OBJECTIVES

The aim of this analysis is to examine whether evaluation time periods of infectious disease therapies influence positive reimbursement decisions from European health technology assessment (HTA) agencies.

METHODS

The analysis used reimbursement decision data between 2011 and 2019 from 4 HTA bodies, namely the Scottish Medicines Consortium (SMC), National Institute for Health and Care excellence (NICE), Haute Autorité de Santé (HAS), and Gemeinsamer Bundesausschuss (G-BA). Abbreviated assessments and those without decisions as well as reviews of therapies indicated for pediatric populations and non-submissions were excluded. A univariate logistic regression analysis was used to determine the association between positive decisions and the year the decisions were made.

RESULTS

A total of 343 decisions were included in the final sample. Approximately 89.50% (n = 307) were positive and 10.50% (n = 36) were negative. The highest number of HTA submissions for infectious disease therapies occurred in 2015 (n = 114), constituting 30.29% (n = 93) of overall positive decisions.

Therapies for the treatment of hepatitis C made up 67.35% (n = 231) of the sample. Treatments for human immunodeficiency virus, hepatitis B, clostridium difficile, and bacterial infections constituted 23.91% (n = 82), 4.96% (n = 17), 1.46% (n = 5), and 2.33% (n = 8) of the decisions, respectively.

G-BA recommended all HTA submissions (n = 107) while positive decisions made up 92.86% (n = 91), 88.14% (n = 52), and 72.15% (n = 57) of HAS, SMC, and NICE evaluations, respectively.

Results from bivariate analyses showed no significant relationship between the HTA dates of infectious disease therapies and positive reimbursement decisions (p = 0.14).

CONCLUSIONS

The evaluation time period appears to not have an influence on positive reimbursement decisions for infectious disease therapies. Additional factors considered during an HTA and agency policies could have more weight than the year of evaluation.