Abstract
Abstract
Introduction
The promise of personalized medicine is having a profound impact on the
healthcare industry. It promises to change the way healthcare is delivered and
how drugs and diagnostics are developed. Pharma companies are still worried.
They do not understand how this area will play out and are risk-averse to
working in the brave new world of RxDx regulation. In addition, the ability to
mine large databases for clinical, genetic, and prescription drug information
must be balanced against an individual' s rights of privacy - yet another issue
that must be resolved before the widespread use of personalized healthcare
becomes a reality. In this report, we discuss business models, strategies, and
opportunities from the perspective of multiple stakeholders.
Get the Answers You Need to Shape Your Strategy
- Fundamental questions remain about the advantages of a personalized
medicine business model. What is the return on investment in personalized
medicine? What is needed to successfully integrate drug and test development?
What dealmaking strategies are appropriate and when?
- Medco senior vice president, fi nance and chief fi nancial offi cer Rich
Rubino says his company' s strategy
- "goes far beyond the cost savings of the script itself, but ultimately
down the road, receiving revenues associated with the signifi cant cost
savings on the medical side that we could generate." What is the personalized
medicine advantage for PBMs? How can the existing PBM income model be extended
to generate income by reducing overall healthcare costs? What assets do PBMs
control that can be used to validate personalized medicine concepts?
- Preparing the healthcare system for personalized medicine is a major
undertaking. Why is physician education critical for translating personalized
medicine from the lab to the clinic? What tools can be developed to help
physicians understand and embrace personalized RxDx products in their clinical
practice?
- Personalized medicine offers great potential to improve patient outcome
and reduce overall healthcare costs, but it also holds the potential for
personal medical information to be exploited in unintended ways. What is the
U.S. Congress doing to protect the security and privacy of personal
information? How do the
- American people feel about electronic health records? Which advocacy
groups and states are taking a leading role in trying to resolve privacy and
security issues?
Scope
- Economics: Deloitte Center for Health Solutions study, quantifying
personalized medicine ROIs for different stakeholders, net present value
(NPV), improving healthcare and reducing costs, clinical utility, patient
outcome.
- Business model: organizational structures, diagnostics division, center of
excellence, acquisition, research institute, types of skilled people needed,
top cover, successfully integrating diagnostic and therapeutic development,
four important issues, parallel processes, iterations of development,
impediment to integration.
- Partnering opportunities: Educating physicians, diagnostic partnering,
academic partnering, government agency partnering, pharmacy benefi t
management company (PBM) partnering, physician partnering.
- Dealmaking strategies: Finding a personalized medicine champion,
industry-standard licensing arrangement, risk-sharing arrangement, academic
partner, commercialization partners, pay-as-you-go arrangement, paying for a
diagnostics development service, ownership/acquisition.
- Pharmacy benefi t management: Mining prescription claims databases, Medco
Health Solutions, mail-order pharmacy, robotic prescription fi lling,
therapeutic resource centers, lives and drug spend, drug usage, compliance,
patient-specifi c medical data, generic drug utilization, pharmacogenomic
services, genotyping programs, R&D programs, drug metabolism, shotgun
medicine, algorithms, intelligent systems, specialty trained pharmacists,
practicing to evidence-based protocols, warfarin, tamoxifen, drug interations,
clopidogrel, pro-drugs, proton pump inhibitors (PPIs).
- Clinical prediction guides: Retrospective and prospective studies,
clinical validation, three steps to developing CPGs, physician decision-making
behavior, patient outcomes, tuberculosis, breast cancer recurrence, Adjuvant!
Online, stratifying groups of patients, translation to the clinic, history of
diabetes categorization, adverse events, resurrecting failed drugs, adaptive
trial design, electronic data capture, global phenotype mapping,
post-traumatic stress disorder, angiotensin-converting enzyme (ACE)-inhibitor
induced angioedema.
- Policy issues: Genomics and Personalized Medicine Act of 2008, regulatory
uncertainty, coverage and reimbursement landscape for diagnostics, Clinical
Laboratory Improvement Amendments (CLIA), IVDMIA guidance, RxDx regulatory
pathway, American Recovery and Reinvestment Act of 2009, electronic health
records, privacy issues, Health Information Technology for Economic and
Clinical Health (HITECH) Act, Harris Interactive survey, Coalition for Patient
Privacy, Healthcare Leadership Council, Confi dentiality Coalition, First
Circuit Court of Appeals, New Hampshire' s prescription privacy law.
Mentioned in This Spectrum Report
Companies, Organizations, and Agencies
- Abbott
- Accredo Health Group
- Aetna
- American Medical Association
- Amgen
- AstraZeneca
- Centers for Disease Control and Prevention
- Centers for Medicare & Medicaid Services
- Chugai
- Cleveland Clinic
- Coalition for Patient Privacy
- Confi dentiality Coalition
- Deloitte Center for Health Solutions
- Dendreon
- Eli Lilly
- FDA
- First Circuit Court of Appeals
- Genentech
- Genome Health
- Harvard Pilgrim Health Care
- Healthcare Leadership Council
- HP
- IBM
- Indiana University
- Kaiser
- LabCorp
- Mayo Clinic
- McKesson
- Medco Health Solutions
- Merck & Co.
- Novartis
- Personalized Medicine Coalition
- Personalized Pharmaceutical Systems
- Pfi zer
- Polymedica
- Roche
- Siemens
- U.S. Congress
- U.S. Department of Health and Human Services
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