Institutionalizing Health Technology Assessment in Egypt (2022) PDF

TYPE Original Research PUBLISHED 09 November 2022 DOI 10.3389/fphar.2022.1...

TYPE Original Research PUBLISHED 09 November 2022 DOI 10.3389/fphar.2022.1014658 Institutionalizing health OPEN ACCESS technology assessment in Egypt: EDITED BY Grigorios L. Kyriakopoulos, National Technical University of Athens, Situational analysis and roadmap Greece REVIEWED BY Pilar Pinilla-Dominguez 1,2*, Shorouk Taha 3*, Hugh McGuire 1, Natasa Duborija-Kovacevic, University of Montenegro, Montenegro Ahmed Elagamy 3*, Amal Sedrak 3,4, Mary Gamal 3, Andrew Lofts Gray, Mariam Eldebeiky 3 and Dalia Dawoud 5,6* University of KwaZulu-Natal, South 1 Africa NICE International—National Institute for Health and Care Excellence (NICE), London, United Kingdom, 2Department of Quantitative Methods for Economics and Management, University of *CORRESPONDENCE Las Palmas de Gran Canaria, Las Palmas, Spain, 3Central Administration of Health Technology Pilar Pinilla-Dominguez, Management (CAHTM), Egyptian Authority for Unified Procurement, Medical Supply and Technology [email protected] Management (UPA), Cairo, Egypt, 4Faculty of Medicine, Department of Public Health, Cairo University, Shorouk Taha, Cairo, Egypt, 5NICE Science, Policy & Research, National Institute for Health and Care Excellence, [email protected] London, United Kingdom, 6Faculty of Pharmacy, Cairo University, Cairo, Egypt Ahmed Elagamy, [email protected] Dalia Dawoud, [email protected] Objective: To conduct a situational analysis with the aim to inform future health SPECIALTY SECTION technology assessment efforts (HTA) in Egypt. This article was submitted to Drugs Outcomes Research and Policies, Introduction: The Egyptian government has set universal health coverage as a a section of the journal 2030 target. Several agencies have been created in the context of the ongoing Frontiers in Pharmacology healthcare reform. The Egyptian Authority for Unified Procurement, Medical RECEIVED 08 August 2022 ACCEPTED 14 October 2022 Supply and the Management of Medical Technology (UPA) is one of them and PUBLISHED 09 November 2022 was established to support strategic procurement using HTA. CITATION Methods: Description of the development of HTA in Egypt supported by a Pinilla-Dominguez P, Taha S, McGuire H, Elagamy A, Sedrak A, literature search as part of a scoping exercise, and a stakeholder analysis and Gamal M, Eldebeiky M and Dawoud D identification of HTA capacity survey, based on previous surveys, with relevant (2022), Institutionalizing health technology assessment in Egypt: stakeholders conducted in 2022. This was followed by a stakeholder event Situational analysis and roadmap. where results were shared and further contextualized. Front. Pharmacol. 13:1014658. doi: 10.3389/fphar.2022.1014658 Results: The UPA is expected to evaluate the cost-effectiveness of health COPYRIGHT technologies and public health programs. The HTA process is being © 2022 Pinilla-Dominguez, Taha, developed, focusing on the assessment of the value of new pharmaceuticals McGuire, Elagamy, Sedrak, Gamal, Eldebeiky and Dawoud. This is an open- being introduced to the Egyptian market. A total of 16 participants responded on access article distributed under the behalf of their organizations to the stakeholder analysis and identification of terms of the Creative Commons HTA capacity survey. More than 80% of the respondents were familiar with Attribution License (CC BY). The use, distribution or reproduction in other current efforts conducted by UPA and strongly support the implementation of forums is permitted, provided the HTA in Egypt. Transparency was highlighted as an important criterion. Over 90% original author(s) and the copyright owner(s) are credited and that the of the respondents mentioned economic analyses as an HTA product being original publication in this journal is developed in Egypt, and medicines were the type of technology that cited, in accordance with accepted stakeholders ranked as first in the rank of health technologies that need the academic practice. No use, distribution or reproduction is permitted which does output from HTA urgently. Capability building and training were highlighted as not comply with these terms. areas in which further support is required. Conclusion: This study represents the first attempt to describe the current path for HTA in Egypt. There seems to be momentum in Egypt to proceed and advance with HTA institutionalization. It would be important that next steps are built on the skills and capabilities already in place in Egypt, ensure methods and Frontiers in Pharmacology 01 frontiersin.org Pinilla-Dominguez et al. 10.3389/fphar.2022.1014658 processes are in place and up to date and involve the wider system in Egypt so stakeholders can appropriately contribute and participate in the HTA process. KEYWORDS health technology assessment (HTA), Egypt, situational analysis, egyptian authority for unified procurement, medical supply and the management of medical technology (UPA), universal health coverage (UHC) Introduction solidarity and includes a separation of functions between the provider and the purchaser of services. (Mathauer et al., 2019; The healthcare system in Egypt is complex and fragmented, World Bank Group, 2020) made up of different public and private providers and funding Law No. 2/2018 also envisioned the creation of new bodies: bodies (Mathauer et al., 2019). Currently the healthcare system in the Universal Health Insurance Agency (UHIA), the General Egypt is constrained by an absence of universal coverage and Authority of Health Care (GAHC), and the General Authority equitable access to healthcare services across the country. Low for Healthcare Accreditation and Regulation (GAHAR). The central government investment in health has been reflected in an UHIA will act as the purchaser of services and be responsible increased reliance on the private sector for the provision of health for pooling provider payments, and the management and services and resulted in out-of-pocket expenditure accounting for investment of the UHI fund. The UHIA will also be able to around 72% of total health spending (Ministry of Health and purchase health services for private insurance beneficiaries under Population, 2014). In 2010, it was reported that Egypt spent 4.7% special arrangements with private insurers. The GAHC will act as of GDP on health (Gericke and Busse, 2018). the public provider of primary, secondary, and tertiary level In 2009, Egypt adopted a new pricing method based on the healthcare services, report to the Ministry of Health and lowest retail price in any country of the world (external reference Population (MOHP) and have ownership of the public health pricing), but this has led to both price increases and decreases facilities to facilitate economies of scale, efficiencies and optimize without substantive implications on affordability (Mohamed and integration of care across the system. The GAHAR will be the Kreling, 2016). Calls have been made to encourage countries in regulator and accreditor providing standards on structural the Middle East and North Africa (MENA) region, including quality, clinical processes, and patient outcomes. Egypt, to move forward in their pricing policies beyond external The Egyptian Authority for Unified Procurement, Medical reference pricing, and introduce value assessment mechanisms Supply and the Management of Medical Technology (UPA) was (Kanavos et al., 2020). Beyond Tunisia, that has the Tunisian subsequently created by Law No. 151/2019. The UPA was Authority of Assessment and Accreditation in Healthcare established to support the efforts to achieve UHC by fostering (INEAS), Egypt and the Kingdom of Saudi Arabia seem to be strategic procurement. The UPA will procure and manage the amongst the first countries in the region to publicly announce supply of pharmaceuticals, medical equipment, and other and commit to the incorporation of value assessment medical supplies for all public healthcare entities. The UPA is mechanisms, such as health technology assessment (HTA) as expected to procure health technologies in a cost-effective part of their healthcare reforms (Fasseeh et al., 2020; Kanavos manner and be able to negotiate prices for health technologies et al., 2020). for both public and private sector providers. Furthermore, the The use of HTA is seen as an important mean for ensuring Egyptian Drug Authority (EDA), which was also established by the sustainability of a universal health coverage (UHC) system Law No. 151/2019 as a public service authority, was created to act (Chalkidou et al., 2016). HTA is an example of an output of as the regulatory authority responsible solely for the registration, explicit, deliberative priority-setting processes and is defined as a licensing, inspection and supervision of all pharmaceutical, multidisciplinary process that uses explicit methods to determine cosmetic products and medical equipment. They also have the value of a health technology at different points in its lifecycle. responsibility for setting public prices for new technologies. The purpose is to inform decision-making in order to promote an (World Bank Group. 2020). equitable, efficient, and high-quality health systems (O’Rourke The Universal Health Insurance Law No. 2/2018 sets out the et al., 2020). legal framework for how the different agencies will work in a The Egyptian government has set UHC as a target to be coordinated manner with the UHIA and GAHC. GAHC facilities achieved by 2030 via the Universal Health Insurance (UHI) will be contracted by the UHIA only after GAHAR accreditation System as outlined in the Universal Health Insurance Law No. 2/ has been obtained. HTA will be the responsibility of the UPA, 2018. This law describes plans to restructure the healthcare who is expected to evaluate the cost-effectiveness of health system by making healthcare services affordable to all citizens technologies and public health programs. The UPA will only with those in vulnerable groups receiving subsidies from the undertake HTA of technologies that have previously received government. The UHI system is based on the principles of social regulatory approval by the EDA. (World Bank Group. 2020). Frontiers in Pharmacology 02 frontiersin.org Pinilla-Dominguez et al. 10.3389/fphar.2022.1014658 In order to institutionalize HTA, countries need to navigate Headings (MeSH) and text-word searches were used to different elements of dynamic policy making. Castro et al. identify literature of interest (see supplementary Table S1). developed a framework for institutionalizing HTA that starts The search was focused on countries in the MENA region. A from a policy setting stage, in which systematic priority setting is translated search was run in EMBASE. The search was performed described as the key policy to develop (Castro and Suharlim, in August 2021 and was limited to January 2011 onwards in order 2020). This leads into an agenda setting stage, where the window to ensure that only current publications on HTA were reviewed. of opportunity is sought and policy analyses to formulate HTA The literature search identified 2,220 results of which policies are conducted. The next phase is the policy formulation 2,206 were excluded on title and abstract screened as not stage, which includes benchmarking good practices and relevant to the HTA context in Egypt. The full text of the conducting situational analyses and stakeholder exercises. This remaining 14 publications was retrieved. Information gleaned is followed by the adoption stage, where legal frameworks, from the literature searches was supplemented with documents institutional arrangements and regulation are established, and and information prepared and shared verbally and in written capacity is assessed. This then leads to the implementation stage, format by the UPA detailing the context of the Egyptian with the development of methodological guidelines and process healthcare system, upcoming changes and current process and guides, alongside capability building efforts. Importantly, this expectations for HTA in Egypt during the scoping exercise. The also needs to be followed by an impact evaluation stage, where UPA described the ongoing development of the HTA process in measures of impact and key performance indicators are set up Egypt. NICE International commented in this process, which is and data collection is put in place to generate such insights. This described in the results section of this manuscript. The results will in turn create a feedback mechanism to keep modifying HTA and learnings were shared between the UPA and NICE policies according to learnings gathered. International during a scoping meeting, where the approach Following this framework, this situational analysis aims to to HTA from both UPA and NICE were shared and compared. inform future HTA efforts in Egypt, particularly as it moves from the agenda setting/policy formulation stage to adoption and implementation. It includes an overview of the development Stakeholder analysis and identification of of HTA in Egypt, stakeholder analysis and assessment of capacity HTA capacity survey and support. It allows for getting deeper understanding of opportunities, challenges, and next steps for implementing In 2022 a survey was delivered to targeted stakeholders in HTA in Egypt. The situational analysis is considered a crucial Egypt to assess the awareness and perceptions of stakeholders of step when establishing a HTA policy in a country (Jeffery et al., the current HTA system and institutional aspects in Egypt, 2018; Castro and Suharlim, 2020; Bertram et al., 2021). Health stakeholders’ attitudes towards HTA in Egypt and their system context plays a major role facilitating the implementation expectations, as well as current HTA capacity and needs in of HTA policy, and stakeholder involvement is an essential aspect Egypt. The survey was based on previous surveys used to to guarantee buy-in and legitimacy of HTA processes. identify stakeholders and HTA capacity (Schmeer, 2000; Li, 2017; Downey et al., 2018; Vlad, 2018; Hollingworth et al., 2021). These surveys have been used to conduct situational Methods analyses in other countries (Addo et al., 2020; Downey et al., 2020; Sharma et al., 2020; Elfarra, 2021). The survey was slightly The situational analysis was co-developed and co-drafted by adapted and modified by the UPA and NICE International for the UPA and the National Institute for Health and Care the purpose of this project and context in Egypt. The survey Excellence (NICE) International and was informed by the included open and closed questions, including Likert scales. A following activities. copy of the full survey can be found in the supplementary materials. The organizations invited to participate in the survey Literature search to inform the context of followed a convenience sample approach based on a HTA in Egypt and scoping exercise prioritized list of organizations involved in the current UPA’s HTA workflow (n = 16). These were organizations that were We conducted a literature search for published and grey expected to be part of or engage directly with the HTA process in literature to identify information related to HTA in the Egyptian Egypt. The list of stakeholders was prepared and prioritized context. This included searches of Medline and EMBASE as well guided by a stakeholder checklist for priority setting in low as grey literature including websites from public authorities in and middle-income countries (Vlad, 2018). This list included Egypt and HTA networks such as the International Society for national government organizations (n = 6), life sciences industry Pharmacoeconomics and Outcomes Research (ISPOR) Egypt (n = 2), public hospital (n = 1), consultancy companies (n = 2), regional chapter. For the Medline search Medical Subject HTA networks with presence/relationship with Egypt and Frontiers in Pharmacology 03 frontiersin.org Pinilla-Dominguez et al. 10.3389/fphar.2022.1014658 MENA region (n = 1), academia (n = 2), and international pharmaceutical value dossier submission template for organizations including the World Bank and the WHO office in companies to complete. During the assessment stage, there Egypt (n = 2). Official invitations were sent to the prioritized will be an initial evaluation of the submission conducted by stakeholders to nominate a representative to participate in UPA staff including the economic and clinical studies. Once the answering the survey. Respondents were at director, president/ UHIA becomes the single payer, the UHIA and the UPA will vicepresident, senior specialist and professor level. Participants collaborate in the HTA process. At this point the UPA will assess were asked to sign consent forms for participation which were the cost effectiveness of the health technologies and programs collected before the survey was sent. Subsequent consent was and the UHIA will assess the budget impact based on the requested to publish the aggregated results. An awareness event population covered by the UHIA. The HTA recommendations was held by the UPA to explain the project and objective of the resulting from the appraisal of the value dossier will be advisory survey with all invited organizations, which was attended by all of and will inform the pricing negotiations for procurement and them (n = 16). It was also an opportunity to provide an overview reimbursement purposes. of the questions to ensure they were understandable by The evaluation is then reviewed by a scientific committee. participants. The survey was distributed online, and This scientific committee includes methodologists in clinical participants were given 3 days after the awareness event to research, health economists and clinical topic experts. Once complete it. the scientific committee has reached a recommendation, the UPA proposed using a general descriptive analysis and UPA then informs the company if the submission is accepted inductive qualitative approach, identifying key themes using or rejected. After the assessment and appraisal of the evidence, Excel for sorting data and categorizing it. Answers to open the UPA evaluation will be submitted to the recommendation questions were categorized for this analysis based on common committee who will make decisions on the appropriate price for responses and summarized using descriptive statistics. NICE the technology. This committee includes representatives of the International reviewed the responses, categorization and UHIA, MOHP, hospitals and other entities entitled by law 151/ analyses. Figures were developed using Datawrapper. 2019 and the procurement central administration team at the In April 2022, the UPA and NICE International held a UPA. The recommendation committee will also consider the stakeholder event to share the results and findings of the assessment of the budget impact analysis which will feed into any stakeholder analysis and HTA capacity survey. All the further negotiations and agreement on the final price. organizations that took part in the survey were invited to an The former Central Administration for Pharmaceutical event in Cairo and 75% of them attended. The invitation was Affairs (CAPA), a regulatory agency within the MOHP, extended to further pharmacy and medical academic institutions developed scientific guidance on how to conduct and report a in Egypt and one further organization attended. At the event both pharmacoeconomic study in 2013 (Elsisi et al., 2013). This the UPA and NICE International presented the results and had a guidance covers a reference case for Egypt. This includes the moderated discussion. perspective, indication, choice of comparator, target population, subgroup analysis, preferred analytical technique, time horizon, choice of outcome measure, preferred method to derive utility, Results synthesis of clinical and economic evidence, costs to be included, sources of costs, modelling, discounting costs and outcomes, HTA agenda setting: Development of the uncertainty, equity issues, generalizability and presenting results. HTA process and methods in Egypt CAPA is now part of the EDA. Following the reform, HTA responsibilities, including methodology sit within the UPA. UPA Based on the findings from the scoping exercise, the HTA is currently developing a HTA methods guide for the evaluations. process is currently being developed by the UPA, focusing at this stage on the assessment of the value of new pharmaceuticals being introduced to the Egyptian market. The objective of this Policy formulation: Stakeholder and HTA HTA is to ensure that the assessment is conducted to support capacity analysis reimbursement decisions and to add the technology to the list for procurement. Organizations with a central role in HTA in Egypt The draft HTA process developed by the UPA is expected to The majority of the respondents (14 out of 16; 88%) last approximately 3 months. The UHIA will work with the UPA highlighted that UPA has a central role in HTA in Egypt (see to identify priority disease areas. At this stage, the process is Table 1). Out of the 14 respondents who mentioned the UPA as restricted to the evaluation of either ‘first to market’ having a central role in HTA, the majority considered their role pharmaceuticals that have a high impact on the budget or as mandatory, which contradicts the intention of the UPA innovative products. In the future, a HTA evaluation could be process to be advisory, highlighting a mismatch in requested by different stakeholders. The UPA is finalizing a expectations. In terms of stakeholders’ perceptions about other Frontiers in Pharmacology 04 frontiersin.org Pinilla-Dominguez et al. 10.3389/fphar.2022.1014658 TABLE 1 Stakeholders’ perceptions about the organizations with a central role in HTA in Egypt. Respondents N = 16 Q1: In Egypt, are you aware of any central organisation(s) undertaking the role of HTA? If yes, please state their name. You may select more than one option Q2: What is the current status of recommendations from the organisation(s) named in response to question 1? MOPH Advisory Mandatory Other n 9 6 1 2 % 56% 67% 11% 22% EDA n 9 6 2 1 % 56% 67% 22% 11% UHIA n 9 5 3 1 % 56% 56% 33% 11% UPA n 14 4 8 2 % 88% 29% 57% 14% NGO n 3 2 0 1 % 19% 67% 0% 33% Private sector n 5 4 0 1 % 31% 80% 0% 20% Other n 4 3 1 0 % 25% 75% 25% 0% Abbreviations: HTA: health technology assessment, MOPH: ministry of public health, EDA: egyptian drug authority, UHIA: universal health insurance agency, UPA: unified procurement authority, NGO: Nong-Governmental Organization. organizations having a central role in HTA, the UPA was the respondents noted that it is the UPA aligned with different followed by other government authorities such as the MOHP, stakeholders and 6% (1 out of 16) considered the UPA to be sole the UHIA and the EDA, each of them being mentioned by 56% of responsible organization (see Figure 1). 31% of respondents the respondents showing that the majority of the respondents (5 out of 16) mentioned that technical agencies follow were familiar with the relevant government organizations aimed international guidelines and HTA expert opinion when to take part in the HTA process being introduced as a result of the developing HTA related products. Among the international ongoing healthcare reform. guidelines being mentioned, these included guidelines from the WHO, NICE and ISPOR. This shows the stakeholders Perceptions on the HTA process in Egypt have some understanding of the methodological developments About 38% (6 out of 16) of respondents mentioned that there conducted by the UPA to conduct HTA. is no formal process for deciding what HTA-related products will be developed. However, these is a level of familiarity with the HTA products developed in Egypt ongoing process. About 19% (3 out of 16) of respondents believe When asked about different HTA products being developed that there is a process currently being developed by UPA and in Egypt, economic HTA analyses (e.g., cost-effectiveness UHIA, 25% (4 out of 16) mentioned that UPA, UHIA, and EDA analysis, budget impact analysis) were mentioned by 94% already have a formal process, 13% (2 out of 16) said there is a (15 out of 16) of the respondents. Other products currently process only for specific technologies like orphan drugs and being developed in Egypt included developing or adapting oncology medicines and 6% (1 out of 16) of respondents reported clinical guidelines, including cost-effectiveness and budget that they were unaware. As for who is responsible for establishing impact considerations, redesigning the basic package or HTA rules and processes that the technical agencies should essential list, systematic literature reviews and meta-analyses, follow when developing HTA products, 44% (7 out of 16) of evidence-informed quality indicators and managed entry Frontiers in Pharmacology 05 frontiersin.org Pinilla-Dominguez et al. 10.3389/fphar.2022.1014658 FIGURE 1 Organizations responsible for HTA rules and processes. agreements (see Figure 2). This shows that there is already submissions for assessment at a national level. Most familiarity with HTA principles in Egypt and that some respondents (63%, 10 out of 16) considered that Egypt products are being developed that could inform HTA efforts, has influence in health policy decisions in similar including evidence submissions. Respondents considered that countries and was mentioned as a reference country for those products are produced mainly by governmental bodies countries in the MENA region, highlighting the relevance of (UPA, UHIA, and EDA) and consultancy companies and clinical the ongoing HTA efforts in Egypt for the wider MENA research organizations. The pharmaceutical and devices industry region. is thought to be the major payer for the HTA related products development (85.7%, 12 out of 14 respondents). This signals that Stakeholders’ expectations from HTA pharmaceutical companies have the relevant resources to Stakeholders ranked in order the type of health technologies that contribute to the process by developing company’s need the output from HTA urgently. Medicines were first in the rank Frontiers in Pharmacology 06 frontiersin.org Pinilla-Dominguez et al. 10.3389/fphar.2022.1014658 FIGURE 2 HTA-related products being developed in Egypt. FIGURE 3 Ranking of health technologies in which output from HTA is needed. Frontiers in Pharmacology 07 frontiersin.org Pinilla-Dominguez et al. 10.3389/fphar.2022.1014658 FIGURE 4 Relevant factors for HTA. FIGURE 5 HTA skills requirements. followed by medical devices and diagnostics (see Figure 3). They conditions need to be present for them to express their highlighted that safety and efficacy information is available from support including: clinical trials but there is a lack of cost-effectiveness, budget impact, and effectiveness information in Egypt (see Figure 4). 1) Transparency of HTA process This aligns with the proposed process being developed by the 2) The ability to influence decision making UPA which will focus first on assessing the clinical and cost- 3) HTA process and decisions based on evidence effectiveness of new pharmaceuticals with high budget impact 4) Fast HTA process or innovative products. 5) Support patients and increase patient access to innovative technologies Stakeholders’ attitude towards HTA 6) Availability of adequate human and financial resources. Of the respondents, 87% (14 out of 16) strongly support the implementation of HTA in Egypt. The other 13% (2 out of 16) Respondents noted that they will support the who are somewhat supporting HTA expressed that some implementation of HTA from units within their organizations Frontiers in Pharmacology 08 frontiersin.org Pinilla-Dominguez et al. 10.3389/fphar.2022.1014658 and by providing essential data for HTA purposes. This shows that there are further activities planned in terms of reviews before the actual commitment of stakeholders to actively contribute to these are made public and noted that making HTA reports the HTA process. publicly available is within their plans for the future. HTA capacity in Egypt Fourteen respondents answered the question about the Discussion specific HTA relevant skills they have technical needs for (see Figure 5). Capacity building and training was mentioned by 57% This study represents the first attempt to describe the current (8 out of 14) of the respondents, followed by collaboration with path for HTA in Egypt. The situational analysis of the HTA experts (36%, five out of 14). system in Egypt provides an overview of the key efforts being The capacity for HTA within the UPA comprises members of undertaken by different health system partners to contribute to staff with diploma or masters level qualifications in health achieving UHC in Egypt. It has also highlighted challenges and economics alongside other qualifications that will support HTA. potential opportunities for the implementation of HTA that Responses to the detailed questions about HTA capacity should be taken into account when considering the next steps. amongst stakeholders in Egypt were too vague to allow for a The analysis of this small sample of stakeholders reveals that formal analysis so a narrative summary of the responses is there is basic knowledge and understanding of the current HTA provided below. process in Egypt among them. They all are keen to support HTA Fewer than 10 staff with a qualification in health economics/ process implementation in Egypt. Some stakeholders have health econometrics (first degree, masters, or PhD level), and five already taken initiatives to support the HTA process at UPA or fewer staff with a qualification in epidemiology/biostatistics by establishing HTA units in their organization and showing a (first degree, masters, or PhD level) were mentioned by each of willingness to collaborate in the process by providing essential the respondents. Respondents mentioned having more staff with data needed for HTA. This shows that there is a national-level medical or pharmacy degrees. Amongst the HTA products effort to promote HTA and evidence-based decision making in published by stakeholders, these included cost-effectiveness Egypt. However, stakeholders have specified a number of analyses, systematic reviews and budget impact analyses. This conditions that should be met for them to support HTA signals that further efforts should be dedicated to build capacity efforts. These include aspects such as transparency, input into and capability amongst the wider stakeholders that will be decision making, evidence-based, timeliness, facilitating market involved in the HTA process. access, and capacity and adequate funding support. These are factors important to stakeholders in Egypt and will need to be carefully considered as Egypt moves forward with the adoption Stakeholder event and implementation of HTA. Therefore, the HTA process currently being developed in Egypt should follow a series of The results presented resonated with the perceptions on principles to be abided by all involved, including the UPA, the HTA from the attendees to the stakeholder event. They all UHIA and the different committees. Importantly, some of these were aware of the efforts from the UPA and showed aspects will require trade-offs between competing principles. willingness to collaborate further, based on their roles. This means that the process should explore how each of the Consultancies and academics highlighted their ability to principles is embedded and how they will be dealt with in the generate evidence relevant for HTA purposes such as burden process, as well as any plans to review them as HTA matures in of illness, costing studies or economic models. Egypt. This will be important, so stakeholders are clear on the The attendees also highlighted the importance of having a expectations from HTA in a medium and longer team and their transparent process, in which each stakeholder can understand support for HTA is maintained. how they can contribute and participate in the HTA process. In terms of ensuring adequate capacity and funding to support UPA noted their work on this matter and explained their HTA, the main barrier highlighted by stakeholders is lack of trained willingness to make this process public once it has been staff. They noted that there is a need for capability building for finalized. Involvement of stakeholders before this is finalized is producing and supporting the analyses required for HTA. Capability encouraged so they can input into the process. This will issues will need to be addressed for successful HTA implementation contribute to improve inclusiveness and buy-in from the in Egypt. For example, it will be important that HTA staff within the community. UPA team, as well as the wider stakeholders involved in the HTA The attendees also encouraged the UPA to publish the HTA process (such as those part of the scientific committee) are reports being conducted in the HTA unit and noted that continuously trained to analyze and critically appraise the capability building efforts should currently focus on critical evidence submissions from the pharmaceutical industry, and that appraisal of economic models. The UPA explained that the academic support is brought up where needed to supplement the HTA reports conducted to date have been part of a pilot and efforts from the UPA. Frontiers in Pharmacology 09 frontiersin.org Pinilla-Dominguez et al. 10.3389/fphar.2022.1014658 Stakeholders also showed interest in the output of the HTA involved with their work. This may have excluded some process at UPA as it matches their organization’s interests which organizations who do not have a formal relationship with include resource allocation and maximizing patient benefits. the UPA, and thus prevented taking a broader overview and They all expressed the importance of HTA in Egypt being reduced the ability to assess wider awareness of HTA in Egypt. influential and informing decision-making transparently and Furthermore, two key stakeholder groups missing from the based on evidence. Having methods and processes for HTA questionnaire were patient organizations and medical that reflect best practices and are publicly available will facilitate societies. This means that results should be considered with the implementation of these principles in the process. caution when trying to generalize them. However, the level of The results of this study, particularly in terms of the needs for seniority of the participants in the survey ratifies the relevance capacity building, align with results from other studies that have of the results for the purpose of the survey, providing insights assessed the preferred status of implementation of HTA in low- from the key organizations that are to be engaged in the HTA and middle-income countries. For example, the analysis of process being devised by the UPA in Egypt. That is why the Fasseeh et al. (Fasseeh et al., 2020) looking at HTA results shown by this survey, albeit based on a small list of implementation in 11 countries in the MENA region also organizations, are of relevance to highlight the initial highlights the limited capacity available for HTA in the region perspectives of stakeholders expected to be directly engaged based on few current options for HTA training being available. with or part of the HTA process in Egypt. It would be Limited funding for HTA assessment was also indicated, with important to repeat this exercise to explore changes in private funding having a prominent role, in line with our results. perceptions and wider involvement of stakeholders in the The fact that HTA was perceived not to have a formal role in future. Buy-in from medical societies and patient many of the countries analyzed contrast with our findings where organizations is crucial in the HTA process and for the majority of the stakeholders believe HTA to have a formal implementation of guidance in the future. Stronger efforts role. This difference may be as a result of our analysis being should be made in the future to approach such important conducted specifically for Egypt, which is currently devising the stakeholder groups for HTA. It would also be important to implementation of HTA following its commitment in legislation, accompany the measuring of the changes in awareness and and because our analysis targets a specific group of stakeholders consensus levels with further stakeholder engagement and aimed to be involved in the HTA process. The study from progress in the HTA implementation process. Fasseeh et al. also notes that stakeholders in the MENA Despite these limitations, the situational analysis including region seem to have shown their willingness to contribute to the stakeholder and HTA capacity survey has highlighted HTA by investing in the generation of evidence, such as patient enlightening information and allowed for a better registries, and that transparency is found to be a key factor in understanding of the current state of HTA in Egypt, the legitimizing HTA, in line with the results from our analysis. relevant organizations associated with HTA in Egypt, their These results also resonate with analyses conducted in other commitment to support HTA efforts, the HTA capacity countries beyond the MENA region, particularly in the reference available and the capability needs in the future. to the need for further local capacity building such as in the case One of the outputs of this exercise has also been the of Sub-Saharan Africa, Ghana, Indonesia, Nigeria or India. agreement for different organizations to form a HTA forum, (Downey et al., 2020; Sharma et al., 2020; Uzochukwu et al., where activities and topics relevant to HTA as well as progress in 2020; Hollingworth et al., 2021). the process for HTA institutionalization can be discussed, This study has strengths and limitations. In terms of showing the benefits of stakeholder engagement to advance limitations, these include: 1) The literature search was in HTA. based on a non-systematic literature review and was strongly guided by documentation and references shared by the UPA during the scoping meeting. This was mitigated by a Conclusions and future research separate review of the literature including grey literature, orientations particularly from searches in websites from international organizations such as the World Bank, the WHO or Using the Framework for institutionalizing HTA (Castro and ISPOR. 2) We acknowledge the challenges for conducting Suharlim, 2020), it seems that currently Egypt is in the Agenda an activity like this survey including difficulties around the Setting/Policy Formulation stage in the institutionalization identification of relevant organizations, willingness to take process. In progressing, the steps of adoption and part, missing data, or complexities in the analysis and implementation should be given sufficient consideration, with generalizability of the results. This hampered our ability to the option to adapt or reframe any policy formulations as a result. formally analyze the HTA capacity section of the survey. 3) HTA should be seen as a dynamic and evolving process, where a The list of stakeholders was based on a small convenience list simpler process is established at the beginning and where of organizations that the UPA had relationships with and were complexity is added as the HTA process matures. Frontiers in Pharmacology 10 frontiersin.org Pinilla-Dominguez et al. 10.3389/fphar.2022.1014658 The recent legislation in Egypt has led to the creation of Ethics statement different organizations that will interact with each other in the healthcare system following the ongoing healthcare reform. The Ethical review and approval was not required for the study roles and responsibilities of each of these organizations are also on human participants in accordance with the local legislation covered in the legislation. However, the particular responsibilities and institutional requirements. The patients/participants and roles that each organization as a well as the wider provided their written informed consent to participate in stakeholders will play in the HTA process in Egypt are still this study. being defined, alongside governance arrangements to facilitate these collaborations and engagements. These should be outlined before the HTA process is finalized and further work is Author contributions undertaken. As the next steps, the process for HTA in Egypt should be clearly described and input from stakeholders should PP-D, ST and HM contributed to the conception and be sought when finalizing it. This process should also account for design of the study. HM conducted the literature search. developing horizon scanning and topic selection criteria that ST, AE and AS organized the distribution of the survey. ST would support the planning and resourcing for HTA at an undertook the data extraction and analysis. PP-D and HM internal level, while also contributing to transparency with reviewed the data extraction and analysis. All authors stakeholders at an external level. This aspect is essential as contributed to the scoping meeting and stakeholder HTA capacity will be limited, particularly at the beginning, awareness event. All the authors contributed to manuscript and there will be a need to set the number of evaluations that writing, revision as well as read and approved the submitted UPA can carry out each year. Adapting the process to the version. capacity available and the different types of technologies to be evaluated could also be considered. A simple and adaptable process that allows for showing the benefits of HTA to all Funding stakeholders could be considered, including adaptive HTA approaches (Nemzoff et al., 2021; Ollendorf and Pinilla NICE International received funding from The Egyptian Domínguez, 2021), where relevant. Agreeing on a Authority for Unified Procurement, Medical Supply, and the methodology to be used in HTA would also be important, so Management of Medical Technology (UPA) to support the stakeholders can input into the process providing the necessary work described in this manuscript. The UPA received evidence. The value dossier being developed by the UPA in funding from an unconditional grant from Novartis Pharma, collaboration with the UHIA should be reflective of the methods Egypt to support the collaboration between NICE International for HTA in Egypt. and the UPA. Based on the lack of technical and institutional capability available in Egypt, further training and support on this matter for health system partners should also be considered. These could be Acknowledgments accompanied by practical HTA pilots. There seems to be momentum in Egypt to proceed and The authors would like to thank other colleagues from advance with HTA institutionalization in the country. It would NICE and the UPA who also supported the project be important that next steps are considered, build on the skills management and delivery of the knowledge transfer sessions and capabilities already in place in Egypt, ensure methods and for the scoping exercise. Colleagues from NICE include Jeanette processes are in place and up to date and involve the wider HTA Kusel, Emily Crowe, Deborah Lee, Mira Patel, and from UPA: system in Egypt so stakeholders can appropriately contribute and Amr Taha, Dina Yasser and Hany Moreid. The authors would participate in the HTA process. For further wider national- also like to thank colleagues from Stellar Consulting who oriented analysis, a larger sample size of participants based on supported the UPA in the project management, particularly a more inclusive selection process and targeting more Yehia Akl and Samar Mansour. We are also grateful to Ahmed organizations and participants should be conducted in the future. Seyam, Hossam Samouly, Nagwan Abd El Rahman, Nermeen Ashoush, Asmaa Saad, Mohammed Talaat, Nouran El Desouky, Khaled El Shazly, Mohamed Solyman, Sherif Abaza, Amr El Data availability statement Shalakani, Ahmed Khalifa, Gihan El sisi, Ahmed Fasseeh who contributed to this study by completing the questionnaire for The raw data supporting the conclusions of this article will be stakeholder analysis and identification of HTA capacity in made available by the authors, without undue reservation. Egypt. 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