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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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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The Challenge of Personalized Medicine

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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


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


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


Our Solutions

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Improve Safety andeffectiveness of care

Reduce waste associated With ineffective therapies

Offer patients and providers

actionable information


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



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Our Solutions



Coverage Management


Close Gaps in Care





Policy Managers

Providers

Patients

clients users


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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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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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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 Solutions



Coverage Management


Close Gaps in Care





Policy Managers

Providers

Patients

clients users


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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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Our SolutionCoverage Management: Provider Portal


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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Our Solutions



Coverage Management


Close Gaps in Care





Policy Managers

Providers

Patients

clients users


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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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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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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


Genomic Medicine InstituteDNA Direct Partnership with El Camino Hospital

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Our Solutions



Coverage Management


Close Gaps in Care





Policy Managers

Providers

Patients

clients users


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


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)*


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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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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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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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


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


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


THANK YOU

[email protected]@dnadirect.com

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