An analysis of the impact of generic medicine reference pricing in a sector of the South African private healthcare insurance industry

Includes bibliographical referencesBackground: Pharmaceuticals are responsible for a substantial percentage of the total cost of health care and continue to exceed economic growth and inflation. Generic medicines play an important role in limiting this expenditure, and consequently there is an international drive to implement pro - generic policies particularly in high income countries. One such policy is generic medicine reference pricing (GRP). Generic reference pricing sets a fixed maximum reimbursement amount for clusters of bio - equivalent drugs without placing any restrictions on the manufacturers' price. Numerous studies have been conducted in high income countries to analyse the impact of generic reference pricing; however, the impact of this reference pricing in low - to - middle income countries (LMIC s) is not well established. Objective: This dissertation aims to address this lack of information in LMICs by providing empirical aggregated claims data on the impact of generic reference pricing on price, expenditure, utilisation and out - of - pocket (OOP) p ayments in a sector of South Africa's private health insurance industry. Methods: This time series intervention study of retrospective claim - level secondary data analyses the impact of one of several generic reference pricing models applied by various private medical insurance companies in South Africa. Criteria applied for the selection of referenced categories and sample claims data intend to maximize the data set as well as the analysis period, while minimizing confounders such as medical insurance member variation and specific managed care policies. The impact of the reference price on variables of drug price, drug expenditure, market share and out - of - pock et payment is measured by analysing changes in the originator, 'authorised generic' ('clone') and generic drugs within each cluster. (An 'authorised generic' (AG) is an exact copy of the originator, approved as a brand - name drug under a patent protection but marketed as a generic.) Results: Two referenced priced categories (Desloratadine and Clopidogrel) and a population of approximately 100,000 were identified as being eligible for inclusion. An authorised generic was launched for Clopidogrel but not for Desloratadine. The implementation of generic reference pricing appears to have had no or minimal impact on the price of the originator and authorised generic - at the end of the study period the price of the originator drugs of the two categories was 268% and 86% higher than the reference and the authorised generic of Clopidogrel was 69 % higher than the reference price. Most often the reference price appeared to be based on the price of a generic drug; however once the reference price was set other generics tended to align at or below the reference price. The implementation of generic reference pricing was associated with an overall increase in dispensed volumes and a decrease in expenditure for both categories; both categories' originator market share declined dramatically by volume (to 23% and 4%) and value (to 35% and 9 %). For Clopidogrel the authorised generic took the majority of market share (63% by volume and 68% by value); the generics only gained one third of the market, despite lower product prices and minimal co - payments. Desloratadine generics captured 80% of the market by the end of the study. For both categories there was no notable change in the total drug expenditure paid out - of - pocket across the study period. The percentage of drugs dispensed that had a co - payment decreased dramatically for Desloratadine, but were only seen to decrease marginally for Clopidogrel. Limitations: Due to the small sample and limited reference categories analysed, the findings from this study are not representative of the South African private healthcare sector and cannot be extrapolated to South Africa. In addition, any savings identified should take the expense of non - referenced alternatives into account