Delivering the Value of Personalized Medicine to Physicians

Latin American Pharmacogenomic Congress
"Delivering the value of personalized medicine
to Physicians, Patients and Payors“
David Logan
Executive Vice President, Genomic Health, Inc.
Safe Harbor Statement
This presentation contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements related to future periods, can be
identified by words such as “believes,” “anticipates,” “plans,”
“expects,” “will,” “intends” and similar expressions, and may include
our future plans and prospects and our product pipeline. Forwardlooking statements are subject to risks and uncertainties which may
cause actual results to differ materially. For a discussion of the
factors that may cause our results to differ, please refer to our filings
with the Securities and Exchange Commission, including our Annual
Report on Form 10-K for the year ended December 31, 2009. These
forward-looking statements speak only as of the date hereof.
Genomic Health disclaims any obligation to update these forwardlooking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX™ and Recurrence Score are trademarks or
registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property
of their respective owners.
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"Delivering the value of personalized medicine
to Physicians, Patients and Payors"
• US Road map to providing a more precise tool (Oncotype DX™)
for making critical treatment decisions in early stage breast
cancer…
– Clinical Development and Validation
– Regulatory and Reimbursement Approaches
– Gaining Practice Guideline Recommendations
– Changing Clinical Practice
• International Road Map for Oncotype DX™
– World wide
– Latin America
3
Genomic Health, Inc
• Genomic Health, a life science company founded August of 2000
• Committed to improving the quality of cancer treatment decisions
• Clinical Reference Lab located in Redwood City, California
• Developed and follow a highly specialized process that (IVD/MIA);
• adheres to CAP (College of American Pathologists) standards
• is regulated by CLIA (Clinical Laboratory Improvement Amendments)
• First Product launched (Oncotype DX™ Breast $3,460) in 2004
• Over 9,000 Physicians have used Oncotype DX
• Over 150,000 patients have been tested to date (50,000 in 2009)
• Orders from over 55 countries
• 5 Product enhancements/new indications in 5 years
• 2009 Revenue $150 Million (Year over Year Growth >40%)
• Second Product (Oncotype DX™ Colon $3,200) in Feb. 2010
4
"One-Size-Fits-All"
DrugFacts…
The
Current
Development
Allocation of
Medicine
Spending
Healthcare
isisNot
Significantly
Resources
Sustainable,
isOutpacing
Does
Results
U.S.
Not
Balanced
Healthcare
Not Deliver
forCosts
Optimal
a Solution
AreValue
Soaring
In Vitro Diagnostics
Drugs
12%
Procedures
35%
18%
Administration
35%
Personnel Cost
Source: Burrill & Company 2009 Biotech Report
5
Personalized Medicine, Center of the Conversation.
Products like Oncotype DX have offered a solution
“We spend far more on treating illnesses that could have been managed for far less.”
– President Barack Obama
Healthcare
Spending
Soaring
Personalized
Medicine
Economy
in Crisis
Healthcare
Reform
Technology
Accelerating
“Oncotype DX is evidence that personalized medicine can help reduce health costs,
saving an average of $2,000 per patient in additional costs from chemotherapy
treatment.” – Dr. Francis Collins, Director of the National Institutes of Health
6
Oncotype DX™:
Unmet Clinical Need for Better Markers
High risk/Large chemo benefit
Biopsy
or
Resection
Optimize
chemotherapy
Robust
Markers
Low risk/Little chemo benefit
Optimize local
therapy and
hormonal
therapy
Our 1st Product was in Breast Cancer in 2004
Why was a personalized approach needed?
• In early stage Breast Cancer,
Node (-), Hormone Positive
(ER+) patients have ~15%
rate of distant recurrence
when treated with Hormonal
therapy alone
• Chemotherapy benefit is
modest in this setting
(~4%)1 yet it is
recommended for most
patients by NCCN guidelines
• We needed an assay to
identify a patients risk of
distant recurrence AND who
benefits from chemotherapy
• One size does not fit all!
For node-negative breast cancer (Lancet 1996 Apr 20; 347(9008):1066-71)
* estimated
1
8
Candidate Gene Selection
From ~30,000 genes
250
cancer-related
candidate genes
*Sources include:
1) Van 't Veer et al, Nature 415:530, 2002
2) Sorlie et al, Proc. Natl. Acad. Sci. 98:10869, 2001
3) Ramaswamy et al, Nature Genetics 33:4, 2003
4) Gruvberger et al, Cancer Res. 61:5979, 2001
Paik et al, SABCS
NSABP B-20
Study,
Pittsburgh, PA
rtPCR
Rush Presbyterian,
Chicago, IL
Providence St.
Josephs Hospital,
Burbank, CA
9
The Most Robust (21) Genes were selected to go
in Clinical Validation and Confirmation Trials
PROLIFERATION
HER2
ESTROGEN
Ki-67
STK15
Survivin
Cyclin B1
MYBL2
GRB7
HER2
ER
PGR
Bcl2
SCUBE2
REFERENCE
CD68
Stromolysin 3
Cathepsin L2
BAG1
Best RT-PCR performance
and most robust predictors
Paik et al, SABCS
• Over 4,000 Patients
• Consistent Results
GSTM1
INVASION
• 13 Key Peer Review
Publications
Beta-actin
GAPDH
RPLPO
GUS
TFRC
• Oncotype DX
identifies patients
more or less likely to
have a recurrence
AND who will benefit
from chemotherapy
The Oncotype DX® Recurrence Score is a
Continuous Predictor of Recurrence Risk
Distant Recurrence at 10 Years
What is the 10-year probability of distant recurrence
LOWER RISK
HIGHER RISK
for a patient with a Recurrence Score of 30?
Dotted lines represent 95% CI
RS 30 =
20% risk of
distant
recurrence at
10 years
Recurrence Score
Multiple Independent Studies Confirm Decision Impact Supports Clinical Utility
Treatment Received by Recurrence Score1
1
12
Liang, SABCS 2007, Abstract #2061
Building the Breast Cancer Franchise
Investment in Clinical Studies Expands Value to Patients
2007
2005
2004
Node Negative
Recurrence
13
Node Negative
Chemotherapy
Benefit
Node Positive
Recurrence,
Chemotherapy Benefit
2008
Quantitative
Single Gene
Publications
• California Technology Assessment Foundation
• Agency for Healthcare Research and Quality
• Blue Cross Blue Shield Technology Evaluation Center
PrivateGovernmental
Payor Coverage
= 98%
• Approval•ofUS
Appropriate
Regulatory
Bodies
• Analytic and
Clinical Validity
• Medicare
Coverage = 100%
• Clinical Utility must Improve Net Health Outcomes
• Benefit Beyond Established Measures
• Benefit Outside of Investigational Setting
• ASCO Guidelines
• NCCN Guidelines
Comparative Effectiveness:
Relationship of NCCN vs. RS Directed Classification
6%
22%
29%
72%
8%
49%
92%
22%
RT-PCR Assay
Reclassification
NCCN Classification
RT-PCR Assay
Reclassification
Low Risk
Low Risk
Low Risk
Intermediate Risk
High Risk
Intermediate Risk
High Risk
High Risk
The Treatment Paradigm Has Changed
Source: US adjuvant chemo usage data for early stage N- patients from OncoReport ICI; Oncotype DX data from
Genomic Heath
Consistent Adoption of our Product line.
> 150,000 Patients benefited from Oncotype DX
60-65K Est.
70,000
60,000
52,000
50,000
40,000
40,000
25,500
30,000
15,000
20,000
7,000
10,000
500
0
2004
Key
Milestones
• NSABP
B14
Publication
• NSABP
B20
Presentation
• Kaiser
Presentation
17
2005
2006
• Medicare
Coverage
• NSABP
B20,
Kaiser
Publications
2007
• Aetna,
United,
Cigna
Coverage
• ASCO and
NCCN
Guidelines
• SWOG 8814
Presentation
2008
2009
• HER2, ER
and PR
Scores
• Node +
Report
• Aromatase
Inhibitors
• 90% U.S.
Coverage
2010
• International
expansion
• Japanese
Clinical
Results
• Node +
Medicare
Coverage
• Latin Am.
Expansion
Our Integrated Service Model
Physicians
Payors
 Managed Care
 Evidence-Based
Appeals
 Effective Utilization
Outcomes
 Clinical Pathways
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






Direct-to-Oncology Sales
Reproducible Standardization
Publications – Evidence Driven
Guidelines – Evidence Supported
CME/Medical Staff
Outstanding Lab and Path Support
World Class Customer Service




Patients
Reimbursement Support
Patient Education Programs
Patient Advocacy
Patient Support - GAP
Redwood City Clinical Reference Lab
ORDER
ENTRY
PATHOLOGY
INTAKE
ANALYTICAL
LABORATORY
REPORT
FULFILLMENT
MATERIAL
RETURN
Insurance
Provider
Phone
Online
Fax
Order Entry
Fax
Request
Benefits
Investigation
Patient
Information
Retrieval
FedEx
Specimen
Retrieval
FedEx
Pathology
Review
Extraction
Quantitation
Results
Generation
Report
Delivery
Materials
Return
gDNA Detection
Specimen
Accessioning
Histopathology
Dissection
Reverse Transcription
Billing
Reimbursement
QPCR
Online, Fax
FedEx
OnBase
Online
Portal
SARP
CRM
GEMTools (LIMS)
SARP
CRM
EDI Services
Material Manager
Result
Generation
Service
EDI
Services
Material
Manager
Data Services
Report
Delivery
Online
Portal
Electronic
Claim
PAS
HARP
Our U.S. lab has processed tests from more than 55 countries to date.
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A Personalized Medicine Approach
Driving a New Standard of Care
•In Summary……
Product Pipeline - Positioned for Growth
Puerto Rico
•
•
•
•
•
•
•
Breast
We placed
a Representative in Puerto Rico 2009
> 60 MD’s have placed order
> 400Renal
Patients have utilized Oncotype DX
Medicare patients and 100% Coverage
Triple S - Has a policy, working on a contract
Humana - Discussion ongoing (US Policy/Contract)
MSC –Colon
Has policy, working on contract
Prostate
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International Expansion (2nd Year)
Highlights:
56 Countries have ordered at least 1 assay
>8,200 Assays Launch to date
>1,100 Physicians
>50% YOY growGeneva Switzerland Office
8 Ongoing studies
(Utilization,
Patient Selection)
Building
the infrastructure.
Establishing clinical experience and
Public and/or Private
Coverage
usage while
advancing reimbursement
submissions in targeted countries
• Germany (Public)
• UK (Private)
• Greece (Public)
• Canada (Public, Province of Ontario)
• Israel: (Public/Private)
Countries that have submitted samples
• Patient (Cash) or Hospital payment is still the primary
Geneva Switzerland EU Office
reimbursement
•
•
•
•
•
•
Global incidence of breast cancer ~ 1.3 million patients1
Distribution partners
Sales/Consultants
1
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Globocan 2002/ACS Cancer Facts & Figures 2007
Latin American Presence & Progress:
2 Years of Effort – General Comments
• Awareness of Personalized Medicine: Hot Topic – The
Promise of the future!
• Awareness of Oncotype DX: Growing with ~800 assays
requested and by over >160 physicians and >50% YOY
• Treatment patterns and therapeutic options
– Less Early Stage patient presentation
– Adjuvant Treatment less aggressive (availability)
• Pathways to regulatory approval for IVD/MIA type
products not always clear (FDA vs. CLIA)
• Public Reimbursement (~90%)- No Coverage to Date:
Reason: Priorities, Access to Care, Pharmacoeconomics differ,
Incentives favor treatment, patients pathway to coverage is
difficult (legal petition)
• Private Coverage (10%) – encouraging: Private Insurers,
Key Hospital and patient pay represent the early supporters of
Oncotype DX
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Latin America Progress
Mexico
Seeking Partner /Study
Private Coverage: Hospital
Public Coverage: Pending
Promising: Mexican Social
Security Institute (IMSS) are
evaluating and Draft guidance
and Consenso Mexicano
(Secretaria de Salud) plan to
include Oncotype DX
Colombia (+ Costa Rica and
Panama)
Distributor: Amarey Nova
Private Coverage: MCO’s Colsanitas and Saludcoop
Peru / Study
TAILORx study at the Instituto
Nacional de Enfermedades
Neoplasicas – Hospital Coverage
Venezuela
Distributor: Fundacion BADAN
Private Coverage: Seguros
Caracas, Seguros Mercantil,
Sanitas de Venezuela,
Multinacional de Seguros
Public - IVSS (Social
Security) has paid first claim
Brazil / Study
Distributor: Diagnostika
Private market is
currently only viable
option for market entry.
Public: Not a current
option
Argentina
Seeking Partner:
Will target Obras
Sociales (Unions) and
PAMI (Argentina
Medicare)
Personalized Medicine is at the Center of the
Conversation… Products like Oncotype DX offer a solution
“We spend far more on treating illnesses that could have been managed for far less.”
– President Barack Obama
As the IVD/MIA Space Moves Foreward
•
•
•
•
•
•
Economy
in Crisis
Regulatory Pathway
Healthcare
Standards in Tec Assessment – Levels of EvidenceSpending
Soaring
Value Proposition and Pricing (CPT System)
Healthcare
Alignment of Incentives
Reform
Personalized
Education
Medicine
Access
Technology
Accelerating
“Oncotype DX is evidence that personalized medicine can help reduce health costs,
saving an average of $2,000 per patient in additional costs from chemotherapy
treatment.” – Dr. Francis Collins, Director of the National Institutes of Health
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Latin American Pharmacogenomic Congress
Thank You!