Kisunla approval and proposed CMS change signal progress against Alzheimer’s

July has turned out to be a good month for the fight against Alzheimer’s, with the approval of a new plaque-reducing drug and a proposal to ease patient access to this type of drug set for official publication on July 22.

On July 2, the U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Kisunla (donanemab), which helps patients in the early stages of Alzheimer’s by reducing amyloid brain plaque. The approval followed an advisory panel’s recommendation in June.

With this approval, there are now two brain-plaque-targeting drugs approved by the FDA, with Biogen and Eisai’s LEQEMBI approved in July 2023.

How can we promote access to Alzheimer’s treatments?

Along with increased options, new rules proposed by the Centers for Medicare & Medicaid Services (CMS) would help patients access these cutting-edge treatments.

In their 984-page proposal for Medicare-Medicaid payment changes, to be published in the Federal Register on July 22, CMS recommends improved reimbursement for radiopharmaceuticals used in Positron Emission Tomography (PET) scans.

PET scans for beta-amyloid brain plaque help determine whether an Alzheimer’s patient would benefit from the two approved drugs targeting brain plaque. Improved diagnostic reimbursement from CMS increases access to these treatments.

“Lilly is encouraged by the Centers for Medicare & Medicaid Services’ (CMS) proposal to establish a more appropriate provider reimbursement policy for diagnostic radiopharmaceuticals,” says a statement from Eli Lilly, shared with Bio.News. “Diagnostics are a critical step at the beginning of an Alzheimer’s patient’s care journey, and we look forward to working with the agency and partners to support policies that address payment issues and enhance patient access to important diagnostic tools.”

The CMS said it will be accepting comments on the proposed rule change until Sept. 9.

What Kisunla means for patients

“Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions,” said Eli Lilly.

“This is real progress. Today’s approval allows people more options and greater opportunity to have more time,” said Joanne Pike, DrPH, President and CEO of the Alzheimer’s Association. “Having multiple treatment options is the kind of advancement we’ve all been waiting for—all of us who have been touched, even blindsided, by this difficult and devastating disease.”

More could be done to get these drugs to patients.

CMS still stipulates coverage with evidence development (CED) for anti-plaque treatments. This means physicians giving the treatments must enter data in a registry. Eliminating the CED requirement would further increase access.

“Early detection and diagnosis are even more critical to ensure individuals receive the most benefit,” said an Alzheimer’s Association press release. “Access to these treatments should not be delayed at any stage or by any entity—not the Centers for Medicare & Medicaid Services (CMS) coverage with evidence development policy, private insurers, health systems or doctors.”