Managed Entry Agreements for Health Technologies: Do’s and Don’ts with a Focus on the Middle East

What are Managed Entry Agreements?

In recent years, the healthcare systems in the Middle East and North Africa (MENA) region have undergone significant transformation to meet the rising demand for high-value care amid increasing budgetary constraints. Prescription drug spending has surged across the region, driven by the introduction of costly innovative therapies in key areas such as oncology, gene therapies, and immunomodulatory diseases, alongside the growing aging population and the rise of non-communicable diseases (NCDs).

Managed Entry Agreements (MEAs) have emerged as a crucial tool to enhance access to specialized and innovative therapies while ensuring cost-effectiveness. Globally, the United Kingdom leads in implementing MEAs, with 65% of agreements in place, followed by the United States (10%) and Australia (10%). In contrast, the MENA region remains in the initial stages of MEA adoption, necessitating the establishment of a structured healthcare framework to facilitate their wider use. One of the key priorities for the region is the creation of independent health technology assessment (HTA) entities to evaluate innovative technologies and treatments based on their social, ethical, and economic impacts.

Importance, Types, and Benefits of Managed Entry Agreements

A MEA is a contractual agreement between manufacturers and payers or providers, designed to mitigate financial risk and address clinical uncertainty surrounding treatments. These agreements are instrumental in assessing the cost-efficiency of treatments and ensuring early, equitable access to high-priced, innovative therapies. MEAs can be segmented into two main types: financial-based (FBMEA) and value-based (VBMEA) agreements.

FBMEAs focus solely on financial aspects such as pricing and reimbursement without considering the clinical effectiveness of the drug. Common approaches in FBMEAs include price-volume agreements, discounts, patient- or dose-dependent discounts, or price caps.

VBMEAs, which are gaining traction due to the shift toward value-based care, are further divided into performance-based MEAs and coverage with evidence development (CED) MEAs. Performance-based MEAs link reimbursement levels to the real-world effectiveness of a drug, while CED MEAs allow early access to promising therapies, contingent on the collection of additional evidence.

Managed Entry Agreements (MEAs) offer distinct benefits for both payers and manufacturers. For payers, MEAs provide the ability to manage the uncertainty surrounding the clinical and cost-effectiveness of new technologies. They also allow payers to limit the financial risk by linking payments to agreed-upon outcomes, ensuring that costs are aligned with real-world performance. Additionally, MEAs can promote earlier access to innovative treatments while securing cost containment, maintaining budget control, and improving patient outcomes through access to cutting-edge therapies.

For manufacturers, MEAs offer the opportunity to bring innovative products to market more quickly by ensuring early access, even in the face of clinical uncertainties. They also provide a mechanism to generate real-world evidence, which can be used to demonstrate the value of a product and potentially expand its use. These agreements can enhance market penetration by overcoming payer concerns and facilitating quicker reimbursement decisions. Furthermore, MEAs can build stronger, trust-based relationships between manufacturers and payers through collaborative approaches.

For payers, the benefits include:

• Enhanced budget predictability by tying reimbursement to actual treatment outcomes.
• Reduced financial risk through outcome-based payment models.
• Earlier access to innovative therapies while ensuring value for money.
• Opportunity to gather real-world data to confirm the long-term effectiveness of treatments.
• Improved healthcare outcomes by enabling patients to access cutting-edge technologies sooner.
• Flexibility in managing the introduction of costly treatments.
• Promoting more efficient resource allocation.

For manufacturers, MEAs offer:

• Accelerated market access for new technologies, despite clinical uncertainties.
• The ability to collect real-world evidence to validate the product’s performance.
• Strengthened payer confidence, leading to greater market acceptance.
• Improved product differentiation and competitive advantage.
• Fostered long-term collaborations with payers.
• Reduced risk of delayed or restricted reimbursement.

These agreements support mutual benefits by mitigating risks associated with uncertainty, improving access to innovation, and enabling sustainable healthcare solutions for all stakeholders. MEAs can broadly be categorized into two types: value-based agreements (VBAs) and performance-based agreements (PBAs). Each type serves a specific purpose, depending on the level of uncertainty surrounding the health technology and the objectives of the payer.

• Value-Based Agreements (VBAs):
  VBAs link reimbursement to the health technology’s assessed value, typically determined through economic evaluations such as cost-effectiveness analysis. These agreements often involve pricing strategies that reflect the technology’s value in terms of clinical outcomes and quality of life improvements.
• Performance-Based Agreements (PBAs):
  PBAs tie reimbursement to the real-world performance of the health technology, requiring the collection of outcome data to assess its impact. If the technology does not meet the agreed-upon performance metrics, the manufacturer may face financial penalties, including rebates or price adjustments.

Managed Entry Agreements (MEAs) encompass various contract models designed to facilitate the integration of high-cost pharmaceuticals into healthcare systems while managing financial risk. Outcomes-dependent agreements tie reimbursement or pricing to the actual health outcomes achieved by the treatment, ensuring payment reflects the clinical benefit delivered. Additional evidence-dependent agreements stipulate that further clinical or economic evidence must be generated post-market to support continued reimbursement, mitigating initial uncertainty about the treatment’s value.

Price-volume linkage models adjust the drug price based on the volume of sales, offering discounts or rebates when sales exceed predefined thresholds. Cost/patient capping involves setting a maximum expenditure per patient, beyond which additional costs are covered by the manufacturer, controlling per-patient financial risk. Discounting provides upfront reductions in the drug price, making it more affordable for healthcare systems. Cost spreading allows the distribution of the drug’s cost over time or across multiple budget periods, easing immediate financial burdens. Free additional devices/goods agreements include supplementary products at no extra cost to enhance the overall value of the treatment.

Disease awareness/education programs focus on improving patient and provider knowledge about the disease and treatment options, potentially enhancing treatment adherence and outcomes. Finally, patient support programs offer various services, such as adherence aids and educational materials, to help patients manage their treatment and health condition effectively, aiming to improve overall treatment success and patient outcomes.

The Need for Managed Entry Agreements in the Middle East

Due to its diverse healthcare systems and rapidly expanding population, the Middle East faces challenges in managing health expenses and gaining access to cutting-edge medical technologies. MEAs, which offer an organized method of managing the introduction of expensive technology, particularly in nations where healthcare systems are rapidly changing, can address this hurdle.

Due to scarcity of data about new technology’ long-term efficacy, safety, and cost-effectiveness, most payers are unsure about them. Healthcare providers find it challenging to allocate resources to the implementation of these technologies due to the lack of clarity on the potential benefits and drawbacks. Managed entry agreements (MEAs) are required to close this gap.

MEAs enable for the conditional coverage or reimbursement of novel technologies, while also lowering uncertainty through the collection of real-world evidence. These contracts facilitate risk sharing among payers, healthcare providers, and manufacturers. They are essential in the case of costly novel medicines that conventional channels would not be sufficiently equipped to assess, such as gene therapies, biologics, or customized medicine.

Types of Uncertainty related to new technologies and potential MEAs

Additionally to alternative contracting models, Innovative contracting models are emerging as solutions to address the affordability and access challenges of high-cost therapies, particularly in healthcare systems burdened by expensive treatments. Various innovative contracting models, each with a distinct mechanism to fund or facilitate access to healthcare can be a medium of facilitation of access to breakthrough therapies:

1. Copayment Through NGOs: This model provides direct financial assistance to patients who cannot afford their treatments, often with the help of charity organizations, reducing their out-of-pocket expenses.
2. Subscription-Based Payment: Payors negotiate fixed payments with manufacturers in exchange for access to specific drugs over a defined period, ensuring treatment affordability and predictability for particular patient populations.
3. Public-Private Insurance Partnership: By fostering collaboration between private insurers and governments, this model expands access to care through enhanced funding mechanisms, ensuring broader patient coverage.
4. Sales-Linked/Service-Linked Donations: Fundraising tied to specific products or services, where a portion of the revenue is dedicated to supporting healthcare, allowing companies to contribute to healthcare access through commercial activities.
5. Mobile Health Wallets: Technological platforms allow patients to save, borrow, or share money for healthcare, connecting them with providers and payers to enhance affordability and convenience.
6. Fundraising Mobile Games: This approach uses gamification to pool funds from multiple donors, typically through in-app purchases, harnessing digital platforms to raise money for healthcare needs.
7. Mutual Aid Platforms: Voluntary contributions from members of a platform help pool resources to cover healthcare costs, providing a low-cost but effective health protection option.
8. Crowdfunding: Crowdfunding connects multiple stakeholders—such as donors, pharmaceutical companies, healthcare providers, and NGOs—to collectively raise funds for needy patients.
9. Deferred Payment: High-cost treatments are paid for in installments over several years, addressing immediate budgetary constraints while managing long-term clinical uncertainties. This model has been used widely for the coverage off gene therapies.
10. Tax-Based Innovation Funds: Governments allocate funds, collected through targeted taxation, to support research, development, and access to new treatments for specific diseases. This model was widely discussed through tobacco and alcohol taxation in Lebanon through “sin tax” in collaboration with the Regie.

These models reflect a shift towards innovative financing in healthcare, leveraging community resources, technological platforms, and partnerships to ensure broader access to expensive therapies.

Healthcare Funding and MEA Adoption Variations in the MENA Region: A Comparative Analysis

The adoption of MEAs in the MENA region varies significantly depending on the country’s healthcare infrastructure. The region’s healthcare models are highly diverse in terms of funding sources, drug registration, pricing processes, reimbursement policies, procurement methods, regulatory structures, and legal frameworks.

For example, in Saudi Arabia, over 90% of healthcare funding is supported by the public sector through universal coverage, while the private sector contributes less than 10%. Conversely, in countries like the UAE, Lebanon, Egypt, and Morocco, public sector healthcare expenditures range from 20% to 40%, with private insurance covering 70% to 80% of healthcare costs in the UAE. In Lebanon, the Ministry of Health (MOH), National Social Security Fund (NSSF), and other public entities provide coverage to most of the population. The NSSF, in particular, offers insurance for a large segment of the population, including private-sector employees.

Healthcare decision-making related to drug approval, pricing, procurement, and formularies is often centralized at the national level. For example, in Saudi Arabia, the Saudi Food and Drug Authority (SFDA) and MOH are responsible for these decisions, while the MOH, SEHA, and Dubai Health Authority oversee them in the UAE.

Lebanon’s NSSF and military healthcare system, Egypt’s MOH and Central Administration of Pharmaceutical Affairs (CAPA), and Morocco’s MOH and National Agency for Health Insurance (ANAM) also play key roles in the decision-making process. Reimbursement policies, however, may be localized, with institutions developing their own formularies.

In some countries, such as Egypt, pharmaceutical companies and semi-government or private insurers are involved in developing reimbursement strategies. Centralized procurement is common in Saudi Arabia (through NUPCO) and the UAE, while other countries use tenders and direct orders for procurement.

In the MENA region, the adoption of Managed Entry Agreements (MEAs) varies not only by country but also by therapeutic area, reflecting distinct regional priorities and healthcare needs. In Saudi Arabia, MEAs are frequently employed for high-cost oncology, immune-mediated inflammatory diseases, and rare disease medications, with approximately 30% of new oncology treatments and 25% of rare disease drugs covered under these agreements. The focus on oncology is driven by the increasing incidence of cancer in the region, necessitating cost-effective strategies to manage expensive treatments.

In the UAE, MEAs are prominently used for both oncology and cardiovascular drugs. About 35% of new oncology medications and 20% of cardiovascular drugs are managed through MEAs, facilitated by the Ministry of Health (MOH) and Dubai Health Authority (DHA). The high prevalence of cardiovascular diseases in the UAE has led to a significant emphasis on managing these therapies through value-based agreements.

Egypt exhibits a more varied approach, with MEAs predominantly applied to high-cost oncology and hepatitis C treatments. Approximately 20% of new oncology drugs and 15% of hepatitis C treatments are covered under MEAs, reflecting the country’s focus on tackling major health challenges and managing budget constraints. The application of MEAs to hepatitis C treatments is particularly notable given the high burden of the disease in Egypt and the government’s efforts to expand access to curative therapies.

In Lebanon, MEAs are less prevalent but are used primarily for oncology and some chronic disease medications. Around 15% of new oncology drugs and 10% of treatments for chronic diseases like diabetes are covered under MEAs, largely managed by the National Social Security Fund (NSSF) and the Ministry of Health (MOH). The limited use of MEAs reflects Lebanon’s constrained healthcare budget and the challenges of negotiating such agreements in a complex healthcare environment.

Managed Entry Agreements Proposition Design

In the proposed Managed Entry Agreement (MEA), the following key components are systematically addressed to ensure a well-rounded approach to medication access and financial management:

• Population Eligibility and Characteristics: Clearly defined criteria for patient eligibility, including demographic and clinical factors relevant to the medication’s intended use, are specified. This ensures that the medication reaches the appropriate patient population and quality assurance and control of agreed on memorandum of understanding.
• Endpoints and Definition of Response: The agreement outlines both primary and secondary clinical endpoints to evaluate the medication’s effectiveness. Additionally, a precise definition of what constitutes a positive response is provided, focusing on improvement in clinical measures and patient-reported outcomes.
• Assessment of Response: Detailed methods for assessing patient responses are described, including the tools and methodologies used, as well as the frequency of assessments, which are scheduled at regular intervals from the start of treatment.
• Time of Assessment: The timing and duration of assessments are outlined, specifying when evaluations will take place, and the overall follow-up period required to measure the medication’s impact effectively.
• Financial Component: The pricing structure of the medication is presented, including any discounts, rebates, or performance-based pricing arrangements. A cost-benefit analysis is also included to project the financial impact on the payer, evaluating potential cost savings and budget implications.

This structured approach ensures that the MEA comprehensively addresses clinical, economic, and operational considerations, supporting effective medication management and access.

 Implementation of Managed Entry Agreements:

The implementation of Managed Entry Agreements (MEAs) follows several key phases, each crucial for ensuring the success of the agreement. These phases include:

1. Pre-Assessment and Feasibility

• Objective: This initial phase involves evaluating whether an MEA is the best strategy for introducing a new product. Stakeholders assess the technology’s clinical and economic uncertainties, and whether these can be addressed through real-world evidence.
• Key Activities:
  • Identification of uncertainties (clinical, cost-effectiveness).
  • Stakeholder engagement (manufacturers, payers, regulatory bodies).
  • Feasibility studies and risk-benefit analysis.

2. Negotiation and Agreement Design

• Objective: Payers and manufacturers negotiate the terms of the MEA, including performance indicators, data requirements, and financial arrangements.
• Key Activities:
  • Defining performance outcomes, metrics, and payment models (outcome-based or financial-based).
  • Setting timelines for data collection and reevaluation.
  • Drafting a legal framework that aligns incentives and mitigates risks for both parties.

3. Data Collection and Monitoring

• Objective: In this phase, the agreed-upon real-world data is collected and monitored to track the product’s performance and patient outcomes. For a holistic analysis of the data collected, PRO survey collection can enhance and endorse the final appraisal with inclusiveness of patients’ and caregivers’ perspectives.
• Key Activities:
  • Implementing tracking and data-gathering systems.
  • Continuous monitoring of clinical outcomes or cost-effectiveness.
  • Compliance with the agreed metrics and timelines for data submission.

Evaluation and Adjustment

• Objective: Based on the real-world data collected, the product’s performance is evaluated against the criteria set in the MEA.
• Key Activities:
  • Data analysis to assess if the product meets the performance benchmarks.
  • Adjusting the terms of the agreement if necessary (e.g., modifying coverage or pricing).
  • Stakeholder collaboration to ensure transparency and address any emerging challenges.

5. Outcome Determination and Final Decision

• Objective: Once sufficient data is gathered, the final phase involves determining whether the technology will continue to be covered, the payment structure will change, or other adjustments will be made.
• Key Activities:
  • Final evaluation of the product’s effectiveness and cost-efficiency.
  • Decision-making on the future of technology: continue, modify, or discontinue the agreement.
  • Formal closing of the MEA or transitioning into long-term reimbursement policies.

6. Post-Agreement Review

• Objective: Review the entire MEA process to derive insights for future agreements, focusing on lessons learned.
• Key Activities:
  • Analysis of data accuracy and agreement success.
  • Feedback gathering from stakeholders for improvement.
  • Adjusting frameworks for future MEAs based on the review outcomes.

These phases ensure a structured and transparent process that facilitates the integration of innovative therapies into healthcare systems while managing financial and clinical risks.

Dos and Don’ts of Implementing Managed Entry Agreements (MEAs)

Do’s of Implementing MEAs

1. Conduct a Comprehensive Assessment of Clinical Uncertainty:
   • The success of an MEA depends on the accurate assessment of clinical uncertainty. VBAs are more suitable for technologies with well-established value, while PBAs are better suited for innovative therapies with uncertain real-world outcomes. Conducting a thorough clinical and economic evaluation is essential before deciding on the type of MEA to implement.
2. Incorporate Robust Data Collection and Monitoring Systems:
   • PBAs require a robust infrastructure for collecting and analyzing real-world data. This includes setting up electronic health records, patient registries, and other data collection systems that can accurately track patient outcomes over time. The data collected should be reliable, timely, and relevant to the agreed-upon performance metrics.
3. Engage Key Stakeholders Early in the Process:
   • The success of MEAs depends on the alignment of objectives among all stakeholders, including payers, manufacturers, healthcare providers, and patients. Engaging stakeholders early in the process helps to build consensus and ensures that the agreement reflects the needs and expectations of all parties involved.
4. Define Clear and Measurable Outcomes:
   • Both VBAs and PBAs should include clear, measurable outcomes that are relevant to the patient population and the healthcare system. These outcomes should be agreed upon by all stakeholders and should be based on clinical evidence and real-world data. Ambiguity in outcome definitions can lead to disputes and undermine the effectiveness of the MEA.
5. Consider the Long-Term Sustainability of the Agreement:
   • MEAs should be designed with long-term sustainability in mind. This includes considering the potential for price adjustments, the duration of data collection, and the ongoing monitoring of outcomes. The agreement should also include provisions for renegotiation if the initial assumptions about the technology’s value or performance prove inaccurate.

Don’ts of Implementing MEAs

1.  Don’t Overlook the Administrative Burden:

1. • Implementing an MEA, particularly a PBA, can be administratively complex and resource intensive. This burden can deter healthcare providers from participating fully in the agreement, leading to data quality issues and compromised outcomes. It is essential to ensure that the administrative requirements of the MEA are manageable and that healthcare providers are adequately supported.
2. Avoid Agreements with Ambiguous or Unmeasurable Outcomes:
   • Outcomes that are difficult to measure or interpret can lead to disputes and undermine the effectiveness of the MEA. It is crucial to avoid outcomes that are subjective or not directly tied to patient benefit. Instead, focus on outcomes that are clinically relevant, measurable, and directly linked to the value or performance of the health technology.
3. Don’t Neglect the Need for Long-Term Follow-Up:
   • MEAs, especially PBAs, require long-term data collection and follow-up to assess the technology’s effectiveness and cost-effectiveness. Neglecting long-term follow-up can result in missed opportunities to refine the agreement and may lead to suboptimal patient outcomes. Ensure that the agreement includes provisions for ongoing data collection and outcome monitoring.
4. Avoid a One-Size-Fits-All Approach:
   • Healthcare systems in different countries have unique characteristics, and what works in one context may not be appropriate in another. MEAs should be tailored to the specific needs of the healthcare system, taking into account local regulations, healthcare infrastructure, and patient population. Avoid adopting MEAs from other countries without adapting them to the local context.

Regional Review: Managed Entry Agreements in the Middle East

The Middle East is a region of diverse healthcare systems, ranging from highly developed systems in the Gulf Cooperation Council (GCC) countries to more nascent systems in other parts of the region. As the demand for innovative therapies grows, several Middle Eastern countries have begun to explore the use of MEAs to manage the introduction of high-cost health technologies.

Saudi Arabia

Saudi Arabia’s healthcare system is undergoing significant transformation as part of the Vision 2030 initiative, which aims to diversify the economy and improve the quality of healthcare services. In this context, MEAs have gained attention as a tool to manage the introduction of new therapies, particularly in the oncology and rare disease sectors. Saudi Arabia and specifically the Ministry of Health have been a beacon globally and regionally in their transformational shift toward value based healthcare including innovative contracting and coverage of highly expensive cutting-edge tehrapies.

Current MEA Practices in Saudi Arabia

Saudi Arabia has begun to experiment with both VBAs and PBAs, particularly for high-cost therapies such as cancer drugs and orphan drugs. The Saudi Food and Drug Authority (SFDA) and the Ministry of Health have been instrumental in shaping the policy framework for MEAs. However, the implementation of MEAs in Saudi Arabia is still in its early stages, with limited public information available on specific agreements.

Challenges and Opportunities in Saudi Arabia

The primary challenge in Saudi Arabia is the lack of a comprehensive data infrastructure to support PBAs. While the country has made significant investments in healthcare IT, there is still a need for more robust systems to track patient outcomes and collect real-world evidence. On the other hand, the government’s commitment to healthcare reform and the growing focus on cost-effectiveness provide a strong foundation for the future expansion of MEAs.

Establishing and executing Managed Entry Agreements (MEAs) comes with a variety of challenges. These include the inherent complexity of negotiating and managing MEAs, given the need for tailored agreements, data tracking systems, and alignment among multiple stakeholders. There are also significant data requirements, as outcome-based MEAs rely on robust data collection and analysis, which can be difficult to achieve due to challenges in securing real-world data and agreeing on the appropriate metrics.Additionally, MEAs require flexibility, as healthcare landscapes and evidence can evolve over time. Agreements must be adaptable to these changes without losing sight of their core objectives.

Finally, sub-national variations in healthcare systems present challenges. MEA practices differ between sectors due to varying healthcare models and regulations, which necessitates adapting insights to local contexts. These challenges underscore the complexity of implementing MEAs, requiring careful planning and collaboration across all involved parties.

Case Study: Oncology Drugs in Saudi Arabia

A published pilot PBA in Saudi Arabia involved a novel oncology drug, where the manufacturer agreed to a reimbursement model based on patient survival rates. The agreement allowed the Ministry of Health to mitigate the financial risk while ensuring that patients had access to the latest treatment options.

Lessons Learned:

• Do: Leverage the government’s commitment to healthcare reform to push for the adoption of MEAs.
• Don’t: Rely solely on traditional data sources; invest in new data collection methods to support PBAs.

United Arab Emirates (UAE)

The UAE has one of the most advanced healthcare systems in the Middle East, with a strong emphasis on innovation and technology. The country’s healthcare system is primarily funded by the government, with significant contributions from the private sector. The UAE has shown a growing interest in MEAs, particularly in the context of high-cost, innovative therapies.

Current MEA Practices in UAE

The UAE has implemented several VBAs, particularly in the field of oncology and rare diseases. The Dubai Health Authority (DHA) and the Abu Dhabi Department of Health (DoH) have been at the forefront of these initiatives, working closely with pharmaceutical companies to negotiate value-based pricing agreements. These agreements have focused on linking reimbursement to clinical outcomes such as progression-free survival and overall survival.

Challenges and Opportunities in UAE

One of the main challenges in the UAE is the lack of a standardized approach to MEAs across the emirates. While Dubai and Abu Dhabi have made significant progress, other emirates are still in the early stages of adopting these agreements. There is also a need for greater collaboration between the public and private sectors to streamline the implementation of MEAs across the country.

Case Study: Diabetes Management in UAE

In the UAE, a pilot Managed Entry Agreement (MEA) was implemented for a novel diabetes management drug. The agreement involved a collaboration between the pharmaceutical manufacturer and private insurers, with reimbursement tied to patient adherence and glycemic control outcomes. The MEA helped mitigate the financial risks associated with the high cost of the drug, while ensuring that patients with diabetes could access this advanced treatment option under conditions that emphasized real-world effectiveness.

Lessons Learned in UAE

Do: Leverage outcome-based contracts to ensure that reimbursement is linked to actual patient outcomes, like adherence and control of the disease.

Don’t: Neglect the need for robust data collection to monitor patient progress and outcomes effectively, which is critical for the success of these agreements. This case study reflects a growing trend in the UAE toward using MEAs to balance innovation with financial sustainability, especially for chronic conditions that require long-term management​

Conclusion

In conclusion, Managed Entry Agreements (MEAs) represent a strategic approach to managing the integration of high-cost pharmaceuticals into the healthcare systems of the Middle East and North Africa (MENA) region. As the demand for innovative therapies grows amidst tightening budgets and increasing prevalence of non-communicable diseases, MEAs offer a flexible mechanism to balance cost and access. These agreements, including outcomes-dependent, additional evidence-dependent, price-volume linkage, cost/patient capping, and other models, provide tools to mitigate financial risks and address clinical uncertainties associated with new treatments.

In the MENA region, the adoption of MEAs varies significantly due to diverse healthcare systems and regulatory frameworks. Countries like Saudi Arabia and the UAE are making strides in implementing MEAs, particularly for high-cost oncology and rare disease treatments, while others, such as Lebanon and Egypt, are still in the early stages of adoption. The challenges include establishing robust health technology assessment entities, overcoming regulatory barriers, and ensuring stakeholder alignment. However, the benefits of MEAs, such as enhanced budget predictability and improved access to innovative therapies, underscore their potential to improve healthcare outcomes and manage costs effectively.

To realize the full potential of MEAs, MENA countries need to advance their healthcare infrastructure, develop standardized assessment frameworks, and foster greater collaboration among stakeholders. By addressing these challenges, the region can better leverage MEAs to ensure sustainable healthcare solutions, providing patients with timely access to cutting-edge therapies while managing financial impacts effectively.

Rita El Ojeil, September 2024

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Rita El Ojeil