OBJECTIVES: To evaluate the impact of orphan drug criteria on Scottish Medicines Consortium (SMC) reimbursement decisions for health technology assessments (HTAs).

METHODS: SMC reimbursement decisions between 2012 and 2022 for oncological conditions containing orphan drug criteria comprised the data set. HTAs with positive and negative decisions were included while HTAs with no decision were excluded. Observations were made and results reported.

RESULTS: A total of 301 HTAs were included: 184 were recommended and 117 were not recommended. Among the 301 HTAs, 41.86 % (n = 126) were assessed under the orphan drug process whereas 58.14% (n = 175) were not. Among the HTAs with a positive decision, 24.25% (n = 73) were assessed under the orphan drug process while 36.88% (n = 111) were not Similarly, among the HTAs with a negative decision, 17.61% (n = 53) were assessed under the orphan drug process while 21.26% (n = 64) were not.

CONCLUSIONS: Based on observations of this data, it can be deduced that a majority of oncology HTAs with a positive reimbursement decision were not assessed through the orphan drug process. Therefore, it can be concluded that reimbursement decisions made by SMC for oncology HTAs are not impacted by the orphan drug process.