Medicare now to cover more amyloid PET scans in Alzheimer’s

Old policy had limited patients to 1 per lifetime and only in trials

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A clinician prepares a patient for an imaging scan.

Medicare, the U.S. health insurance program for people ages 65 and older, will now provide additional coverage for an imaging test, called an amyloid PET scan, that can be used to help diagnose and monitor Alzheimer’s disease.

The decision by the Centers for Medicare and Medicaid Services (CMS) abolishes the previous nationwide policy that limited the scans to one per lifetime, and specifically to patients participating in clinical trials.

“Broader access to amyloid PET scans will enable earlier and more accurate diagnosis, and better care management,” Maria Carrillo, PhD, the chief science officer of the Alzheimer’s Association, said in a press release from the nonprofit regarding the CMS decision.

“Their use can lead to better health outcomes for people living with Alzheimer’s or another dementia,” Carrillo said.

An amyloid PET scan typically is more sensitive than other imaging scans, and thus may be a better tool for making a diagnosis. However, such tests are expensive: Without insurance, amyloid PET scans can cost an average of $3,000 per test or more. People on Medicare generally pay 20% of the costs of imaging scans after meeting their deductible.

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The policy change by the CMS hands PET scan coverage decisions to MACS, or Medicare Administrative Contractors. MACs are private health insurers hired to oversee Medicare coverage in specific geographic locations.

“With the recent development of treatments directed against amyloid such as [Leqembi (lecanemab)], PET [amyloid] scans could not only help select patients suitable for treatment, but also demonstrate treatment response (sufficient brain amyloid beta clearance) thus potentially altering the course of treatment including when to taper, stop or restart the drug,” the CMS wrote in its decision memo.

Appropriate patient selection also is “key to ensuring benefits outweigh harms of newly developed drugs targeting amyloid,” the CMS added.

Amyloid PET scans can be used to visualize amyloid plaques — toxic amyloid-beta protein clumps that are thought to drive Alzheimer’s neurodegeneration — in the brains of living patients. Prior to the advent of this technology, it wasn’t possible to assess amyloid plaques before an autopsy.

“It is essential that the MACs continue the CMS practice of covering PET scans in support of treatment,” Carrillo said, adding that amyloid PET scans “are a proven tool and can be an important part of Alzheimer’s diagnosis and treatment.”

The U.S. Food and Drug Administration (FDA) earlier this year granted full approval to the first anti-amyloid therapy for Alzheimer’s. Called Leqembi, from Eisai and Biogen, it was shown in clinical trial data to slow cognitive function decline in people with early Alzheimer’s.

The antibody-based therapy is designed to decrease amyloid plaques. Importantly, it is not expected to provide any benefit to patients who don’t have such plaques.

As such, it is only indicated for patients who have clear evidence of amyloid plaques in their brains — meaning amyloid PET scans are required to determine their eligibility to treatment. These eligibility scans have been covered by the CMS since Leqembi’s full approval.

Amyloid PET scans [can] become even more valuable as they are used to determine diagnosis and eligibility for FDA-approved treatments.

Given that other anti-amyloid antibodies are conditionally approved or under review for the treatment of Alzheimer’s, “amyloid PET scans become even more valuable as they are used to determine diagnosis and eligibility for FDA-approved treatments,” Carrillo said.

She added that data from recent clinical trials suggest amyloid PET technology “is also useful to track changes in a person’s level of beta amyloid throughout the course of treatment because it may be possible to pause treatment, as the amyloid beta levels decrease.”

“This decision reflects the FDA’s confidence in this technology after many years of evaluation,” Carrillo added.

The Alzheimer’s Association and CMS have previously collaborated on research, such as the IDEAS (Imaging Dementia — Evidence for Amyloid Scanning) Study, that helped to demonstrate the usefulness of amyloid PET scans in the management of dementias such as Alzheimer’s. Using this imaging technology was shown to lead to changes in treatment management for most patients.

Healthcare providers, industry representatives, patients and advocates have been calling for broader insurance coverage for years.