Pharmacogenomic Testing in Cancer

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=53 | meeting_date=2010-01-27

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.

Actions Taken: November 25, 2009 Posted questions to panel. January 25, 2010 Posted roster and agenda for meeting. February 2, 2010 Posted scoresheet [PDF, 93KB] from meeting. August 3, 2010 Posted minutes [PDF, 137KB] and transcript [PDF, 327KB] from meeting. Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee January 27, 2010 7:30 AM - 4:30 PM CMS Auditorium Clifford Goodman, PhD, Chair Saty Satya-Murti, MD, Vice Chair Louis Jacques, MD, Director, Coverage and Analysis Group Maria Ellis , Executive Secretary 7:30 - 8:00 AM Registration 8:00 - 8:20 AM Opening Remarks— Maria Ellis/ Louis Jacques, MD/Clifford Goodman, PhD 8:20 - 8:40 AM CMS Presentation & Voting Questions - Lisa Eggleston/Jeffrey Roche, MD 8:40 - 9:10 AM Andrew N. Freedman, PhD , Chief, Clinical and Translational Epidemiology Branch, National Cancer Institute 9:10 - 10:10 AM TA Presentation: Thomas A. Trikalinos, MD, PhD , Assistant Director, Tufts-New England Medical Center, EPC, Assistant Professor of Medicine, Tufts University 10:10 - 10:25 AM BREAK 10:25 - 11:10 AM Scheduled Public Comments (Refer to Speaker List) Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting. 11:10 - 11:20 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 11:20 - 12:00 PM Questions to Presenters 12:00 - 1:00 PM LUNCH (on your own) 1:00 - 2:00 PM Initial Open Panel Discussion: Dr. Goodman 2:00 - 3:00 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions 3:00 - 4:00 PM Final Open Panel Discussion: Dr. Goodman 4:00 - 4:30 PM Closing Remarks/Adjournment: Dr. Jacques & Dr. Goodman Issue: 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. Minutes: Download Meeting Minutes [PDF, 137KB] Other Material: Transcript 1 Panel Voting Questions: January 2010 MEDCAC Questions Pharmacogenomic Testing for Anticancer Therapies 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.) a) CYP2D6 for breast cancer patients who are candidates for tamoxifen b) UGT1A1 for colon cancer patients who are candidates for irinotecan c) HER2/neu for breast cancer patients who are candidates for trastuzumab d) BCR-ABL for chronic myelogenous leukemia patients who are candidates for imatinib e) K-ras for metastatic colorectal cancer patients who are candidates for cetuximab and/or panitumumab 1 2 3 4 5 Low Intermediate High Confidence Confidence Confidence 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.) a) CYP2D6 for breast cancer patients who are candidates for tamoxifen b) UGT1A1 for colon cancer patients who are candidates for irinotecan c) HER2/neu for breast cancer patients who are candidates for trastuzumab d) BCR-ABL for chronic myelogenous leukemia patients who are candidates for imatinib e) K-ras for metastatic colorectal cancer patients who are candidates for cetuximab and/or panitumumab 1 2 3 4 5 Low Intermediate High Confidence Confidence Confidence 3. How confident are you that these conclusions are generalizable to a. community based settings; b. the Medicare beneficiary population? 1 2 3 4 5 Low Intermediate High Confidence Confidence Confidence 4. Please discuss any important evidence gaps and recommend how they should be addressed. Download scoresheet [PDF, 93KB] Roster: January 27, 2010 MEDCAC Roster Clifford Goodman, PhD Chair Senior Vice President The Lewin Group Saty Satya-Murti, MD, FAAN Vice Chair Health Policy Consultant Phyllis Atkinson, RN, MS, GNP-BC Gertonological Nurse Practitioner Co-Owner, Advanced Geriatric Education & Consulting, LLC Catherine Eng, MD, FACP Medical Director On Lok Lifeways On Lok Senior Health Services John Cox, DO, FACP Texas Oncology, PA Methodist Charlton Cancer Center Josef E. Fischer, MD Professor of Surgery Harvard Medical School Daniel F. Hayes, MD Professor, Internal Medicine Clinical Director Breast Oncology Program University of Michigan Comprehensive Cancer Center Nora A. Janjan, MD, MPSA Adjunct Professor MD Anderson Karen Kaul, MD, PhD Department of Pathology & Laboratory Medicine NorthShore University HealthSystem Evanston Hospital Karl Matuszewski, MS, PharmD Vice President, Editor-in-Chief Elsevier/Gold Standard Maren T. Scheuner, MD, MPH Natural Scientist Research Health Scientist RAND Corporation & VA Greater Los Angeles Steven Teutsch, MD, MPH Chief Science Officer LA County Public Health Department Industry Representative Peter Juhn, MD, MPH President Therapeutic Resource Centers Medco Health Solutions, Inc. Guest Panel Members Elaine K. Jeter, MD Medical Director, Part A & B Palmetto Elizabeth Mansfield, PhD Director, Personalized Medicine Food and Drug Administration William Pao, MD, PhD Associate Professor of Medicine Vanderbilt University Guest Speakers Andrew N. Freedman, PhD Chief, Clinical and Translational Epidemiology Branch National Cancer Institute CMS Liaison Louis Jacques, MD Director Coverage and Analysis Group Executive Secretary Maria A. Ellis