “This strategy would even have prolonged protection of Aduhelm to extra sufferers at present residing with Alzheimer’s illness.”
He additionally welcomed the pliability CMS outlined for future protection of medicine with extra compelling information.
“Medication in the identical class should not essentially equal and every ought to be evaluated and made out there to sufferers by itself deserves,” Fillit stated.
In an announcement, aducanumab producer Biogen disagreed with CMS’ restrict on protection for the drug and protested the two-tiered strategy created for amyloid-targeting antibody medication.
“These protection restrictions, together with the excellence between accelerated approval and conventional approval, have by no means been utilized to FDA-approved medicines for different illness areas,” Biogen stated.
Biogen and different critics of the CMS choice contend it denies sufferers entry to a drugs that may gradual Alzheimer’s-related psychological decline, whereas supporters query whether or not displaying the drug eliminated beta-amyloid from the mind means it helps sufferers’ signs.
CMS officers stated the company tried to make the method resulting in as we speak’s choice clear and evidence-based. It famous it gathered greater than 10,000 stakeholder feedback on its draft choice and regarded greater than 250 peer-reviewed paperwork.
“This ultimate Nationwide Protection Dedication displays CMS’ dedication to offer the American public with a clear, trusted, evidence-based choice — with out regard to value — that’s made solely after a radical evaluation of public suggestions,” CMS Administrator Chiquita Brooks-LaSure stated in an announcement.
“By way of this choice, we’re making a pathway for individuals with Medicare to rapidly entry medication the FDA determines have proven a scientific profit and encourages producers and trial directors to make sure that the scientific trials recruit racially various individuals,” she added.