The Centers for Medicare & Medicaid Services has finalized its decision to limit coverage for a divisive new Alzheimer’s drug and any related medical imaging.
CMS announced its determination late Thursday, planning to only pay for aducanumab (brand name Aduhelm) in the context of clinical trials approved by the agency. Imaging advocates expressed dismay in January that the initial proposal did not include a broad, national coverage determination for beta-amyloid PET scans.
However, CMS maintained the same imaging pay restrictions in the final policy, only covering positron emission tomography, if required by a clinical trial protocol. The decision comes after controversy surrounding approval of the blockbuster drug from Biogen, with questions about its effectiveness.
“There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare, which is a key consideration for CMS when making national coverage determinations,” Chief Medical Officer Lee Fleisher, MD, said in a statement. “In arriving at this final decision, we looked at the very unique circumstances around this class of treatments and made a decision that weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm.”
The determination also covers any future FDA-approved monoclonal antibodies directed against amyloid with an indication for use in treating Alzheimer’s. Fleisher and colleagues said they reached their determination after considering 250 peer-reviewed documents and 10,000-plus stakeholder comments. Its decision is specific to individuals who have a clinical diagnosis of mild cognitive impairment due to the brain disease or mild dementia with a confirmed presence of plaque on the brain.
The Society of Nuclear Medicine & Molecular Imaging — which voiced concerns about limited PET coverage in the initial January proposal — did not have comment late Thursday.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.