Alzheimer's Association Welcomes Announcement of CMS Coverage for FDA-approved Treatments

• Association to Also Work with Other Payers, Health Systems to Deliver Broad Access
• Association Calls on CMS to Open Reconsideration of National Coverage Determination

CHICAGO, July 6, 2023 /PRNewswire/ -- The Alzheimer's Association welcomes today's announcement by the Centers for Medicare & Medicaid Services (CMS) about their plan to enable access to Food and Drug Administration (FDA) traditionally approved Alzheimer's treatments. The announcement — which includes additional details about its own low touch registry — is an important development for people living with Alzheimer's disease and their families. 

"We appreciate today's action by CMS and their efforts to reduce physician burden in their registry approach. It is clear that CMS leaders have listened to experts, advocates, people living with Alzheimer's and families. It is reflected in their plan for delivering coverage of traditionally approved treatments proven to deliver meaningful benefit," said Joanne Pike, DrPH, Alzheimer's Association president and CEO. "Now, CMS's policy must be implemented effectively to minimize clinician burden and maximize patient access. We are committed to working with CMS, the physician community, our health system partners and other community partners to ensure a smooth rollout."

Today's announcement by CMS to open up Medicare coverage comes following extensive efforts by the Alzheimer's Association, bipartisan members of Congress, state attorneys general, clinicians, and, most importantly, advocates from communities all across the country.

"Alzheimer's Association advocates have tirelessly shared their stories in congressional hearings and in rallies at the White House and in all 50 states about the impact that clinically meaningful treatments like Leqembi will have on their lives," said Robert Egge, Alzheimer's Association chief public policy officer. "Today is an important advance in making access to this and future treatments a reality."

"We were disappointed, however, that CMS did not take this opportunity to initiate the formal process to reconsider their National Coverage Determination policy. This reconsideration is extremely important and long overdue. We will continue to work with the administration and Congress to ensure the initiation of this process," said Egge.

The additional details released today will help physicians and health systems be better prepared to assist patients in getting access to Leqembi and future traditionally approved FDA treatments.

"For people not enrolled in Medicare, including many treatment-eligible individuals under age 65, we expect other payers to ensure burden free access. For payers that were waiting for CMS to be clear about their intentions, CMS has now indicated that their objective is broad access. It is time for all payers to deliver broad access," said Pike.

Registries — an important tool to gather much-needed real-world evidence to transform and improve patient care — should not be a requirement for coverage of an FDA-approved treatment.

The prescriber information for Leqembi acknowledges the need for real-world evidence and long-term safety data collection. Participation in the Alzheimer's Association's Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) by clinicians and patients is encouraged by the FDA in the prescribing information.

"An early and accurate diagnosis of Alzheimer's has a positive impact on health outcomes, access to treatments, and eligibility for research trials, plus vital support and information services," said Maria C. Carrillo, Ph.D., chief science officer, Alzheimer's Association. "CMS also said they will cover amyloid confirmation diagnostics, removing an obstacle to accurate diagnosis that far too many individuals have faced."

The Alzheimer's Association is here all day, every day for people facing Alzheimer's and other dementia. The Association strongly encourages anyone experiencing memory changes to speak with a health care provider for a thorough evaluation, diagnosis and to discuss treatment options.

Alzheimer's Association
The Alzheimer's Association leads the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia. Visit alz.org or call the 24/7 Helpline at 800.272.3900.

SOURCE Alzheimer's Association