Integrating Genomic Medicine into Patient...
Transcript of Integrating Genomic Medicine into Patient...
Medco is a registered trademark of Medco Health Solutions, Inc.© 2010 Medco Health Solutions, Inc. All rights reserved.
Integrating Genomic Medicine into Patient Care
Ryan PhelanFounder & President, DNA Direct06/10/2010
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
DNA Direct Overview
• Based in San Francisco, with a national call center of genetic experts and a network of medical & science advisors with expertise in all key areas of genomic medicine
• 30 employees across clinical, technical, marketing and sales providing guidance and decision support services for genomic medicine.
• In 2005, launched a web-based consumer portal offering medical genetic testing services.
• In 2009, launched coverage management program with Humana – a national health plan covering +2 million lives
• Acquired by Fortune 500 Company, Medco Health Solutions – the largest pharmacy benefit manager (PBM) in the U.S – in February 2010 becoming a wholly-owned subsidiary
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
DNA Direct Overview
Our Mission:
To bring the power of personalized medicine to patients, providers, and payors – reducing health risks, preventing disease, and better targeting therapies
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
The Challenge of Personalized Medicine
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Genetics:One of Fastest Growing Areas in Healthcare
2008 2009 2010E= inappropriate tests 20% of total costs
$4.0
$5.5
$8.0M
olec
ular
Dx
Spe
nd
$800M
$1.1
$1.6
Sources: Washington G-2 Reports Advisory Services’ 2008 Molecular Diagnostics Survey, health plan data, Genefacts
2000+ Molecular Diagnostic and Genetic Tests
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$8B
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Cost of Sequencing is Plummeting Genomics Research is Growing
*PubMed search 10/21/09 / Eric Landor, Broad Institute
20 127 151 79 64 100276
647
2,714
3,890
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
1960-4 1965-9 1970-4 1975-9 1980-4 1985-9 1990-4 1995-9 2000-4 2005-9*
Years
# of
Pee
r-re
view
ed A
rtic
les
Publ
ishe
d
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• 2003 Human genome $3B• 2007 Craig Venter’s genome $100M• 2008 James Watson’s genome $1M• 2009 Whole genome analysis $5k• When: whole genome for? $1K
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Diagnostics Impact Healthcare Decisions
Diagnostics driving > 70% of healthcare decisions
Drug selection and
dosing
Prevention strategies
Chronic disease
management
Oncology
Prenatal & fertility
*College of American Pathologists
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Our Solutions
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Improve Safety andeffectiveness of care
Reduce waste associated With ineffective therapies
Offer patients and providers
actionable information
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Our Product Portfolio
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Policy/ Benefit Consultation
Genetic Testing Management Strategies
Our Solutions
Develop Clinical Policies
Enforce Clinical Policies
Coverage Management
Provide Access to Expertise
Close Gaps in Care
Decision Support Tools
Clinical Testing Programs
Health Plans/Government
Self-Insured Employers & Medical Centers
Policy Managers
Providers
Patients
clients users
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Our Product Portfolio
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Policy/ Benefit Consultation
Genetic Testing Management Strategies
Our Solutions
Develop Clinical Policies
Enforce Clinical Policies
Coverage Management
Provide Access to Expertise
Close Gaps in Care
Decision Support Tools
Clinical Testing Programs
Health Plans/Government
Self-Insured Employers & Medical Centers
Policy Managers
Providers
Patients
clients users
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
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Our SolutionPolicy/ Benefit Consultation
Consulting services and data and analytic modeling and proprietary software to help refine/establish genetic testing policy and benefit design
Access to 600+ test coverage recommendations
Access to online genetic resource center
On demand access to genetic experts
Implement clear, consistent coverage criteria
Expert recommendations based on a thorough review of the data on new technologies and tests
Guidance for creating policies
Gain access to expertise across genetic specialties
Make timely, evidence-based coverage decisions
Key Features
Value Proposition
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
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Our SolutionPolicy/Benefit Consultation
Policy/ Benefit Consultation offers clients the ability to: gain access to expertise across genetic specialties make timely, evidence-based coverage decisions that will ensure maximum value is
derived from the appropriate test and test results Stratify the testing in discreet coverage categories
Some genetic tests are routinely covered: BCR-ABL testing that measures treatment response Carrier tests for genetic disorders such as Tay Sachs disease and cystic fibrosis that
are typically offered as part of prenatal screening
Some genetic tests are covered only in specific circumstances: BRCA1 and BRCA2 testing used to identify the risk of hereditary breast and ovarian
cancer. Oncotype DX testing that measures treatment response
Some genetic test are not covered: New tests with little evidence, such as genome tests for common disease risk Obsolete tests where new technology is the gold standard, like chromosome
breakage studies for Fanconia anemia C (DNA is a better option)
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
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Our SolutionPolicy/ Benefit Consultation
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
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Our SolutionPolicy/ Benefit Consultation
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Co-branded Call Center representing every major
genetic specialty
Routing to genetic experts based on expertise
Research Organizer & Workflow Tools extend
expertise and learning’s throughout call center
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Our SolutionPolicy/ Benefit Consultation
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Our Product Portfolio
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Policy/ Benefit Consultation
Genetic Testing Management Strategies
Our Solutions
Develop Clinical Policies
Enforce Clinical Policies
Coverage Management
Provide Access to Expertise
Close Gaps in Care
Decision Support Tools
Clinical Testing Programs
Health Plans/Government
Self-Insured Employers & Medical Centers
Policy Managers
Providers
Patients
clients users
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
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Our SolutionCoverage Management
Web-based system combined with genetic experts to support prior authorization and appeals criteria
Automation of coverage policies
– Access to details on over 2,000 molecular tests.
– Clinical summaries criteria on the highest utilized testing areas.
Utilization Management tools and services
Web-enabled, automated eligibility & pre-authorization
The only genetic information and management offering that is URAC and NCQA compliant
Reduce inappropriate use of testing Gain insight into test utilization Increase compliance with participating labs
Key Features
Value Proposition
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
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Our SolutionCoverage Management: Provider Portal
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Current results of genomic strategy
Reduction in inappropriate testing– Early indicator – inappropriate testing volume in line with
published literature Reduction in out-of-pocket costs for members
– 30-40% of total requests received for non-par labs. Almost all requests were steered to par labs (for same or comparable test)
– Education on inappropriate testing requests Provider Education/Guidance
– Appropriate testing based on individual and family history, signs and symptoms• Redirection• Assistance in determining
Member Education/Guidance– 20-25% of calls for pre-auth initiated by members receive
direct interaction with certified genetic counselor.
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Humana Case Study
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Our Product Portfolio
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Policy/ Benefit Consultation
Genetic Testing Management Strategies
Our Solutions
Develop Clinical Policies
Enforce Clinical Policies
Coverage Management
Provide Access to Expertise
Close Gaps in Care
Decision Support Tools
Clinical Testing Programs
Health Plans/Government
Self-Insured Employers & Medical Centers
Policy Managers
Providers
Patients
clients users
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
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Our SolutionDecision Support Tools
Personalized Web-based educational tools for providers and patients that provides patient-specific information about genetic and pharmacogenomic testing
Provider and patient access to online and phone decision support tools
Content and resources to help drive appropriate treatment decisions and support test result interpretation.
Support around when/ why to use a test Avoid inappropriate testing Follow-up on test results to consult on therapy
options
Detailed content on the most highly prescribed genetic tests including conditions such as:
– Oncology - Fertility
– Pre-Natal - Cardiology
Key Features
Value Proposition
Sample of Indications Covered
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
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Our SolutionPersonalized Medicine Resource Center
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0 23
Our SolutionWeb-enabled Genetic Guidance
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Medco/American Medical Association Research Study
Physicians not adequately equipped
Source: Stanek EJ, et al. American Society of Human Genetics 2009, Abstract 2256.
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Nationwide survey of 397,000 physicians (+10,000 responded) to establish benchmark for current U.S. physician use of pharmacogenomics tests, and to explore physician adoption.
98% of Physicians agree that genetic profiles may influence drug therapy
10% of physicians believe they are adequately informed about PGx testing
26% of physicians have had some formal PGx training at medical school or postgraduate education
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Genomic Medicine InstituteDNA Direct Partnership with El Camino Hospital
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Our Product Portfolio
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Policy/ Benefit Consultation
Genetic Testing Management Strategies
Our Solutions
Develop Clinical Policies
Enforce Clinical Policies
Coverage Management
Provide Access to Expertise
Close Gaps in Care
Decision Support Tools
Clinical Testing Programs
Health Plans/Government
Self-Insured Employers & Medical Centers
Policy Managers
Providers
Patients
clients users
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Our SolutionClinical Testing Programs
Physician and patient engagement and education of testing
Access to the test Follow-up discussion re: testing results
Improved health outcomes
Ability to lower healthcare cost by reducing
expenses tied to adverse events and hospitalization
Key Features
Value Proposition
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Identifying patients who are on specific medications where genetic testing will help support the optimization of drug therapy
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Our SolutionCurrent PGx Testing Programs
*Available in September
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Warfarin (Blood Thinner)
Tamoxifen (Breast Cancer)
2C19 (Plavix)
CCR5 (HIV)
HLA-B5701 (HIV)
A1c and Lipid Home Testing (Diabetes and “at risk for Diabetes)
BCR-ABL (Oncology – Chronic Myeloid Leukemia)*
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
WarfarinCYP2C9 Testing Overview
An anticoagulant (blood thinner)What is it?
Prevention of blood clots Prevention and treatment of blood clots due to
atrial fibrillation and/or cardiac valve replacement To reduce the risk of death, recurrent heart attack,
and blood clots after a heart attack
Deep venous thrombosis (DVT) – 2 million/year Atrial Fibrillation (AF) – 2.5 million patients Heart Attack (MI) – 1.255 million/year
Using the results of genetic testing, physicians will be better able to identify the optimal dose needed to achieve anticoagulation for each patient
– Over dosing warfarin can lead to serious bleeding while under dosing warfarin can lead to blood clots
What is it used for?
How many people are affected?
What are the benefits of testing?
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Warfarin TestingFDA Announcements/ Label Changes
August 2007:
FDA first updated the warfarin label to suggest that prescribers consider a patient's genetic makeup when prescribing warfarin.
January 2009:
FDA again updates warfarin label with specific dosing recommendations based on the patient's genotype.
– This is the first time that the FDA has updated a drug label to recommend dosing based upon a patient's genotype.
FDA announces label changes for warfarin
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
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Clinical Testing ProgramsWarfarin CYP2C9 Testing Workflow
QueryMedco Database Contact MD Contact Patient Facilitate Lab &
InterpretationSend Test Kit
Identify pharmacy claim indicating an eligible drug was dispensed
Contact physician for approval to test patient
Contact patient to discuss program and test kit mailing/ blood draw
800 number provided for questions
Cheek swab completed by patient and mailed to lab/ blood draw completed
Lab processes test, sends results and interpretation to physician and Medco TRC pharmacist
Therapy change made if applicable
Monitor lab outcomes and follow-up as needed
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© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Medco-Mayo Effectiveness Study
Source: Caldwell MD, et al. Blood. 2008;8(111):4106-4112.
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Hospitalization rates for heart patients taking warfarin
dropped by 30% when genetic information was available to
doctors prescribing the drug
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
Warfarin (Coumadin) One of Most Frequently prescribed Drugs in US
Source: Caldwell MD, et al. Blood. 2008;8(111):4106-4112.
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30% of the population have at least one variant that can that can
impact warfarin dosing
“We estimate that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 85,000 serious bleeding events and 17,000 strokes annually.
We estimate the reduced health care spending from integrating genetic testing into warfarin therapy to be $1.1 billion annually, with a range of about $100 million to $2 billion”
AEI-Brookings Joint Center for Regulatory Studies, 2006
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
In Summary
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Personalized Medicine is being translated into patient care today across the U.S
The potential for personalized medicine to improve outcomes and decrease healthcare costs is great
The need for personalized medicine is global and requires international collaboration
© 2010 Medco Health Solutions, Inc. DNA Direct, Inc, All rights reserved./ Version 1.0
THANK YOU
[email protected]@dnadirect.com
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