A comparative review of the pharmacoeconomic guidelines in South Africa

Objective: To compare the pharmacoeconomic guidelines in South Africa (SA) with other middle-and high-income countries. Methods: A comparative review of key features of the pharmacoeconomic guidelines in SA was undertaken using the Comparative Table of Pharmacoeconomic Guidelines developed by the International Society of Pharmacoeconomics and Outcomes Research, and published country-level pharmacoeconomics guidelines. A random sample of guidelines in high-and middle-income countries were analyzed if data on all key features were available. Key features of the pharmacoeconomic guidelines in SA were compared with those in other countries, and divergent features were identified and elaborated. Results: Five upper middle-income countries (Brazil, Colombia, Cuba, Malaysia, and Mexico), one lower middle-income country (Egypt), and six high-income countries (Germany, Ireland, Norway, Portugal, Taiwan, and the Netherlands) were analyzed. The pharmacoeconomic guidelines in SA differ in important areas when compared with other countries. In SA, the study perspective and costs are limited to private health-insurance companies, complex modelling is discouraged and models require pre-approval, equity issues are not explicitly stated, a budget impact analysis is not required, and pharmacoeconomic submissions are voluntary. Conclusions: Future updates to the pharmacoeconomic guidelines in SA may include a societal perspective with limitations, incentivize complex and transparent models, and integrate equity issues. The pharmacoeconomic guidelines could be improved by addressing conflicting objectives with policies on National Health Insurance, incentivize private health insurance companies to disclose reimbursement data, and require the inclusion of a budget impact analysis in all pharmacoeconomic submissions. Further research is also needed on the impact of mandatory pharmacoeconomic submissions in middle-income countries.