As more stakeholders from the healthcare sector embrace evidence-based policy development and decision-making, we take a look at the latest developments in the MENA region and their implications for manufacturers.
By Rachel Galloway, Senior Consultant
Introduction
Across the globe interest in and use of health technology assessments (HTA) in emerging markets is increasing as payers seek to assess the clinical and economic value of healthcare interventions and ensure efficient use of resource within their healthcare systems. This has been spurred on by recommendations from the World Health Organization (WHO), as well as the growing burden of chronic diseases in low- and middle-income countries, which increasingly require payers to prioritise healthcare interventions in the face of aging populations, financial concerns, and various social and ethical issues. In China, a market that has long focused on cost-containment to ensure the sustainability of a healthcare system serving a large patient population, use of HTA has developed rapidly over the last few years. The National Centre for Drug and Technology Assessment was established and HTA outcomes are now routinely used as evidence for price negotiations and decision-making in the development of the National Reimbursement Drug List (NRDL). However, many aspects of HTA in China still need to be standardised and transparency improved, making it an important area to monitor over the coming years. In Brazil health technology assessment has been used since 2011 with the National Committee for Health Technology Incorporation (CONITEC) advising the Ministry of Health on which health technologies should be incorporated into the universal public healthcare system (SUS)1.
In the Middle East and North Africa (MENA) region HTA entities and processes are beginning to emerge. They have taken on a variety of different scopes, shaped by the characteristics of the healthcare system they serve, the availability of resources, and institutional capacity. As in many developed markets, the outcomes of newly implemented HTAs are primarily being used to inform pricing and reimbursement (P&R) of new healthcare interventions.
In this article we’ll explore the status of HTA across various markets in the MENA region and their implications for the pharmaceutical industry.
Background
Historically most countries in the MENA region have determined pharmaceutical prices via external reference pricing (ERP) and have utilised it to minimise pharmaceutical prices by anchoring them to the lowest or average in a reference basket.
However, ERP does not account for the value of a pharmaceutical and as healthcare payers and policy makers seek to balance the budget impact of and access to innovative medicines, many are now looking to HTA to solve the balancing act.
Will this open up new opportunities for multinational pharmaceutical companies seeking to expand their access and share of the market within MENA or create additional workload and P&R challenges?
Scope
In this article we’ll review the current HTA landscape in 7 markets; the Kingdom of Saudi Arabia (KSA), Jordan, Tunisia, Egypt, Lebanon, Qatar and Kuwait.
The World Health Organisation’s Choosing Interventions that are Cost-Effective (WHO-CHOICE) project recommends cost-effectiveness thresholds are less than 3 times the GDP per capita3.
Kingdom of Saudi Arabia (KSA)
A centralised HTA system is being implemented and pharmaceutical pricing now considers added value.
KSA is the largest country in the gulf region and, as non-communicable disease rates and life expectancy are both increasing, the government is seeking to ensure healthcare resources are used efficiently while maintaining access to effective innovative treatments.
The Kingdom’s Vision 2030 programme6 - an economic and social reform – includes a health sector transformation programme that aims to manage the rising costs of healthcare. The Ministry of Health has announced that it includes the creation of a national health technology assessment entity that will assist “effective, evidence-based decision-making, specific to its population and healthcare system needs”.
Previously, only in specific cases were cost-effectiveness or budget impact analyses requested for innovative medicines and the requests were typically from hospital Pharmacy and Therapeutics committees to inform formulary listings. Now such assessments will be mandatory for all high-cost drugs and conducted in a centralised manner by the new HTA entity. Additionally, it’s anticipated that the HTA outcomes will be used to aid policy and decision-makers in both the public and private sectors.
New Pricing Guidelines
In 2021 the Saudi Food and Drug Authority (SFDA) announced new pricing guidelines. In a shift away from the previous ERP-focused system, an innovative medicine’s price will now be determined according to seven key criteria7:
Therapeutic value add of the product
Price of comparators registered in KSA
Ex-factory price in the countries where the product is marketed
Wholesaler price in the country of origin (COO)
Price to public in the COO and the countries where the product is marketed
Proposed price to KSA and to all countries where the product is marketed (Cost, Insurance and Freight price (CIF))
The price of the product is in the adopted price references.
The “Therapeutic Value Add” of the product is a new criterion that should be demonstrated through comparative clinical trials and pharmacoeconomic studies. This marks the beginning of the SFDA’s engagement with health economic studies.
The pricing changes will likely see KSA remain an important early launch country in the MENA region as they may increase the price potential of innovative drugs both in KSA as well as other MENA counties due to KSA’s inclusion in many of its neighbours ERP reference baskets.
There are two key changes in the new pricing guidelines that are likely to have a significant impact on future pharmaceutical prices. The first is the removal of Egypt, Turkey, and Argentina from the ERP reference basket, which should allow higher average prices to be determined via the ERP criterion. The second is new guidance on determining the price of a healthcare intervention if a therapeutic alternative is not available or registered in KSA. In this scenario the intervention’s price in other countries and economic models (i.e. HTA) will be used to determine pricing. This could support a high price given KSA’s updated ERP reference basket and the common practice of manufacturers launching early in western European markets with high price potential.
Takeaways
As the implementation of HTA in KSA is ongoing this will be a key area to monitor over the coming years to understand if changes to launch sequencing and readiness are required. For example, local staff may need to develop more extensive dossiers and conduct broader pre-launch activities to generate local clinical or economic evidence.
Jordan
A hospital based HTA system is influencing innovative oncology medicine pricing and patient access.
In Jordan innovative drug prices are set through ERP with the final price being set at the lowest of the reference prices. Currently pharmacoeconomic evidence has a limited impact on pricing decisions.
Despite this price minimisation approach, the increasing prices of innovative oncology medicines have posed an economic challenge to the Jordanian healthcare system and risked patient access. To address this challenge a hospital-based HTA programme was launched at King Hussein Cancer Centre (KHCC) a little over a decade ago8.
The KHCC established a Centre for Drug Policy and Technology Assessment (CDPTA), which became the body responsible for conducting cancer specific HTAs. It trained staff to conduct assessments that review clinical pharmacology, clinical efficacy, safety, economic evaluations (i.e., pharmacoeconomic and cost effectiveness analyses) and expected resource utilisation. The outcomes of the assessment are appraised by the hospital’s P&T committee and used to inform formulary listing decisions. Additionally, the outcomes of the economic evaluation may also be used to support direct pricing negotiations between KHCC and manufacturers with the objective of attaining acquisition costs at or below the KHCC’s cancer specific cost-effectiveness threshold.
Over the past decade 31 HTA reports have been produced. All have been utilised and resulted in 23 medicines being listed under restriction (21 of these medicines were only listed after manufacturers agreed to lower their prices) and 8 medicines excluded from the hospital formulary9.
The KHCC – the country’s de facto national cancer institute – has a strong influence across hospitals in Jordan and its HTA outcomes may be impacting pricing and patient access to innovative oncology medicines across the country.
HTA implementation success factors
The successful implementation of an effective and well-utilised HTA system in KHCC was driven by some key activities. Firstly, the implementation of capacity building programmes for technical staff and decision makers (i.e., HTA doers and users) ensured HTAs were conducted effectively and the outcomes used in subsequent decision-making. Secondly, the establishment of standardised submission, assessment, and appraisal forms, templates and pathways provided clarity on the process and requirements. Lastly, the development and utilisation of methodological guidelines for efficacy, safety, and cost-effectiveness assessments has provided transparency and consistency.
Takeaways
While the KHCC HTA system may be robust and transparent, it has ultimately resulted in only 6% of submissions being listed under restriction without price concessions. Given the prevalence of ERP in the MENA region, manufacturers may need to evaluate future oncology launch opportunities by determining the price level at which gaining access to the Jordanian market is offset by the subsequent erosion of prices in neighbouring markets.
Tunisia
A central HTA system supports reimbursement decision making for high-cost medicines.
The Tunisian Authority of Assessment and Accreditation in Healthcare (INEAS) is the central HTA body in Tunisia and one of the oldest HTA entities in the MENA region. It assesses the clinical and cost-effectiveness of health technologies anticipated to have a high-cost or high impact on the Tunisian healthcare system10.
INEAS conducts HTAs via systematic reviews, in addition to cost effectiveness and budget impact analyses. The outcomes inform evidence-based recommendations on reimbursement decisions.
In addition to HTA, INEAS is also responsible for the development of clinical practice guidelines and care pathways, the accreditation of healthcare organisations and the ongoing education of healthcare professionals.
Trastuzumab case study
INEAS published its first HTA report in 2018 which evaluated the clinical and cost-effectiveness of trastuzumab, which has been the biggest budgetary expenditure for the compulsory national social health insurance scheme (CaisseNationale d'AssuranceMaladie (CNAM)) since 2008. Cost-effectiveness analyses were conducted by an adaptation of a Latin American cost-effectiveness study, followed by a sensitivity analysis and the estimation of the cost effective price. The analyses concluded a discount of 78% on trastuzumab’s acquisition price was required to reach the national payer’s cost-effectiveness threshold and these results subsequently informed biosimilar pricing negotiations.
The HTA report on trastuzumab is considered “an encouraging example of the ability of a newly established agency to conduct a transparent and evidence driven assessment” but highlighted limitations including the transferability of economics evaluations when determining local cost-effectiveness11.
HTA implementation success factors
The success of the Tunisian HTA system can be accredited to:
Investment in the training of its own staff, policy makers and clinicians to improve the utilisation of HTAs in decision making
Postgraduate education programmes for INEAS researchers to improve HTA capabilities
Broad healthcare stakeholder collaboration; INEAS works with healthcare decision makers, professionals, scientific societies, and universities. These collaborations take place via peer-review groups, seminars, conferences, meetings and involvement in INEAS projects
Secure funding from the Tunisian government
Transparency; INEAS’s HTA reports are publicly available (albeit in French but some English summaries are available)
Communication and reach; HTA reports are broadly communicated to healthcare sector stakeholders and some are published in peer-reviewed papers
International collaborations; INEAS joined the International Network of Agencies in HTA (INAHTA) to improve international knowledge and best practice sharing12
Focus; HTA is a key focus and mission of INEAS. Its name was changed in 2018 to better reflect this - previously it was INASanté (National Authority for Accreditation in Healthcare)
Takeaways
The ingenuity INEAS demonstrated in its cost effectiveness analysis of trastuzumab may see it become a pioneer that shapes how lower- and middle-income countries (LMIC) approach economic evaluations where local data is not available or analyses are not submitted.
If manufacturers do not consider evidence or studies from other LMICs to be relevant to the Tunisian context and/or for their product, they should be prepared to explain why such data may not be transferable and excluded from the HTA.
Egypt
Universal health insurance and HTA implementation are in the pilot phase.
After a period of economic challenge, the Egyptian economy has now stabilised and the pharmaceutical market has demonstrated strong growth, driven by an increasing population and large investments by the government.
In 2018 the government passed a universal health insurance (UHI) law, which will cover all Egyptians for any condition by 2030.
To help with the delivery of UHI two new entities were established: the Egyptian Authority for Unified Procurement, Medical Supply, and Technology Management (UPA) and the Egyptian Drug Authority (EDA).
The UPA is planning to implement a new HTA system to inform future pricing and reimbursement decisions. In its own words it “aims to ensure an equitable access of medicinal and health technology products through conducting evidence-based technology assessments, strategic value driven procurement methods and establishing a robust and sustainable supply chain”13.
Additionally, the UHI law mandates that health economists are included in the governing boards of the new UHI authority and health care providers, which should help ensure HTA outcomes are used to support decision making.
Collaboration with NICE
In the summer of 2022 England’s NICE and the UPA signed a statement of collaboration14. NICE conducted a situational analysis, which indicated that the small number of trained staff competent at conducting HTA at UPA was a key barrier to its successful implementation.
In light of these findings future support from NICE will be focused on institutional capability building, technical training in HTA and a review of the UPA’s health technology evaluation process and methods, and the health technology evaluation pilots.
Takeaways
Egypt represents the second biggest market in terms of value in the MENA region but it also has a relatively low GDP per capita. Consequently, it will be important to see what cost-effectiveness threshold is set in Egypt and how procurement of medicines is conducted for the public healthcare system. A national level buyer for ~100 million lives could have significant bargaining power in future pricing negotiations, which could lead to lower price potential, particularly for innovative medicines where therapeutic alternatives exist.
Implementation of UHI and HTA in Egypt is in the pilot phase with full implementation anticipated by 2030. Manufacturers should keep track of major HTA announcements during this time to understand the future opportunities in the Egyptian pharmaceutical market.
Lebanon
No formal HTA system but cost-effectiveness may be considered.
In Lebanon pharmaceutical prices for innovative medicines are primarily determined by external reference pricing and mark-up regulations15.
While it is recommended that drug manufacturers submit an economic analysis to aid their pricing negotiations there is no formal requirement and no mandatory HTA process.
Cost effectiveness is only formally considered when determining entry to the Lebanese essential medicines list (EML)16.
In 2016 the Ministry of Public Health (MoPH) published a strategic health plan that recognised the need to establish an efficient national HTA entity and procedure but few details have been released.
Over the last decade, several factors have limited the implementation of a formal HTA system in Lebanon. The lack of formal endorsement from national authorities is a key factor alongside limited transparency, the dominance of private providers, and limited regulation.
Takeaways
The current Lebanese liquidity crisis will likely hinder any further HTA initiatives in the country in the foreseeable future. Current efforts are focused on preventing the collapse of the public healthcare system amid a surge in demand and a shrunken budget.
Qatar
No formal HTA system but economic evaluations may be considered during the pricing process.
Similar to Lebanon, pharmaceutical pricing in Qatar is mainly based on ERP and mark-up regulations17. However, an economic evaluation or the therapeutic importance of a medicine may also be used to set the price if these analyses, or an HTA report, is available at the time of registration.
Although no formal plans to implement HTA have been announced, Qatar is currently implementing a national E-Health ecosystem that will generate data that could support future local evidence-based assessments18.
Takeaways
As one of the world’s richest countries there is little need or urgency for the government to invest significant resource to institutionalise HTA. Expect limited change here, at least in the short term.
Kuwait
No formal HTA process and no indication that the implementation of a HTA system is on the horizon.
In Kuwait medicine prices are set to the average of the ERP reference basket then approved by the Medicines Pricing Department of the Ministry of Health19,20.
Currently there is no formal HTA process and limited awareness of HTA among healthcare stakeholders21 thus it is unlikely that a HTA system is likely to be implemented in Kuwait in the short term.
A study that sought to qualitatively explore the main barriers to HTA implementation in Kuwait through primary research identified the following21:
Minimal awareness of HTA
Lack of institutional and human capacity
A fragmented healthcare system
Poor communication between researchers and policy makers
Wealth and political challenges (i.e. an abundance of financial resources can hinder recognising the need for HTA)
Data quality, availability and sharing.
The researchers concluded that HTA implementation was most likely to be successful in Kuwait if it was institutionalised and enforced by law.
Takeaways
Similar to Qatar, limited change is expected here requiring no immediate change to launch strategy or market access resourcing.
Conclusion
While only a handful of countries in the MENA region have implemented or begun to establish HTA entities and pathways, research has indicated that more countries, particularly low- and middle-income countries, would like to implement HTA to support future pricing and reimbursement decision making22.
This is a step away from the status quo; many countries in the region rely heavily on ERP to determine pharmaceutical pricing and use economic evidence to a limited, often informal, extent.
Despite an increased willingness across MENA to explore HTA as a tool to optimise value in healthcare and rationalise future spending, its implementation can be challenging, particularly for lower- to mid-income countries, due to the financial resources and human capital required.
Fasseeh et al.22 identified activities that are key to achieving successful HTA implementation in the MENA region. These included:
Broad stakeholder engagement: stakeholders across the healthcare sector – both HTA doers and users – should be involved in HTA processes and communications
HTA capacity building: ideally via graduate and postgraduate programmes
Public funding and institutionalisation of the HTA entity: this ensures the financial sustainability of HTA, reduces conflict of interest, and demonstrates a government’s commitment to implementing HTA
Prioritised HTA scope in the short term: initially as processes and capabilities are being developed, HTA may be limited to high-cost drugs anticipated to have a high budget impact
Broader HTA scope in the long term: HTA processes should be extended to other health technologies (e.g. devices, surgical interventions, or older pharmaceuticals)
Availability and strength of local evidence: investment in patient registries and databases is needed to improve the evidence base for assessments
Country specific HTA roadmaps: HTA systems should be adapted to account for country size, economic status, demographics, public health priorities and health care financing.
As pressure mounts on the sustainability of healthcare systems across the region, the evolution of pricing and reimbursement decision making across MENA will be a key area for international pharmaceutical companies to monitor, with KSA being an important market to watch over the short term.
Table 1. Summary of HTA systems and key activities for pharmaceutical companies in MENA markets
References
SimõesCorrêa Galendi J, Caramori CA, Lemmen C, Müller D, Stock S. Expectations for the Development of Health Technology Assessment in Brazil. Int J Environ Res Public Health. 2021 Nov 13;18(22):11912. doi: 10.3390/ijerph182211912. PMID: 34831668; PMCID: PMC8625173.
World bank
Making Choices in Health: WHO Guide to Cost-effectiveness Analysis, Volume 1
Treish, I., Al Rabayah, A., Jaddoua, S. et al. Impact of a New Cost-Effectiveness Threshold Implementation on Cancer Formulary Decisions in Jordan. PharmacoEconomics Open 6, 137–145 (2022). https://doi.org/10.1007/s41669-021-00293-4
Al-Rabayah AA, Jaddoua SM. Establishment and implementation of hospital-based health technology assessment at King Hussein Cancer Center: can our model be an example? Int J Technol Assess Health Care. 2021 Apr 12;37(1):e55. doi: 10.1017/S0266462321000246. PMID: 33843517.
PCN255 Health Technology Assessment in Low- and Middle-Income Countries: Where to Begin? a Case Study of Tunisia's First Assessment of Trastuzumab in EARLY and Locally Advanced HER-2 Positive Breast Cancer. https://www.valueinhealthjournal.com/article/S1098-3015(20)32648-6/fulltext
Abdel Rida, N., Mohamed Ibrahim, M.I. and Babar, Z.-U. (2019), Pharmaceutical pricing policies in Qatar and Lebanon: narrative review and document analysis. J Pharm Health Serv Res, 10: 277-287.
Pharmaceutical pricing policies in Qatar and Lebanon: narrative review and document analysis. https://onlinelibrary.wiley.com/doi/full/10.1111/jphs.12304
https://www.lse.ac.uk/business/consulting/assets/documents/pharmaceutical-pricing-and-reimbursement-in-the-middle-east-and-north-africa-region.pdf
https://www.cambridge.org/core/journals/international-journal-of-technology-assessment-in-health-care/article/abs/implementing-health-technology-assessment-in-kuwait-a-qualitative-study-of-perceived-barriers-and-facilitators/8A3D6E915989CCB4D057A658A5B0FEED
Fasseeh A, Karam R, Jameleddine M, George M, Kristensen FB, Al-Rabayah AA, Alsaggabi AH, El Rabbat M, Alowayesh MS, Chamova J, Ismail A, Abaza S and Kaló Z (2020) Implementation of Health Technology Assessment in the Middle East and North Africa: Comparison Between the Current and Preferred Status. Front. Pharmacol. 11:15. doi: 10.3389/fphar.2020.00015