Terms of reference for OBMEA monitoring committees
This is a template that explains how to set up and run a monitoring committee for an outcomes-based managed entry agreement (OBMEA) for a rare disease treatment. The committee helps make sure that real-world data is collected properly and used to assess whether the treatment works as expected in routine care.
At a glance
Use when
Setting up a monitoring committee for an outcomes-based managed entry agreement for a rare disease treatment, particularly when real-world evidence is required to inform reimbursement decisions.
Avoid when
When a simple data monitoring committee for clinical trial safety is needed, or when there is no formal OBMEA in place requiring coordinated stakeholder oversight.
Inputs
Details of the OBMEA, list of signatories, data collection plan, confidentiality and governance policies, stakeholder roles.
Outputs
Agreed monitoring processes, meeting minutes, status updates, mid-term and final reports, recommendations for data quality improvements, approved communications.
How it works
A standardized template outlining the structure, responsibilities, membership, governance, and operating procedures for a Monitoring Committee overseeing an Outcomes-Based Managed Entry Agreement (OBMEA) for a rare disease treatment. It defines roles, meeting frequency, data quality oversight, reporting requirements, and confidentiality protocols, aligned with the IMPACT HTA framework and adapted from NICE practices.
- Project
- IMPACT HTA
- Funding
- Horizon 2020
- Project status
- Completed 2021
- HTA domains
- Aspects Beyond HTA
- Categories
- Pricing/Payer
- Technology
- Medicines
- Assumptions
- The treatment is authorized and used within its licensed indication; standard safety reporting is in place; stakeholders will collaborate in good faith; data can be shared securely while maintaining confidentiality.
- Strengths
- Promotes transparency and collaboration among all stakeholders; supports high-quality real-world data collection; includes patient and clinician input; provides structured oversight without interfering in commercial terms.
- Limitations
- Does not allow discussion of pricing or expansion of indications; cannot review individual patient cases; dependent on stakeholder attendance and consensus-building.
- Also known as
- OBMEA Monitoring Committee ToR, Template for Monitoring Committee of Outcomes-Based MEA, Terms of Reference for Rare Disease OBMEA Monitoring
Questions this answers
- › What is the purpose of the OBMEA monitoring committee?
- › Who should be on the monitoring committee and how are decisions made?
- › How does the committee ensure data quality in real-world use of a rare disease treatment?
- › What can the committee do if data collection is delayed or incomplete?
- › How does the committee protect patient confidentiality and manage conflicts of interest?
- › What reports does the committee produce and to whom are they submitted?
References & sources
- websiteimpact-hta.eu ↗
- paperDOI: 10.1007/s40273-021-01050-5 ↗
Related methods
Similar by meaning
Beta record. Generated from the primary source via AI extraction and independent audit, pending final human review.