A Roadmap to Embedding Real-World Evidence Into Health Technology Assessment Processes for Cancer Medicines: Experiences From Scotland

OBJECTIVES: To describe the development of a robust, sustainable pathway for the generation of real-world evidence (RWE) for cancer medicines, and how this was embedded into routine Health Technology Assessment (HTA) processes in Scotland to support decision making. METHODS: Requirements were agreed between Scotland's HTA body (Scottish Medicines Consortium, SMC) and Cancer Medicines Outcomes Programme-Public Health Scotland (CMOP-PHS). Nationally held administrative healthcare data are used to estimate patient numbers and identify comparator treatments. An educational workshop was held for SMC staff to explain CMOP-PHS reports. Feedback was sought from SMC assessors via an online form aimed at understanding the informativeness of CMOP-PHS reports and findings. RESULTS: Out of 13 requests made by SMC between February and July 2025, CMOP-PHS provided RWE reports for 8 (61.5%) cancer medicine assessments: 7 initial assessments, and one reassessment. Reports provided information on the number of patients being treated for the indication of interest in the last 12 months; the regimens used for treatment; and patient characteristics. Reasons for not providing RWE related to data completeness/granularity and insufficient patient numbers. Feedback indicated positive experiences; all responses (n = 13) confirmed that CMOP-PHS's work was informative. Respondents most strongly agreed that information on the number of patients treated for the same conditions in the last 12 months, and information on current comparator treatments, were helpful. CONCLUSIONS: CMOP-PHS has developed a rigorous, standardized approach for providing RWE to inform cancer HTA, which is now firmly embedded into SMC processes. Future developments are aimed at further improving data availability and quality.