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Therapeutics Industry Participation in P4P
The Value Proposition
Alex Ruggieri, MD MHSChief Medical Officer
Senior Director Safety SolutionsCerner Galt
Cerner CorporationBeverly Hills, California
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The global health and life sciences market A $4 trillion ecosystem
Consumers/Patients
Licenses RegulationsApplications and Approvals
CoverageCare
$
“orders” $Products$
PolicyMakers
AccreditationEntities
Premium $
Licensed Health
Prof’nals
Diagnostic Services/GCRCs
Health Delivery Systems/Facilities
Nursing and Home Health
Pharma.(including Biotech)
MedicalProducts
Distributors
Pharmacies ContractServices
InfoCompanies
Providers
Products
PayersRegulators
$
Employers
Health Plans/
Govt. Programs
CarveOuts
(PBMs, others)
Global InsurersGeneric
Mfgs.
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Questions
Can the therapeutics industry be a participant in P4P initiatives?Should the therapeutics industry be a participant in P4P initiatives?How best can the therapeutics industry become a partner in P4P?
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A bad screenplay can make for bad acting
General Alexander HaigSenate Foreign Relations Committee's confirmation hearings on Alexander Haig Jr., Ronald Reagan's nominee for Secretary of State April 2, 1984
“Nobody has a monopoly on virtue….”
“Few men have sufficient virtue to withstand the highest bidder”
George WashingtonFirst president of US (1732 - 1799)
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Prerequisites for Constructive Engagement in P4P
Clear and uniform understanding of what we mean by “performance” ( types of performance?)“Value per dollar spent” is as important as the “dollar spent”Time window from which to view performance can be wide or variableLegal obstacles can be realistically overcome
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Basis for Partnership
Coupling of needs, capabilities, resources for mutually beneficial solutions
TI Resource
P4P Resource
P4P NeedTI Need
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Tools for P4P
Process toolsSupport workflow in executing performance
Information toolsSupport decisions in executing performance
Therapeutic toolsSupport actual patient care in executing performance
Measurement toolsSupport the capture of data for performance analytics
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12. Pharmaco-economics
13. Marketing Comparative Studies
14. Pharmaceutical/ Disease ManagementPrograms
15. e-Prescribing
10. Post-Marketing a. Safety / Adverse
Event Monitoringb. Pharmaco-
vigilancec. P-Epi & Data
Mining
11. Manufacturer’s Recall
3. Clinical Trial Executiona. Connect Patients to
Trialsb. Data Collection &
Mgmtc. Investigator Servicesd. Compliancee. Placebo Populations
4. Clinical Trial Simulation5. New Indication
Identification6. Interim analyses
1. Genetic Association and Linkage Analysis
2. Clinical Validation – Target, Biomarker, and Diagnostic
CommercialRegulatory / SafetyClinical DevelopmentClinical Research
7. Personalized Medicine – Pharmacogenomics8. Outcomes Studies
9. Disease and Care Management Modeling
Uses Cases in the Therapeutics Industry
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Tools for Therapeutics Development & Life Cycle Management
InformationRefinement and definition of target populations, sub-populations with specific therapeutic needThe experiences of patients / subpopulations of patients using products in the post approval setting
Safety and risk managementPotential new indications, or new exceptions to indications
Study IdeasWhere, what is there need to improve or alter outcomes?
SubjectsParticipants for clinical trialsVirtual Clinical Trials
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Opportunities for PartnershipIndustry to P4P Partners
Process toolsInformation Tools
Development of shared data and messaging standardsContribution to infrastructure development
Therapeutic toolsMeasurement tools
Better precision, more specificity
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Opportunities for PartnershipP4P Partner and Industry
Sharing of information on post approval patient experiences
Drug safetyRefinement of indicationsAdded therapeutic value
New therapies for high expenditure-low value conditionsSupport for clinical trial enrollmentSupport possible re-examination of safe harbors
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Paradigm for Moving Forward
Convening a “Policy Study Group” of industry and P4P stakeholders
Teambuilding and trustTechnical Study Group
Participation in HIT standards and platform development activities
Clinical Data Management Study GroupExamine data, measurement, and analytic standards and practices
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Opportunities for Leadership by P4P Experts and Advocates
Diplomatic ChannelsOvercome biases and mistrust
No one has a monopoly on virtue in a bad systemOpen mindedness to partnering opportunities
Financial Incentives for industryProduct development partneringIT Investment PartneringMeasurement PartneringPost approval commitment
Willingness to share experiences (data)Post approval data
Address existing legal barriers