VP33 Pharmacoeconomic Submission Requirements: Africa Compared With England

Abstract

IntroductionThe South African Pharmacoeconomic Submissions Guideline (SAPG) is currently voluntary for medicines in the private health sector but may become mandatory and more widely used under the proposed National Health Insurance system. To make recommendations on evidence generation and areas where the SAPG could be strengthened, the study compared the SAPG requirements with other African pharmacoeconomic guidelines and the National Institute for Health and Care Excellence Methods Guide (NICE MG).MethodsThe World Health Organisation, International Network of Agencies for Health Technology Assessment (INAHTA), HTA International, and the International Society for Pharmacoeconomics and Outcomes Research websites were consulted, and email requests sent to named individuals from retrieved source material. The European Network for HTA Core Model® (version 3.0) (the Model®) provided the evaluation and comparison framework, using three criteria: completely, partly or not completely requiring the same or similar information as the Model®.ResultsOf the forty-five countries identified, only Egypt had a publicly available pharmacoeconomic guideline (Egyptian Pharmacoeconomic Guideline (EPG)). The guidelines varied considerably in their intended audience, size and content. All three guidelines’ primary focus was the cost and economic evaluation, and health problem and current use domains. Safety, organisational, ethical and legal aspects were poorly covered by the SAPG and EPG guidelines (less than thirty percent of issues in each domain completely / partly covered). The SAPG completely or partly required the same or similar information in the Model® for thirty-nine percent of total issues, the EPG thirty-three percent and the NICE MG sixty-six percentConclusionsThe SAPG was not as comprehensive as the NICE MG and poorly covered some key aspects of HTAs, suggesting that the SAPG could be developed to be more informative for decision-makers. Evidence generation should focus on describing the health problem the technology is targeting and on evidence that can be synthesized into cost-effectiveness analyses.