MEDCAC Meeting

Molecular Pathology Testing to Estimate Prognosis in Cancer

03/24/2015

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Issue

On March 24, 2015, CMS will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The MEDCAC panel will consider the evidence about molecular pathology tests that estimate the prognosis of several frequently encountered types of cancer, including:

  • Adenocarcinoma of the colon and rectum;
  • Invasive breast cancer; and
  • Non-small cell lung cancer.

Outcomes of interest to CMS include both beneficial and harmful outcomes experienced by patients from anti-tumor treatment decisions based on results of tests estimating cancer prognosis. Such outcomes may include, among others: mortality/survival; quality of life; and avoiding harms of anti-cancer treatment. Results of a technology assessment of such tests will be presented.

By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS about the extent to which it may wish to use existing evidence as the basis for any future determinations about coverage for tests that estimate cancer prognosis. MEDCAC panels do not make coverage determinations, but CMS often benefits from their advice.

Actions Taken

Tree/Earth - CMS Goes Green

CMS WILL NOT PROVIDE PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED HERE.



January 23, 2015

CMS posts MEDCAC meeting announcement, including Federal Register notice.

January 23, 2015

Posted questions to panel.

March 17, 2015

Posted agenda, roster, speakers list, and presentations [4MB, ZIP] for meeting.

March 18, 2015

March 19, 2015

March 25, 2015

Posted scoresheet from meeting.

May 4, 2015

Posted minutes and transcript from meeting.


  
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  • Agenda

    Agenda
    Medicare Evidence Development & Coverage Advisory Committee
    March 24, 2015
    7:30 AM – 4:30 PM
    CMS Auditorium     

    I. Craig Henderson, MD, Acting Chair
    James Rollins, MD, Director, Division of Items and Devices
    Maria Ellis, Executive Secretary


    7:30 – 8:00 AM

    Registration

    8:00 – 8:15 AM  

    Opening Remarks— Maria Ellis/James Rollins, MD/I. Craig Henderson, MD

    8:15 - 8:35 AM

    CMS Presentation & Voting Questions – Cheryl Gilbreath, PharmD, MBA, RPh

    8:35 – 9:20 AM

    TA Presentation:  Sreelatha Meleth, PhD, Senior Research Statistician Social Statistical and Environmental Sciences, RTI International-University of North Carolina at Chapel Hill Evidence Based Practice Center (RTI-UNC EPC)

    9:20 – 9:40 AM

    Barbara Conley, MD, Associate Director, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute

    9:40 – 10:00 AM

    Jeffrey S. Ross, MD, Cyrus Strong Merrill Professor and Chair, Department of Pathology and Laboratory Medicine, Albany Medical College

    10:00 – 10:05 AM

    BREAK

    10:05 – 10:50 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.


    10:50 – 11:00 AM

    Open Public Comments
    Public Attendees who wish to address the panel will be given that opportunity

    11:00 – 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. Henderson

    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. Henderson

    4:00 – 4:30 PM

    Closing Remarks/Adjournment: Dr. Rollins & Dr. Henderson

    Minutes

    Download meeting minutes [PDF, 120KB]

    Panel Voting Questions

    Download scoresheet

    March 24, 2015 MEDCAC Questions
    Molecular Pathology Testing to Estimate Prognosis in Cancer

    On March 24, 2015, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) will consider evidence about molecular pathology tests[1] that estimate prognosis for Medicare beneficiaries with several frequently encountered types of cancer:

    Cancer Type Test to Estimate Prognosis Q1a Q1b Q2 Q3
    Adenocarcinoma of the colon and rectum BRAF        
    KRAS        
    Microsatellite instability        
    MLH1 promoter methylation        
    Oncotype DX® Colon        
    Breast cancer (invasive duct and lobular cancers) MammaPrint®        
    Oncotype DX® Breast        
    Non-small cell lung cancers ALK        
    EGFR        
    KRAS        

    Outcomes of interest for CMS reflect beneficiaries’ benefits or harms due to anti-cancer treatment decisions based on test results. Outcomes of interest include (among others) mortality, avoidance of harms of inappropriate anti-cancer treatments, and quality of life.

    Voting Questions

    For each voting question regarding each molecular pathology test in the grid above, please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence, and 5 representing high confidence:

    1      —      2      —      3      —      4     —      5
    Low                   Intermediate                      High
    Confidence                                            Confidence
      1. For each prognostic test listed above, how confident are you that existing evidence is sufficient to confirm the analytical validity of the molecular pathology test to estimate prognosis for Medicare beneficiaries with that cancer type?

      For each prognostic test, if the average of voting members’ answers for Question 1a is in the ‘Intermediate’ range (i.e., mean score is ≥ 2.5) please vote on Question 1b.

      1. For each prognostic test listed above, how confident are you that existing evidence is sufficient to confirm the clinical validity of the molecular pathology test to estimate prognosis in Medicare beneficiaries with that cancer type?

      [Note: The definitions of analytical and clinical validity, based on the ACCE assessment process, as used by the Center for Disease Control and Prevention (CDC)’s “Evidence of Genomic Applications in Practice and Prevention” (EGAPP) working group, are summarized at http://www.cdc.gov/genomics/gtesting/EGAPP/recommend/method.htm from which the following table is adapted. The terms ‘diagnostic test’ and ‘prognostic test’ are defined in the footnote.[2]]

      Analytic Validity
      (Technical Performance)
      Clinical Validity
      (Correlation with Prognosis)
      Test’s ability to accurately and reliably measure analyte or genotype of interest.
      Related concepts:
      • (Instrumental) Sensitivity
      • (Instrumental) Specificity
      • Assay robustness
      • Quality control
      Test’s ability to accurately and reliably estimate the prognosis for the condition of interest.
      Related concepts:
      • (Clinical) Sensitivity
      • (Clinical) Specificity
      • Positive Predictive Value
      • Negative Predictive Value

      For each prognostic test, if the averages of voting members’ answers for Questions 1a and 1b are both in the ‘Intermediate’ range (i.e., mean score is ≥ 2.5) please vote on Question 2.

    1. How confident are you that there is sufficient evidence to conclude that using the molecular pathology test to estimate prognosis affects health outcomes (including benefits and harms) for Medicare beneficiaries with cancer whose anti-cancer treatment strategy is guided by the test’s result?

      For each prognostic test for which the average of voting members’ answers for Question 2 is in the ‘Intermediate’ range (i.e., mean score is ≥ 2.5), please vote on Question 3.

    2. How confident are you that there is sufficient evidence to conclude that using the molecular pathology test to estimate prognosis has clinical utility (meaning, that it improves health outcomes either due to increased benefits and/or reduced harms) for Medicare beneficiaries with cancer whose anti-cancer treatment strategy is guided by the test’s result?

    Discussion Question

    1. Please discuss whether each factor below might change the generalizability of evidence about prognostic molecular pathology tests in Medicare beneficiaries with cancer:
      1. Regulatory status of test (e.g., US Food & Drug Administration (FDA) approved/cleared vs. laboratory-developed test)?
      2. Type of performing laboratory (i.e., university medical center laboratories, independent commercial laboratories, or community hospital-based laboratories)?
      3. Subgroups in the Medicare beneficiary population (e.g., by age)?
      4. Genomic variations within cancers (e.g., diversity of cancer genomes)?

    [1] Molecular pathology test is a type of genomic test.

    [2] A diagnostic test is defined as a medical test performed to aid in the diagnosis or detection of disease in a beneficiary with signs or symptoms of an illness or injury. In contrast, a prognostic test is a test performed for a beneficiary with cancer that measures or assesses one or more biomarkers, including the biological and genetic properties of the cancer cells, which are thought to be associated with future outcomes.

    Roster

    Acting Chair

    I. Craig Henderson, MD
    Adjunct Professor of Medicine
    University of California, San Francisco

    MEDCAC Members

    Harry Burke, MD, PhD
    Associate Professor
    Department of Medicine
    Uniformed Services
    University of the Health Sciences
    Clinician Internal Medicine Service

    Josef E. Fischer, MD
    William V. McDermott Professor
    Department of Surgery
    Harvard Medical School and
    Beth Israel Deaconess Medical Center

    Mark D. Grant, MD, PhD
    Associate Director
    Technology Evaluation Center
    Blue Cross Blue Shield Association

    Beverly A. Guadagnolo, MD, MPH
    Associate Professor
    Department of Radiation Oncology
    Division of Radiation Oncology
    The University of Texas MD Anderson Cancer Center

    Mitchell R. Kamrava, MD
    Assistant Clinical Professor
    Department of Radiation Oncology
    Director, Gynecologic Services
    University of California, Los Angeles
    UCLA Health System
    David Geffen School of Medicine

    Marcel Salive, MD, MPH
    Medical Officer
    National Institute on Aging
    National Institute of Health

    Maren T. Scheuner, MD, MPH
    Chief, Medical Genetics
    VA Greater Los Angeles Healthcare System

    Diana Zuckerman, PhD
    President
    National Research Center for Women & Families
    Cancer Prevention and Treatment Fund

    Industry Representative

    Lakshman Ramamurthy PhD
    Director
    Avalere Health, LLC

    Guest Panel Members

    Barry M. Berger, MD FCAP
    Chief Medical Officer
    Exact Sciences Corporation

    Invited Guest Speakers

    Barbara Conley, MD
    Associate Director
    Cancer Diagnosis Program
    Division of Cancer Treatment and Diagnosis
    National Cancer Institute
    National Institute of Health

    Jeffrey S. Ross, MD
    Cyrus Strong Merrill Professor and Chair
    Department of Pathology and Laboratory Medicine
    Albany Medical College

    CMS Liaison

    James Rollins, MD
    Director
    Division of Medical and Surgical Services
    Coverage and Analysis Group

    Executive Secretary

    Maria Ellis
    Coverage and Analysis Group

    Speakers list

    Medicare Evidence Development & Coverage Advisory Committee
    March 24, 2015

    SPEAKER LIST


    *5 MINUTES PER SPEAKER*
    • Jan A. Nowak, MD, PhD, FCAP, Medical Director, Molecular Diagnostics & Cytogenetics, NorthShore University HealthSystem


    • Sam Caughron, MD, Laboratory Medical Director at Shawnee Mission Medical Center - Representing: Association for Molecular Pathology


    • Bas van der Baan, VP Clinical Affairs & Business Development, Agendia


    • Robert Bilkovski, MD, MBA, Senior Associate Medical Director of Medical, Regulatory and Clinical Affairs, Abbott Molecular