Initial Medical Policy and Model Coverage Guidelines
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The document summarizes key themes from a webinar on developing medical policies and coverage guidelines for next generation sequencing in oncology. It discusses the challenges of evaluating genomic tests and gaining insurance coverage. Recommendations include requiring laboratories to obtain accreditation for analytic validity, covering small gene panels when clinical utility is established, and facilitating data collection to support coverage of larger tests and off-label drug use. The webinar included perspectives from various stakeholders on addressing these issues.
Initial Medical Policy and Model Coverage Guidelines
- 1. INITIAL MEDICAL POLICY AND MODEL COVERAGE GUIDELINES WEBINAR: POLICIES FOR NEXT GEN SEQUENCING IN ONCOLOGY Sean Tunis, MD, MSc, President and CEO Donna A. Messner, PhD, Vice President, Sr. Research Director November 24, 2015
- 2. WHO WE ARE The Center for Medical Technology Policy (CMTP): independent, non-profit 501(c)(3) organization…aims to make health care more effective and affordable by improving the quality, relevance, and efficiency of health care research We are committed to engaging all relevant stakeholders… • in research design, implementation, and dissemination • in the development of new policy approaches for evaluating and paying for promising new medical technologies Green Park Collaborative-USA (GPC-USA) is a major initiative of CMTP: • a neutral forum to support dialogue and consensus among stakeholders on methodological standards for clinical research and • focused on real-world effectiveness and value, emphasizing evidence expectations of payers, informed by the views of patients and clinicians.
- 3. KEY THEMES FOR WEBINAR What challenge do we work to address? What conclusions have we reached so far? Where do we go from here? Panel perspectives Group questions
- 4. BACKGROUND What is the challenge we seek to address?
- 5. CONCEPTS FOR GENOMIC ASSAY EVALUATION Clinical utility Clinical benefit to patient when test is used for care Clinical validity Variant is significantly correlated with a phenotype of interest Analytic validity Assay identifies presence or absence of a variant of interest
- 6. COVERAGE BOTTLENECK In past, large proportion of genetic tests on market have failed to gain positive coverage decisions Coverage reviews often never done due to lack of clinical utility studies1 Possible reasons: For some tests, there is no benefit Lack of clarity over required studies Lack of incentives/infrastructure to conduct necessary studies 1. Hresko A & Haga SB. Insurance coverage policies for personalized medicine. J Pers Med 2012;2:201-16.
- 7. CHALLENGE: SHIFT FROM “TEST” TO “SEQUENCING” Past and Continuing Molecular Pathology Methods Single mutation Single gene Few genes Genomic Analysis: Clinically Used Now Gene Panels Whole exome Potential Future Uses of Genomics Whole Genome Transcriptome (RNA) Adapted from College of American Pathologists, Genomics Resource Guide v. 5.0 Large-scale sequencing Many answers per question Many questions per test One test per question One answer per test 11
- 8. NGS PROJECT PHASE 1 Approach and Recommendations to Date
- 9. NGS PROJECT OVERVIEW Kickoff workshop July 2014 Teleconferences Multi-stakeholder deliberation of key questions Fall 2014 – Spring 2015 In-Person Conference April 2015 Wrap-up teleconferences May and June 2015 Demonstrating the Clinical Utility of Next Generation Sequencing in Oncology, Meeting Summary Initial Medical Policy and Model Coverage Guidelines for Clinical Next Generation Sequencing in Oncology, Report and Recommendations
- 10. RECOMMENDATION: COLLEGE OF AMERICAN PATHOLOGISTS ACCREDITATION Payers assess utility – not analytic performance How can they have confidence in testing validity, consistency? Require covered laboratories to participate in new CAP NGS accreditation • Includes wet-bench, dry-bench proficiency testing • CAP/CMS must allow transparency for payers Challenge Recommendation
- 11. RECOMMENDATION: COVERAGE OF SMALL PANELS How to cover panels that analyze many different genes and variants at one time? Cover NGS panels conforming to 5-to- 50 CPT codes when: • >= 5 guideline- directed genes sequenced for patient care • Panel cost <= cost of sequencing individual genes by other methods Challenge Recommendation
- 12. WHAT ABOUT LARGER PANELS? • No consensus on covering >50 gene panels when smaller panels can address guideline-directed patient care – Some say: do comprehensive tumor profiling on 1st diagnosis; don’t wait until patient has advanced disease and is heavily pretreated to get full picture – Payers respond: benefit of doing so is unproven • GPC report: consider covering >50 panels when patient has unknown primary site, no standard treatment, or exhausted treatment options – Topic for future discussion
- 13. NGS PROJECT PHASE 2 Looking ahead
- 14. MORE RAPID LEARNING IMPERATIVE • Need to investigate clinical significance of genomic variants more rapidly • “Extra” variant data on covered panels represents potentially rich source of info for research • Topics for future discussion: • How can payers use policy levers to facilitate high-quality data collection? • How can various data collection efforts be made interoperable?
- 15. MORE SEQUENCING AND THE EVIDENCE NEEDED Additional Discussion Points • What is place of large panels, whole exome, whole genome sequencing? • What evidence is needed to support coverage? • Will high-quality registries and observational studies support coverage?
- 16. RATIONAL COVERAGE OF OFF-LABEL USE Issue How to pay for off-label use of molecularly-targeted therapies when clinically justified? Proposal for discussion: pharma and payers share risk Pharma provides off-label agent for first 3 months of treatment (expanded access or other program) If patient exhibits benefit after 3 months (stable disease), health plan begins to cover treatment on month 4.
- 17. PANELIST PERSPECTIVES Jeff Allen, PhD Executive Director Friends of Cancer Research Dane Dickson, MD Chief Executive Officer Molecular Evidence Development Consortium Robert Dumanois Manager, Reimbursement Strategy ThermoFisher Scientific Michael Kolodziej, MD National Medical Director, Oncology Solutions Aetna Vincent Miller, MD Chief Medical Officer Foundation Medicine
- 18. FOR MORE INFORMATION Get involved! To learn more, contact: Marty Johnson GPC Marketing & Project Coordinator marty.johnson@cmtpnet.org