Initial Medical Policy and Model Coverage Guidelines
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Transcript of Initial Medical Policy and Model Coverage Guidelines
INITIAL MEDICAL POLICY AND MODEL COVERAGE GUIDELINESWEBINAR: POLICIES FOR NEXT GEN SEQUENCING IN ONCOLOGYSean Tunis, MD, MSc, President and CEODonna A. Messner, PhD, Vice President, Sr. Research DirectorNovember 24, 2015
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.
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
BACKGROUND
What is the challenge we seek to address?
CONCEPTS FOR GENOMIC ASSAY EVALUATION
Clinical utility
Clinical benefit to
patient when test
is used for careClinical
validityVariant is
significantly correlated
with a phenotype of
interest
Analytic validityAssay
identifies presence
or absence
of a variant of interest
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 studiesLack 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.
CHALLENGE: SHIFT FROM “TEST” TO “SEQUENCING”
Past and Continuing Molecular Pathology Methods
Single mutation
Single gene
Few genesAdapted from College of American Pathologists, Genomics Resource Guide v. 5.0
Large-scale sequencing
Many answers per questionMany questions per test
One test per questionOne answer per test
11
NGS PROJECT PHASE 1
Approach and Recommendations to Date
NGS PROJECT OVERVIEW
Kickoff workshop
July 2014 Teleconferences
Multi-stakeholder deliberation of key questionsFall 2014 – Spring 2015
In-Person Conference
April 2015Wrap-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
RECOMMENDATION: COLLEGE OF AMERICAN PATHOLOGISTS ACCREDITATION
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
RECOMMENDATION: COVERAGE OF SMALL PANELS
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
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
NGS PROJECT PHASE 2
Looking ahead
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?
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?
RATIONAL COVERAGE OF OFF-LABEL USE
IssueHow 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.
PANELIST PERSPECTIVES
Jeff Allen, PhD
Executive Director
Friends of Cancer
Research
Dane Dickson, MD
Chief Executive
OfficerMolecular Evidence
Development Consortium
Robert Dumanois Manager,
Reimbursement
StrategyThermoFisher Scientific
Michael Kolodziej,
MDNational Medical Director, Oncology Solutions
Aetna
Vincent Miller, MD
Chief Medical Officer
Foundation Medicine
FOR MORE INFORMATION
Get involved!
To learn more, contact:
Marty JohnsonGPC Marketing & Project [email protected]