Problem Statement: The Innovative Medicines Fund is a Managed Access Fund in England designed to allow patient access to clinically uncertain promising medicines while further evidence is collected to address uncertainty. The NICE Managed Access Team assesses the suitability of new technologies for managed access by producing a feasibility assessment and discussing suitability with stakeholders. The Managed Access Team has recently considered the suitability of tixagevimab–cilgavimab for managed access.

Description: Several factors emerged indicating that managed access would not feasibly resolve uncertainty. While there are uncertainties in the clinical evidence and further evidence generation will likely be relevant, it is unfeasible that these would be resolved by data collection through managed access. Unpredictable landscape changes including changes to baseline rates of infections and hospitalisations and emergence of new variants would not be resolved through further pre-specified data collection. Monitoring these changes would require constant surveillance and reactive guidance updates. Discussing real-world evidence with stakeholders identified several barriers. To generate evidence in managed access, widespread testing for COVID-19 infection and genomic analysis would be required. Additionally, a new national dataset would be required, or multiple diverse datasets linked: no single unified dataset exists that could track patients through the multiple services relevant to delivering tixagevimab-cilgavimab and subsequent care and testing. There is no relevant primary care data collection that has national coverage, and varied data collection practices exist between primary and secondary care. Therefore, effective collection would require significant amendments to existing, large data sources. Furthermore, existing patient consent and ethical approval would not allow data sharing between sources.

Lessons Learned: Tixagevimab–cilgavimab is currently not considered suitable for managed access by the NICE Managed Access Team. Barriers to managed access identified for this topic are likely to be common across infectious disease prevention topics.

Stakeholder perspective: Government-affiliated