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MEDCAC Meeting 1/27/2010 - Pharmacogenomic Testing in Cancer

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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.

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.
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

Download Meeting Minutes [PDF, 137KB]

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]

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
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