Medicare broadens coverage of FDA-approved Alzheimer's treatment

Photo: Andrew Brookes/Getty Images

Broader Medicare coverage is now available for Biogen and Eisai's Leqembi, the brand name for lecanemab, following the Food and Drug Administration's move to grant traditional approval to the drug, which treats individuals with Alzheimer's disease. 

The Centers for Medicare and Medicaid Services had previously announced this would be the case, and released more details on coverage. Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in a registry, CMS said.

A CMS-facilitated registry is open for clinicians, with additional information available for providers. Clinicians participating in the registry will need to complete a short, data submission.

WHY THIS MATTERS

Alzheimer's drugs have come with a high price tag, with studies showing only limited benefit, according to previous information released by CMS. CMS formerly limited their use to individuals taking part in clinical trials.

In June, CMS said it would cover the high cost of Alzheimer's drugs, if the FDA granted traditional approval, and when a physician and clinical team participated in the collection of evidence about how these drugs work in the real world, also known as a registry.

The caveat had at least two organizations – PhRMA and UsAgainstAlzheimer's – protesting that CMS' new release on Alzheimer drug coverage makes treatment no more accessible than it was under the agency's policy of covering the drugs only for those taking part in clinical trials.

UsAgainstAlzheimer's applauded CMS' latest announcement, as compared to what the agency released in June.

"The clarification in the label of which a segment of the Alzheimer's population – about 15% – has an increased risk of side effects should allow patients and their doctors to have a better-informed conversation, tailored to the particular patient's situation. We applaud the company's commitments to develop and report information about the experience of patients using Leqembi so that the community can continue to learn," said George Vradenburg, chairman and cofounder of UsAgainstAlzheimer's.

"A large and robust clinical trial has demonstrated Leqembi's benefit in slowing cognitive and functional decline for patients in the early stages of the disease. While this decision is unquestionably welcome news for people living with disease, attention now turns to the Centers for Medicare & Medicaid Services to fulfill their public commitment to provide broad coverage for the treatment." 

A professor of neurology cautioned that Leqembi has only been approved for the early stages of the disease.

"Leqembi's full FDA approval is a huge step forward when it comes to the options available to patients to treat Alzheimer's and preserve quality of life," said Dr. Alvaro Pascual-Leone, professor of neurology at Harvard Medical School, and medical director at the Wolk Center for Memory Health, Hebrew SeniorLife, and CMO for Linus Health. "However, at this turning point, it's important to recognize that it is only approved to treat patients in the early stages of the disease and, even if caught early, the risks of any single drug may outweigh the benefits for some eligible patients.

"All patients, however, can benefit from proactive and personalized lifestyle interventions, for which there is a growing body of evidence. As we work to diagnose cognitive impairment and dementia early, the intervention approach must be a holistic one – supporting all patients with actionable lifestyle steps to take to preserve their cognitive health, not just treatments." 

In yesterday's release, CMS said Individuals with Original Medicare will pay the standard 20% coinsurance of the Medicare-approved amount for Leqembi once they meet their Part B deductible. 

Costs may be different for people with Medicare supplemental coverage (such as a Medigap plan) or other secondary insurance, or those enrolled in a Medicare Advantage plan. Individuals should contact their plan for more specific cost information, CMS said.

To receive Medicare coverage, people will need to:

• be enrolled in Medicare.
• be diagnosed with mild cognitive impairment or mild Alzheimer's disease dementia, with documented evidence of beta-amyloid plaque on the brain.
• have a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care. 

THE LARGER TREND

Consistent with CMS' National Coverage Determination, Medicare is covering this drug when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry. 

Under the Medicare National Coverage Determination, if FDA grants traditional approval to other drugs in this class, Medicare will cover them using this same coverage framework, CMS said.

In June, CMS released details about how people can get drugs that may slow the progression of Alzheimer's disease covered by Medicare.

On Thursday, the FDA converted novel Alzheimer's disease treatment for Leqembi to traditional approval. Leqembi is given intravenously every other week.

Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer's disease. The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease, the FDA said. 

ON THE RECORD

"CMS today affirms our commitment to help people with Alzheimer's disease have timely access to innovative treatments that may lead to improved care and better outcomes," said CMS Administrator Chiquita Brooks-LaSure. "With FDA's decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works. This is welcome news for the millions of people in this country and their families who are affected by this debilitating disease."

Twitter: @SusanJMorse
Email the writer: SMorse@himss.org