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Published by: Decision Resources
Published: Mar. 26, 2009 - 31 Pages
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Personalized Medicine Return on Investment: What’s In It for Me?
- Expert Commentary—How to Advance the Concept of Personalized Healthcare and Integrate It into Standard Medical Practice
- Integrating Diagnostics into Drug Development
- The Ideal Organizational Structure for a Personalized Medicine Endeavor
- Championing Personalized Medicine
- Deal Structures Between the Diagnostics and Pharmaceutical Companies
- Addressing Policy Issues Related to Personalized Healthcare
- Does Personalized Medicine Improve Healthcare and Reduce Cost?
- Educating the Care Delivery Community
- Mining Prescription Claims Databases to Advance Personalized Medicine
- Medco Health Solutions
- Striking Gold in PBM Prescription Claim Databases
- New Business Opportunities and Strategies for PBM Companies
- Generic and Biosimilar Drugs
- Diagnostic Testing
- Pharmacogenomics
- Value-Added Clinical Opportunity
- R&D Pipeline and Clinical Programs
- Mayo Clinic Collaboration
- LabCorp and Indiana University Collaboration
- Drug Interactions Between Plavix and Proton Pump Inhibitors
- Member Genotyping Program
- Expert Commentary—Clinical Predictive Guides: Novel Enrichment Strategies Create
- New Partnering Opportunities
- Clinical Predictive Rules—Diagnostic and Treatment Algorithms
- Validated CPGs
- Opportunities in Diagnostics and Drug Development
- Diagnostics
- Drug Development
- Evolving Partnering Opportunities
- Clinical Trial Enrichment—Global Phenotype Mapping
- Infl uencing Physician Behavior
- Nexus Between Personalized Healthcare and Information Privacy
- Tables
- 1. Personalized Medicine Return on Investment: Two Studies on Newly Diagnosed Breast Cancer
- 2. Medco’s R&D Pipeline and Client Clinical Programs
- 3. Select Clinical Prediction Rules
- 4. Phenotype Mapping: Subgroups of Patients with Post-Traumatic Stress Disorder
- Figures
- 1. Personalized Medicine Coalition
- 2. Major Issues in Integrating Diagnostics into Therapeutic Development
- 3. Deal Timeline: Multiple Diagnostic Partners and Different Deal Structures
- 4. How Government Can Accelerate Adoption of Personalized Medicine
- 5. Medco Therapeutic Resource Centers
- 6. Value Proposition for Pharmacy Benefi t Management Clients
- 7. Clinical Prediction Rules: Development and Validation Trends
- 8. Evolution of Diabetes Mellitus: Classifi cation of Disease
- Experts Featured
- Todd A. Hoover, M.D., Vice President, and Paul Herscu, N.D., Chief Science Offi cer,
- Personalized Pharmaceutical Systems
- Wayne A. Rosenkrans, Jr., Ph.D. Chairman and President, Personalized Medicine Coalition
AbstractIntroduction
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 benefit 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.
Please note, the PDF e-mail from publisher version of this report is for a global site license.
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