Horizon Scanning Methods for Identification of New and Repurposed Medicines for Stakeholders in the United Kingdom

Abstract

Horizon scanning (HS) is a method for the identification of emerging change through systematic analysis of trusted sources using a defined scope and prespecified methods. In health research, it can provide early awareness of potential developments ahead of market access. Within the medicines space, HS is supported by international requirements for clinical trial registration, conduct and reporting, and by transparent regulatory processes. Potential changes can be identified at different stages of development, emerging, transitional, and imminent to launch. This paper delineates a comprehensive methodological approach for medicines HS within the transitional horizon from a national HS center, the National Institute for Health and Care Research Innovation Observatory (IO) in the United Kingdom. The UK single-payer healthcare system supports access to medicines approved by the National Institute for Health and Care Excellence (NICE); the assessment process for this requires an early awareness program ahead of regulatory approval. We report an expansive step-by-step HS process at the IO that has been tailored to meet stakeholder requirements. Manual and automated methods are used in tandem to extract and sift data from clinical trial registries, industry databases and medical databases. Intensive industry engagement and news media sources are used to supplement data collection. Data are sifted and triangulated to populate an internal database. Records are monitored to allow tracking of technologies through the pipeline and to trigger our notification processes. This HS program is a potential model for other agencies wishing to establish such an early awareness program internationally.