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The National Department of Health of South Africa recently published guidelines for pharmaco-economic (PE) submissions in accordance with the Medicines and Related Substances Act (Act 101 of 1965), which came into effect on 1 April 2013. These guidelines relate to the compilation of PE submissions for evidence of cost-effectiveness of medicine or scheduled substances. The PE guidelines are a first step towards the creation of a mechanism whereby the value of medicine can be quantified in a transparent manner. The 'voluntary' nature of PE submissions speaks to the current lack of knowledge, understanding and capacity related to pharmaco-economics that exists in the private healthcare market. The current disconnect between the PE guidelines and the Medical Schemes Act should be addressed as a matter of urgency to provide a mechanism whereby guidance in terms of cost-effectiveness from a PE evaluation will be supported by guaranteed reimbursement by medical schemes.

A first step towards transparency in pricing of medicines and scheduled substances – publication of guidelines for pharmaco-economic submissions