BIOTECH 2011 NJ/DE/PA Case studies

BIOTECH 2011 The Impact of a Powerful Payer: Reimbursement and Pricing Roadmap Demonstrating Value in the Era of a Powerful Payer Nathan White, CPC Executive Director, Access & Reimbursement inVentiv Patient Access Solutions inVentiv Health October 24, 2011

Learning Objectives ,[object Object],[object Object],[object Object],[object Object],[object Object]

What is evidence-based medicine? ,[object Object],[object Object]

Number of Occurrences of Value Terminology by Year in Core Clinical Journals SOURCE: Reich, S., & White, N. (2010). Speaking of Value in Healthcare: The Need for Common Understanding of Terminology. Poster Session, International Society for Medical Publication Professionals.

Percent of Increase of Occurrences of Value Terminology from 2006 to 2009 in Core Clinical Journals SOURCE: Reich, S., & White, N. (2010). Speaking of Value in Healthcare: The Need for Common Understanding of Terminology. Poster Session, International Society for Medical Publication Professionals.

The Value Equation: Safety + Efficacy + Comparative Cost/Clinical Effectiveness Industry ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

What is Evidence Used For? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Who Needs Real World Evidence? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],WellPoint's CER Guide Describes How It Will Determine Usefulness Of Studies Observational Studies Of "Real-World" Questions The guidelines state that, "while randomized, controlled clinical trials remain the gold standard for producing reliable efficacy and safety data, WellPoint recognizes that there are circumstances in which RCTs alone may not be sufficient for decision-making. Accordingly, a well-conducted CER or observational study may complement RCT-based information by providing effectiveness data, or data on outcomes achieved in a 'real-world' setting.“ ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Patient Centered Outcomes Research Institute (PCORI) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Patient Centered Outcomes Research Institute (PCORI) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

SOURCE: National Pharmaceutical Council, PCORI Methodology Committee: Resource Guide, February 2011

European HTA/Payer Landscape ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

US HTA/Payer Landscape ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

BCBS TEC Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object]

Evidence Development: Pre- and Post-Approval ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Post-approval Research Today – Safety & Value ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

The Future of Payer-Industry Relationships? Innovative Contracts! Innovative Contracting Contract Types Performance-Based Contracts ,[object Object],[object Object],[object Object],Risk-Sharing Agreements ,[object Object],[object Object],[object Object],Traditional With a “Twist” ,[object Object],[object Object],2 3 1

A Glimpse Into the Future ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Benefit Design Shift ,[object Object],[object Object],[object Object],Outcomes Focus ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Value Focus ,[object Object],[object Object],[object Object],[object Object],Cost Reduction ,[object Object],[object Object],[object Object],Cost Shifting Trends in Benefit Management Objectives of Innovative Contracts Cost Reduction Risk Shifting ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Budget Predictability Budget Predictability Trends mentioned in benefit management align well with the goals of innovative contracting. 1 2 3 1 2 3 4 4

How Do We Communicate Value To Payers? Principles of Payer Communication Simplicity ,[object Object],[object Object],Transparency ,[object Object],[object Object],Credibility ,[object Object],[object Object],Successful communication with payers requires following three principles: II III I

Organizational Requirements Hypothesis Validation Evidence Generation Value Communication Rigorous Scientist Credible Ambassador Strategic Visionary The right value evidence needs to be delivered to the right audience at the right time by the right people. Stakeholder mapping and engagement is pivotal in rolling out the study outputs efficiently and effectively.

Final Thoughts ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

BIOTECH 2011 NJ/DE/PA Case studies

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BIOTECH 2011 NJ/DE/PA Case studies