After potential drug treatments for Alzheimer’s disease came a-knocking this year, the Centers for Medicare and Medicaid Services have now opened up the door to wider coverage of PET diagnostic scans.
Previously, CMS had limited reimbursements for the imaging procedure, which is capable of highlighting the disease’s telltale clumps of beta amyloid proteins within the brain and distinguishing Alzheimer’s from other causes of dementia or memory loss.
Under a decade-long nationwide policy, the agency had said they would only pay for one brain scan per person over the course of the patient’s lifetime, and then only if that person was also enrolled in a clinical trial for Alzheimer’s.
But earlier this year—in the days following the FDA’s granting of full approval status to Eisai and Biogen’s Leqembi, which has shown it can help slow the rate of cognitive decline and reduce amyloid buildup—CMS said in mid-July that it would consider lifting its restrictions.
The agency followed through with its proposal October 13, removing its previous national coverage determination and allowing its network of Medicare Administrative Contractors to make their own PET reimbursement decisions.
“Amyloid PET scans are a proven tool and can be an important part of Alzheimer’s diagnosis and treatment,” Maria Carrillo, Ph.D., chief science officer of the Alzheimer’s Association, said in a statement urging MACs to quickly cover the procedure, through regional processes that could take months.
“Broader access to amyloid PET scans will enable earlier and more accurate diagnosis, and better care management. Their use can lead to better health outcomes for people living with Alzheimer’s or another dementia,” Carrillo said.
A PET scan, short for positron emission tomography, relies on the injection of radioactive tracers to illuminate the inner workings of the body’s blood flow and metabolism. The FDA has greenlit three imaging agents for use in Alzheimer’s: Eli Lilly’s Amyvid, GE HealthCare’s Vizamyl, and Life Molecular Imaging’s NeuraCeq.
Other diagnostic options for Alzheimer’s have included a spinal tap, through lumbar puncture procedures to examine cerebrospinal fluid. Meanwhile, several companies this year have put forward non-invasive, ultra-sensitive blood tests for beta amyloid proteins, as part of a gold rush kicked off by Leqembi’s early July approval.
Leqembi, the antibody also known as lecanemab, previously received an accelerated nod from the FDA in January. Elsewhere, Lilly has been developing its potential competitor, donanemab, and is angling for an FDA green light before the end of this year.
As more therapies become a reality, patients may need multiple PET scans to test for treatment eligibility, establish a baseline and keep tabs on amyloid levels over time, according to the Alzheimer’s Association.
“Additionally, recent clinical trial results tell us it is also useful to track changes in a person's level of beta amyloid throughout the course of treatment because it may be possible to pause treatment, as the amyloid beta levels decrease,” Carrillo said.