Outcomes-based managed entry agreements can in some circumstances help resolve uncertainties relating to the value and optimal use of a rare disease treatment, but they should be supported by a covenant agreed by all stakeholders providing assurance that all necessary actions will be taken to ensure that the data collected will be sufficient for decision making.

When used, outcomes-based managed entry agreement constructs for data collection and reports of clinical results should be published and shared to enable agreement of core data across jurisdictions, data aggregation and to support health system learnings.

An international public repository for outcomes-based managed entry agreement reports akin to the HTA database hosted by the International Network of Agencies for Health Technology Assessment would be valuable.