PNS250 CADTH PARALLEL SCIENTIFIC ADVICE PROGRAMS WITH NICE AND HEALTH CANADA

Abstract

In 2019, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced two parallel scientific advice (SA) programs: with the National Institute for Health and Care Excellence (NICE) and with Health Canada. The study objective was to outline the processes for obtaining advice through these programs and identify the value to manufacturers. Information about CADTH’s parallel SA programs was obtained through public-domain sources, and through strategic discussion and collaboration with CADTH (abstract authors). Topics included similarities and differences between the programs and the rationale for CADTH’s collaboration with NICE. CADTH’s parallel SA programs with NICE and Health Canada include submission of the same briefing book to each organization, a face-to-face meeting, and provision of separate advice reports. Slight differences between the parallel SA programs include the fee schedule, format/location of face-to-face meeting, timelines, and a summary of alignment which is provided by the CADTH-NICE program only. The collaboration between CADTH and NICE allows for synergies between the standard SA programs of each health technology assessment (HTA) body which have inherent similarities. However, CADTH’s standard SA program differs from that of NICE in the provision of advice. During the face-to-face meeting with CADTH, manufacturers can discuss draft advice and raise points of clarification in real-time. This differs from NICE’s standard SA program where face-to-face meetings tend to occur earlier in the process and are more exploratory in nature. CADTH’s parallel SA processes allow manufacturers to confirm a single approach for their evidence-generation plans that meets the needs of both organizations, including with the CADTH-NICE program which enables a streamlined process for obtaining advice in two distinct markets.