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 Coordinatormarty.johnson@cmtpnet.org