Horizon scanning methods for identification of new and repurposed medicines for stakeholders in UK

Horizon scanning (HS) is a method for 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.We report the methodological approach of a mature national medicines HS programme within the transitional horizon. The United Kingdom 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 programme ahead of regulatory approval, provided by the National Institute for Health and Care Research Innovation Observatory. This uses: a clearly specified remit tailored to stakeholder requirements, multiple data sources, manual and semi-automated sifting. Data sources include: clinical trials registries, confidential industry database access alongside intensive industry engagement, news media sources. These are sifted and triangulated to populate an internal database. Automated prioritisation coupled with manual monitoring of records allows tracking of technologies through pipeline and triggers notification to NICE at 24 months ahead of anticipated market authorisation. Throughout the process, NICE have real-time intelligence through a live dashboard linked to records in an internal database.This horizon scanning programme is a potential model for other agencies wishing to establish such an early awareness programme internationally.