April 8, 2022 — Federal officers have made their ultimate determination: Medicare will handiest pay for sufferers to get the brand new Alzheimer’s drug aducanumab (Aduhelm) if the sufferers are collaborating in scientific trials.
On Thursday, the Facilities for Medicare & Medicaid Services and products (CMS) launched its nationwide protection decision for aducanumab and different identical medication that concentrate on beta-amyloid within the mind, which is regarded as an indicator of Alzheimer’s illness.
In a press free up, the CMS stated its determination is a two-part coverage in response to the lately to be had proof for anti-amyloid brokers.
Closing yr, the FDA permitted aducanumab for Alzheimer’s illness the use of the speeded up approval pathway, as a result of trials had proven the drug got rid of beta-amyloid from the mind, nevertheless it wasn’t transparent the drug had progressed the indications of folks with Alzheimer’s.
The verdict sparked controversy and resulted in the resignation of 3 contributors of the FDA’s advisory panel that had voted towards approving the drug.
CMS set some distance much less restrictive prerequisites for doable protection of anti-amyloid medication that can get complete FDA approval someday. In such instances, protection can be pegged to participation in CMS-approved research, reminiscent of an information assortment thru regimen scientific observe or registries, now not handiest scientific trials.
Howard Fillit, MD, co-founder and Leader Science Officer of the Alzheimer’s Drug Discovery Basis, supported the verdict.
“Medicare will now provide coverage for patients enrolled in any FDA- or NIH-approved trial,” Fillit said. “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 approach would also have extended coverage of Aduhelm to more patients currently living with Alzheimer’s disease.”
He additionally welcomed the versatility CMS defined for long term protection of gear with extra compelling knowledge.
“Drugs in the same class are not necessarily equal and each should be evaluated and made available to patients on its own merits,” Fillit stated.
In a observation, 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 coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas,” Biogen stated.
Biogen and different critics of the CMS determination contend it denies sufferers get right of entry to to a medicine that would possibly sluggish Alzheimer’s-related psychological decline, whilst supporters query whether or not appearing the drug got rid of beta-amyloid from the mind way it is helping sufferers’ signs.
CMS officers stated the company attempted to make the method resulting in lately’s determination clear and evidence-based. It famous it accumulated greater than 10,000 stakeholder feedback on its draft determination and regarded as greater than 250 peer-reviewed paperwork.
“This final National Coverage Determination reflects CMS’ commitment to provide the American public with a transparent, trusted, evidence-based decision — without regard to cost — that is made only after a thorough analysis of public feedback,” CMS Administrator Chiquita Brooks-LaSure stated in a observation.
“Through this decision, we are creating a pathway for people with Medicare to quickly access drugs the FDA determines have shown a clinical benefit and encourages manufacturers and trial administrators to ensure that the clinical trials recruit racially diverse participants,” she added.