9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA
Real Time Conference Coverage with Social Media
@Computer History Museum by Dr. Aviva Lev-Ari, PhD, RN
Regulatory & Reimbursement Frameworks for Molecular Testing
9:15AM – 9:30AM
9:30AM – 9:45AM Bill McGivney, McGivney Adv. (Chair)
- Access of patients to the right treatment
- Improvement of efficacious outcomes
- Multi-Gene platform
- FoundationOne – what is your experience with Mutations?
- Consortium – what are the goals?
- Diet and Medicine – Last Observation
Dane Dickson, Palmetto GBA – Oncologist, CEO Consortium of pharma companies
- On Access to Treatment
- Treatment decision making (Physician Behavior) is changing by patient heterogeneity (offer a test to one patient for a condition and not to another patient) – The Benefit of Test in the eye of the MD matters
- Cost of therapy and ordering tests: Transitional, genes in experiments, activation of tumor cells, Medicare’s concern is “per one test” – effect found can’t be leveraged on other patients
- Patient population and retention of knowledge
- Companies recommend Bone marrow transplantation to patients with some indication — 65% are at age 80 in the Medicaid category, recommendation by MD Anderson Study followed 20 years.
- Testing is effective, data need be shared among the Members of the Consortium
- Pricing and Platform relations
- Publication – a mutation that needed to be picked up by companion diagnostics
Mike Pellini, Foundation Medicine – FoundationMedicine, CEO
- No standards, FoundationMedicine had the best standards from Day One.
- NCLCN – Profiling, clinical Trials, Payers bell curve so high patient, clinicians
- Mutations in Cancer – 50% of Oncology drugs are all off label
- mutation, translocations
- FDA, Payers, Pharma, Illumina – Tier 1: Companion Diagnostics, Tier 2: Not FDA approved, evidence in literature, response to therapy, Tier 3: More research is needed, information in Category 3 moves to Category 1, Category e2 moves to category 3
- Breast Cancer: if early stage no need for genomics, molecular testing is enough
- Future – Pharma and Payers must working together
- DataBase of drugs and disease : Molecular literature is queried as a learning tool – augmentation of Clinical Trials
- Value added pieces are added together, FoundationOne – DataBase can be queried
- cost of sequencing: multiple ways: Medicare asked FoundationMedicine to collect mutation data
- articulate the challenges: information changes, FDA need to continue to update requirements
- Indications that the new technology leads to an ERA that will wipe out diagnostics practices that lasted 70 years !
Reimbursement Challenges (and Solutions?) for Personalized Medicine
10:30AM – 11:30 Ira Klein, AETNA (Chair)
- How medical diagnostics
- Payer — Private Payers View: Integrity
Use of Genomics testing
- phase 1
- phase 2
- phase 3
- phase 4
Because the data at Aetna is National – trend can be analyzed on the universe of insured patients at the national level
- Sharing data could lower cost of testing
- testing by Ethnicity – more affluent area MDs would order BRCA testing more often than for patient in poorer area
- What is the Clinical Utility of Genomics Testing
- wide spread or none
- NGS in the payer space
- How to determine cost for testing
- Patients will be responsible for copayment, drugs and tests
- HealthCare re-design
- Validation of Genomics Prostate Scoring
- Addition of GPS to NCCN
- Not a revolution but an evolution
- Precision Medicine – Oncology struggles with overwhelming information on Testing
- Labs and education of patients
- MDs behavior has not changed – Genetic Engineering testing is not Trained in Diagnostics
- a mismatch of types of test performed in Medicine vs type of tests taught in Medical Schools — Pharmacogenetics is a Case in Point
- number of claims increases exponentially
- Vanderbilt University Medical Center Savings: Pulmonary Embolism is tested correctly saved the institution: Pharmacogenomics Testing for PLAVIX: saved $1.5 Million
- Unnecessary testing for leukemia cost the Institution $888 Millions
- Pay for Value: Labs only reimbursed for correctly ordered testes producing actionable results
- RISK SHARING for Coverage Determination Payers, Payers,
- Decision Support: MDs
- Registry is the best use for test validation of outcomes
- In Novartis presentation: Evidence
Peter Bach, Memorial Sloan Kettering
- Rapid change in the causes for cancer
- Personalization promise in Oncology
- Drivers of cancer – Understanding improvement is occurring
- Implications of findings from tests a matter of controversy
- Trade off between Insurance: Not changing policy vs Hospital move forward with complex testing comprehensive gene profiling
- No diagnostics test SAVED one life – “actionable alteration” vs Test Sensitivity
- Pulmonology: Companion Diagnostics approved for Zykadia: Differential ALK detection with NGS – FISH cases for actionable alteration
- Clinical Trials — if alteration leads to Clinical Trial — not expected to be beneficial, switch expectation – “Expectation to be beneficial” getting into Phase 1,2 — may not be beneficial
- Market for ALK Inhibitors – Roche’s Product – 100% price increase in drug: Price of “value” over time – each year increase in survival increases the price of the oncology drug by $84,000.
- Average across patents: FDA – evidence
Girish Putcha, Palmetto GBA (MolDX)
- MolDX Clinical Test
- Coverage of Oncology Drugs: With limited data validation, limited coverage
- Coverage with Data Development (CDD) – requires data collection and reporting
- Analytical Validity (AV)
- Clinical Validity (CV)
- Clinical Utility (CU)
- vs “what” based on 22 tests — Standard of Care: based on a Score [NSABP B-14 and B-20: Clinical Trials]
- Payers for Reimbursement: Private vs Commercial
- “Reasonable and Necessary” by CMS: Mammogram – unambiguous
- Avastin by Genentech
- Payer Risk vs Patient benefits in: Coverage with evidence development for Predictive, diagnostic, prognostic
- Value based reimbursement
- choice: CMS gets input on Patient Management, MD is not free to practice with our CMS guidelines
Final Thoughts
- Social engineering – winners and losers
11:30AM – 11:45AM Panel, Q&A
Q. from Dr. Abrams in the Audience to Dr. Buch:
Dr. Bach Answer: Immunotherapy the most exciting area in oncology – MOST exciting results are coming
Dr. Kahn: Diagnostics and Treatments varies between Community Hospitals vs University Hospitals vs
Dr. Bach: NCCN authority given by CMS: Medicare authority to has a test
Q from the audience: Genomics Testing different than reimbursement for Chemistry tests
Dr. Kahn: Network covered population — risk sharing and data accumulation within the network.
Rina Wolf: Precision Medicine vs Population Studies
11:45AM – 12:00PM Richard Klausner, Illumina – CMO & Interim GM, Oncology, Illumina
Actionable Genome Consortium to guide NGS in Clinical Medicine
- Randomization Pediatrics leukemia – 1-00% mortality vs 1000% cure in 2015
- 12 patients clinical genetic testing gene replacement
- companion diagnostics vs therapeutics
- FoundationMedicine transformation: Genomics diagnostics vs companion diagnostics then treatment
- Illumina – transition from Research to Clinical
- Consortium – What we should know: What is the definition to practice oncology, what is the value of SNP on NonTumor Cells vs on Tumor Cells
- 15 genes in level 1
- 8 genes in level 2
- Entry in Clinical Trial is a Mutation – without knowing outcome of participation in the trial = challenging Equifos??
- Long term Study for the Consortium – the whole Genome sequencing: NGS for new Clinical Trials
- Chinese Actionable Genome Consortium will be launch in the near future
Navigating Reimbursement for Oncology Patients & Care Teams
1:00PM – 2:00PM John Steiner, CTCA (Chair) Cancer Treatment Centers of America
LIVE FROM THE PODIUM
- CTCA
- Genetic Testing vs Genomics Testing Integrative treatment, Precision Medicine – Molecular Testing, Precision Cancer Treatment
- Coverage determination
- Opti0ns for Coverage:
- Parallel review FDA & CMS
- Coverage with Evidence development
- Emerging ideas: Palmetto
- Consumers, Providers and Payers
vs medically necessary, reasonable and necessary for the diagnosis and treatment
What is the definition of Diagnosis? AMA, 1998 — prevention, treatment, clinically appropriate,
- American Bar Association: Health Policy Task Force 2015
- Clinical coverage criteria: effectiveness appropriateness of service – do not lend themselves to protococl or standardization: Cancer, Alzheimer’s
- AMA – CPT – Activity based not Value-based services
- Clinical Utility
- Coverage based on 1065 regulation
- Traditional pathway: Clinical Test Evaluation
- Molecular Evidence Development Consortium
- Medicare Benefit Coverage: is based on
- Basis of studies, Randomized, Retrospective, Data source: Lab test obtain
- Archived Tissues samples
- no duplication of Trial possible 30 yrs cohort studies
- 1% mutation
- Molecular testing – low return on investment
NEW Paradigm: Medicare should not cover transitional, phase 1 clinical trial
- Expedited review
MED-C Organization: to create a DB on mutation data, pathways of what works and what not
MED-C N1N Protocol
- Prospective interventional Registry: Testing, Treatment, Outcomes
- modify data
Maurie Markman, CTCA President, CTCA Medicine & Science
LIVE FROM THE PODIUM
The Present
Cancer treatment determined by location and molecular characterization
The Future
- CML vs GIST to optimal cancer treatment – molecular characterization in a different cancer
- Symptoms control
Randomized clinical trials are irrelevant in the realm of cancer precision medicine
Solutions: Publicly available n-to-1 trials
1:45PM – 2:00PM Panel, Q&A
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