By Kenneth E. Thorpe
The FDA has recently approved exciting new treatments that can slow the progression of Alzheimer’s disease, a scourge that claims more American lives than breast cancer and prostate cancer combined.
One such medicine, Leqembi, reduced early-stage Alzheimer’s patients’ cognitive decline by 27% in clinical trials — a breakthrough that offers hope to millions of Americans with degenerative dementia.
The question, though, is whether Medicare will allow access to these and other game-changing medications through seniors’ prescription drug coverage. For Leqembi, the answer as of July is yes — but it’s complicated. And the complications should be ringing alarm bells for seniors nationwide.
Medicare initially balked at providing coverage for Leqembi and similar Alzheimer’s treatments.
In a nutshell, Medicare officials decided unilaterally that FDA approval wasn’t good enough. Without the expertise or even necessarily the authority to do so, CMS demanded additional testing for monoclonal antibody treatments for Alzheimer’s before covering them without requiring patients to join a study.
The first FDA approvals for these treatments came under the FDA’s “accelerated approval” pathway, which is designed to get critical medicines to patients as soon as safely possible.
Leqembi received accelerated approval in January this year based on its ability to clear the brain of plaques associated with Alzheimer’s disease. In theory, this should have allowed hundreds of thousands of Medicare patients access to a medicine that could substantially slow the progress of their Alzheimer’s.
It didn’t. CMS effectively refused to cover the medicine by requiring participation in agency-approved clinical trials or an evidence-gathering data registry as a condition of coverage — neither of which existed at the time.
The CMS actions suggest that the agency was working to avoid having the government pay for the medication. But doing so violated a core Medicare tenet of equal access to FDA-approved medications, setting a dangerous precedent.
Leqembi went on to gain traditional approval in July. CMS now says it will provide coverage as long as a patient’s prescribing clinician participates in an easily accessible national registry. That’s a big improvement — but it still leaves troubling precedents in place and restricts coverage to people willing to share their data with a registry.
Worse, delaying or denying access to medications like Leqembi is incredibly short-sighted. The Alzheimer’s Association estimates that Alzheimer’s and other dementias will cost the United States over $345 billion in 2023, with Medicare and Medicaid covering much of those costs. Without adequate treatments, such expenditures will balloon to nearly $1 trillion annually by 2050.
Leqembi is designed to treat patients in the early stages of Alzheimer’s. Yet every day during the six months that separated its accelerated and traditional FDA approvals — when CMS was refusing to cover it for almost all patients — more than 2,000 people with Alzheimer’s progressed past the point at which Leqembi could have slowed their cognitive decline.
President Biden pledged to reduce the “heartbreaking human toll” of Alzheimer’s. We are on the cusp of doing so — provided officials at CMS stop trying to ration treatments.
Kenneth E. Thorpe is chair of the Department of Health Policy and Management at the Rollins School of Public Health, Emory University. He is also chairman of the Partnership to Fight Chronic Disease.