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.

[The costs of new drugs compared to current standard treatment]. / Die Preise neuer Arzneimittel im Vergleich zu ihren therapeutischen Alternativen.

BACKGROUND: Until AMNOG came into effect Germany had free pricing of new drugs. Our exemplary work investigates the costs of new drugs that were licensed in the two years prior to AMNOG, and compares them to the costs of standard treatment that has been used in pivotal trials. Also, the important components of pharmaceutical prices will be illustrated. METHOD: We retrospectively analysed the European Public Assessment Reports of proprietary medicinal products that the European Medicinal Agency initially approved in 2009 and 2010 and that were tested against an active control in at least one pivotal trial. RESULTS: If the standard treatment was a generic, the average pharmacy retail price of new drugs was 7.4 times (median 7.1) higher than that of standard treatment. If the standard treatment was an originator drug the average price was 1.4 times (median 1.2) higher than that of the new drug. There was no clear correlation of an increase in costs for new drugs and their "grade of innovation" as rated according to the criteria of Fricke. Our study shows that prices of new drugs must be linked to the evidence of comparative benefit; since German drug pricing is complex, cost saving effects obtained thereby will depend on a range of other rules and decisions.