Next On Medicare’s To Do List For Alzheimer’s: Coverage Of PET Scans And Genetic Testing

By Cathy Kelly

Medicare policymakers have felt that without an effective approved treatment, coverage of amyloid PET scans and APOE4 genetic tests was not warranted. But that is changing.

There is more to Medicare coverage for Alzheimer’s treatment than Leqembi, Eisai Co., Ltd. and Biogen, Inc.’s newly-approved amyloid-targeting monoclonal antibody. Now the program also is considering amending restrictive coverage policies for PET scans and genetic testing that help target the drug to the right patients.

Key Takeaways

  • Medicare will resume efforts to revise its restrictive national coverage policy for beta amyloid-PET scans in the near future.
  • The program also is likely to work on changing widespread regional non-coverage policies for the APOE4 genetic test, which is recommended in Leqembi labeling.
  • Stakeholders may push for Medicare coverage of genetic counseling as an adjunct to APOE4 testing.

Leqembi was approved 6 July by the US Food and Drug Administration, making it the first amyloid beta-directed antibody – and the first disease-modifying drug – to receive traditional approval for the treatment of Alzheimer’s disease.  (Also see “Eisai/Biogen’s Leqembi: US FDA’s Full Approval Comes With A Boxed Warning On ARIA Risk” – Pink Sheet, 6 Jul, 2023.)

The Centers for Medicare and Medicaid Services announced a plan for deploying its coverage with evidence development policy for the drug with a CMS-facilitated patient registry the same day.  (Also see “Broader Medicare Coverage For Leqembi Begins As CMS-Backed Registry Opens For Business” – Pink Sheet, 6 Jul, 2023.)

CMS expects to release a revised Medicare coverage policy for beta amyloid PET scans in dementia and neurodegenerative disease “soon” to address one of the more formidable obstacles facing patient access to Eisai and Biogen’s recently approved Leqembi, the agency told the Pink Sheet.

Under a 2013 national coverage determination, Medicare covers only one amyloid PET scan per patient per lifetime and only when they are enrolled in a clinical study. The restriction hampers access because although CMS does cover cerebrospinal fluid (CSF) testing via lumbar puncture, many patients are leery of a spinal tap and would prefer the less invasive PET scan.

However, the Leqembi label and Medicare require that only patients with confirmed presence of amyloid plaques in their brains can be treated with the drug, which means that amyloid PET scans or CSF testing is needed prior to prescribing. 

CMS opened a reconsideration of the PET NCD in June 2022, then postponed the planned December 2022 release of a proposed revised decision in order to review new data on the diagnostic.

The agency has not announced a new release date for the proposed decision and it’s unclear what “soon” means in terms of weeks or months. The Medicare Coverage and Analysis Group that oversees NCDs within CMS has a relatively small staff and a full plate. But public pressure on the agency to enable broad access to Leqembi has been intense and that will likely help accelerate the timeline.

Broader access to PET scans that can confirm amyloid pathology and patient eligibility for Leqembi also will benefit Eli Lilly and Company’s donanemab, which may be approved by the US Food and Drug Administration for early Alzheimer’s by the end of 2023. Lilly is planning to release pivotal donanemab phase III data on 17 July at the Alzheimer’s Association International Conference in Amsterdam.

Will CMS Issue National Coverage Decision For APOE4 Testing?

CMS also may consider establishing a national coverage policy for APOE4 genetic tests, which are recommended (though not required) in the approved label for Leqembi. The recommendation was prompted by the fact that severe amyloid-related imaging abnormalities occurred more frequently in the pivotal phase III trial on Leqembi in patients who are homozygotes with more than one allele of the APOE4 gene.

Currently most Medicare beneficiaries are covered by Medicare Administrative Contractors (MACs) that do not cover APOE4 tests. A recent report by Washington Analysis notes that “about 70% of both US beneficiaries and CMS-registered facilities reside in jurisdictions that have historically blocked access to the testing that Leqembi’s labeling now suggests takes place prior to use.”

A MAC is a private health care insurer that has been awarded a geographic jurisdiction to process Medicare Part A and Part B medical claims for fee-for-service beneficiaries. They are free to make decisions for the populations they serve in the absence of a national policy from CMS. As with amyloid PET scans, Medicare policymakers likely have felt that without an effective approved treatment, coverage of APOE4 tests was not warranted. But that is changing with Leqembi.If Medicare covers Leqembi to label, which is the plan, “they should be covering the genetic tests called out in the label,” Global Alzheimer’s Platform Foundation president John Dwyer told the Pink Sheet. “In fact, I believe health systems and malpractice insurers will conclude that it is malpractice per se if a physician prescribes Leqembi without knowing the patient’s genetic status.” 

However, he also said Medicare also does not cover genetic counseling, which stakeholders believe may be an important adjunct to APOE4 testing.

The Washington Analysis report notes that APOE4 tests have so far only been reviewed in the context of risk assessments for cardiovascular disease, and not to mitigate potential adverse events associated with an FDA-approved treatment. Therefore, “the absence of a more formalized review of Alzheimer’s specific testing indications speaks to an improved potential for the MACs, likely with CMS prompting, to reevaluate current non-coverage policies.”

The MACs have fairly detailed regulations and guidance on what data is needed to obtain coverage but it could take a few months to work through the process. CMS could expedite it at a national level. Alzheimer’s disease-related genetic tests are “coverable” under Medicare now, CMS told the Pink Sheet, by which the agency presumably means there is no NCD in place that would prevent MACs from covering the test if they want to.

This article was originally published in The Pink Sheet

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