The specialty pharmacy community should remain alert in the coming months as the MEDCAC receives public comments and considers the future of Medicare coverage for 2 major therapies. The MEDCAC decision can have far-reaching impact on patient access.

In October, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), Medicare’s clinical advisory committee, announced a review of aprepitant (Emend), a popular antiemetic for patients undergoing chemotherapy treatment. The committee’s decision, expected in mid-2013, will have a dramatic effect on patient access to this important product.

One week after the Emend request, Eli Lilly and Company requested a MEDCAC consideration of Positron Emission Tomography (PET) scans as they relate to beta-amyloid imaging in the context of the diagnosis of dementia. Eli Lilly’s request comes in the wake of approval of its product Amyvid (florbetapir F 18 injection), which allowed for the identification of beta-amyloid plaques in the brain.

In the case of Emend, the National Comprehensive Cancer Network (NCCN) has asked that the coverage for this popular antiemetic be expanded to include the use of Emend in combination with dexamethasone and a 5-HT3 antagonist in patients receiving moderately emetogenic anticancer chemotherapeutic agents.

Medicare Payments

The MEDCAC’s decision, while not binding on the Centers for Medicare & Medicaid Services (CMS), will strongly weigh on whether or not Medicare’s coverage of Emend is expanded for this additional indication. So, too, will the MEDCAC’s opinion strongly weigh on whether or not CMS finds sufficient evidence to authorize Medicare payment nationally for PET scans for patients being evaluated for Alzheimer’s disease.

The specialty pharmacy community should remain alert in the coming months as the MEDCAC receives public comments and considers the future of Medicare coverage for 2 major therapies. As other major insurers tend to follow Medicare coverage for items and services, a MEDCAC decision can have a far-reaching impact on patient access.

The MEDCAC was established by the Secretary of Health and Human Services (HHS) in 1998 as an advisory body to provide independent guidance and expert advice to CMS on specific clinical topics. It is composed of representatives from academia, clinical practice, government agencies, patient advocacy organizations, and industry.

Specifically, the MEDCAC provides advice and recommendations to CMS about whether scientific evidence is adequate to determine whether the medical item or service under review is “reasonable and necessary” within the meaning of the Medicare statute. The MEDCAC panels do not directly vote on whether CMS should “cover” or “not cover” a service, but they do vote on whether there is convincing evidence that the service improves health outcomes in the Medicare population. As stated above, the MEDCAC recommendations are advisory only and not binding on CMS.

An Early View

In the case of both Emend and PET scans for patients being evaluated for Alzheimer’s disease, the MEDCAC accepted public comments throughout the month of October, allowing for stakeholder input into any changes to Medicare coverage for both of these technologies.

In early 2013, CMS will hold separate MEDCAC meetings for each technology, allowing the reques-tor and other members of the public to present data and findings about the MEDCAC proposal. Following the MEDCAC meeting, the MEDCAC generally issues a proposed memorandum 6 months after opening up the analysis and issues a final memorandum 9 months following the initial action.

These decisions will give stakeholders an early view of how the next administration will tackle complicated clinical issues. The results of these coverage decisions will start the careful process of balancing appropriate access to established technologies against the evolving clinical data.

Ross Margulies, JD, MPH, is a health policy specialist at Foley Hoag LLP with expertise in federal and state health law and policy issues including Medicare and Medicaid, community health, and the impact of health care reform.

Jayson Slotnik, JD, MPH, focuses on health regulatory issues. He was formerly the Director of Medicare Reimbursement and Economic Policy at the Biotechnology Industry Organization in Washington, DC. Mr. Slotnick is a member of the
Specialty Pharmacy Times Editorial Board.