Template for OBMEA data collection agreements
A ready-to-use template that helps stakeholders create formal agreements on how data will be collected for outcomes-based managed entry agreements (OBMEAs) for rare disease treatments.
At a glance
Use when
Setting up an OBMEA for a rare disease treatment where real-world outcomes will inform reimbursement or access decisions
Avoid when
When data collection is not required, or when stakeholders cannot agree on outcomes or responsibilities
Inputs
Details of the treatment, rare disease context, involved stakeholders, data sources, and outcome measures
Outputs
A formalized data collection agreement outlining responsibilities, data specifications, timelines, and governance
How it works
This template structures the data collection agreement among stakeholders involved in an OBMEA, specifying roles, data types, collection methods, timelines, data ownership, and reporting requirements, ensuring alignment and transparency in real-world evidence generation for rare disease therapies.
- Project
- IMPACT HTA
- Funding
- Horizon 2020
- Project status
- Completed 2021
- HTA domains
- Aspects Beyond HTA
- Categories
- Pricing/Payer
- Technology
- Medicines
- Assumptions
- Stakeholders are willing to collaborate; data sources are accessible; outcomes are measurable and agreed upon
- Strengths
- Promotes clarity and accountability among stakeholders; supports consistent and reliable data collection; adaptable to various rare diseases and treatments
- Limitations
- May require legal review; less effective if stakeholder alignment is weak; not suitable for non-outcomes-based agreements
- Also known as
- OBMEA Data Collection Agreement Template
Questions this answers
- › What should be included in a data collection agreement for an OBMEA?
- › Who is responsible for collecting and sharing data in an OBMEA?
- › How should data be managed and reported in an OBMEA for a rare disease treatment?
- › What kind of data should be collected under an OBMEA?
- › How do stakeholders agree on data collection processes?
- › What happens if data collection fails or is delayed?
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.