Pricing of in-patent pharmaceuticals in the Middle East and North Africa: Is external reference pricing implemented optimally?

Abstract

In this paper we outline and compare pharmaceutical pricing policies for in-patent prescription pharmaceuticals with emphasis on external reference pricing (ERP) in eleven countries across the Middle East and North Africa (MENA) region and explore possible improvements in their pricing systems. Primary and secondary evidence was used to inform our analysis. Comparative analysis of ERP systems across countries followed an analytical framework distilling ERP into twelve salient features, while ERP system performance was benchmarked against a framework of best practice principles across (a) objectives and scope, (b) administration and operations, (c) methods used, and (d) implementation. Results suggest that ERP is the dominant pricing method for in-patent pharmaceuticals. Although several good practice cases were identified, none of the eleven countries satisfy all best practice principles. ERP basket sizes vary significantly and are commonly composed using geographical proximity and low-price countries as criteria. Nine countries do not use the mean or median prices, but resort to using the lowest. Exchange rate fluctuations are routinely used to arrive at price reductions in local currency. Significant opportunities exist for MENA countries to develop their ERP regimes to achieve greater compliance with best practice principles. Over the short-term, incremental changes could be implemented to several ERP salient features and can be achieved relatively easily, thereby enhancing the functionality and performance of national ERP systems. Countries in the region can also focus on the development of explicit value assessment systems, and minimize their dependence on ERP over the longer-term.

Institutionalizing health technology assessment in Egypt: Situational analysis and roadmap

“…In 2009, Egypt adopted a new pricing method based on the lowest retail price in any country of the world (external reference pricing), but this has led to both price increases and decreases without substantive implications on affordability ( Mohamed and Kreling, 2016 ). Calls have been made to encourage countries in the Middle East and North Africa (MENA) region, including Egypt, to move forward in their pricing policies beyond external reference pricing, and introduce value assessment mechanisms ( Kanavos et al, 2020 ). Beyond Tunisia, that has the Tunisian Authority of Assessment and Accreditation in Healthcare (INEAS), Egypt and the Kingdom of Saudi Arabia seem to be amongst the first countries in the region to publicly announce and commit to the incorporation of value assessment mechanisms, such as health technology assessment (HTA) as part of their healthcare reforms ( Fasseeh et al, 2020 ; Kanavos et al, 2020 ).…”

International Nonproprietary Names prescription in a specialized public hospital in Egypt

“…28 In Egypt, there is no explicit policy mandating generic prescription. 16 Physicians in all MOHP hospitals are mandated to prescribe in INN, however there is no sanctions for non-adherents. This was similar to the policy followed in France where INN prescription was mandated for all prescribers but there was no sanctions in case of failure with the obligation.…”

“…Egypt has no explicit generic prescribing policy, however, there is a generics policy with the name of ‘generics box’. 16 The box system is followed for registration of pharmaceutical in Egypt. According to the ‘box’ policy, any dosage form (tablet, vial, syrup, suppositories, drops and so on) of any active pharmaceutical ingredient must be registered with not more than 12 similar products.…”

Disease-Related Costs Published in The Middle East and North Africa Region: Systematic Review and Analysis of Transferability

“…As a means to inform decision making in order to promote equitable, efficient, and high-quality health systems [ 6 ], HTA has been recognized as an important tool in the pursuit of universal health coverage and sustainable healthcare financing worldwide [ 7 ]. In MENA, despite the growing interest from countries, the implementation of HTA is still in its early stage [ 8 ]. Health economic evaluations in MENA have been systematically reviewed in multiple studies [ 9 – 13 ].…”