April 8, 2022 — Federal officers have made their closing determination: Medicare will solely pay for sufferers to get the brand new Alzheimer’s drug aducanumab (Aduhelm) if the sufferers are taking part in medical trials.
On Thursday, the Facilities for Medicare & Medicaid Companies (CMS) launched its nationwide protection dedication for aducanumab and different related 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 determination is a two-part coverage primarily based on the at present out there proof for anti-amyloid brokers.
Final 12 months, 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 situations for potential protection of anti-amyloid medication which will get full FDA approval sooner or later. In such circumstances, protection can be pegged to participation in CMS-approved research, comparable to a knowledge assortment via routine medical apply 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 vital change that can broaden 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 gather real-world proof that extra carefully displays the precise inhabitants residing 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 at present residing with Alzheimer’s illness.”
He additionally welcomed the pliability CMS outlined for future protection of medicine with extra compelling knowledge.
“Medication in the identical class should not essentially equal and every needs to be evaluated and made out there 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 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 determination contend it denies sufferers entry to a medicine that may gradual 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 immediately’s determination clear and evidence-based. It famous it gathered greater than 10,000 stakeholder feedback on its draft determination and thought of greater than 250 peer-reviewed paperwork.
“This closing Nationwide Protection Dedication displays CMS’ dedication to supply the American public with a clear, trusted, evidence-based determination — with out regard to price — that’s made solely after an intensive evaluation of public suggestions,” CMS Administrator Chiquita Brooks-LaSure stated in a press release.
“By means of this determination, we’re making a pathway for individuals with Medicare to rapidly entry medication the FDA determines have proven a medical profit and encourages producers and trial directors to make sure that the medical trials recruit racially numerous contributors,” she added.