Medicare Committee Gives Thumbs Down to New Genetic Tests for Cancer

June 2013, Vol 4, No 5
Ross D. Margulies, JD, MPH
Health Policy Specialist, Foley Hoag, LLP
Jayson Slotnik, JD, MPH
Managing Partner
Health Policy Strategies, Inc.
Bethesda, MD

Mr Margulies is an Associate, Foley Hoag, LLP, and Mr Slotnik is a Partner, Health Policy Strategies, LLC, Washington, DC

On May 1, 2013, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), Medicare’s clinical advisory committee, held a public advisory board meeting on “Selected Genetic Tests for Cancer Diagnosis and Treatment Selection.” MEDCAC typically holds several meetings annually to evaluate new and emerging technologies that have the potential to greatly impact the health of Medicare beneficiaries (the last meeting, which was held in January 2013, featured an evaluation of positron emission tomography imaging in the management of dementia).

Any MEDCAC recommendation to the Centers for Medicare & Medicaid Services (CMS) on whether to support coverage for a technology, although not binding, can have a tremendous impact on CMS’s decision to issue a National Coverage Determination (NCD) on an existing technology. Based on a number of concerns voiced by panelists about the 2 genetic tests that were considered, it seems unlikely that CMS will open up an NCD on either test.

The 2 Oncology Tests
On the agenda for the meeting were 2 very different tests. The first, a genetic test to predict a cancer diagnosis in patients presenting with a cancer of unknown primary (CUP) site, has been developed by several independent laboratory companies and is focused on the small percentage of cancers in which a patient is not easily classified to a primary tumor type by location. The second test, fluorescent in situ hybridization (FISH) tests for high-risk human papillomavirus (HPV) genotypes, is designed for women who have abnormal Pap smear results.

Although MEDCAC considers a number of various resources in reviewing a technology—including input from scientific experts and industry, medical literature, and the general public—to aid in its decision-making, MEDCAC often solicits a technology assessment report from the Agency for Healthcare Research and Quality. At this most recent meeting, the panelists reviewed technology assessment reports on both technologies, and both reports were moderately negative and focused on the lack of outcomes data for patients who used or did not use the test under a clinical trial design.
In particular, the CUP technology assessment focused on the lack of any gold standard in identifying a tumor of an “unknown” origin, and the panelists questioned whether treating patients with chemotherapy targeted to the CUP’s biological tissue might have greater harm than benefit. Furthermore, the panelists were generally concerned that the FISH tests for HPV lacked robust evidence, pointing to major research gaps in the harm versus benefit to the patient. Neither technology was able to meet even the first voting roadblock, which asks the panelists to vote on whether there is enough evidence to confirm any impact on patient care. The panelists voted down both technologies, emphasizing the need for randomized controlled trials to generate appropriate evidence.

For the larger cancer community, this recent MEDCAC meeting provides a glimpse of what is often seen as an overly bureaucratic Medicare coverage process. The discussion (see full transcript at www.cms.gov) also adds color to the burden faced by the biopharmaceutical industry in developing new molecular diagnostic tests, and the significant barriers to approval when facing medical evidence committees. Perhaps most important, it gives oncologists an insight into what is (and, in this case, what is not) coming down the diagnostic pipeline.

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