Organized by the ISPOR Arabic Network, the forum titled Economic Evaluation Guidelines in Middle East and North Africa: From Development to Implementation was held on November 8th, 2022 during ISPOR Europe 2022. This event brought together a panel of experts from countries in the Middle East to talk about their experiences in developing and implementing economic evaluation guidelines. The speakers discussed the issues and challenges of developing and implementing their guidelines and the impact of these guidelines on their healthcare systems. Evidence, data, and insights into the development and implementation of these guidelines were provided in this session. This brief summarized reflections from these experts.
Importance of Economic Evaluation Guidelines on the Health Sector
Presented by: Rita Karam, PharmD, PhD, Chair of ISPOR Arabic Network, Director of Quality Assurance of Pharmaceutical Products Program of Ministry of Public Health, and Professor of Faculty of Sciences and Medical Sciences, Lebanese University, Beirut, Lebanon
The Universal Health Coverage Cube by the WHO , demonstrate clearly that the pool of funds dedicated for healthcare is an essential building block that impacts all of the 3 axes of the cube: The percentage of the population covered, the services covered, and the proportion of the costs covered. Pooling additional funds for healthcare is a way to deliver more on each of these axes but that is not an easy task, especially with the competing priorities at national level. However, another way for delivering better on these axes, would be to optimize the efficiency of the health system’s investment in healthcare. Therefore, the discipline of HTA emerged, to support the decision-making process related to the investment decisions in healthcare.
One of the main objectives of HTA, is to optimize the efficiency and so, when efficiency is in scope, measuring the value of interventions is primordial. Thus, tools such as economic evaluations were developed in order to measure the added clinical benefit and cost of each intervention, across its lifecycle. The methodologies of these tools have evolved over time, in an attempt to better measure the value of interventions; and it also became relatively complex. Since decision makers will rely on Economic Evaluations, at least partly, in order to conclude investment decisions in healthcare, it is essential that these Economic Evaluations are of quality. Therefore, researchers have developed checklists such as the Consolidated Health Economic Evaluation Reporting Standards or CHEERS with the objective of ensuring the completeness of the reporting of economic evaluations. Despite similarity in the overall processes, variation in several recommendations given by various national HEE guidelines was observed. This is perhaps unsurprising given the differences in the health systems and financing mechanisms, capacity of local researchers, and data availability.
Economic Evaluation Guideline Development: The Lebanese experience
Presented by: Caroline Daccache, MSc, Ph.D. candidate in the Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands, Research & Development Manager in Mediphar Laboratories, Dbayeh, Lebanon, and Maastricht Health Economics and Technology Assessment Center affiliate.
At a national level, developing Economic Evaluation Guidelines (EEGs) to conduct, and assess Economic Evaluation studies, is fundamental. Our objective was to transparently share and report the steps followed in developing the Lebanese Economic Evaluation Guideline (LEEG). This development consists of a structured, and systematic process. The guideline development group is composed of an expert in health systems and representative of potential users; an expert in Health Technology Assessment and health economics, and an expert in research synthesis and knowledge translation. To retrieve the evidence, two systematic reviews were conducted; “EEGs in LMICs” https://doi.org/10.1017/S0266462321000659, and “The development process of EEGs in LMICs” https://doi.org/10.1017/S0266462322000186. Lebanese key stakeholders were selected purposively and equitably given their involvement in the healthcare system. The participants were involved in a deliberative process for issuing recommendations. Survey filling, in-person interviews and consensus workshop were performed to draft the recommendations. Moreover, consulting experts were crucial to set and issue LEEG. This methodological roadmap will be a tool for health system guideline developers to develop their national guideline.
Economic Evaluation Guidelines Implementation: The Egyptian experience
Presented by: Randa Eldessouki MBBCH, MSc, MD, Member of ISPOR Egypt Chapter and Associate professor of Public Health, and Health Economics, Faculty of Medicine, Fayoum University, Egypt
Egypt was the first country in the MENA region to develop and implement economic evaluation guidelines for pharmaceuticals in 2013. The guideline set the standards by which the Pharmacoeconomic unit under the Egyptian Ministry of Health and Population will conduct the economic evaluation and appraisal of high budget impact pharmaceuticals. Following the guideline’s recommendations, eighty-six economic evaluations/appraisals were conducted in 2015. Recommendations were adopted in 90% of cases despite being not mandatory optimizing resources use.
Recognizing the fragmentation of the health care system and the need for Universal Health Care Coverage to achieve equity and ensure sustainability of quality health care services, new laws and decrees were declared in 2018-2019. Accordingly, a restructure of the health care system was implemented. Five autonomous authorities supporting the Ministry of Health were founded to improve governance, accountability and to efficiently allocate resources and contain the rise in health expenditure. Under the Unified Procurement Agency (UPA), an HTA central administration was created with the aim of expanding economic evaluation into a full Health Technology Assessment covering all health technologies and not just pharmaceuticals for optimum allocation of resources across all sectors of health care services.
One of the initial activities of the HTA was to develop in collaboration with the Universal Health Insurance Authority (UHIA), the national payer, a submission dossier guideline for health technologies including an economic evaluation section. Abiding by the guideline is one of the mandatory requirements for procurement/coverage submission. The first in the series of submission dossier guidelines with an economic evaluation section was developed in 2021 for first to market high budget impact pharmaceuticals. The guideline is based upon the EUnetHTA technical guideline as well as the Egyptian economic evaluation recommendations published in 2013 with modifications and adaptations to fit the current need and follow the most up to date methodologies. It went through a pilot phase before formally being launched in 2022. A paper outlining and detailing the steps and process taken to develop the guideline and the interpretation of its different part is currently going through the process of publication and expected to be available early 2023.
The HTA submission dossier including its economic evaluation section which is adopted by both the main procurement as well as the reimbursement agency, constitute the first HTA guideline to be implemented for procurement/coverage in the MENA region
Practical considerations concerning the development and implementation of HTA and Economic Evaluations, relevant to countries with limited capacities
Presented by: Wadih Mina, Pharm D, MSc Pharmaceutical Marketing, MSc Health Economics, MSc Global Health Policy (2024), Access & Policy Enabler at Roche.
Health Technology Assessment (HTA) frameworks have often been positioned as the “state-of-the-art” tools that rely on extensive data and complex analyses, so decision makers optimize the quality of the investment decisions in healthcare. However, from the perspective of the health systems with limited capacities, these frameworks might look as an “unattainable objective” once framed as “state-of-the-art”. Accordingly, this framing of “HTA” reinforces their status-quo bias, and leads to no significant improvements on their decision-making process. An alternative perspective, would look at HTA as the current decision-making process, mapping it, and trying to improve its attributes; making the process explicit, relying on evidence, ensuring a multi-stakeholder’ involvement. The presentation also draws the attention to the Evidence Informed Deliberative Process, as a possible framework to guide decisions within countries with limited capacities.
Marc J. Roberts, William C. Hsiao & Michael R. Reich (2015) Disaggregating the Universal Coverage Cube: Putting Equity in the Picture, Health Systems & Reform, 1:1, 22-27, DOI: 10.1080/23288604.2014.995981