9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA | Leaders in Pharmaceutical Business Intelligence (LPBI) Group

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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

January 27, 2015 by 2012pharmaceutical

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:

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

Dane Dickson, Palmetto GBA