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

Area of Science:

• Health Services Research
• Oncology
• Health Technology Assessment

Background:

• Developing robust real-world evidence (RWE) pathways is crucial for informed decision-making in cancer medicine.
• Integrating RWE into routine Health Technology Assessment (HTA) processes presents unique challenges.

Purpose of the Study:

• To describe the development of a sustainable pathway for generating RWE for cancer medicines.
• To detail the integration of this RWE pathway into Scotland's routine HTA processes.
• To support evidence-based decision-making for cancer medicines.

Main Methods:

• Collaboration between Scotland's HTA body (Scottish Medicines Consortium, SMC) and the Cancer Medicines Outcomes Programme-Public Health Scotland (CMOP-PHS).
• Utilization of nationally held administrative healthcare data for patient number estimation and comparator treatment identification.
• Educational workshops for SMC staff and feedback collection from assessors on the utility of CMOP-PHS reports.

Main Results:

• CMOP-PHS provided RWE reports for 8 out of 13 (61.5%) cancer medicine assessments reviewed by SMC.
• Reports included data on patient numbers, treatment regimens, and patient characteristics.
• Feedback confirmed the informativeness of RWE reports, particularly regarding patient numbers and comparator treatments.

Conclusions:

• A rigorous and standardized approach for RWE generation for cancer HTA has been established and embedded in SMC processes.
• The developed pathway effectively supports HTA decision-making for cancer medicines in Scotland.
• Future efforts will focus on enhancing data availability and quality for RWE generation.