Alignment Between Health Technology Assessment (HTA) Requirements and Current Practices in Global Value Dossier (GVD) Development

OBJECTIVES: Many countries have established frameworks for HTA. GVDs provide standardized information for country specific HTA submissions. This review investigates the alignment between current practices in HTA requirements and GVD development to identify trends and propose improvements.

METHODS: HTA submission guidelines from Australia (PBAC guideline V5.0), the European Union (EUnetHTA; HTA Core Model Version 3.0), and England (NICE Feb 2022) were evaluated. A qualitative descriptive analysis was used to compare the amount of information (low, medium, or detailed) required by HTA agencies to the core domains outlined in a typical GVD framework. Similarities and differences were evaluated to identify gaps in current practice and areas of overlap for content across the 4 domains: unmet need, clinical effectiveness and safety, economic, and “other evidence” (e.g., patient reported outcomes [PRO], real-world evidence [RWE]).

RESULTS: HTA agencies consistently require a similar amount of information across domains, and although there is some overlap, diversity in the types of data is noted among them. Notably, in the unmet need domain, two HTA agencies seek low level of detail, and one medium-level, while GVDs are more detailed. Clinical effectiveness and safety domain align in the amount of information, whereas the economic domain exhibits variability in types of information required. Areas emphasized included safety (EUnetha), cost minimization (PBAC), and cost-effectiveness (NICE). Both HTAs and GVDs include detailed cost-effective analysis, with HTAs emphasizing local market data and GVDs having a global focus. The “other evidence” domain requirements vary, with EUnetha focusing on cost-effectiveness integrating efficacy and safety. In contrast, PBAC mandates budget impact analyses based on RWE, while NICE emphasizes cost utility analyses including PROs and quality of life.

CONCLUSIONS: This review offers valuable insights for optimizing GVDs to ensure better alignment with HTA standards and facilitating seamless information transfer from GVDs to HTA submissions to ensure timely patient access to medicines.