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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

Rina Wolf, XIFIN

• 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:

1. Parallel review FDA & CMS
2. Coverage with Evidence development
3. 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

Dane Dickson, Palmetto GBA 

• 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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