Framework for developing cost-effectiveness analysis threshold: the case of Egypt.

BACKGROUND: Cost-effectiveness analyses rarely offer useful insights to policy decisions unless their results are compared against a benchmark threshold. The cost-effectiveness threshold (CET) represents the maximum acceptable monetary value for achieving a unit of health gain. This study aimed to identify CET values on a global scale, provide an overview of using multiple CETs, and propose a country-specific CET framework specifically tailored for Egypt. The proposed framework aims to consider the globally identified CETs, analyze global trends, and consider the local structure of Egypt's healthcare system. METHODS: We conducted a literature review to identify CET values, with a particular focus on understanding the basis of differentiation when multiple thresholds are present. CETs of different countries were reviewed from secondary sources. Additionally, we assembled an expert panel to develop a national CET framework in Egypt and propose an initial design. This was followed by a multistakeholder workshop, bringing together representatives of different governmental bodies to vote on the threshold value and finalize the recommended framework. RESULTS: The average CET, expressed as a percentage of the gross domestic product (GDP) per capita across all countries, was 135%, with a range of 21 to 300%. Interestingly, while the absolute value of CET increased with a country's income level, the average CET/GDP per capita showed an inverse relationship. Some countries applied multiple thresholds based on disease severity or rarity. In the case of Egypt, the consensus workshop recommended a threshold ranging from one to three times the GDP per capita, taking into account the incremental relative quality-adjusted life years (QALY) gain. For orphan medicines, a CET multiplier between 1.5 and 3.0, based on the disease rarity, was recommended. A two-times multiplier was proposed for the private reimbursement threshold compared to the public threshold. CONCLUSION: The CET values in most countries appear to be closely related to the GDP per capita. Higher-income countries tend to use a lower threshold as a percentage of their GDP per capita, contrasted with lower-income countries. In Egypt, experts opted for a multiple CET framework to assess the value of health technologies in terms of reimbursement and pricing.

Maximizing the benefits of using biosimilars in Egypt.

BACKGROUND: Biosimilars constitute a pathway for sustainable financing of healthcare systems in the era of expensive biologics. However, such a pathway is not free of challenges. Since the biosimilars market is expanding in Egypt, there is an urgent need for a policy framework to optimize their use and diffusion in the market. We aim to characterize a national framework based on the experiences of other countries and consultation with local experts. METHODS: A narrative literature review was conducted to identify biosimilars' policy elements worldwide. A workshop was organized with experts to discuss the narrative review findings and create consensus on recommendations. RESULTS: The narrative literature review highlighted the need for biosimilar policy actions in four areas: market authorization, pricing, reimbursement, and uptake. Eighteen experts representing the Egyptian healthcare authorities attended the workshop. The most significant conclusions from the workshop included setting the price of the biosimilar at 30-40% less than its originator's price and establishing financing protocols, in which the more expensive biologics with significant price premiums should be excluded from the formulary. CONCLUSIONS: A summarized national framework policy recommendation for biosimilars was created by local experts from the main public healthcare entities in Egypt. These recommendations coincide with the international policies adopted across different countries that aim to improve patient access while sustaining health expenditure.

A roadmap toward implementing health technology assessment in Egypt.

Background: The Egyptian healthcare system is currently in the early phase of health technology assessment (HTA) implementation. The aim of this study is to propose an implementation roadmap based on the national healthcare system status. Methods: A survey was conducted among Egyptian healthcare sector decision-makers to assess the current and future (preferred) HTA implementation status in Egypt based on a widely used international scorecard methodology. Subsequently, interviews were conducted with experts representing middle- and top-tier management in the Egyptian healthcare system to interpret the survey results and recommend specific actions. Results: Experts recommended more capacity-building programs for HTA and health economics. Additionally, they proposed establishing HTA units in separate healthcare authorities and merging them into a single central HTA unit in the long term. Regarding the scope of implementation, experts recommended commencing with the assessment of innovative pharmaceuticals, and thereafter, expanding the scope to cover all health technologies in the long term. Additionally, they recommended using innovative tools such as "multi-criteria decision analysis (MCDA)" for tendering, and "managed entry agreements" for reimbursement decisions. Local burden of diseases and costing studies were also recommended to facilitate the implementation of HTA. Conclusion: Experts agreed that several actions are required for successful HTA implementation in Egypt, including coordination between HTA bodies, application of an explicit MCDA framework, and strengthening of local evidence generation. To implement these actions, investment in technical capacity-building is indispensable. Most experts favored using multiple and soft cost-effectiveness thresholds. Efforts should be made to publish HTA submission guidelines and timelines of the processes.

Delayed payment schemes in Central-Eastern Europe and Middle-East.

The need for innovative payment models for health technologies with high upfront costs has emerged due to affordability concerns across the world. Early technology adopter countries have been experimenting with delayed payment schemes. Our objective included listing potential barriers for implementing delayed payment models and recommendations on how to address these barriers in lower income countries of Central and Eastern Europe (CEE) and the Middle East (ME). We conducted a survey, an exploratory literature review and an iterative brainstorming about potential barriers and solutions to implement delayed payment models in these two regions. A draft list of recommendations was validated in a virtual workshop with payer experts from the two regions. Eight barriers were identified in 4 areas, including transaction costs and administrative burden, payment schedule, information technology and data infrastructure, and governance. Fifteen practical recommendations were prepared to address these barriers, including recommendations that are specific to lower income countries, and recommendations that can be applied more universally, but are more crucial in countries with severe budget constraints. Conclusions of this policy research can be considered as an initial step in a multistakeholder dialogue about implementing delayed payment schemes in CEE and ME countries.

Dapagliflozin cost-effectiveness analysis in heart failure patients in Egypt.

AIMS: In Egypt, cardiovascular (CV) diseases are not only the cause of 33% of disability-adjusted life years but are also a leading cause of death. This study aimed to evaluate dapagliflozin's cost-effectiveness as an add-on to the standard of care (SOC) for the treatment of heart failure with reduced ejection fraction (HF-rEF) from the Egyptian healthcare system perspective. MATERIALS AND METHODS: A state transition model was utilized to assess the cost-effectiveness of dapagliflozin as an add-on to the SOC and a cost-minimization analysis was performed to compare dapagliflozin to sacubitril/valsartan, as they have had similar efficacy. Patients were stratified into four health states using the KCCQ-TSS, in addition to a CV and non-CV mortality health states. Urgent heart failure (HF) visits and hospitalizations were captured as transient states. Clinical parameters and baseline characteristics were based on the DAPA-HF trial, utility scores were extracted from published articles, and costs were derived from the Universal Health Insurance Authority national database. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The treatment costs of HF-rEF patients receiving dapagliflozin compared to SOC are 47,901EGP ($10,550) and 34,377EGP ($7,572), respectively. The quality-adjusted life-years (QALYs) of dapagliflozin compared to SOC are 4.57 and 4.20, respectively. This resulted in an incremental cost per effectiveness ratio (ICER) of 36,449EGP ($8,028) per QALY gained over the lifetime horizon, suggesting this is cost-effective. Results of the cost-minimization analysis showed cost savings where the annual costs of dapagliflozin vs. sacubitril/valsartan are 10,914EGP ($2,404) and 32,242EGP ($7,101), respectively. CONCLUSION: Dapagliflozin was found to be a highly cost-effective and cost-saving medication when compared to SOC and sacubitril/valsartan, respectively, in the treatment of HF-rEF from Egyptian healthcare system perspective. The ICER was below the willingness-to-pay threshold because dapagliflozin improved outcomes (less frequent hospitalization and mortality).