Terms of reference for OBMEA monitoring committees
This template helps HTA bodies create clear guidelines for committees that monitor outcome-based managed entry agreements (OBMEAs). These agreements link payment for health technologies to their real-world performance. The template outlines what the committee should do, how it should operate, and what issues it needs to track over time.
At a glance
Use when
Setting up a new monitoring committee for OBMEAs or formalizing the governance of existing ones
Avoid when
When no OBMEAs are in place or when there is no capacity to convene or support a monitoring committee
Inputs
Outcome-based managed entry agreement (OBMEA) terms, stakeholder roles, performance indicators, reporting timelines
Outputs
Defined committee structure, governance model, monitoring plan, escalation pathways, remediation protocols
How it works
A structured template defining governance, responsibilities, and operational procedures for monitoring committees overseeing outcome-based managed entry agreements (OBMEAs). It includes provisions for ongoing review of agreement performance, identification of deviations, and implementation of remedial actions. Designed for customization by HTA bodies to fit national or regional contexts.
- Project
- IMPACT HTA
- Funding
- Horizon 2020
- Project status
- Completed 2021
- HTA domains
- Aspects Beyond HTA
- Categories
- Pricing/Payer
- Technology
- Medicines
- Assumptions
- OBMEAs are in place and require independent oversight; HTA bodies have authority to establish monitoring committees; data on outcomes will be available for review
- Strengths
- Promotes accountability and transparency in OBMEAs; supports consistent monitoring across agreements; facilitates early detection of issues; adaptable to different health systems
- Limitations
- Requires commitment from multiple stakeholders; effectiveness depends on data availability and quality; may need legal or regulatory support for enforcement
- Also known as
- OBMEA Monitoring Committee ToR, Terms of Reference Template for OBMEA Oversight
Questions this answers
- › What should a committee overseeing an outcome-based agreement actually do?
- › How should monitoring committees be structured and governed?
- › What issues need ongoing review during an OBMEA?
- › When should corrective actions be taken in an OBMEA?
- › Who is responsible for tracking and reporting on OBMEA outcomes?
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.