WASHINGTON — A week after the Food and Drug Administration granted full, traditional approval to a new Alzheimer’s treatment, insurers are finalizing their plans to cover it as well as associated scans and diagnostic tests.
Medicare will cover most patients eligible for Leqembi, a new treatment developed by Eisai and Cambridge-based Biogen to help slow the progression of Alzheimer’s disease. The drug, which has modest benefits, has potentially serious side effects for some patients including brain swelling and bleeding.
Medicare told STAT that it would cover brain scans and genetic testing that will help screen for and monitor potential side effects. Medicare already covers one amyloid PET scan per lifetime, but the agency is reconsidering that policy and plans to release a new proposed policy “soon,’’ an agency spokesperson said.
Medicare was supposed to release a proposed policy for covering the PET scans in December, but delayed the decision until after the Centers for Medicare and Medicaid Services “has reviewed newly published evidence that is relevant to the proposed [coverage decision].’’
Other tests including MRIs to diagnose potential side effects, cerebrospinal fluid analysis, or other tests to detect the presence of amyloid plaques that the drug is designed to eliminate, and genetic testing for a certain mutation proven to increase the risk of adverse side effects are all coverable now, the spokesperson said.
As a condition of coverage, Medicare also rolled out a new patient registry to collect more information from physicians prescribing Leqembi. Information is supposed to be submitted every six months. Physicians who had previewed the registry said it appeared to function, though many clinics are still finalizing protocols for prescribing Leqembi.
“I’m not sure it’s sufficiently detailed to answer the [coverage with evidence development] questions that the [national coverage decision] put forth. We and others would need to collect more detailed information to understand the true benefits and risks of the medicine,’’ said Ronald Petersen, the director of the Mayo Clinic Alzheimer’s Disease Research Center.
Mayo Clinic isn’t prescribing Leqembi yet, as it’s planning to launch an Alzheimer’s treatment clinic in October, Petersen said. He said there has been interest from patients, but it “hasn’t been a landslide.’’
Petersen is hoping to start a new research study at Mayo Clinic to do more detailed monitoring on patients. To start, Mayo physicians will likely only agree to treat patients in the geographic area close to the facility so they can oversee the follow-up appointments.
“We’d be more than happy to share our data with broader communities or merge it with data from CMS. It is incumbent upon all of us to share data to learn from each other what works,’’ Petersen said.
Joy Snider, a neurologist at the Washington University in St. Louis, said her institution isn’t prescribing Leqembi quite yet, but she was impressed that Medicare rolled out the registry information so quickly.
The rollout also exceeded the expectations of Lon Schneider, the director of the California Alzheimer’s Disease Center and a professor at the University of Southern California, who expected the registry rollout to take two or three months.
“I am frankly surprised that they’re up and ready. … They at least have a basic system,’’ Schneider said.
He said the information requested is pretty basic overall, and is information that clinicians should be collecting anyway.
Keith Vossel, a professor of neurology and the director of the Mary S. Easton Center for Alzheimer’s Research and Care at the University of California Los Angeles, concurred that it was easy to use, though he said the six-month reporting requirement seemed rigid.
Though UCLA isn’t offering Leqembi yet, he said there’s been interest along with news coverage of the approval.
“My e-mail inbox is getting flooded with physicians and patients interested in learning more about it,’’ Vossel said.
Private insurers administer many private Medicare plans, and the top five companies in the program are UnitedHealthcare, Humana, Blue Cross Blue Shield plans, Aetna, and Kaiser Permanente.
Humana said its coverage policy is consistent with CMS guidance that ensures the program provides access to Leqembi. Aetna said that Medicare coverage will continue to follow all CMS Medicare guidelines, and its commercial plans will assess any updated FDA labeling for Leqembi.
Kaiser Permanente said it will evaluate all available data to understand the benefits and risks associated with Leqembi.
“As we do with all FDA-approved pharmaceuticals, we will cover this drug when it is determined to be medically necessary by the member’s treating physician. For Medicare patients, we will follow all CMS coverage requirements,’’ a spokesperson said.
UnitedHealthcare did not respond to a request for comment about its coverage policy.