CMS has called this meeting of the panel to consider and make recommendations to CMS regarding the evidence that supports the use of pharmacogenomic testing in the diagnosis and treatment of cancer. Currently, Medicare does not have a National Coverage Determination for using such tests for diagnosis or treatment of cancer.
Evidence from clinical studies suggests that tumor genetic factors may be significant markers or predictors for a tumor's development and sustained growth, and for its likely response to certain anti-cancer agents. An individual cancer patient's genetic factors also may determine his or her likely response to certain anti-cancer agents. It may be possible to extrapolate from such evidence that pharmacogenomic testing might benefit Medicare beneficiaries with malignancies by providing: better and timelier diagnostic and prognostic information to guide treatment decisions; improved prediction of the more effective anti-cancer agent(s) for an individual; and more informed, patient-specific guidance on minimizing adverse effects of chemotherapy.
CMS is aware that the body of evidence on the role of pharmacogenomic testing in cancer continues to evolve. Recognizing the rapid accumulation of such evidence, CMS seeks guidance from the panel to inform future coverage determinations. We want to ensure that Medicare beneficiaries have access to any demonstrated improved health outcomes of pharmacogenomic testing, and are protected from inaccurate or inappropriate pharmacogenomic testing that could compromise therapy or increase the risks of adverse events during therapy.
Clifford Goodman, PhD, Chair
Saty Satya-Murti, MD, Vice Chair
Louis Jacques, MD, Director, Coverage and Analysis Group
Maria Ellis, Executive Secretary
Download Meeting Minutes [PDF, 137KB]
1. How confident are you that there is sufficient evidence to determine whether pharmacogenomic testing affects health outcomes (including benefits and harms) for patients with cancer whose anticancer treatment strategy is guided by the results of testing as described below? (Please consider this question separately for each test in the following clinical situations.)
2. For those items where the answer to Question 1 is at least in the Intermediate range (mean score > 2.5), how confident are you that pharmacogenomic testing improves health outcomes for patients with cancer whose anticancer treatment strategy is guided by the results of testing as described below? (Please consider this question separately for each test in the following clinical situations.)
3. How confident are you that these conclusions are generalizable to
4. Please discuss any important evidence gaps and recommend how they should be addressed.
Download scoresheet [PDF, 93KB]