Around The World in HTAs: Egypt – The Road Ahead

The health care system in Egypt

Universal health coverage is a 2030 target for the Egyptian government, yet the Egyptian health care system is complex and fragmented, with various disparate public and private providers and funding mechanisms. The system is divided into the private and public sector. In the public sector, the Ministry of Health and Population (MOHP) is the primary government body, both funding and providing subsidised preventative and curative services (Fasseeh et al., 2022). Similarly, the health insurance organisation (HIO) is an independent government organization operating under the supervision of the MOHP, providing compulsory insurance to most formal sector employees, encompassing financing and provider functions under one entity (Fasseeh et al., 2022).

The Universal Health Insurance (UHI) system was established in 2018 to restructure the healthcare system and ensure equitable access to healthcare services across the country, limiting out-of-pocket payments and catastrophic health expenditures. It is intended to be financed through multiple sources, including citizen-paid premiums, government subsidization, and taxes, and is meant to be implemented in six phases by 2032 (Fasseeh et al., 2022).

The UHI scheme is a step towards the separation of the unified payer-provider system and away from the domination of public providers. The UHI Law of 2018 (Law No. 2/2018) set the stage for the creation of the UHI Agency (UHIA), the General Authority of Health Care (GAHC), and the General Authority for Healthcare Accreditation and Regulation (GAHAR) (Pinilla-Dominguez et al., 2022). The UHIA’s intended role is to purchase services, pool provider payments, manage the UHI fund, and purchase health services for private insurance beneficiaries. The GAHC’s role will be to provide primary, secondary, and tertiary level healthcare services, report to the MOHP, and – as the owner of the public health facilities – to enable economies of scale, maximise efficiencies and optimize integrated care across the system. The GAHAR will act as the regulatory and accreditation authority, establishing criteria for structural quality, clinical processes, and patient outcomes.

Healthcare services (outpatient and hospitalization services) in Egypt are mostly cheaper than regional averages whereas, due to external price referencing (ERP), innovative pharmaceuticals have a narrower price corridor than healthcare services without significant implications for affordability (Fasseeh et al., 2022; Pinilla-Dominguez et al., 2022). This results in pharmaceutical expenditure representing a significant part of the healthcare budget in Egypt compared to other countries: about 32% of total health expenditure and 43% of household expenditures (Fasseeh et al., 2022). Previous research in the MENA region confirms that ERP results in higher pharmaceutical prices compared to non-pharmaceutical service prices in low- and middle-income countries (Kaló et al., 2015). Egypt is among the first countries in the region to attempt to move beyond ERP by introducing value assessment mechanisms like HTA processes as part of its healthcare reform (Pinilla-Dominguez et al., 2022).

A roadmap for new technologies

The Egyptian Authority for Unified Procurement, Medical Supply and the Management of Medical technology (UPA) was created in 2019 (according to Law No. 151/2019) to support efforts towards universal health coverage by encouraging strategic procurement and subsequent management of pharmaceuticals, medical equipment, and other medical supplies for all public healthcare bodies (Pinilla-Dominguez et al., 2022). The UPA is intended to be responsible for HTA, ensuring cost-effective procurement of health technologies and negotiating prices for providers in both private and public sectors, while acting independently from purchasers, providers, and pharmaceutical actors. The Egyptian Drug Authority (EDA) was also created in 2019 as the regulatory body exclusively responsible for registering, licensing, inspecting and supervising all pharmaceutical and cosmetic products and medical equipment, as well as setting public prices for new technologies (Pinilla-Dominguez et al., 2022).

UPA is developing a draft HTA process, which at this stage is restricted to the evaluation of either ‘first to market’ pharmaceuticals with a significant impact on the budget and innovative products (Pinilla-Dominguez et al., 2022). For now, the UHIA will work with the UPA to identify priority disease areas and evaluate products that have already received regulatory approval by the EDA. However, the process will be expanded so that different stakeholders can request an HTA evaluation in the future (Pinilla-Dominguez et al., 2022).

The draft process involves pharmaceutical value dossier submission template to be completed by companies and evaluated by UPA staff, along with any economic and clinical evidence. Once UHIA becomes the single payer, UPA and UHIA will collaborate in the HTA process, with UPA responsible for cost-effectiveness assessments and UHIA responsible for analysing budget impact based on the population it covers (Pinilla-Dominguez et al., 2022). The resulting HTA recommendations from the value dossier appraisal will guide price negotiations for procurement and reimbursement. The evaluation will then be assessed by a scientific committee composed of health economists and clinical researchers and topic experts. Based on the committee’s recommendation, the UPA will update the company on the approval status of the submission.

Following the evidence assessment and appraisal, the UPA’s evaluation will be submitted to a recommendation committee to determine the appropriate pricing. This committee will be composed of representatives from the UHIA and MOHP, hospitals and other authorized entities, as well as the UPA’s procurement central administration team. The assessment of the budget impact analysis will also be considered in further negotiations and final price agreements.

Anticipated challenges of HTA in Egypt

The HTA process has not yet been implemented and institutionalized in Egypt, yet there are already some anticipated challenges on the horizon.

Lack of finalization of the HTA process has meant that it has not been made public so far. Transparency in the HTA process will be crucial, with evidence-based decision making and clarity to all stakeholders about their potential roles in the process necessary in order to foster community buy-in.

Limited staff capacity for HTA within the UPA and the wider stakeholder groups involved in the HTA process (like the scientific committee) for generating and supporting HTA analyses is a significant barrier to HTA implementation in Egypt (Fasseeh et al., 2020). The supply of trained HTA professionals is constrained by the limited number of postgraduate courses relevant to HTA practice and fewer opportunities for collaborations with academics to support the HTA process.

Limited funding is available for investment into HTA phases, and the move towards dependence on public investment is necessary to ensure sustainability of HTA, reduce the conflict of interest, and guarantee political will to implement HTA processes and use it for decision making (Fasseeh et al., 2020).

There is a potential mismatch in stakeholder expectations and responsibilities: aligning with stakeholders on the advisory- rather than mandatory – role of the UPA process, and agreeing roles and responsibilities of each stakeholder in the HTA process. At the moment there is mismatch in stakeholders’ expectations and conflicting power dynamics. This may lead to inefficiencies and duplicated efforts.

Next steps for the Egyptian HTA system

According to Castro et al.’s (2020), Egypt is in the Agenda Setting/Policy Formulation stage in the HTA reform process, in which it is critical to seize the opportunity to elevate the significance of HTA policies, benchmark good practices, analyse the current situation and engage stakeholders. Progressing to the adoption and implementation stages requires the establishment of formal processes, although it may be valuable to start simple and allow for the flexibility to adapt and reframe policy formulations through an evolving, dynamic process and add complexity as it matures (Pinilla-Dominguez et al., 2022).

Engagement of the wider HTA community in Egypt will be important in the next stages to ensure buy-in and the validity of HTA processes. Stakeholders have demonstrated their willingness to support the process by establishing their own HTA units and providing data required for HTA if certain conditions are met (Pinilla-Dominguez et al., 2022). These conditions include transparency in processes and decision-making and opportunities to contribute inputs, facilitation of market access, and capacity and funding support.

Making the process – and the resulting HTA reports- evidence-based and public once they are reviewed and finalized will be vital, while continuous capacity building and training efforts within the UPA and among the involved stakeholders are needed to expand on relevant skills and address technical needs (Pinilla-Dominguez et al., 2022). Given the novelty of the process and limited internal capacity, collaborating with stakeholders, including academic experts, and seeking their input is essential to supplement internal efforts and propel national-level momentum on HTA institutionalization in the country.

Relevant organisations in Egypt have formed a HTA forum. The purpose of the group is to progress HTA in the country. UPA has published version 1.0 of its HTA process guide. This is a significant step forward to institutionalise HTA in Egypt. Additional steps can be taken to strengthen the HTA process and make it more transparent. This includes a delineation of each of the steps within the appraisal process, the development of a reference case and a structured decision-making framework, and the specification of the roles and responsibilities of the HTA committee.

The HTA process is also aimed to be as inclusive as possible, and initial steps on patient and public involvement are being explored. Ongoing HTA efforts and progress in Egypt are significant, as the country is often used as a reference in the region (and other similar countries) and is believed to have influence in health policy decisions in the Middle East and North Africa region and beyond (Pinilla-Dominguez et al., 2022).