Medicare will cover drugs that may slow the progression of Alzheimer’s disease if the FDA grants these drugs traditional approval, the Centers for Medicare & Medicaid Services (CMS) recently announced.
To be eligible for coverage, people must be enrolled in Medicare Part B, diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s disease, and receiving treatment and follow-up care from qualified medical providers, CMS said in its release. A patient’s physician and clinical team are required to participate in a registry that collects evidence about how effectively these drugs work with Medicare patients in the real world.
The FDA has not yet given traditional approval to any drugs used to slow the progression of Alzheimer’s although it did grant accelerated approval to two such drugs. The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is scheduled on June 9 to discuss the results of a confirmatory trial of one of those drugs, Leqembi. A potential decision on traditional approval of the drug is possible within weeks, noted CMS.
“Broader Medicare coverage would begin on the same day the FDA grants traditional approval,” CMS also stated.
According to Stanford Medicine, Leqembi and the other drug granted accelerated FDA approval, Aduhelm, target removal of brain amyloid. Amyloid is one of the proteins that build up in brain in people with Alzheimer’s.
“Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and caregivers in a way that almost no other illness does. CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” CMS Administrator Chiquita Brooks-LaSure Brooks-LaSure said in the statement. “I hope we see more private sector partners in this work making their own announcements soon.”
CMS is making efforts to address data security concerns for drug registries. A CMS-facilitated portal will collect information for the registry in an easy-to-use format once an Alzheimer’s drug wins traditional approval. According to CMS, the portal will adhere to robust privacy protections in accordance with federal laws and regulations, including HIPAA. CMS is also working with multiple organizations that are preparing to open their own registries.
