April 8, 2022 — Federal officers have made their last choice: 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 Companies (CMS) launched its nationwide protection dedication for aducanumab and different related medication that concentrate 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 choice is a two-part coverage primarily based on the at the moment obtainable proof for anti-amyloid brokers.
Final yr, the FDA accredited 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 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 by means of 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 mentioned. “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 will 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 method would even have prolonged protection of Aduhelm to extra sufferers at the moment residing with Alzheimer’s illness.”
He additionally welcomed the pliability CMS outlined for future protection of medication with extra compelling knowledge.
“Medication in the identical class should not essentially equal and every ought to be evaluated and made obtainable 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 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 mentioned.
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 exhibiting 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 present’s choice clear and evidence-based. It famous it gathered greater than 10,000 stakeholder feedback on its draft choice and thought of greater than 250 peer-reviewed paperwork.
“This last Nationwide Protection Willpower displays CMS’ dedication to offer the American public with a clear, trusted, evidence-based choice — with out regard to price — that’s made solely after an intensive evaluation of public suggestions,” CMS Administrator Chiquita Brooks-LaSure mentioned in an announcement.
“By this choice, we’re making a pathway for individuals with Medicare to shortly 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 members,” she added.
