Inside Health Policy: ALZ CED

  July 7, 2023, 5:22 PM, Carey, Brian <BCarey@foleyhoag.com> wrote:

CMS Drafting PET Scan NCD, To Cover Alzheimer’s MRIs

By Jessica Karins<https://insidehealthpolicy.com/authors/Jessica-Karins> / July 7, 2023 at 6:48 PM

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https://insidehealthpolicy.com/daily-news/cms-drafting-pet-scan-ncd-cover-alzheimer-s-mris?destination=node/136115 

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Alongside its plan to gather observational data on potential adverse effects linked to the newly approved Alzheimer’s drug Leqembi, CMS will also soon propose a national coverage determination loosening current PET scan restrictions and will cover reasonable and necessary MRIs, a CMS spokesperson told Inside Health Policy Friday (July 7).

Currently, the spokesperson said, Medicare covers one positron emission tomography (PET) scan per lifetime to detect amyloid beta plaque, but the agency is currently reconsidering that and intends to issue a proposed NCD soon.

FDA granted full approval to Leqembi (lecanemab)<https://insidehealthpolicy.com/node/136089>, made by Biogen Inc. and Eisai Inc., Thursday (July 6). CMS immediately made available its registry for prescribing physicians, which patients must participate in as a condition of receiving Medicare coverage.

To qualify for the drug, Medicare patients will need a clinical diagnosis of mild Alzheimer's disease dementia or mild cognitive impairment due to Alzheimer’s disease, along with confirmation of amyloid beta plaque on the brain. The latter can be confirmed by biomarker testing including PET imaging, cerebral spinal fluid (CSF) studies or blood tests.

CMS also told IHP that reasonable and necessary diagnostic tests related to monitoring for adverse events will be covered, including MRIs to diagnose ARIA, CSF studies, and tests to identify the genetic marker APOE4, which is associated with negative reactions to anti-amyloid drugs.

CMS plans to conduct an observational study of patients<https://www.cms.gov/files/document/ced-study-description.pdf> using anti-amyloid drugs, based on registry and Medicare claims data. Prescribing physicians will need to submit data about patients’ cognitive function and any adverse events every six months, and initial results will be posted once a minimum sample size has been observed for 24 months.

The objectives of the study are to assess whether the treatment meaningfully improves health outcomes; how harms and benefits change over time; and whether benefits and harms vary according to the characteristics of patients, providers, and treatment settings.

“In addition to performing the required cognition and function assessments, prescribing clinicians will need to report on the patient’s use of anti-platelet and/or anti-coagulation therapy and whether the patient has developed new amyloid related imaging abnormalities (ARIA) since the last assessment data submission,” CMS wrote.

FDA issued a “black box” warning with Leqembi, meaining providers should be aware of serious safety risks. It is the most serious type of warning FDA attaches to a drug. The black box warns of brain bleeding, swelling and ARIA. It also says genetic testing should be performed before administering the drug because APOE4 are at higher risk of adverse events, but does not require the testing.

While not included in the black box warning, Leqembi’s label will also carry a warning about adverse events associated with anti-platelet or anti-coagulation blood thinners.

Diana Zuckerman, president of the National Center for Health Research (NCHR) and a critic of FDA’s decision to approve Leqembi, told Inside Health Policy she was disappointed the warning about blood thinners was not included in the black box, where providers would be most likely to see it. Although physicians should read a drug’s label in full, Zuckerman said, not all do.

Zuckerman is among several health researchers and providers who have said evidence is still limited<https://insidehealthpolicy.com/node/136112> on lecanemab’s safety and efficacy. While she said the CMS study will likely be able to identify the groups most at risk of serious side effects, she added that data without a control group likely will not produce reliable evidence of clinical benefit. -- Jessica Karins (jkarins@iwpnews.com<mailto:jkarins@iwpnews.com>