Wednesday FoREMS: REMS Challenges - The Payer's Perspective

Wednesday, May 12th, 2010

REMS Challenges: The Payer's Perspective

The May session of Wednesday FoREMS features guest presenter Jennifer Restivo of inVentiv Health.  In this session the current and future impact of emerging REMS trends is assessed, particularly from manufacturer and payer perspectives.   Jennifer presents learnings from her manufacturer and payer research and provides an overview of key considerations for optimal REMS implementation.

Jennifer shares key insights on:

  • How payers have, and will, integrate REMS into utilization management practices
  • Critical factors and collaborative efforts between payers and manufacturers to ensure successful design and execution of REMS
  • Approaches to minimize implementation challenges and realizing opportunities for improving REMS execution

 

Webinar Slide Set

click to view:
REMS Challenges: The Payer's Perspective
Today's Session – an Overview
REMS Challenges: The Payer's Perspective
Agenda - Origin and Purpose of REMS
FDAAA has given the FDA authority to require a REMS
REMS is the latest development in the field of Risk Management
The number and complexity of REMS has grown since 2007
Large specialty pipeline is expected to generate additional REMS
The FDA REMS industry guidance document is an excellent resource
REMS programs vary from simple communication tools to complex ETASUs
ETASU Objective
REMS Program introduction scenarios
REMS programs have direct impact to multiple stakeholders
Agenda - Payer and Manufacturer REMS Research
Project Objectives
Methodology
Payers understand REMS, but are unsure of its relevance
Many payers believe programs with ETASUs to be more effective
Payer perception of the ability of REMS to mitigate risk
Manufacturers face significant challenges
Testing provides an opportunity to proactively identify risks
Payers believe that certain REMS programs support key objectives
REMS generally does not influence formulary and medical policy decision-making
Payers were divided on how REMS might impact comparative evaluations
Payers willingness to reduce or eliminate Prior Authorization
Manufacturers believe that REMS may impact payer policies...
Payers anticipate additional costs as a result of increasing REMS
Manufacturers generally have to invest significant resources in REMS
Manufacturers have to rely on business partners
Agenda - Implications for REMS Design and Implementation
Payers and manufacturers are aligned on many points related to REMS
Opportunities exist to increase collaborations, but the unspoken barriers exist
REMS provides the platform for payer / manufacturer to achieve individual and common goals
Both payers and manufacturers identified REMS Best Practices
Agenda - Key REMS Learnings & Insights
Summary of Key Findings
Contact Information - Questions

 

Session Replay



 

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