Medicare Will Only Cover New Alzheimer’s Drug in Trials

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 collaborating in medical trials.

On Thursday, the Centers for Medicare & Medicaid Services (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 a trademark of Alzheimer’s illness.

In a press launch, the CMS stated its determination is a two-part coverage based mostly on the at present accessible proof for anti-amyloid brokers.

Last yr, the FDA authorized 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 determination 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 medication that will get full FDA approval sooner or later. In such circumstances, protection could be pegged to participation in CMS-approved research, comparable to an information assortment by routine medical follow or registries, not solely medical trials.

Howard Fillit, MD, co-founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation, supported the choice.

“Medicare will now present protection for sufferers enrolled in any FDA- or NIH-approved trial,” Fillit stated. “This is an important change that will expand access for more patients to access the drug in additional settings.”

“Although this is an improvement, it would have been preferable for CMS to include patient registries, which collect real-world evidence that more closely reflects the actual population living with Alzheimer’s, compared to the limited populations that enroll in clinical trials,” he added. “This method would even have prolonged protection of Aduhelm to extra sufferers at present residing with Alzheimer’s illness.”

He additionally welcomed the flexibleness CMS outlined for future protection of medicine with extra compelling knowledge.

“Drugs in the identical class aren’t essentially equal and every must be evaluated and made accessible 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 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 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 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 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 National Coverage Determination 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.

“Through this determination, we’re making a pathway for folks 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 various members,” she added.