Disruptive Innovation in Health Care Adoption of Personalized Medicine and Beyond. Mara G. Aspinall President and CEO VivirHealth

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2 Disruptive Innovation in Health Care Adoption of Personalized Medicine and Beyond Mara G. Aspinall President and CEO VivirHealth

3 The Fundamentals Diagnosis Save Lives Diagnosis Save Money Monitoring Ensures Both

4 Fundamentals Three Stage Process of Adoption Fear Value Adoption

5 Personalized / Precision Medicine Old Paradigm: Trial and Error Medicine Successful When it Leads to Innovation and Improves Standard of Care. Fails When We Settle for Trial and Error Medicine AS the Standard of Care.

6 Personalized / Precision Medicine New Paradigm: Personalized Medicine Linking Tests to Action and Therapy Observation Test Action Predictable Response Breaking The Cycle of Trial and Error Medicine

7 Precision Medicine Saves Lives 100 Years Ago 80 Years Ago 60 Years Ago Disease of the Blood Leukemia or Lymphoma 5 Year Survival ~ 0% Chronic Leukemia Acute Leukemia Preleukemia Indolent Lymphoma Aggressive Lymphoma Today 38 Leukemia types identified: 51 Lymphomas identified: Acute myeloid leukemia ( 12 types) Mature B-cell lymphomas ( 14 types) Acute lymphoblastic leukemia (2 types) Mature T-cell lymphomas (15 types) Acute promyelocytic leukemia (2 types) Plasma cell neoplasm (3 types) Acute monocytic leukemia (2 types) Immature (precursor) lymphomas (2 types) Acute erythroid leukemia (2 types) Hodgkin s lymphoma (5 types) Acute megakaryoblastic leukemia Immunodeficiency associated lymphomas ( 5 types) Acute myelomonocytic leukemia (2 types) Other hematolymphoid neoplasms ( 7 types) Chronic myeloid leukemia Chronic myeloproliferative disorders (5 types) Myelodysplastic syndromes (6 types) Mixed myeloproliferative/myelodysplastic syndromes (3 types) 70% Ries LAG, Eisner MP, Kosary CL, Hankey BF, Miller BA, Clegg L, Mariotto A, Feuer EJ, Edwards BK (eds). SEER Cancer Statistics Review, , National Cancer Institute. Bethesda, MD, based on Nov 2004 SEER data submission, posted to the SEER web site 2005.

8 Precision Medicine Saves Money Her2 Testing For Breast Cancer Cost of Herceptin Therapy Per Patient $79,181 $24,000 savings $54,738 Price of HER2 testing per patient* CPT Code Description Morphometric analysis, in situ hybridization (probe #1) Morphometric analysis, in situ hybridization (probe #2) Fee $183 $183 Without HER2 Test With HER2 Test Total $366 HER2 Test Delivers Healthcare Savings that are ~65x its Cost * As measured by FISH and reimbursed by CMS, Los Angeles, 2007 rates Source: Elkin et al. HER-2 Testing and Trastuzumab Therapy for Metastatic Breast Cancer: A Cost-Effectivensss Analysis. J Clin Oncol (2004) 22: ; Genzyme analysis

9 Personalized Medicine Friend or Foe? Personalized Medicine Needs to be a Friend Pathologists Need to : - Own Personalized Medicine - Source of expertise on all tests available - Interpreter and consolidator of all test results - Educator of all other physicians on diagnosis Move Industry from Fear to Acceptance

10 Pathology Call to Action Need to Capture the Future Present Future Morphology Tests Stable Base of Technology Single Gene Tests Tissue Samples Timeframe Controlled by Pathologist Pathologist Initiates & Interprets Diagnosis Molecular Tests Many New Emerging Technologies Multi Gene / Multi Technology Tests Multiple Sample Types Point of Care Diagnostics Growth Molecular Lab Provides Diagnosis directly to Treating Physician

11 ASCO 2009 Theme - Personalizing Cancer Care Most Promising New Technology: Circulating Tumor Cells Most Important New Approach: DNA Damage Repair Vivir 11

12 ASCO 2002 Theme - Making a World of Difference Aspinall Personalized Medicine Presentation You have to be kidding We are oncologists we personalize everything we do by definition Not Realistic We do not need diagnostics to tell us how to practice Vivir 12

13 Classic Customer Adoption # of New Customers Time EARLY ADOPTER EARLY MAJORITY LATE MAJORITY LAGGARDS

14 How do Physicians think about Innovation Adoption? Aware of New Inventions Journals, CME, Colleagues, Web Skeptical Claim Reality Never black or white Typically Conservative Subtleties matter Protective of time Already >100% Practical What will I do differently? How does it impact me and my patients?

15 Clinical Practice Achievement Clinical Procedure Landmark Trial NHQR 2005 Years Flu Vaccine % 37 Diabetic Eye Exam % 24 Mammography % 23 Cholesterol Screening Pneumococcal Vaccine % % 8 Balas EA, Boren SA., Managing Clinical Knowledge for health Care Improvement, Yearbook of Medical Informatins 2008

16 Slow Adoption - Not new problem Eating Oranges 1591 Lancaster documents value of Lime Juice Hand Washing 1846 Ignatz Semmelweiss: puerperal fever is spread by OB s 203 Years 1747James Lind RCT of Oranges & Limes 1754 Lind publishes Treatise of the Scurvy 45 Years 1848 Hand washing reduces mortality 76% 1861 Results published but rejected 1794 British Admiralty adopts as standard 1891 Pasteur s germ theory leads to adoption of standard Doherty, S. History of evidence-based medicine. Oranges, chloride of lime and leeches: Barriers to teaching old dogs new tricks. Emergency Medicine Australasia (2005) 17,

17 Why MD s ignore clinical innovations Their own clinical experience Over reliance on a surrogate outcome Natural history of the illness vs. study Love of a wrong patho-physiological model Ritual and mystique A need to do something No one asks the question Patients expectation (real or assumed) Doust J, Del Mar C. Why do doctors use treatments that do not work? BMJ 2004; 328:

18 Stages to Full Adoption - Past Complete Product Development and Launch Key Opinion Leaders Present Journal Articles Standard of Care Adopted

19 Stages to full adoption - Today Technology Introduction Key Opinion Leaders Present Trial Design Debate Pro/Con Journal Articles AHRQ Technology Assessment Payors Weigh In System Economics Analysis Complete Product Development and Launch Patient Groups Weigh In Physician Association Guidelines Phase 4 Trials Standard Of Care Adopted

20 Stages to full adoption - Future Pathology Impact Technology Introduction Key Opinion Leaders Present Trial Design Debate Pro/Con Journal Articles AHRQ Technology Assessment Payors Weigh In System Economics Analysis Complete Product Development and Launch Patient Groups Weigh In Physician Association Guidelines Phase 4 Trials Standard Of Care Adopted

21 Adoption of a New BioMarker Positive Effect Benefit Neutral (RR=1) NY Times Next Nobel Prize NEJM Buffalo Evening News Needs repeating J Clin Onc Ca Res J Immuno Histo J. Lab. Med. Editorial Important in a small % of patients Ultimate Estimate of RR (or Predictive Value) Ann. Int. Med editorial Doesn t work & we knew it wouldn t 5 years ago NEJM 15 years after discovery, Big Pharma announces a breakthrough. While testing has been available for 10 years it took until now to design and obtain approval for a treatment. Adapted from D. Hayes, in Prin. Molec. Oncol., Humana Press, 2000

22 Personalized Medicine Diagnostic Adoption Years to $100 million in Revenue 120 Revenue in Millions Myriad Genomic Helath Years Post Launch 22

23 Best Practices to achieve Adoption Acute/Serious (easier than chronic) Clear description of desired change High quality evidence Simple decision-making Simple to do No new skills needed Low cost Fair compensation for MD time Low collaboration required No organizational change required Compatible with existing values Adapted from Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patients care. Lancet 2003; 362 :

24 Personalized Medicine is a challenge Acute/Serious (easier than chronic) Clear description of desired change High quality evidence Simple decision-making Simple to do No new skills needed Low cost but who gains? Fair compensation for MD time Little collaboration required No organizational change required Compatible with existing values

25 Where is the adoption of Personalized Medicine on the spectrum? Acute/Serious High quality evidence Low cost Compatible with existing values Simple decision-making? Simple to do? New skills needed? Collaboration? Organizational change? Clear description of change? Compensation for MD time?

26 Moving From Fear To Acceptance Physician Education Pathologists Lead Data & Integration into the EMR Pathologists Lead Policy Reimbursement and Regulatory Pathologists Lead Aspinall and Hamermesh, Harvard Business Review, Oct 2007

27 Moving from Fear to Acceptance Physician Education Imperatives Increased Medical Education on Diagnosis 15% of medical school have no genetics education Enhanced Use of CME and Boarding Exams to Focus on Diagnosis Aggressive Issuance of Guidelines for use of Personalized Medicine and New Diagnostics Publish, Publish, Publish

28 Moving from fear to acceptance Educate Physicians Percent of Physicians Receiving Training in Genetic Testing During Medical School Practicing Physician Views on Genetic Testing Year of Graduation I feel comfortable with my 18 % knowledge of available genetic tests I have a standard for deciding 28 % when patients need to be informed about the option of genetic testing Laurie Demmer MD, et al., University Of Massachusetts Medical School, Department of Pediatrics and Office of Ethics

29 Moving From Fear To Acceptance Physician Education Pathologists Lead Data & Integration into the EMR Pathologists Lead Policy Reimbursement and Regulatory Pathologists Lead Aspinall and Hamermesh, Harvard Business Review, Oct 2007

30 Moving from Fear to Acceptance Regulatory Policy Imperatives Need Dedicated Federal expertise in diagnostics Recognition of diagnostics unique needs Action #1 Create a new FDA Center for Advanced Diagnostics Evaluation and Review (CADER) #2 Establish diagnostics-specific regulatory standards Include appropriate use of retrospective case controlled studies of archived samples Mara G. Aspinall Copyright 2008

31 Moving from Fear to Acceptance Reimbursement Policy Imperatives Need Reimbursement based on Value not Activity Transparency and Clarity Action #1 Create new reimbursement system that rewards Value #2 Create new market pricing system where diagnostic innovators choose and justify their price #3 Create new coding system with unique national identifying codes Mara G. Aspinall Copyright 2008

32 Moving From Fear To Acceptance Physician Education Pathologists Lead Data & Integration into the EMR Pathologists Lead Policy Reimbursement and Regulatory Pathologists Lead Change the Game Aspinall and Hamermesh, Harvard Business Review, Oct 2007

33 Change Clinical Orientation from Silos to Disease Pathway Teams Specialty Silos Pathologists not embracing personalized medicine tests Diagnosis ends pathologist involvement Communication one way Treating MDs looking for more explanation Labs marketing Treating MDs Integrated Disease Team Patient centered process Pathologists create Team with Treating MDs Pathologists know and analyze all new tests and publicly comment Diagnosis is supplemented with active Monitoring Decision making across team

34 Health Care Today Organ-Based Treatment Paradigm Leukemia Pancreatic Cancer Brain Cancer Lung Cancer Colon Cancer Breast Cancer

35 Health Care in the Future Mechanism-Based Treatment Paradigm jak-2 c-kit P53 EGFR kras Her-2

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