OBJECTIVES: In 2014, the Scottish Medicines Consortium (SMC) introduced Patient and Clinician Engagement (PACE) meetings for therapies used to treat end-of-life (EoL) and/or rare conditions following an initial ‘not recommended’ decision by the New Drugs Committee (NDC). Their stated purpose was to gain additional perspectives that may not be captured within conventional clinical and economic assessment processes. This research explores the impact of PACE meetings on SMC decision making.

METHODS: SMC assessments published between 1 January 2014 and 20 June 2023 that included a PACE meeting were identified via the SMC website. Dates, decisions, process (EoL, orphan or ultra-orphan), indication, and inclusion of a patient access scheme (PAS) were analysed.

RESULTS: Of the 229 appraisals identified most PACE meetings were for EoL or orphan appraisals (94%), and 6% were for ultra-orphan disease; 71% were associated with oncology indications. After PACE meetings, 107 therapies were accepted (47%), 78 were restricted (34%), 35 were not recommended (15%), 7 received interim acceptance (3%), and 2 were superseded (1%). A PAS was agreed for 175 of the appraisals (76%). Between 2015 and 2022, approximately 17 to 20 meetings were conducted each year; only 3 PACE meetings were conducted in 2014.

CONCLUSIONS: While PACE meetings extend the appraisal process, over 80% of appraisals that included one resulted in a positive recommendation, demonstrating the benefit of incorporating the patient perspective into SMC decision making. Interestingly, 24% of appraisals did not incorporate a PAS, indicating that PACE meetings have had a positive impact on therapy approval irrespective of any net price discount proposed by the manufacturer. Given the high approval rate, these data suggest that PACE meetings, whilst not the deciding factor, contribute positively to SMC decision making and support manufacturers in ensuring timely access to new therapies.