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The Contribution & Value of
Molecular Diagnostics in Addressing
Women’s Healthcare Needs
Rx
Washington DC – July 2009
Ester Stein
Reimbursement Manager
Global Healthcare Policy,
Abbott Molecular
Dx
What is Molecular Diagnostics?
Rx
• Human Genome Project (2000) revolutionized the
way in which scientists search for the mechanisms
of diseases
Dx
• Tests that identify molecular and genetic markers for
an individual patient
• These markers determine potential benefit from a
specific therapy, or risk of developing a specific
disease or other health condition
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Rx
Molecular Diagnostics (MDx)
Growth of the Industry
• $5.5 Billion Industry
• $8 Billion by 2010
• 40 million annual test volumes in the U.S.
Dx
• Projected to be 1/3 of all diagnostic testing
Source: Washington G-2 Reports Advisory Services’ 2008 Molecular Diagnostics Survey
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Rx
Molecular Diagnostics (MDx)
Test Volumes
• 55% - Infectious disease
• 23% - Blood Screening
• 13% - Genetic Testing
Dx
• 7% - Cancer
Source: Washington G-2 Reports Advisory Services’ 2008 Molecular Diagnostics Survey
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Buzz Words of the Industry
Rx
• Personalized Medicine
• Pharmacogenomics
• Companion Diagnostics
Dx
• These terms are used interchangeably and most
associated with Cancer
POSTER CHILD FOR PERSONALIZED MEDICINE IS
HERCEPTIN AND HER2 TESTING
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Targeted Therapy for Breast Cancer
Rx
• 211,000 women diagnosed with breast cancer and
40,000 deaths – 2005 estimate
• Herceptin (trastuzumab), a chemotherapy drug
approved by the FDA in 1998
Dx
• Risk of congestive heart failure
• Data showed Herceptin could benefit women, who
over-expressed a protein – HER2/Neu
• Molecular diagnostic tests reveal who could and will not
benefit from Herceptin
• DNA test (i.e., FISH) cost $500*
• Herceptin costs $25,000 – $80,000*
• Getting the “right” women on Herceptin
*Total costs for Herceptin based on oncologist surveys as part of the construction of an economic model by Altarum*
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Rx
Dx
Bladder cancer considered to be a male
disease, however
• Bladder Cancer in women is considered rare
• Prevalence**
– Women with bladder cancer -143,000
– Women with ovarian cancer - 162,000
– Women with cervical cancer – 189,000
• Females are approximately twice as likely as males to die
from the disease.*
• Women with bladder cancer survive 5 years less than
men*
• Women are diagnosed 6-9 months later than men *
• Paradigm of treatment with hematuria?
• Urine based molecular tests accurately detect bladder
cancer and recurrence often before visible signs and
symptoms
* National Cancer Institute - http://planning.cancer.gov/pdfprgreports/2002kidneyreport.pdf
** SEER Cancer Statistics Review 1975-2003, National Cancer Institute
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Infectious Disease and Chlamydia
Rx
Dx
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Chlamydia is a curable sexually transmitted disease
4 million annual cases including undiagnosed
Easily treated with antibiotics
If untreated can cause Pelvic Inflammatory disease (PID),
a serious infection of reproductive organs
Up to 1 million women in the United States develop PID
As many as half of all cases of PID may be due to
Chlamydia infection
100,000 (Est.) women each year become infertile
because of PID.
Chlamydia infections and the other problems they cause
cost Americans more than $2 billion a year
Molecular tests are widely used, sensitive and specific
Molecular Test per Medicaid approx. $50
Source: Chlamydial Infection, NIAID Fact Sheet, 2000 (a component of the National Institutes of Health)
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Rx
Molecular Diagnostics (MDx)
Teaches Us About the Disease
• Prediction of risk – Oncotype DX
• Early detection - Fragile X
• Classification of disease - Lukemias
Dx
– Diagnosis, sub classification, prognosis
• Therapeutic hitting of presumptive target – drug
development
• Prediction of toxicity - Warfarin
– Dose adjustment
• Prediction of response – Her2
• Monitoring disease activity following treatment - HIV
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Rx
Clinical Laboratory Services
The Value Proposition…
• Largest single source of objective health and
disease status information
• Less than 5% of global health cost
Dx
• Drives up to 70% of clinical decisions
• Diagnosis, therapy, prognosis
• Admit, isolate, CCU, blood, discharge
• Acute, chronic, preventive
• Validates resource use, cost
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Rx
Molecular Diagnostics (MDx)
What is driving the market?
• Aging population and knowledgeable consumers
• Personalized Medicine and Companion Diagnostics
• Dynamic biotech industry
Dx
• Genetic Information Nondiscrimination Act (GINA)
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Rx
Molecular Diagnostics has the potential to
transform Health Care
• More accurate disease diagnosis
• Health care providers more efficient
• Targeted medicine
Dx
• Response, dosing, adverse events
• New, better, safer medicines
• Diagnostic, prognostic process
• When, whether, how to treat
Source: *“The Effect of Health on Economic Growth: Theory and Evidence.”
Bloom, Canning, Sevilla, National Bureau of Economic Research, Working Paper No. 8587 November, 2001
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Barriers to Adoption
Rx
• Coverage
– Medicare policies that restrict coverage for molecular tests
– Screening not covered without legislation
• Molecular tests promise significant benefits, prediction and risk
Dx
assessment (cardio vascular disease)
• Coding
– Our coding systems have become archaic and do not
accurately describe current and emerging molecular tests
• More denials by insurers
• Payment
– Cross walking and gap filling have proven to be inadequate
resulting in low payments that do not cover costs
– Payment does not take into account the VALUE and the
clinical utility in the patient care continuum
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Rx
The Message for Policy Makers
We need your help!!
• Ensuring patient access to preventative and early
diagnostic services
– inclusion of laboratory services in covered benefits of
both public and private plans
Dx
• Reimbursement policies should be reformed to
recognize the added value and savings to the health
care system
• Provide incentives for the co-development of drugs
and laboratory tests
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