OBJECTIVES

Sound clinical, access, and reimbursement decisions rely on high-quality data. Many of these decisions now include inputs from value and health technology assessments (V/HTA), which also need to be founded on sound data. However, V/HTA data-source selection may not be transparent, a necessary element for stakeholder understanding and trust, and to foster true accountability among decision-makers. Peer review is considered one mechanism for judging data trustworthiness. We set out to identify V/HTA methods requirements/recommendations for inclusion of peer-reviewed publications, and to compare and contrast US and non-US approaches

METHODS

Using publicly available V/HTA methods documentation from 11 established V/HTA organizations (US: ACC-AHA, ASCO, AV/FC, IVI, ICER, MSKCC and NCCN; non-US: CADTH, HAS, IQWIG and NICE), requirements/recommendations regarding data sources were systematically, manually abstracted. Two reviewers evaluated each document; abstractions were crosschecked for reliability; and a third reviewer served as tie-breaker.

RESULTS

Evidence-source selection and retrieval guidance varied across V/HTA organizations, although differences between US and non-US organizations were more pronounced. While all non-US organizations provided literature search strategy guidance, only 4 of 7 US organizations did so. Even fewer organizations overall provided information regarding acceptable or preferred sources of data, such as published literature. US organizations were more likely to explicitly reference or stipulate use of peer-reviewed literature (3/7) than non-US organizations (0/4). Proprietary, manufacturer-provided data not publicly available were accepted by all non-US organizations (4/4), whereas ICER was the only US organization to do so (1/7).

CONCLUSIONS

V/HTA methods documents include little guidance regarding use of peer-reviewed publication search or inclusion. There are noted differences between US and non-US V/HTA approaches, possibly due to longevity in experience. Scant guidance makes replicability and judging data-source quality tenuous. Standardization among established V/HTA organizations in recommendations regarding use of peer-reviewed sources could help improve V/HTA transparency and subsequent decision-making.