Improving Evidence for and Patient Access to Potentially Beneficial Clinical Genomic Technologies and Targeted Therapies

This phase of work in genomics followed the August 2015 release of model policy guidelines for coverage of next generation sequencing-based testing and sought to promote the conditions needed for adoption of the guidelines.  Because one of the largest barriers to achieving the full potential of precision medicine is the inability to track outcomes for patients treated with molecularly targeted therapies, CMTP collaborated with the Medical Evidence Development Consortium (MED-C) and several other groups in the US and abroad to develop a set of consensus core clinical data elements and standards to be collected across all cancer genomics repositories.  We also worked with the College of American Pathologists (CAP) to broaden understanding, particularly among payers, of the changes being made in 2017 in the CAP accreditation program for next generation sequencing (NGS).  Finally, in order to advance knowledge and development of important genomic and related clinical technologies, CMTP held a Genomic Technologies Forum where innovators, payers, patients, clinicians, and other stakeholders came together to discuss the current state of evidence development for innovative approaches to DNA sampling and sequencing, as well as RNA, proteomics, and other methods for the prediction, diagnosis, prevention, or treatment of disease.   

  • Oregon Health & Science University
  • European Organization for Research & Treatment of Cancer
  • Oklahoma Health Care Authority
  • National Cancer Institute
  • Addario Lung Cancer Foundation
  • Arizona State University
  • Food and Drug Administration (FDA)
  • The Life Science Group
  • Patient Advocates In Research (PAIR)
  • U.S. Department of Health & Human Services
  • Indiana University
  • National Comprehensive Cancer Network
  • Centers for Medicare and Medicaid Services (CMS)
  • Harvard Medical School
  • Molecular Evidence Development Consortium
  • Research Advocacy Network
  • Aetna
  • University of California San Diego
  • Cleveland Clinic
  • American Association for Cancer Research
  • The University of Texas MD Anderson Cancer Center
  • European Bioinformatics Institute
  • Humana, Inc.
  • Association for Molecular Pathology (AMP) 

Gathering Opinions and Input to Encourage and Expand Coverage

  • November 2015: Webinar to introduce the model policy guidelines developed in Phase I and to seek broader input from a range of patient groups, academic laboratories, community cancer centers, and payers to gain perspective from those who were not part of that phase
  • Fall 2015: Project participants and sponsors recruited
  • Early 2016: Formation of Data Standards and Clinical Standards working groups for core clinical data elements and standards development
  • Spring 2016: First draft of data dictionaries for genomic cancer repositories released to Task Force members for review
  • April 2016: In-person meeting of Genomic Task Forces in Baltimore, MD
  • Summer 2016: Recruitment of panelists and speakers for Genomics Technology Forum
  • November 2016: Genomics Technology Forum to discuss the current state of evidence development for innovative approaches to genomic and related clinical technologies
  • Early 2017: Release of draft core clinical data elements and standards manuscript
  • March 2017: College of American Pathologists (CAP) webinar to present the details of its new accreditation program for next generation sequencing (NGS) 
  • November 2017: Publication in Cell of “Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-stakeholder Consensus”