Paying for Genomic Testing and Associated Care. Scott Ramsey, MD, PhD FRED HUTCHINSON CANCER RESEARCH CENTER

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1 Paying for Genomic Testing and Associated Care Scott Ramsey, MD, PhD FRED HUTCHINSON CANCER RESEARCH CENTER

2 Cost of Cancer Genome Sequencing Will vary with: Approach Whole genome, exome, transcriptome Number of genes sequenced Falling rapidly Technological improvements allow efficiencies: Sequence more genes for same cost Centers with in house sequencing capacity can reproduce the same tests as marketed assays plus identify many other mutations for one fee

3 Cost per Genome $100M $10M Moore s Law $1M $100K $10K $1K National Human Genome Research Institute genome.gov/sequencingcosts

4 Multi-Gene Sequencing PRO Single panel can replace multiple tests All information about the tumor is available immediately Data may indicate patient eligibility for clinical trials Potential data resource for target discovery CON Tests are not standardized Different platforms: Illumina, Roche, etc. Different centers creating their own panels of genes Clinically significant mutations can be missed on one panel and detected on another Cost can be higher than necessary A panel isn t always needed Panels may create the temptation to treat to target in the absence of evidence that the drug works for that type of tumor

5 Approaches to Genome-Driven Cancer Care Genome Backward Initial therapy selection based on known mutations and prospective and retrospective data on prior patients with similar genomic profiles whose outcomes are known Genome Forward For patients who have failed conventional therapies or for whom there are no clearly delineated guidelines on therapy choice, new therapeutic strategies based on the comprehensive analysis of the tumor s genetic signature Kamalakaran S, et al. MolOncol 2013; 7:743

6 Paying for Genome Forward Cancer Care Presents Challenges Health insurers will have problems with genome-forward approaches when choices are made based on mutational signatures but where evidence supporting the use of targeted therapies in the particular clinical situation is insufficient or lacking

7 Insurers Traditional Methods of Managing Use of High Cost Care will be Problematic for Genome Driven Cancer Care Prior authorization Formulary exclusions Tiered formularies

8 Moving to Multi-Gene Sequencing: Key Issues Partnerships Performance-based risk sharing Informed evidence generation

9 Partnerships

10 Partnerships Payer-provider relationship with common goals Improve management and reduce costs for cancer patients today Build information base that can improve care and care efficiency for future patients

11 Risk Sharing

12 Risk Sharing Because genome wide cancer sequencing technologies are promising but unproven, sharing financial risk is reasonable Risk sharing could take several forms, but is based on a principle of conditional coverage Many examples of risk sharing from the US and abroad

13 Performance-Based Risk Sharing Agreements (PBRSA s) Contract between a payer and a product developer where the price level, reimbursement, or revenue received is linked to the future performance of the product Two general types of arrangements: 1. Reimbursement linked to product performance 2. Limited access with plans to collect additional evidence (coverage with evidence development)

14 Reimbursement Linked To Product Identifies a guaranteed outcome resulting from treatment: - Clinical outcome - Humanistic/QOL outcome - Resource outcome impact on healthcare resource use - Financial outcome impact on healthcare budgets Performance - Economic outcome a cost effectiveness threshold Paired with evidence generation to monitor outcomes Outcome > guarantee rebate Outcome < guarantee financial penalty

15 Coverage with Evidence Development Applies to technology + indication where there is disagreement about quality or quantity of evidence supporting use Health insurer views use as promising but experimental Health insurer agrees to pay for technology only for patients enrolled in a prospective study Range from observational to RCT Design is agreed upon beforehand by all parties Pre-specified endpoints for determining benefit If technology meets pre-specified outcomes at the end of the study, then coverage is expanded

16 Overall survival (ideal if n allows) Health-related quality of life Frequency & severity of adverse treatment events Proportion clinical trial enrollment Physician interpretation of panel & patient understanding role in Tx choice Resource utilization and unit costs (health plan & patient) Proportion identified with actionable mutations Genomic Cancer Care: Potential Outcomes Metrics Proportion receiving and/or completing anticancer therapy

17 Challenges for PBRSA in Genomic Driven Cancer Care Traditional PRBSA Between the product developer and a payer Focus on a single technology in a specific clinical setting Genomic Care PRBSA: Multiple parties potentially involved e.g., payer, product developer, testing facility, and prescribing facility Multiple treatments in varying clinical settings

18 Evidence Generation Existing data can be used to track outcomes and costs EMR: clinical indication Claims: utilization and cost Cancer registry: clinical at diagnosis and survival Comparison of PM-driven care vs. usual care or prespecified results is critical

19 Minimum Data Sharing Set 1) Clinical indication e.g., cancer type and stage, previous therapies applied 2) Genomic sequencing technology used 3) Treatments applied including supportive care medicines 4) Prespecified adverse outcomes that constitute clinically significant events e.g., febrile neutropenia, cardiovascular events, nausea or vomiting requiring hospital admission) 5) Measures of therapeutic success that can be compared with clinical endpoints that are reported for alternative strategies

20 PBRSAs: Protecting Cancer Care Facilities and Providers from Excess Risk Exposure Participation requires sophisticated information systems Link treatment to response, survival, and cost Losses are possible in the short term as facilities transition and gain knowledge PBRSA contracts would probably need to err toward protecting cancer care facilities and providers in the short run Monitor outcomes and costs closely!

21 ` Thank You