The Centers for Medicare & Medicaid Services is assessing whether it should reimburse for Alzheimer’s disease therapy directed via beta-amyloid PET scans results.
On June 7, the Food and Drug Administration made the controversial move to approve Biogen’s monoclonal antibody treatment for Alzheimer’s known as Aduhelm. And now, following calls from imaging advocates, CMS is opening a national coverage determination (NCD) into amyloid PET’s role in guiding treatment decision making.
The government payer is seeking public comment through Aug. 11 and expects to wrap up the process by April 2022.
The Society of Nuclear Medicine & Molecular Imaging, which has been at the forefront of calls to mandate amyloid results to qualify for Aduhelm, said it will be participating.
“SNMMI is working with its Brain Imaging Council to provide comments, including the importance of covering beta-amyloid PET scans,” the society said in a July 19 update. “At this point in time, beta-amyloid PET is the only FDA-approved diagnostic to identify amyloid plaque.”
CMS specifically mentioned Aduhelm in its NCD, noting it’s interested in comments and evidence regarding five specific questions:
- Which patient outcomes are important, and what level of improvement is “meaningful” for those undergoing treatment?
- What traits in patients with Alzheimer’s are key to ensuring positive post-treatment outcomes?
- What equity and inclusion issues should be considered in diagnosing and treating AD?
- What healthcare providers are important in treating this disease, and if specialists are needed who should they be?
- What setting should patients receive treatment and care?
Last month’s approval has led to fallout and criticism from across the imaging community. SNMMI past President Alan Packard said he was “extremely surprised” upon learning there was no amyloid PET requirement to initiate Aduhelm treatment.
Both SNMMI and the Medical Imaging & Technology Alliance have also called on CMS to revise its “legacy” coverage and payment policies restricting access to amyloid PET.
The consumer-focused imaging world has also taken notice. GE Healthcare said it's doubling distribution of its imaging tracer to meet expected demand. And providers such as RadNet and Rad Partners believe radiology could see an upcoming surge in MRI volumes.
Read CMS’ full breakdown here.