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Dealmaking and Business Strategies in the Age of Personalized Medicine
Decision Resources, Inc., March 2009, Pages: 31
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 deal-making strategies are appropriate and when?
- Medco senior vice president, finance and chief financial officer 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 significant 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 benefit management: Mining prescription claims databases, Medco Health Solutions, mail-order pharmacy, robotic prescription filling, therapeutic resource centers, lives and drug spend, drug usage, compliance, patient-specific 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, Confidentiality Coalition, First Circuit Court of Appeals, New Hampshire’s prescription privacy law.
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