OP55 Classification System For Innovative Medicines In The Pipeline: New Or Repurposed?

Introduction While various criteria exist to define or categorize innovative medicines as new repurposed, our knowledge there are no standardized systems that sufficiently capture the range of pipeline products. The National Institute for Health and Care Research Innovation Observatory (NIHR IO) undertakes routine horizon scanning support health technology assessment (HTA) in England maintains a comprehensive Medicines Database (MInD). aim this project is develop ‘technology type’ (new versus repurposed) classification system application within MInD provide high-level analysis emergent data. Methods We reviewed gray literature, regulatory websites, drug repositories identify existing criteria. Preliminary definitions classifications use on were discussed, refined, agreed by consensus. Innovative classified either repurposed based their approval status (Marketing Authorization) using data from electronic compendium. For medicines, further was undertaken abbreviated (ANDA) FDA Orange Book generic (patency exclusivity status). combined semi-automated manually derived during process. Results Six types identified applied MInD: (i) technology; (ii) (on-patent/branded); (iii) (off-patent/generic); (iv) (never commercialized); (v) (combinations); (vi) (combinations). subset records July 2021 (n = 113) found mainly 52 percent technologies, 27 technologies (combinations) 14 commercialized). Further approximately 7000 ongoing will report temporal trends, status, key challenges. Conclusions Our novel evidence-based approach developing resulted six mutually exclusive states can be larger dataset. believe offers HTA stakeholders mechanism gain valuable insights into innovation gaps, areas unmet need.