April 8, 2022 — Federal officers have made their ultimate resolution: Medicare will solely pay for sufferers to get the brand new Alzheimer’s drug aducanumab (Aduhelm) if the sufferers are collaborating in medical trials.
On Thursday, the Facilities for Medicare & Medicaid Providers (CMS) launched its nationwide protection willpower for aducanumab and different related medicine that focus on beta-amyloid within the mind, which is taken into account a trademark of Alzheimer’s illness.
In a press launch, the CMS mentioned its resolution is a two-part coverage primarily based on the at the moment out there proof for anti-amyloid brokers.
Final yr, the FDA accepted 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, however 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 towards approving the drug.
CMS set far much less restrictive circumstances for potential protection of anti-amyloid medicine that will get full FDA approval sooner or later. In such circumstances, protection could be pegged to participation in CMS-approved research, equivalent to an information assortment by way of routine medical follow or registries, not solely medical 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 mentioned. “This is a crucial change that may increase entry for extra sufferers to entry the drug in extra settings.”
“Though that is an enchancment, it could have been preferable for CMS to incorporate affected person registries, which acquire real-world proof that extra intently displays the precise inhabitants dwelling with Alzheimer’s, in comparison with the restricted populations that enroll in medical trials,” he added. “This method would even have prolonged protection of Aduhelm to extra sufferers at the moment dwelling with Alzheimer’s illness.”
He additionally welcomed the flexibleness CMS outlined for future protection of medicine with extra compelling knowledge.
“Medicine in the identical class should not essentially equal and every needs to be evaluated and made out there to sufferers by itself deserves,” Fillit mentioned.
In an announcement, aducanumab producer Biogen disagreed with CMS’ restrict on protection for the drug and protested the two-tiered method created for amyloid-targeting antibody medicine.
“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 mentioned.
Biogen and different critics of the CMS resolution contend it denies sufferers entry to a medicine which may sluggish 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 mentioned the company tried to make the method resulting in at this time’s resolution clear and evidence-based. It famous it gathered greater than 10,000 stakeholder feedback on its draft resolution and thought of greater than 250 peer-reviewed paperwork.
“This ultimate Nationwide Protection Dedication displays CMS’ dedication to supply the American public with a clear, trusted, evidence-based resolution — with out regard to value — that’s made solely after a radical evaluation of public suggestions,” CMS Administrator Chiquita Brooks-LaSure mentioned in an announcement.
“Via this resolution, we’re making a pathway for individuals with Medicare to shortly entry medicine the FDA determines have proven a medical profit and encourages producers and trial directors to make sure that the medical trials recruit racially various members,” she added.