Pioneering Value-Based Healthcare in MENA

10 Key Takeaways from “Pioneering Value-Based Healthcare in MENA” by Rita El Ojeil

1. Rising Healthcare Costs and Shift to Value-Based Care: Traditional volume-based fee-for-service models have led to escalating healthcare costs. There’s a global shift towards value-based care, which prioritizes patient outcomes over treatment volumes, integrating interdisciplinary services for comprehensive care.
2. Benefits of Value-Based Healthcare (VBHC): VBHC not only improves clinical outcomes for patients but also benefits providers, manufacturers, payers, and society. The COVID-19 pandemic has underscored the importance of VBHC in enhancing healthcare decision-making focused on patient health and quality of life.
3. Health Technology Assessment (HTA): HTA is crucial in VBHC, evaluating the medical, social, ethical, and economic impacts of health technologies. While well-established in regions like North America and Europe, HTA is still emerging in the MENA region, necessitating region-specific strategies.
4. Healthcare Landscape in MENA: The MENA region displays significant economic diversity, with both high-income and low- to middle-income countries. There is a growing recognition of the need for cost-effective health management and rapid access to novel technologies.
5. Managed Entry Agreements (MEAs): MEAs are vital for managing the clinical and financial uncertainties of innovative treatments. They include financial and performance-based arrangements, allowing for controlled drug budgets and ensuring value for money.
6. Challenges and Barriers: The MENA region faces numerous challenges in adopting VBHC, including fragmented healthcare systems, lack of robust data infrastructure, financial constraints, regulatory issues, and resistance to change among healthcare providers and patients.
7. Drivers of VBHC Shift: Key drivers include the need for cost-effective healthcare, the implementation of health economic evaluations, universal health insurance, policy shaping, and the adoption of value-based managed entry agreements.
8. Current Initiatives and Best Practices: Various MENA countries are implementing VBHC elements. For instance, the UAE’s EJADAH model focuses on patient-centric care, and Saudi Arabia is making significant strides with structured health technology assessments and innovative contracting models.
9. Role of Stakeholders: Successful VBHC implementation requires collaboration among governments, healthcare providers, payers, and other stakeholders. Partnerships and negotiations for value-based contracts are essential to establish mutually beneficial agreements.
10. Conclusion and Future Outlook: To advance VBHC in the MENA region, it is crucial to increase awareness among all stakeholders, enhance data infrastructure, adopt outcome-based MEAs, improve cost transparency, fast-track registration and reimbursement processes, include patient advocacy groups in HTA, and foster public-private partnerships.

Please look at the Market Access & HEOR Resource category for more articles.

Introduction

Healthcare prices are on the rise due in part to the conventional External reference pricing system, volume-based fee-for-service care delivery model, which puts pressure on providers to deliver value. Global healthcare systems are gradually shifting from volume-based to value- based care, placing an emphasis on better patient outcomes in comparison to treatment costs.

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Value-based care integrates and coordinates a range of services to provide interdisciplinary expertise and specialized care for people with a particular disease. Value-based healthcare (VBHC) system implementation involves a strategic framework that prioritizes understanding patients’ shared health needs, creating a comprehensive plan to enhance health outcomes, incorporating learning teams, tracking costs and health outcomes, and growing partnerships.

Understanding value-based healthcare

In addition to helping patients achieve better clinical outcomes, VBHC also benefits providers, manufacturers, payers and patients by defining prices that are aligned with patient outcomes, all of which contribute to a healthier society. Moreover, the pandemic of coronavirus illness has highlighted the significance of the VBHC method in distinguishing historical mistakes and readjusting healthcare decision-making to patient health and quality of life.

As a result, it is imperative that the healthcare system be rebuilt with the ability to support patients’ continuous care integrated in its infrastructure. Delivering VBHC calls for a methodical approach and instruments that have consistently produced the desired outcomes, such as managed entry agreements (MEA), multiple criteria decision analysis, and health technology assessment (HTA) principles and agencies.

The main goal of HTA, a multidisciplinary approach, is to maximize the value of public resource allocation by assessing the medical, social, ethical, and economic consequences of developing and utilizing health technology. Pharmaceuticals, medical equipment, and the administrative and support networks that surround healthcare delivery are all considered health technology.

Health technology can be subjected to HTA at many stages of its lifetime, such as pre-market, post-approval, and market phases. The use of HTA to inform policy- decision making is established in North America, Australia, several European countries, and flourishing in Latin America and Asia.

However, in the Middle East and North Africa (MENA), implementation of HTA is still in its early stages. Although HTA implementation strategies from other countries can be considered as a guide, it is prudent for all MENA countries to develop region-specific HTA roadmaps. Currently, in the MENA region, there are several unmet needs for implementation of HTA including inadequate capacity building of human resources, insufficient public budget and institutionalization of scope of HTA from pharmaceuticals to non-pharmaceutical technologies, non-consideration of additional HTA categories such as health care policies, screening initiatives, medical devices etc. with dearth in local data and evidence in terms of patient registries and payer databases.

Current healthcare landscape in the MENA region

 The countries in the MENA region are heterogeneous in terms of economic status, as the region includes some of the highest-income countries globally alongside several low- and middle-income countries. In the recent era of lower oil prices, even high-income Middle East countries are compelled to reevaluate their health policies toward cost-effective management.

Furthermore, there is an increasing recognition among all stakeholders to provide rapid access to novel technologies to patients that address unmet medical needs and provide value for money. Managed Entry Agreements comprise discrete forms of confidential agreements between the pharmaceutical manufacturers and payers (insurance companies, hospitals) that addresses the clinical uncertainties of innovative treatments pertinent to budget impact, cost-effectiveness, and access to new therapies or technologies in health care.

MEAs may enable policy action, allowing stakeholders to probe into a wide range of different types of instruments to address context-specific needs. For pharmaceutical companies, MEAs may provide some predictability about initial price conditions and potential market size estimations and could also help create a more collaborative environment between payers and manufacturers.

The MEAs are typically categorized as finance- or outcomes/performance-based arrangements or a hybrid model of both. The finance-based MEA caters to financial aspects such as product-level cost-sharing efforts and does not link reimbursement decisions to health outcomes. The performance-based MEAs are the arrangements that propose the reimbursement levels based on the clinical outcomes through meaningful real-world effectiveness of the drug.

The healthcare structure across the MENA countries is largely varied in terms of funding, drug registration, pricing process, reimbursement policies, procurement methods, regulatory structure, and legal framework. In general, there is dearth of published evidence on MEA experiences in the MENA region, as compared to the United States, Australia, and the United Kingdom.

The promotion of VBHC involves integrated healthcare, meaningful patient-centered outcome measures, high level policy, existence of HTA organizations, evidence-based guidelines, and innovative funding models. In addition, the education of health professionals, development of a skilled workforce in VBHC, maintenance of interoperable electronic health records and stakeholder engagement are required for addressing knowledge gaps of the existing healthcare system.

The value-based structure drives manufacturers to focus on innovative patient outcomes in a cost-effective manner. Financial-based and value-based model systems are two different types of contract systems of MEAs. The value-based system supports the Coverage with Evidence Development (CED) model that follows a system for payers to provide a conditional price when there is uncertainty about the cost-effectiveness of a new health technology at the time of reimbursement.

In some circumstances, the value-based system favors performance-linked payments as most of the payers are willing to pay for real-life outcomes and test results. Most of the MEAs executed in Middle East countries are financial–based and outcome-based agreements are at a relatively nascent stage.

In the UAE, there has been no HTA policy or the Health Economics strategy at a national level to date. In Dubai, the EJADAH model was launched in 2022 with the goal of developing a sustainable and patient-centric healthcare system.

In Saudi Arabia, the Ministry of Health spearheaded since 2018 a transformational shift with a 4 phased-out approach towards a full transition through the adoption of a strategic guidance on health economic evaluation, spearheading the execution of the willingness-to-pay threshold and Valuation studies along the first national pilot on multi-criteria decision analysis. Recently the SFDA released their strategic guidance on health technology assessment however implementation is yet to be observed.

The Egyptian Pharmacoeconomic Evaluation Unit was established in 2013 to support various reimbursement decisions, especially for new technologies. The Universal Health Care Coverage Law of 2018 helps in improving access to health services of Egypt. This law was implemented in July 2019 and stimulated substantial progress towards Universal Health Coverage (UHC). Within 15 years all Egyptians are expected to be under the coverage of the Universal Health Insurance (UHI) scheme, with a benefit package of quality health services and financial protection.

With the Health Vision 2050, the Omani government’s strategic development plan for healthcare in the country outlines the need for the expansion of specialist services and development of innovative healthcare financing and insurance solutions. Kuwait has also taken initiative to improve its healthcare system at a reasonable cost by implementing the Development Plan of 2010 –2020 as well as 2035.

Challenges and Barriers for the Adoption of VBHC in MENA

 Adopting Value-Based Healthcare (VBHC) in the Middle East and North Africa (MENA) region presents a unique set of challenges and barriers. The healthcare systems in many MENA countries are fragmented, making the standardization of VBHC practices difficult. Additionally, there is a significant lack of robust data infrastructure essential for effective VBHC implementation. Financial and economic constraints also play a critical role; transitioning to VBHC requires substantial investment in technology, training, and infrastructure, which can be prohibitive for resource-constrained nations. Traditional fee-for-service payment models are still prevalent, creating further difficulties in shifting towards value-based payment structures.

Regulatory and policy issues add another layer of complexity. Many countries in the MENA region lack the necessary regulatory frameworks to support VBHC initiatives, and aligning national health policies with VBHC principles can be a long and arduous process. Cultural and social factors, such as resistance to change from healthcare providers and patients accustomed to the current system, also pose significant challenges. Furthermore, there is a general lack of awareness and understanding of VBHC among healthcare professionals and the public.

Human resource constraints are another barrier. The successful implementation of VBHC requires extensive training and education of healthcare providers, and some countries face a shortage of skilled healthcare professionals. Technological barriers, including the nascent stage of health information technology (HIT) adoption and the lack of interoperability between different health information systems, also impede progress. Lastly, effective VBHC relies on accurate measurement of health outcomes, but the lack of standardized metrics and data, as well as the difficulty in establishing benchmarks for health outcomes and quality, presents additional hurdles.

Addressing these multifaceted challenges requires a concerted effort from governments, healthcare providers, and other stakeholders to create an enabling environment for the successful adoption of VBHC in the MENA region.

Drivers of the shift to VBHC in the region

 Regional market readiness for VBHCs

 Current status of implementation of VBHC and VBHC enablers

 The transition from a volume-based to a value-based healthcare model is in its early or slightly advanced stages. In the UAE, several institutions have made progress in adopting VBHC through health economic evaluations, outcome measurements, universal health insurance, policy shaping, and value-based managed entry agreements (MEAs). Key enablers in this region include value-based agreements and real-world data generation.

In Egypt, the adoption of Health Technology Assessment (HTA) for pharmaceuticals and medical devices is emerging. The Egyptian Authority for Unified Procurement (UPA) plays a crucial role in the ongoing healthcare restructuring. UPA sets specifications and criteria for pharmaceutical preparations, medical supplies, and equipment, with devices meeting these standards receiving a unique GS1 code. Suppliers must use the GS1 global trade item number (GTIN) to code their products in the UPA database, allowing for product tracking and price monitoring. Additionally, acquisition prices for medications with generics and biosimilars are low, and notably, 90% of medications without generics or biosimilars are sold without discounts.

In Saudi Arabia, the healthcare system is more structured compared to several well- developed countries and has made significant strides in transitioning to a value-based model. Various metrics, including structured guidance on health technology assessment including Burden of disease models, mandatory Budget impact analysis and with the publication of the Saudi Valuation study the introduction of cost-utility analysis with negotiated confidential innovative contracting models oscillating towards a hybrid model of performance based agreements with free treatment initiation periods, price agreements, capping, and financial-based agreements, are being utilized to facilitate this transition. The Saudi Ministry of health have been a beacon in this transformational shift spearheading multiple initiative falling under VBHC such as willingness-to-pay thresholds, EQ-5D-5L and MCDA studies.

 VBHC adoption process in the MENA region

 Distribution of financial vs outcome-based MEA

 In Saudi Arabia, several finance-based agreements have been implemented, with metrics including discounts, free treatment initiation periods, price agreements, and capping. Value- based or outcome-based agreements are supported by state-of-the-art registry platforms and prospective studies. Reimbursement plans for outcome-based agreements are based on remission or response criteria of the disease state.

For each disease condition, a specialized committee led by an expert defines strategies to guide the use of managed entry agreements (MEAs) and implement a governance framework that ensures transparency. A significant barrier to the successful implementation of MEAs is the lack of robust data and infrastructure.

In the MENA region, negotiations for value-based managed entry agreements (VBMEAs) have been a focal point. Effective VBHC is supported by value-based contracts that facilitate population health management and other activities. Partnerships are crucial for value-based care, and the negotiation process is key to establishing mutually beneficial partnerships. Provider organizations must be prepared to negotiate with payer partners to ensure appropriate and favorable contracts, with a fundamental understanding of their organization and patient population setting the stage for smooth negotiations.

Execution of VBMEAs in collaboration with national tender entities involves regulators, payers, and sponsors. Regardless of the discounts offered by sponsors, the Ministry of Health (MOH) opts for value-based agreements, a similar approach usually considered throughout budget impact models (BIM) and cost-effective analysis (CEA). Collaboration for value-based contracting is expected to improve with cost transparency of medical devices and drugs.

In Egypt, a study evaluating the final cost of medications from tender sequences found that in 40% of cases, MOH services were cheaper, and in 30% of cases, they were the same price. A basic understanding of the organization and patients is required for contract negotiations.

Collaboration among stakeholders, appropriate rules and regulations, and oversight of clinical, economic, and human-centric outcomes are essential for the transition to VBHC.

Healthcare models in the MENA region are predominantly fragmented, supply-driven and the cost of healthcare expenditure of senior citizens is expected to double by 2050. In addition, MENA countries have significantly higher burden of NCDs, oncology, cardiology, diabetes, and other metabolic disorders. Therefore, a shift towards VBHC will be utmost necessary and beneficial for the MENA countries to develop a cost-effective, patient-centric, sustainable healthcare system. In recent years, the value-based system is being propagated across the MENA regions. The healthcare system in MENA has been undergoing transformation to facilitate successful integration of the MEAs. However, the design, policies, and implementation of value-based models in different MENA countries can vary based on the requirements and perceptions of different stakeholders, policy makers, government payers, regulators, and market experts.

Current Initiatives and Best Practices:

 Several healthcare institutions in UAE have adopted multiple components of VBHC concept in terms of health economic evaluation, outcome measurement, universal health insurance, policy shaping, and value-based MEA. With 10M individuals covered by health insurance, the UAE ranks 20th in the World Index of Healthcare Innovation, with an overall score of 45.23. This is much higher in comparison to several developed countries.

Dubai Health Authority (DHA) and its health insurance regulatory body have launched a “first-of-its-kind” digital-led program called EJADAH that will emphasize value rather than volume and will improve health sector by overseeing clinical, economic, and human- centric outcomes.

This model unique to Dubai has been introduced by the health insurance regulator of the city. The value-based EJADAH model will implement policies and regulations to accelerate the development of the health sector giving priority to the patients. This value-based model aims to provide healthcare service providers with evidence-based guidelines which will be a framework for all physicians to follow with regard to treatment protocols. The model will implement new technologies for early detection of diseases that can eventually minimize the treatment expenses. The value-based model will give priority to patient-centricity and lead to a sustainable health system while allowing access to next-generation technology. In addition, this will pave the way and inspire other territories in the region to consider similar approaches to improve the healthcare system.

The healthcare system of Egypt is primarily financed through out-of-pocket payments. In most cases, there are no subsidies, and the funds are directly paid to providers causing serious financial hardships for the user. Moreover, the private sector is getting dominant in Egypt and there is an involvement of multiple stakeholders and semi-autonomous providers along with their own sets of rules and regulations therefore there is an utmost need for a HTA related policy and guideline for the benefit of patients.

In Egypt, HTA adoption for the pharmaceuticals and medical implants are in the emerging stage and highlighted that MEAs were slowly getting integrated with the healthcare system. There is also an abundant need for Real-World Data, such as claims data, electronic medical records, population-based surveys that can estimate the overall burden, expenditure, and Patient- centered Outcome of the treatment.

The Egyptian Authority for Unified Procurement (UPA) was established under Law act No.151 of 2019 as an integral part of the current healthcare restructuring. The health sector of Egypt is undergoing a massive reformation, which will provide Universal Health Coverage (UHC) by 2030. UPA is a strategic health technology management entity that enables efficient utilization of resources and a sustainable equitable access to all Egyptians. The role of UPA is to effectively contribute to the core values of Egypt’s 2030 healthcare vision: Equity, Solidarity, and Efficient Allocation of Resources. The focus of UPA is to achieve financial sustainability for the Egyptian healthcare system by maximizing the available resources. In addition, UPA also sets goal in increasing the efficiency of the inventory management process, supporting the insurance project, promoting the competitiveness of the local pharmaceutical industry, improving the country’s trade balance, business climate, inter-regional collaboration, and eventually expanding new markets for exportation and enhancing the productivity of the robust and sustainable medical supply chain operations.

UPA develops procurement policies and takes the necessary measures to purchase pharmaceutical preparations, medical supplies, and equipment for the benefit of the requesting parties. Another important role of UPA is coordination with the requesting parties for the assessment of advanced health care technology. In addition, UPA helps in developing the management of the unified maintenance system for medical devices to improve after-sales services. HTA within UPA started evaluating the costs and benefits of some of the expensive treatments, such as oncology pharmaceuticals.

All medical equipment that met the standards and specifications set by the UPA was provided with a unique GS1 code. All the suppliers were obligated to use GS1 global trade item number (GTIN) to code their product via UPA database, so that UPA could track the products and follow up with the prices of the products. Using the data, UPA could assess the use and value for the price of the medical product and decide upon further steps.

Healthcare expenditure is a top priority of the KSA Government, and it accounts for 60% of the Gulf Cooperation Council (GCC) countries’ healthcare expenditure. KSA is planning to invest

$66.67 billion and boost private sector participation from the current 40% to 65% by 2030 on healthcare and social development. There is a target of privatization of 290 hospitals and 2,300 primary health centers to boost the quality and efficiency of the health care sector for a value-based model of care.

Saudi Arabia’s Vision 2030 has taken initiative in the development of its healthcare sector through privatization of some government services and adopting Public Private Partnerships (PPPs). The Saudi government has laid out a roadmap with the legislative framework. Primary healthcare in Saudi Arabia is the first level of healthcare services provided by the MOH as basic curative and preventative services, while those requiring higher levels of health services are referred to the secondary and tertiary level of care.

As the life expectancy in KSA is projected to increase from 76.4 to 81.8 years by 2050, and the population is expected to grow from 33.5 million in 2018 to 39.5 million by 2030, therefore an increased investment and improvised healthcare system will be beneficial for healthcare sector. Because of the improvement in life expectancy, the number of older populations is expected to grow from 1.96 million in 2018 to 4.63 million by 2030. The major demographic shift in population dynamics will be associated with an increased burden of lifestyle related diseases and NCDs emphasizing the requirement of the specialized and improvised healthcare system. The MOH has already implemented a multitude of VBMEAs in various therapeutic areas of Hematology, rare diseases, immune mediated inflammatory diseases, CNS and beyond.

MEAs are important for optimizing access to innovative medications for patients and help in managing the budget impact on healthcare expenditure. There is acknowledgement that regulators, payers and sponsors would get involved to execute VBMEA in collaboration with National tender entities and regardless of what the sponsor offers as discount, MOH would opt for value-based agreement. A similar approach was implemented for budget impact model (BIM) and cost-effective analysis (CEA). It should be also mentioned that collaboration for value-based contracting would improve with cost transparency of medical devices/drugs.

We should emphasize the importance of inclusion of patient advocacy groups in the HTA process. A patient-centric approach to healthcare is critical in enhancing clinical outcomes and quality of life; this approach includes involvement of patients in their own care and clinical decision-making process. Patient advocacy groups also help healthcare providers and regulators to understand the needs, wishes, concerns and priorities of patients, and caregivers.

Conclusion:

Countries in this region are in the emerging to evolved phases of integrating VBHC elements into their healthcare systems. Increasing awareness of VBHC among all stakeholders, including providers and patients, is crucial for further progress across the MENA region. A robust data infrastructure is essential to enable the measurement of costs and outcomes, driving continuous improvement in VBHC. Key elements for improving health outcomes and ensuring equity and sustainability in a high-quality, value-based healthcare system in the MENA region include increased adoption of outcome-based managed entry agreements (MEAs), enhanced cost transparency and negotiations, fast-tracking registration and reimbursement processes, including patient advocacy groups in the Health Technology Assessment (HTA) process, and fostering public-private partnerships.

Rita El Ojeil, August 2024

10 FAQs on “Pioneering Value-Based Healthcare in MENA” by Rita El Ojeil

1. What is Value-Based Healthcare (VBHC)?

Answer: VBHC is a healthcare delivery model that prioritizes patient outcomes relative to the cost of treatment. It integrates and coordinates a range of services to provide comprehensive and specialized care, aiming to improve the overall quality of care while controlling costs.

2. Why is there a shift from volume-based to value-based care?

Answer: The traditional volume-based fee-for-service model has led to rising healthcare costs without necessarily improving patient outcomes. The shift to value-based care aims to address these issues by focusing on better health outcomes, patient satisfaction, and cost-efficiency.

3. What are the main benefits of VBHC?

Answer: VBHC benefits patients by improving clinical outcomes and overall health. It also benefits providers, manufacturers, and payers by aligning prices with patient outcomes, reducing inefficiencies, and fostering a healthier society.

4. How does Health Technology Assessment (HTA) contribute to VBHC?

Answer: HTA is a multidisciplinary approach that evaluates the medical, social, ethical, and economic impacts of health technologies. It helps in making informed decisions about the allocation of public resources, ensuring that health technologies provide value for money and meet patient needs.

5. What are Managed Entry Agreements (MEAs)?

Answer: MEAs are confidential agreements between pharmaceutical manufacturers and payers that address clinical uncertainties and budget impacts of innovative treatments. They can be financial-based or performance-based, helping to manage costs and ensure access to new therapies.

6. What challenges does the MENA region face in adopting VBHC?

Answer: The MENA region faces challenges such as fragmented healthcare systems, lack of robust data infrastructure, financial and economic constraints, regulatory and policy issues, resistance to change, and a shortage of skilled healthcare professionals.

7. What are the drivers of the shift to VBHC in the MENA region?

Answer: Drivers include the need for cost-effective healthcare management, the implementation of health economic evaluations, the establishment of universal health insurance, policy shaping, and the adoption of value-based managed entry agreements.

8. What current initiatives and best practices are being implemented in the MENA region?

Answer: Various MENA countries have adopted components of VBHC. For example, the UAE’s EJADAH model emphasizes patient-centric care, and Saudi Arabia has implemented structured health technology assessments and innovative contracting models to facilitate the transition to VBHC.

9. How important are partnerships and stakeholder collaboration in VBHC?

Answer: Successful VBHC implementation relies heavily on partnerships and collaboration among governments, healthcare providers, payers, and other stakeholders. These partnerships help negotiate value-based contracts, align interests, and ensure that healthcare delivery is patient-centric and cost-effective.

10. What is the future outlook for VBHC in the MENA region?

Answer: The future outlook for VBHC in the MENA region involves increasing awareness among stakeholders, enhancing data infrastructure, adopting outcome-based MEAs, improving cost transparency, fast-tracking registration and reimbursement processes, including patient advocacy groups in HTA, and fostering public-private partnerships. These efforts aim to build a sustainable, equitable, and high-quality healthcare system.

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Rita El Ojeil