OBJECTIVES: To determine how HTA agencies around the world incorporate novel and societal elements of value in their assessment guidelines.

METHODS: We reviewed different HTA guidelines, searching for mention of 21 defined societal (10) or novel (11) element of value, and whether guideline recommended the element’s inclusion in the base case, sensitivity analysis, or qualitative discussion. Our review was drawn from websites of relevant HTA organizations and Ministries of Health, and the ISPOR inventory of Pharmacoeconomic Guidelines Around the World. We classified HTA guidelines using The World Bank country income (high (HIC), upper middle (UMIC), lower-middle-(LMIC) and lower (LIC)) level segmentation. For each guideline, we recorded the type of organization (independent HTA vs. government or private agency), and the benefit assessment criteria (clinical effectiveness, economic analysis, other).

RESULTS: Our sample included 53 guidelines representing 52 countries and three supranational guidelines; We also screened six global non-government guidelines. 71% (38/53) of the country-specific guidelines (43% HIC, 15% UMIC, 5% LMIC) and 83% (5/6) of non-government guidelines mention any novel element of value. On average, 28% (6/21) of the value elements were identified (Societal: 23% (2/10), 33% Novel: (4/11)). The proportion of HTA guidelines considering each value element varied greatly, ranging from 0 - 79%. Only four value elements (productivity, family spillover, equity, and transportation) appear in over half of the HTA guidelines.

CONCLUSIONS: Individual societal and novel elements of value varied substantially across HTA organizations being mentioned in fewer than one-sixth of the guidelines. Additionally, we found a lack of consensus on how to include the elements in the base case, sensitivity analysis, and qualitative discussion. Appropriate methodological guidelines will support best practices to translate societal and novel value elements into decision making processes., Product manufacturers should further explore the novel and societal value when creating their evidence packages.