After the Centers for Medicare & Medicaid Services (CMS) slapped down a recent petition for wider coverage of Eisai and Biogen’s new drug Leqembi, the Alzheimer’s Association is digging its heels in.
The lobbying group is mobilizing hundreds of people diagnosed with or caring for someone with the debilitating neurodegenerative disease as part of a grassroots campaign to press Medicare for early access to Leqembi (lecanemab) plus other potential Alzheimer’s drugs in the amyloid-clearing class.
The campaign is being led by state-based chapters and aims to meet with all 535 members of Congress across the U.S., Reuters reports. The group is pushing for “full and unrestricted” coverage of the drug class upon receipt of an accelerated approval from the U.S. FDA.
Leqembi's accelerated nod came in January. Until it gets a traditional full approval—a decision for which is expected to come this summer—the drug can only be reimbursed in clinical trial settings under what’s known as the “coverage with evidence development” pathway.
The Alzheimer’s Association says that’s time patients don’t have. "Treatments taken in the early stages of Alzheimer’s would allow people more time to participate in daily life, remain independent and make healthcare decisions for their future," said the group’s president, Joanne Pike, as quoted by Reuters.
The Alzheimer’s Association’s latest effort comes shortly after CMS rejected a petition from the group seeking wider coverage for Leqembi and its anti-amyloid classmates.
CMS has said it will consider broader coverage upon Leqembi’s receipt of a full approval. "CMS is committed to being nimble when reconsidering this coverage framework in light of any new evidence related to the clinical benefit of this drug, and we continue to encourage clinicians, patients and caregivers to send us relevant evidence," an agency spokesperson told Reuters.
As for last month’s Leqembi coverage snub, Eisai wasn’t surprised, with a spokesperson telling Fierce Parma the company “anticipated that CMS would wait for the traditional FDA approval of Leqembi to make a public statement about any coverage change.” The drugmaker is “actively working with CMS to determine the most efficient path to appropriate access,” the spokesperson added.
As the Alzheimer’s Association continues to press CMS, Leqembi coverage is faring better elsewhere. Earlier this week, the U.S. Veterans Health Administration (VHA) ruled that it would cover the treatment, allowing access to veterans with early-stage disease.
“This is an important step toward access to medically necessary and beneficial treatments for people living with mild cognitive impairment,” Pike said in a release responding to the coverage decision.
As for wider coverage this summer, the FDA has set a target date of July 6 to decide whether to grant Leqembi a full approval.