Introduction
For some manufacturers, launching in the Middle East and North Africa (MENA) is fraught with uncertainty given the reliance on pricing via the international reference pricing (IRP) method. However, as with other regions across the world, interest in assessment through health technology assessment (HTA) within the MENA region is growing. The country leading the way in the Middle East appears to be the Kingdom of Saudi Arabia (KSA). This article will explore why manufacturers should look to the KSA as a possible indicator of change in the Middle East, and how the country could inspire other countries in the Middle East to invest in national HTA agencies.
What is the current HTA situation in the Middle East?
The most commonly used pricing process within the MENA region is the pricing of products via the referencing of prices from a basket with a large number of countries (>20), either through calculating the average price or selecting the lowest price of the basket. As research conducted by the London School of Economics (LSE) points out, relying on IRP does not take into account the value of innovation in the majority of cases, and the system itself can be incredibly complex to administer1
The use of HTA as a tool for the assessment and pricing of products is not widespread throughout MENA. Tunisia is currently the only country in MENA with an independent national HTA agency (INEAS, established in 2012). In contrast, other countries in the region may have subnational payers or treatment institutions with their own private HTA units. Major issues preventing the establishment of national HTA agencies revolve primarily around the recruitment of specialised HTA professionals, lack of public funding into HTA research and no legislation on organisational structure for HTA appraisal2. Prior to an ISPOR event in the MENA region, there was clear indication from all survey respondents for a desire to move towards a European-style HTA system (public HTA institute/agencies supported by expert academic groups, with transparent decision-making processes, thresholds and published reports)2
Several countries have declared the establishment of national HTA agencies as a major health policy priority. Two of these are big players in the MENA region: Egypt and the KSA. As part of its 2030 Vision, KSA is establishing a centralised HTA entity that aims to “support effective, evidence-based decision-making, specific to its population and healthcare system needs”3. Manufacturers seem to be onboard, according to research conducted and published by the Ministry of Health in June 2020. The report of this meeting concluded that “the pharmaceutical company participants were positive about HTA’s value for the Saudi healthcare system and expressed willingness to adapt to meet its future requirements”4.
Why is the KSA seen as an indicator of change within MENA?
Given the country’s political influence in the region, and inclusion within many of its neighbours referencing baskets, the KSA should be seen as a ‘flagship’ market within the region. The Saudi Arabian market is already showing signs of innovation, such as the use of innovative contracting methods such as managed entry agreements (MEA’s). One presentation at the World EPA Congress 2022 indicated that there are currently more than 18 managed entry agreements (MEA’s) established within the country, including one risk-sharing, performance-based agreement.
Back in early 2021, the KSA introduced pricing guidelines which looked to consider added therapeutic value (demonstrated through comparative studies against therapeutic alternative) and pharmacoeconomic studies in the pricing of innovative products, amongst other factors. Additionally, the basket of reference countries was shrunk from 30 to 20. These two moves demonstrate that the KSA is seeking to improve the quality of its healthcare decision-making, while making the country more attractive to manufacturers of products considered innovative.
The successful implementation of a national, public HTA system in KSA, combined with pricing policies that are more considerate towards innovative products, could inspire other important MENA countries to move away from the current pricing system. Given the influence exerted by KSA in the surrounding region, which is currently dominated by IRP and fragmented, privately-funded HTA, this could be a substantial step-change. However, whether the surrounding countries have the financial resources and infrastructure available to implement such a system will be interesting to consider.
Conclusion
If change in the KSA proves successful, this could lead to the MENA market becoming more attractive for manufacturers of innovative products looking to launch in public payer systems. Arguments were made at the World EPA Congress 2022 that certain high-value markets within the Middle East should be considered as first-launch markets alongside the US, Japan and key European markets. Manufacturers should keep close track of developments within the KSA to understand if this prediction becomes reality.
Sources:
- Kanavos P, et al. Pharmaceutical pricing and reimbursement in the Middle East and North Africa region. 2018. Available at: https://www.lse.ac.uk/business/consulting/assets/documents/pharmaceutical-pricing-and-reimbursement-in-the-middle-east-and-north-africa-region.pdf
- Fasseeh A, et al. Implementation of Health Technology Assessment in the Middle East and North Africa: Comparison Between the Current and Preferred Status. Front. Pharmacol. 2020; 11. https://doi.org/10.3389/fphar.2020.00015
- Al-Omar HA, Aljuffali IA, Solà-Morales O. Value drivers for pharmaceutical products in health technology assessment (HTA) in Saudi Arabia: Results from a capacity Building, Multi-Stakeholder workshop. Saudi Pharmaceutical Journal. 2021; 29(9): 946-954. https://doi.org/10.1016/j.jsps.2021.08.001.
- Al-Omar HA, Attuwaijri AA, Aljuffali IA. Pharmaceutical companies’ views on a health technology assessment (HTA) entity in Saudi Arabia. Saudi Pharmaceutical Journal. 2020; 28(6): 662-668. https://doi.org/10.1016/j.jsps.2020.04.006