Template for OBMEA data collection agreements
A template to standardize data collection agreements for Outcomes-Based Managed Entry Agreements (OBMEAs) in rare disease treatments, ensuring structured, transparent, and comparable real-world evidence generation across health systems.
At a glance
Use when
When implementing an OBMEA to address uncertainties in clinical or economic evidence for a treatment, especially in rare diseases or where long-term outcomes are unknown.
Avoid when
When a treatment has robust evidence already, or when data collection is not feasible due to lack of infrastructure, stakeholder agreement, or patient consent.
Inputs
Details of the treatment, indication, healthcare system, patient population, key uncertainties from HTA appraisal, data sources, and stakeholder roles.
Outputs
A standardized, adaptable agreement document outlining the data collection plan and responsibilities for an OBMEA.
How it works
This template outlines the structure and content for data collection under an OBMEA, including patient eligibility, data management, responsibilities, monitoring, and re-appraisal processes. It incorporates input from international HTA bodies and is aligned with GDPR and national data governance standards. Developed within the EU Horizon 2020 IMPACT HTA project, it supports post-appraisal data collection to resolve key clinical and economic uncertainties.
- Project
- IMPACT HTA
- Funding
- Horizon 2020
- Project status
- Completed 2021
- HTA domains
- Aspects Beyond HTA
- Categories
- Pricing/Payer
- Technology
- Medicines
- Assumptions
- Additional real-world data can reduce decision-relevant uncertainties; stakeholders agree on data sharing and governance; patients provide informed consent; data collection is feasible within routine care or registry settings.
- Strengths
- Developed through mixed-methods research with international stakeholders; aligns with existing HTA practices; promotes transparency by recommending public release; adaptable to different health systems and conditions.
- Limitations
- May require customization for specific legal or clinical contexts; relies on consistent data entry and stakeholder collaboration; not all outcomes may be measurable in all patients (e.g., due to comorbidities).
- Also known as
- OBMEA Data Collection Template, IMPACT HTA OBMEA Template
Questions this answers
- › What data should be collected under an OBMEA for a rare disease treatment?
- › Who is responsible for data collection, management, and analysis?
- › How should patient eligibility and continuation criteria be defined?
- › How can data quality and governance be ensured?
- › What are the key uncertainties to be addressed during the OBMEA?
- › When and how should the agreement be reviewed or reappraised?
References & sources
- websiteimpact-hta.eu ↗
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