Therapeutics Industry Participation in P4P The Value Proposition

Transcription

1 Therapeutics Industry Participation in P4P The Value Proposition Alex Ruggieri, MD MHS Chief Medical Officer Senior Director Safety Solutions Cerner Galt Cerner Corporation Beverly Hills, California

2 The global health and life sciences market A $4 trillion ecosystem Providers Regulators Payers Diagnostic Services/ GCRCs Policy Makers Accreditation Entities Govt. Programs Licensed Health Prof nals Health Delivery Systems/ Facilities Nursing and Home Health Licenses $ Care Applications and Approvals Consumers/ Patients Regulations Coverage Premium $ orders $ Products $ Pharma. (including Biotech) Generic Mfgs. $ Medical Products Distributors Products Pharmacies Info Companies Contract Services Employers Health Plans/ Carve Outs (PBMs, others) Global Insurers

3 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?

4 A bad screenplay can make for bad acting Nobody has a monopoly on virtue. General Alexander Haig Senate Foreign Relations Committee's confirmation hearings on Alexander Haig Jr., Ronald Reagan's nominee for Secretary of State April 2, 1984 Few men have sufficient virtue to withstand the highest bidder George Washington First president of US ( )

5 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 variable Legal obstacles can be realistically overcome

6 Basis for Partnership Coupling of needs, capabilities, resources for mutually beneficial solutions TI Need P4P Need P4P Resource TI Resource

7 Tools for P4P Process tools Support workflow in executing performance Information tools Support decisions in executing performance Therapeutic tools Support actual patient care in executing performance Measurement tools Support the capture of data for performance analytics

8 Uses Cases in the Therapeutics Industry Clinical Research Clinical Development Regulatory / Safety Commercial 1. Genetic Association and Linkage Analysis 2. Clinical Validation Target, Biomarker, and Diagnostic 3. Clinical Trial Execution a. Connect Patients to Trials b. Data Collection & Mgmt c. Investigator Services d. Compliance e. Placebo Populations 4. Clinical Trial Simulation 5. New Indication Identification 6. Interim analyses 10. Post-Marketing a. Safety / Adverse Event Monitoring b. Pharmacovigilance c. P-Epi & Data Mining 11. Manufacturer s Recall 12. Pharmacoeconomics 13. Marketing Comparative Studies 14. Pharmaceutical/ Disease Management Programs 15. e-prescribing 7. Personalized Medicine Pharmacogenomics 8. Outcomes Studies 9. Disease and Care Management Modeling

9 Tools for Therapeutics Development & Life Cycle Management Information Refinement and definition of target populations, sub-populations with specific therapeutic need The experiences of patients / subpopulations of patients using products in the post approval setting Safety and risk management Potential new indications, or new exceptions to indications Study Ideas Where, what is there need to improve or alter outcomes? Subjects Participants for clinical trials Virtual Clinical Trials

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11 Opportunities for Partnership Industry to P4P Partners Process tools Information Tools Development of shared data and messaging standards Contribution to infrastructure development Therapeutic tools Measurement tools Better precision, more specificity

12 Opportunities for Partnership P4P Partner and Industry Sharing of information on post approval patient experiences Drug safety Refinement of indications Added therapeutic value New therapies for high expenditure-low value conditions Support for clinical trial enrollment Support possible re-examination of safe harbors

13 Paradigm for Moving Forward Convening a Policy Study Group of industry and P4P stakeholders Teambuilding and trust Technical Study Group Participation in HIT standards and platform development activities Clinical Data Management Study Group Examine data, measurement, and analytic standards and practices

14 Opportunities for Leadership by P4P Experts and Advocates Diplomatic Channels Overcome biases and mistrust No one has a monopoly on virtue in a bad system Open mindedness to partnering opportunities Financial Incentives for industry Product development partnering IT Investment Partnering Measurement Partnering Post approval commitment Willingness to share experiences (data) Post approval data Address existing legal barriers

15 Questions and Comments