This year, promising drug treatments for Alzheimer’s disease have emerged, prompting the Centers for Medicare and Medicaid Services (CMS) to expand coverage of PET diagnostic scans.
Previously, CMS had limited reimbursement for PET scans, a diagnostic imaging procedure capable of detecting beta amyloid protein clumps in the brain, a hallmark of Alzheimer’s. These scans help distinguish Alzheimer’s from other causes of dementia and memory loss.
Under a decade-long nationwide policy, CMS only covered one brain scan per person during their lifetime, and that too only if the individual was enrolled in a clinical trial for Alzheimer’s. However, earlier this year, after the FDA granted full approval to Eisai and Biogen’s Leqembi, a drug that can slow cognitive decline and reduce amyloid buildup, CMS indicated its willingness to reconsider these restrictions.
On October 13, CMS followed through with its proposal and removed its previous national coverage determination, allowing its network of Medicare Administrative Contractors (MACs) to decide on PET scan reimbursement. Dr. Maria Carrillo, Chief Science Officer of the Alzheimer’s Association, emphasized the importance of this decision, urging MACs to quickly cover the procedure through regional processes, which may take several months.
Also Read: CMS Unveils Details Of Its Registry Strategy For Drugs Targeting Alzheimer’s Disease
PET scans, or positron emission tomography scans, involve the injection of radioactive tracers to visualize the body’s blood flow and metabolism. The FDA has approved three imaging agents for Alzheimer’s diagnosis: Eli Lilly’s Amyvid, GE HealthCare’s Vizamyl, and Life Molecular Imaging’s NeuraCeq. Alternative diagnostic methods for Alzheimer’s have included spinal taps to examine cerebrospinal fluid. In addition, various companies have introduced non-invasive, ultra-sensitive blood tests for beta amyloid proteins, inspired by Leqembi’s approval earlier this year.
Leqembi, an antibody also known as lecanemab, received accelerated FDA approval in January. Eli Lilly is developing a potential competitor, donanemab, with hopes for FDA approval by the year’s end. With more Alzheimer’s therapies on the horizon, patients may require multiple PET scans to assess treatment eligibility, establish a baseline, and monitor amyloid levels over time, as noted by the Alzheimer’s Association. This step by CMS signifies an important shift in Alzheimer’s disease management.
“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.
