Presentation (CTI)

OBJECTIVES: In the past three years, there have been significant changes to health technology assessment (HTA) submission requirements in multiple countries, including introduction of new topics, methods and entirely new submission dossier templates. The objective of this study is to review guidance on these updates and consider their incorporation into best practice core reimbursement dossiers for global use.
METHODS: Guidance from HTA and reimbursement bodies in major markets, issued since January 2022 was reviewed. HTA bodies/regulations included: EU Regulation on HTA (EU HTAR), the National Institute for Health and Care Excellence (NICE), the US Institute for Clinical and Economic Review (ICER), Academy of Managed Care Pharmacy (AMCP), Canada’s Drug Agency (CDA), Pharmaceutical Benefits Advisory Committee, National Institute of Public Health (NIPH) in Japan, Brazil’s National Committee for Health Technology Incorporation, National Healthcare Security Administration in China, and Saudi Food and Drug Authority (SFDA).
RESULTS: Common themes were more rigour in evidence review, synthesis and reporting (e.g., EU HTAR: comprehensive searches, multiple methods of evidence synthesis, detailed reporting and appraisal; NICE: robust quality appraisal of evidence identified and synthesis methods; Japan: detailed data extraction for included studies), increased importance of real-world evidence (RWE; EU HTAR: systematic search of study and patient registries; NICE: formal framework for reporting RWE), consideration of health inequalities (NICE, CDA, AMCP, ICER), and incorporation of detailed outcomes from HTA appraisals of the product in other markets (EU HTAR, Japan, SFDA). Other key updates include: a summary for patients; consideration of patient centricity in trial design; organizational and societal impact of condition and treatment; need for structured expert elicitation; and formal consideration of uncertainty. Detailed analyses of specific methodology requirements and subsequent recommendations for global dossier structure will be presented.
CONCLUSIONS: Recent updates to global HTA requirements should inform core reimbursement dossier structure to ensure relevant learnings are captured for global implementation.