Therapeutics Industry Participation in P4P The Value ... · Therapeutics Industry Participation in...

Therapeutics Industry Participation in P4P

The Value Proposition

Alex Ruggieri, MD MHSChief Medical Officer

Senior Director Safety SolutionsCerner Galt

Cerner CorporationBeverly Hills, California

© Cerner Corporation All Rights Reserved

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.


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?


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)


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


Basis for Partnership

Coupling of needs, capabilities, resources for mutually beneficial solutions

TI Resource

P4P Resource

P4P NeedTI Need


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


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


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


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


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


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


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


Questions and Comments

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