Reimbursement Strategy for Companion Diagnostics

Reimbursement Strategy for Companion Diagnostics: Emerging Models and Requirements Edward E. Berger, Ph.D. Larchmont Strategic Advisors

Definition Companion diagnostic – A diagnostic test used to predict the likely clinical effectiveness and/or safety of a particular therapeutic intervention for a specific individual; the term is most often used to describe a molecular diagnostic test that stratifies a patient population with regard to the likelihood of response to, or the safety of, a pharmacologic therapy.

An Ongoing Medical Revolution ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Limits of Traditional Medicine ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Low Response Rates to Rx Do higher response rates yield more complications?

Drug Developers Have A Parallel Problem ,[object Object],[object Object],[object Object],[object Object],[object Object]

Companion Diagnostics ,[object Object],[object Object],[object Object]

In the Clinic … ,[object Object],[object Object],[object Object],[object Object],[object Object]

In Drug Development … ,[object Object],[object Object],[object Object],[object Object],[object Object]

For Society … ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Success Ought to Follow ,[object Object],[object Object],[object Object]

Many Positive Signs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

DHHS Is Supportive ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

FDA Programmatic Activities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Significant Rate-Limiting Factors ,[object Object],[object Object],[object Object],[object Object]

CHICKEN / EGG PROBLEM ,[object Object],[object Object],[object Object],[object Object]

Private Payer Coverage Status ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Critical Mass Not Yet Achieved ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Where is Medicare? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Priorities for Gaining Coverage ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

TEC* Coverage Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object],* Blue Cross Blue Shield Technology Evaluation Center

TEC Review is Rigorous ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CMS Coverage Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object]

CMS Hierarchy of Trial Designs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CMS Considers Multiple Inputs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Leverage FDA Process For … ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

FDA Process Design (1) Biomarker Development

FDA Process Design (2) Dx-Rx Co-Development

Co-Development Works Best ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Other Scenarios Raise Problems ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Payment is Uneven ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Lab Coding System is Broken ,[object Object],[object Object],[object Object],[object Object],[object Object]

Need To Pay For Value ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

If Payment is Inadequate… ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Conclusions (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Conclusions (2) ,[object Object],[object Object],[object Object],[object Object]

Edward E. Berger, Ph.D. Principal Larchmont Strategic Advisors 2400 Beacon St. #203 Chestnut Hill, MA 02467 Tel: (617)645-8452 Email: [email_address]

Reimbursement Strategy for Companion Diagnostics

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