Disruptive Innovation in Health CareAdoption of Personalized Medicine and Beyond
Mara G. AspinallPresident and CEOVivirHealth
Diagnosis Save LivesDiagnosis Save Money
Monitoring Ensures Both
The Fundamentals
ValueFear Adoption
FundamentalsThree Stage Process of Adoption
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.
Old Paradigm: Trial and Error Medicine
Personalized / Precision Medicine
Personalized / Precision Medicine
New Paradigm: Personalized MedicineLinking Tests to Action and Therapy
Observation Test Action PredictableResponse
Breaking The Cycle of Trial and Error Medicine
Ries LAG, Eisner MP, Kosary CL, Hankey BF, Miller BA, Clegg L, Mariotto A, Feuer EJ, Edwards BK (eds). SEER Cancer Statistics Review, 1975-2002, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2002/, based on Nov 2004 SEER data submission, posted to the SEER web site 2005.
Precision Medicine Saves Lives
80 Years Ago
Leukemia or Lymphoma60 Years Ago
Chronic LeukemiaAcute LeukemiaPreleukemia
Indolent LymphomaAggressive Lymphoma
100 Years Ago
“Disease of the Blood”
Today
∼38 Leukemia types identified:Acute myeloid leukemia (∼12 types)Acute lymphoblastic leukemia (2 types)Acute promyelocytic leukemia (2 types)Acute monocytic leukemia (2 types)Acute erythroid leukemia (2 types)Acute megakaryoblastic leukemiaAcute myelomonocytic leukemia (2 types)Chronic myeloid leukemiaChronic myeloproliferative disorders (5 types)Myelodysplastic syndromes (6 types)Mixed myeloproliferative/myelodysplastic syndromes (3 types)
∼51 Lymphomas identified:Mature B-cell lymphomas (∼14 types)Mature T-cell lymphomas (15 types)Plasma cell neoplasm (3 types)Immature (precursor) lymphomas (2 types)Hodgkin’s lymphoma (5 types)Immunodeficiency associated lymphomas (∼5 types)Other hematolymphoid neoplasms (∼7 types)
5 YearSurvival
~ 0%
70%
Precision Medicine Saves MoneyHer2 Testing For Breast Cancer
$24,000savings
HER2 Test Delivers Healthcare Savings that are ~65x its Cost
* As measured by FISH and reimbursed by CMS, Los Angeles, 2007 ratesSource: Elkin et al. HER-2 Testing and Trastuzumab Therapy for Metastatic Breast Cancer: A Cost-Effectivensss Analysis. J Clin Oncol (2004) 22: 854-863; Genzyme analysis
$79,181
$54,738
Without HER2 Test With HER2 Test
Cost of Herceptin Therapy Per Patient
Fee
Price of HER2 testing per patient*
CPT Code Description
88368 Morphometric analysis, in situ hybridization (probe #1)
$183
88368 Morphometric analysis, in situ hybridization (probe #2)
$183
Total $366
Personalized MedicineFriend or Foe?
Personalized Medicine Needs to be a FriendPathologists 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
Pathology Call to Action Need to Capture the Future
Present Future
Morphology Tests Molecular Tests
Stable Base of Technology Many New Emerging Technologies
Single Gene Tests Multi Gene / Multi Technology Tests
Tissue Samples Multiple Sample Types
Timeframe Controlled by Pathologist Point of Care Diagnostics Growth
Pathologist Initiates & Interprets Diagnosis
Molecular Lab Provides Diagnosis directly to Treating Physician
ASCO 2009 Theme - Personalizing Cancer Care
Vivir 11
Most Important “New” Approach:DNA Damage Repair
Most Promising New Technology: Circulating Tumor Cells
ASCO 2002Theme - Making a World of Difference
Vivir 12
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”
Classic Customer Adoption
# of New Customers
Time
EARLYADOPTER
EARLYMAJORITY
LAGGARDSLATE MAJORITY
Aware of New InventionsJournals, CME, Colleagues, Web
Skeptical Claim ≠ Reality
Never black or white – Typically ConservativeSubtleties matter
Protective of timeAlready >100%
PracticalWhat will I do differently?How does it impact me and my patients?
How do Physicians think about Innovation Adoption?
Clinical Practice Achievement
Clinical Procedure
Landmark Trial NHQR 2005 Years
Flu Vaccine 1968 63 % 37
Diabetic Eye Exam 1981 70 % 24
Mammography 1982 70 % 23
Cholesterol Screening 1984 67 % 21
Pneumococcal Vaccine 1997 54 % 8
Balas EA, Boren SA., Managing Clinical Knowledge for healthCare Improvement, Yearbook of Medical Informatins 2008
Slow Adoption - Not new problem
Eating Oranges Hand Washing
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, 314–321
1591 Lancaster documents value of Lime Juice
1747James Lind ‘RCT’of Oranges & Limes
1754 Lind publishes ‘Treatise of the Scurvy’
1794 British Admiralty adopts as standard
203
Yea
rs
1846 Ignatz Semmelweiss: puerperal fever is spread by OB’s
1848 Hand washing reduces mortality 76%
1891 Pasteur’s germ theory leads to adoption of standard
1861 Results published but rejected
45 Y
ears
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: 474–5.
Key Opinion Leaders Present
JournalArticles
CompleteProduct
Developmentand
Launch
Standard of Care
Adopted
Stages to Full Adoption - Past
KeyOpinionLeadersPresent
TrialDesignDebate
TechnologyIntroduction
Pro/ConJournalArticles
Stages to full adoption - Today
PayorsWeigh In
SystemEconomics
Analysis
AHRQTechnologyAssessment
CompleteProduct
Developmentand Launch
PhysicianAssociationGuidelines
Phase 4Trials
PatientGroups
Weigh In
StandardOf CareAdopted
KeyOpinionLeadersPresent
TrialDesignDebate
TechnologyIntroduction
Pro/ConJournalArticles
Stages to full adoption - FuturePathology Impact
PayorsWeigh In
SystemEconomics
Analysis
AHRQTechnologyAssessment
CompleteProduct
Developmentand Launch
PhysicianAssociationGuidelines
Phase 4Trials
PatientGroups
Weigh In
StandardOf CareAdopted
PositiveEffect
BenefitNeutral(RR=1)
NEJM
J Clin Onc
Ca ResUltimate Estimate of RR
(or Predictive Value)
Adoption of a New BioMarker
Adapted from D. Hayes, in Prin. Molec. Oncol., Humana Press, 2000
J ImmunoHisto
NY Times“Next Nobel Prize”
Buffalo Evening News“Needs repeating”
Ann. Int. Med editorial“Doesn’t work & we knew
it wouldn’t 5 years ago”
J. Lab. Med. Editorial“Important in a small %
of patients”
NEJM“15 years after discovery,
Big Pharma announcesa breakthrough. While testinghas been available for 10 yearsit took until now to design and
obtain approval for a treatment.”
Personalized Medicine Diagnostic Adoption Years to $100 million in Revenue
22
Years Post Launch
Rev
enue
in M
illio
ns
0
20
40
60
80
100
120
0 1 2 3 4 5 6 7 8 9
Myriad
Genomic Helath
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 : 1225–30.
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
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?
Physician EducationPathologists Lead
Data & Integration into the EMRPathologists Lead
Policy – Reimbursement and Regulatory
Pathologists Lead
Moving From Fear To Acceptance
Aspinall and Hamermesh, Harvard Business Review, Oct 2007
Moving from Fear to Acceptance Physician Education Imperatives
Increased Medical Education on Diagnosis15% of medical school have no genetics education
Enhanced Use of CME and Boarding Exams to Focus on DiagnosisAggressive Issuance of Guidelines for use of Personalized Medicine and New Diagnostics Publish, Publish, Publish
Moving from fear to acceptanceEducate Physicians
Laurie Demmer MD, et al., University Of Massachusetts Medical School, Department of Pediatrics and Office of Ethics
Practicing PhysicianViews on Genetic Testing
“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”
Percent of Physicians Receiving Training inGenetic Testing During Medical School
8577
71
38
0
20
40
60
80
100
1990-1999 1980-1989 1970-1979 1940-1969Year of Graduation
Physician EducationPathologists Lead
Data & Integration into the EMRPathologists Lead
Policy – Reimbursement and Regulatory
Pathologists Lead
Moving From Fear To Acceptance
Aspinall and Hamermesh, Harvard Business Review, Oct 2007
Moving from Fear to AcceptanceRegulatory Policy Imperatives
Need Dedicated Federal expertise in diagnosticsRecognition 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. AspinallCopyright 2008
Moving from Fear to AcceptanceReimbursement 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. AspinallCopyright 2008
Physician EducationPathologists Lead
Data & Integration into the EMRPathologists Lead
Policy – Reimbursement and RegulatoryPathologists Lead
Change the Game
Moving From Fear To Acceptance
Aspinall and Hamermesh, Harvard Business Review, Oct 2007
Change Clinical Orientation fromSilos to Disease Pathway Teams
SpecialtySilos
Integrated Disease Team
• Pathologists not embracing personalized medicine tests
• Diagnosis ends pathologist involvement
• Communication one way• Treating MDs looking for more
explanation• Labs marketing Treating MDs
• 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
Health Care TodayOrgan-Based Treatment Paradigm
Colon Cancer
Breast Cancer
Leukemia
Lung Cancer
Brain Cancer
Pancreatic Cancer
Health Care in the Future –Mechanism-Based Treatment Paradigm
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jak-2
EGFRP53
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