April 8, 2022 — Federal officers have made their remaining resolution: Medicare will solely pay for sufferers to get the brand new Alzheimer’s drug aducanumab (Aduhelm) if the sufferers are collaborating in clinical trials.
On Thursday, the Facilities for Medicare & Medicaid Companies (CMS) launched its national coverage determination for aducanumab and different comparable 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 stated its resolution is a two-part coverage primarily based on the presently obtainable proof for anti-amyloid brokers.
Last year, 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, 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 medicine that will get full FDA approval sooner or later. In such instances, protection could be pegged to participation in CMS-approved research, equivalent to an information assortment via routine medical observe 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 stated. “This is a crucial change that can increase entry for extra sufferers to entry the drug in further 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 living with Alzheimer’s, in comparison with the restricted populations that enroll in medical trials,” he added. “This strategy would even have prolonged protection of Aduhelm to extra sufferers presently dwelling with Alzheimer’s illness.”
He additionally welcomed the flexibleness CMS outlined for future protection of medicine with extra compelling information.
“Medication in the identical class aren’t essentially equal and every ought to be evaluated and made obtainable to sufferers by itself deserves,” Fillit stated.
In a press release, aducanumab producer Biogen disagreed with CMS’ restrict on protection for the drug and protested the two-tiered strategy 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 stated.
Biogen and different critics of the CMS resolution contend it denies sufferers entry to a drugs that may sluggish Alzheimer’s-related psychological decline, whereas supporters query whether or not exhibiting 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 at this time’s resolution clear and evidence-based. It famous it gathered greater than 10,000 stakeholder feedback on its draft resolution and regarded greater than 250 peer-reviewed paperwork.
“This remaining Nationwide Protection Dedication displays CMS’ dedication to offer the American public with a clear, trusted, evidence-based resolution — with out regard to value — that’s made solely after an intensive evaluation of public suggestions,” CMS Administrator Chiquita Brooks-LaSure stated in a press release.
“By this resolution, we’re making a pathway for individuals with Medicare to rapidly 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 numerous members,” she added.