Institutionalizing Health Technology Assessment in Ghana: Enablers, Constraints, and Lessons

ABSTRACT Health Technology Assessment (HTA) has been institutionalized in Ghana with structures, processes, and methods. This paper identifies and analyzes the policy players involved; the way in which issues were framed; and the manner in which administrative structures were used to set the agenda for, adopt, and implement HTA. It shows that the Ministry of Health, supported by other players, led HTA agenda-setting through training activities and discussions on evidence of selection pharmaceuticals, medical devices, and other health-related technologies. HTA was then captured in a health sector aide memoire that summarized the decisions made at a national health summit. In implementing the HTA policy, technical working groups and a steering committee were constituted to provide recommendations to the minister of health on high-level decisions. The ability of agenda influencers to maneuver existing administrative and bureaucratic structures, align them with national strategic goals, and sustain HTA implementation enabled Ghana to institutionalize HTA. Limited financial support and a dearth of in-country expertise are being addressed through capacity building and funding. To ensure early national buy-in and uptake, policy makers and agenda influencers need to understand each country’s health system and align HTA with national policy decision-making processes.


Introduction
Health Technology Assessment (HTA) is a tool that addresses the direct and indirect consequences of health technology by evaluating the social, economic, organizational, and ethical consequences of a health intervention or technology. 1,2It is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle in order to promote an equitable, efficient, and high-quality health system. 3TA helps ensure that governments make good decisions about health care and patients and health care practitioners are provided with the information they need to make the optimal treatment choices.It has evolved into a standard policy tool that guides decision-makers responsible for managing the incorporation and application of pharmaceuticals, medical devices, and other technologies, including complex interventions, within health care systems. 4,5[8] Ghana launched its strategy for HTA in 2020 with the primary objective "to strengthen the science and practice of HTA to support evidence-based decisions for the health sector." 1 The strategy seeks to achieve the following objectives: • establish the country structures needed to institutionalize HTA in Ghana in a way that aligns with its national medicines policy • develop local capacity to conduct and use HTA within the health system • strengthen the conduct (science and practice) of HTA in Ghana in order to produce quality evidence-informed decisions and efficient practice, based on agreed upon standards for the conduct, dissemination, and use of HTA The launch of the national HTA strategy followed several years of collective efforts by both local and international players advocating for and sustaining HTA on the government's agenda for the health sector.These agenda influencers framed HTA ideas and gained political and financial support to move HTA into policy adoption and implementation, institutionalizing it within the Ghanaian health sector.HTA institutionalization involved the establishment of structures, processes, methods, and standards for the conduct and uptake of HTA outputs and recommendations. 9he approach used by agenda influencers to frame issues and adapt organizational structures and processes was essential for promoting the policy agenda and ensuring that it was adopted and implemented.The government's agenda reflects the context of the health system, existing national policies, and the institutional processing of issue framing and local and international players and their use of power. 10,11ocal and international agenda influencers can be broadly categorized as follows: • agenda directors, such as the president of Ghana, who wield political power to set a policy agenda; • agenda approvers, such as ministers of health, with political and administrative authority to approve or remove an existing policy; • agenda advisers, such as international donors, with the financial means and ideas to reshape policy discourse; and • agenda advocates, such as professional bodies, with campaigning skills and voice to promote issues for their benefit. 11derstanding how agenda influencers promoted the HTA agenda for adoption and implementation and specific administrative and bureaucratic processes, as well as the enablers and constraints to HTA policy agenda-setting, adoption, and implementation are essential for developing and implementing HTA policy.However, few studies of HTA policy agenda-setting, adoption, and implementation have been conducted in Ghana.Past studies have focused on data sources to support HTA in Ghana 12 ; implementation of HTA in Ghana 13 ; the capacity of Ghana to introduce HTA 14 ; development of a national HTA strategy 15 ; and HTA institutionalization and contribution to health care decisions in Thailand. 16his paper analyzes the policy players involved and how they framed issues and created the administrative and bureaucratic structures needed to set the agenda and adopt and implement HTA in Ghana, a lower-middle-income country.It also examines the contextual factors enabling and constraining the HTA institutionalization process.The objective of this paper is to distill the lessons from Ghana's experience for the benefit of other low-and middle-income countries.

Data and Methods
We conducted a case study to investigate the institutionalization of HTA in Ghana by investigating agenda-setting, adoption, implementation; the stakeholders involved and how they framed issues; and the administrative frameworks utilized for HTA decision and execution.This study design was used because it allows the collection and analysis of comprehensive and systematic data at different periods, allowing us to trace policy players, ideas, and changes over time. 17A case study allows the use of multiple sources of evidence and triangulation to explain contemporary events. 17ata collection, using in-depth interviews and document review, occurred between January and August 2022.We also drew on our recollections of Ghana's HTA institutionalization process.Documents were identified from the Ministry of Health (MOH) website and the Pharmacy Directorate (part of the MOH).Our main inclusion criterion was relevance to HTA institutionalization, the players involved, and contextual factors enabling or constraining HTA institutionalization in Ghana.
The following documents were analyzed: • the Ghana Strategy for Health Technology Assessment 1 • process guidelines for HTA in Ghana 18 • management of pediatric Burkitt lymphoma 19 • HTA Technical Working Group Meeting and Steering Committee Meeting Reports • the health sector program of work for 2018 and 2019.
We mapped the sequence of events and decisions; identified players, their roles, and contextual factors; and cross-referenced our findings with information gleaned from interviews.Fifteen interviews were conducted, with five members of HTA Technical Working Group or Steering Committee, four beneficiaries, three academics, two development partners, and one professional association representative.Interviews were conducted using a semi-structured guide (see Supplementary material 1) to investigate how local and international players contributed to the HTA policy processes, the administrative and bureaucratic structures used, HTA uptake, and contextual barriers and enablers.The interviews were conducted face-to-face or via phone and lasted 30 minutes on average.All interviews were recorded after obtaining verbal or written consent from respondents.The respondents' names and positions are not stated to ensure confidentiality.Ethical approval was obtained from the Ghana Health Service Ethics Review Committee (GHS-ERC:013/ 07/21).No financial incentive was provided to interviewees.

Data Analysis
Thematic content analysis was used.It involved seven steps: transcription, familiarization with the data, coding of the data, development of a working analytical framework, application of the analytical framework, charting of the data into the framework matrix, and interpretation of the data. 20After transcription, two of the authors (AK and JAB) examined the anonymized interview transcripts and data from the document reviews.
The data were then coded and organized into five themes: agenda-setting, policy adoption, policy implementation, contextual barriers, and contextual enablers.Subthemes included key stakeholders and their roles, administrative and bureaucratic structures, and framing and ideas (Table 1).
Our working analytical framework-the organizational forms and political analyses for policy development for HTA in Ghana-is based on five themes.It draws on the following: • Campos and Reich 24 political analysis of health policy implementation, to categorize key stakeholders and their roles • Kingdon 10 framework of agenda-setting, to understand the window of opportunity for HTA institutionalization in Ghana • Grindle and Thomas 25 conceptualization of context of policy choice to explain the bureaucratic arenas of policy-making processes and categorize organizational forms.
Table 2 summarizes this paper's main findings.

Setting the HTA Agenda
Led by the MOH and supported by the World Health Organization (WHO) and others, training activities and discussions on evidence of medicines created awareness on the use of HTA.This awareness offered an opportunity to elevate HTA on the policy agenda.For example, training by the National Medicines Selection Committee on the appraisal of evidence between 2009 and 2012 initiated discussions on incountry economic evaluations and the generation of evidence summaries for the selection of medicines for the Standard Treatment Guidelines and Essential Medicines List, thereby creating awareness on the Table 1.Documents reviewed and themes and subthemes identified.

Document
Themes and subthemes Ghana Strategy for Health Technology Assessment. 1 Policy adoption, agenda-setting, administrative and bureaucratic structures, Process Guidelines for Health Technology Assessments (HTA) in Ghana. 18olicy implementation, administrative and bureaucratic structures Managing Pediatric Burkitt lymphoma in Ghana: A Health Technology Assessment. 19licy implementation Health Technology Assessment and Antimicrobial Resistance Donor Meeting. 21olicy adoption, key stakeholders and their roles, framing and ideas HTA Technical Working Group and HTA Steering Committee meetings.
Policy implementation, policy adoption, key contextual barriers, contextual enablers, key stakeholders and their roles, framing and ideas Ghana Health Sector Program of Work (2017, 2018).
Agenda-setting, policy adoption, framing and ideas, window of opportunity Follow-through steps for Health Technology Assessment (HTA) on Childhood Cancers in Ghana. 22

Policy implementation
Draft Reference Case for Health Technology Assessment in Ghana (2022) Policy implementation Institutionalizing Health Technology Assessment in Ghana to Support Access to New Health Technologies: Inception Report. 23enda-setting, key stakeholders and their roles, policy adoption, framing and ideas, window of opportunity  • Parliament Select Committee on Health • HTA Technical Working Group (HTA-TWG) and HTA Steering Committee (HTA- SC) • HTA Secretariat at the Pharmacy Directorate • Links and partnerships with country institutions and international partners through the HTA Secretariat • Increasing political buy-in and capacity building for evidence-informed priority course on evidence, cost, and drug selection, which introduced them to elements of HTA, such as critical appraisal of evidence, randomized controlled trials, evidence summaries, interpretation of evidence, assessment of types of bias, and relevant and appropriate literature searches.HTA was further supported in the 2017 National Medicines Policy, 26 with the objective of strengthening the science and practice of HTA in support of evidence-based reimbursement decisions by the government, and the National Health Insurance Scheme (NHIS).
The National Medicines Policy guided HTA.Box 1 summarizes its policy statements.Advocates of HTA used organizational structures such as the health summit (a platform for high-level policy-making in the Ghanaian health sector) to garner support and buy-in.
We have always had tight budget pressure, and there is a need to efficiently allocate the little available.So once the key actors recognized that HTA can bring about some efficiency in resource allocation we had their buyin.I think that is one of the reasons why HTA was pushed and institutionalized in Ghana.Interviewee 7   In setting and sustaining the HTA agenda, the MOH and donors advocated for the institutionalization of HTA into the Ghanaian health system.The MOH maneuvered institutional hurdles by securing slots at the April 19-21, 2017, and April 23-27, 2018, health summits and positioning the HTA Secretariat in the Pharmacy Directorate as a unit within the MOH responsible for the design of pharmaceutical policies and pharmaceutical sector oversight.
The minister of health, an agenda approver, endorsed the "Setting Priorities Fairly: Sustainable Policies for Effective Resource Allocation" event, demonstrating political commitment to the HTA agenda.The event was organized by the Ghanaian MOH, Health Technology Assessment international (HTAi), and the International Decision Support Initiative (iDSI) in Accra on September 26-27, 2018. 27iscussions in Ghana and the framing of the selection of medicines and the need for Ghana-specific economic evaluation and evidence summaries played a pivotal role in incorporating HTA into Ghana's health system. 9Local and international champions advocated for and framed HTA issues to align with the processes for national medicine selection and supported HTA activities and governance structures to sustain the HTA agenda.Characteristics of local and international players and policy issues, including how the issue is framed, are key for health agenda-setting. 28

Adopting HTA Policy
Four main events helped operationalize and adopt the HTA policy agenda.First, in 2014 and 2015, the Program for Appropriate Technology in Health (PATH), under the Access and Delivery Partnership (ADP), assessed the health sector's readiness for institutionalizing HTA and provided options and recommendations that guided decisions on how to institutionalize HTA in Ghana. 1 Because HTA varies in different contexts, we had a consultant working with the ministry to come up with an inception document on how we institutionalize HTA in Ghana.We worked together with the ministry to

Box 1. Policy statements on health technology assessments in Ghana's 2017 National Medicines Policy 26
x There shall be a standing technical committee established by the Minister of Health responsible for Health Technology Assessments for the health system.The capacity of the standing technical committee shall be built to perform HTA functions to meet the needs of the pharmaceutical sector.
x There shall be developed and regularly updated HTA guidelines which shall detail methods, processes, benchmarks, perspectives and agreeable standards for the conduction, dissemination and use of HTA in-country.
x HTA assessment reports shall be applied to evidence-informed context-based decisions on health technologies, with a focus on reimbursement decisions on new expensive vaccines, diagnostics and medicines.
x The Secretariat on HTAs shall collaborate with other HTA groups regionally and globally, to contextualize existing knowledge when available.
x Institutionalization of HTAs shall not usurp, but align with the statutory authority and functions of existing institutions such as the FDA, NHIA, GNDP (National Medicines Selection Committee) etc.
strengthen the governance around HTA through ADP support.Interviewee 12   Second, in 2018, HTA was included in the health sector aide memoire, which summarized the decisions made at the national health summit.That summit brought together local and international stakeholders to review the health sector agenda and agree on the priorities, policies, and programs for the following year.The decisions captured in the aide memoire were expanded in the health program of work by the MOH for implementation.
Third, in 2020, the MOH developed and launched the Ghana Strategy for HTA.It detailed nine interrelated areas for implementation: governance, topic selection and technical work, guidelines and manuals, resourcing and tooling, resource mobilization and funding, implementation and follow-through actions, communication and dissemination, collaborations and partnerships, and capacity development.
Developing and launching the strategy for HTA was critical, and this strategy is to inform decision-making and promote equitable, efficient, and high-quality health care.Interviewee 5 Fourth, the process guidelines for HTA defined the sequential and stepwise approach for HTA in Ghana with the aim of ensuring consistency of approach for assessment and appraisal.The development of the process guidelines was coordinated by the HTA Secretariat, with support from ADP, PATH, the United Nations Development Programme (UNDP), and the WHO.The steps include topic nomination, topic selection, scoping and stakeholder engagement, assessment, appraisal, deliberation, recommendations, communication and appeal, and implementation. 18

Implementing HTA Policy
To implement and sustain HTA policy on the national agenda, the MOH put in place governance structures and sought expertise and partnerships through discussions with donors and members of the HTA Technical Working Group and Steering Committee.The minister of health approved and inaugurated the governance structure on October 4, 2019.It consists of a multisectoral HTA Technical Working Group (HTA-TWG) and HTA Steering Committee (HTA-SC).The HTA-TWG was tasked with generating evidence and providing recommendations to the HTA-SC.HTA-SC members included representatives from the MOH and agencies such as the Ghana Health Service and National Health Insurance Authority, the Ministry of Finance, a coalition of nongovernmental organizations (NGOs) in health, academics, the WHO Country Office in Ghana, the National Medicines Selection Committee, the Christian Health Association of Ghana, and the Ghana Association of Quasi Health Institutions.The HTA-SC is responsible for providing recommendations to the minister of health for high-level decisions on investment or disinvestment in medicines and other health technologies.
Organizational governance structures and multipartnership were very important to institutionalizing HTA, an HTA secretariat, a steering committee, and a technical working group (TWG) were established, and various partners such as the Norwegian Institute (NIPH), the National Institute for Health and Care Excellence (NICE) International, the Thai Government, the WHO, UNDP, and PATH were engaged.Interviewee 9 iDSI, the National Institute for Health and Care Excellence (NICE), and the University of Southampton supported Ghana's efforts to develop an HTA model for hypertension.Findings informed the selection of antihypertensives for the 2017 Standard Treatment Guidelines and Essential Medicines List.At the request of the National Health Insurance Authority (NHIA), the TWG, supported by the Norwegian Institute of Public Health (NIPH), assessed the clinical and economic impact of extending the coverage of cancer medicines on the National Health Insurance Scheme (NHIS) medicines list to include treatment for childhood cancers.As a result, the NHIS now covers treatment for childhood cancers. 19HTA optimized resource utilization by providing evidence for setting priorities of the services provided under the scheme.
NHIA is interested in efficiency and value for money, and therefore are keen in having the best interventions selected at the lowest possible cost.Interviewee 6 The HTA-TWG and the School of Public Health University of Ghana (SPH-UG) supported the MOH by estimating the total cost of COVID-19 vaccination and its main driver.HTA capacity building is ongoing at academic institutions.For example, since 2021, the SPH-UG, together with the WHO country office, has been training MOH staff in economic evaluation through its health economics master's program.
A multistakeholder approach is critical to HTA policy implementation. 15,16,29HTA policy agenda advocates and advisers promoted a hands-on approach to HTA in Ghana that has resulted in capacity-building activities and outputs such as the hypertension model 30 ; COVID-19 vaccination costing 31 ; and management of pediatric Burkitt lymphoma. 19TA-TWG members are constantly building their expertise, helping mitigate the challenges of insufficient in-country expertise.

Contextual Enablers and Barriers to the Institutionalization of Health Technology Assessment in Ghana
Three factors facilitated the institutionalization and application of HTA in Ghana.First, champions advocating for and pushing the HTA agenda-both local and international advocates-framed HTA issues to convince others and attract technical and financial support.
I think we had champions from the beginning-for example, the Directorate of Pharmaceutical Services of the Ministry of Health engaged international organizations for support on how to use economic assessment for decisions on medicines selections.This led to the incorporation of HTA in the selection process by the Ministry of Health.Interviewee 7 I know the Ministry of Health is the main driver for HTA institutionalization.Of course, you cannot overlook the role of international partners as well.International partners have also played a role in supporting with expertise as well as funding.Interviewee 8 Second, the MOH was receptive to aligning national strategic goals with HTA institutionalization. Governance structures such as the HTA Secretariat, the HTA-TWG, and the HTA-SC were constituted to drive the institutionalization process.The HTA agenda aligned with the MOH's strategic goal of promoting evidence-informed decisions, especially for universal health coverage, and promoting access to affordable, safe, and effective medicines and other health products. 27e MOH was interested in HTA and initiated governance processes.The ministry is the decision-making body when it comes to policies and interventions or whatever decisions the government wants to take for public health.So having understood the value of HTA, the MOH took the lead in the institutionalization of HTA.Interviewee 2 Third, the Pharmacy Directorate at the MOH was designated to lead and coordinate the HTA agenda-setting, policy adoption, and implementation.It engaged stakeholders at the national level and ensured that HTA got onto the agenda of the health summit for consideration for policy implementation.Staff of the Pharmacy Directorate also engaged both local and international multisectoral partners to place and sustain HTA on the national agenda.
Our partners include iDSI, the Norwegian Institute of Public Health, ADP and PATH, the WHO Country Office, the London School of Hygiene and Tropical Medicines, the University of Health and Allied Sciences, and our own Kwame Nkrumah University of Science and Technology (KNUST) and the SPH-UG and the University of Ghana School of Pharmacy.All of these partners work with us.We are able to share and take ideas and build capacities and sustain the HTA agenda.Interviewee 10 Ghana's long experience in the design and implementation of the Standard Treatment Guidelines and Essential Medicines List through the Ghana national medicines selection committee created an enabling environment for discussions on HTA and its relevance for prioritysetting and the selection of medicines and other health products.The National Medicines Policy guided the institutionalization of HTA, providing clear policy directions.Existing administrative and policy legislations were useful in supporting HTA institutionalization. 8,32 We identified three main barriers to the institutionalization of HTA.The first is the lack of local technical expertise.Capacity-building activities are ongoing with the HTA-TWG, supported by several partners, such as the NIPH and PATH, to promote a learning-by-doing approach, and the SPH-UG and KNUST have increased capacity building and research in areas relevant to HTA.
There is insufficient local expertise for HTA, but the academic and research environment are supportive of ongoing HTA capacity building programs.This is important and of course the academic and research institutions had funding from the government itself and donors.Interviewee 13 Second, there was an initial conflict over where to house the HTA unit.After internal discussions within the MOH and consideration of the recommendations and options from the report Institutionalizing Health HTA in Ghana to Support Access to New Health Technologies (2017), the decision was made to host the HTA unit in the MOH Pharmacy Directorate, which coordinates the Standard Treatment Guidelines and the Essential Medicines List.
Third, there have been insufficient financial and technical resources to support sustained HTA activities.There is a need to recruit additional technical and administrative officers, strengthen the HTA-TWG, and enhance collaboration with all stakeholders, including academics.
Adequate technical expertise and funding are required to support HTA activities.It is important that the government allocate more resources to support the institutionalization of HTA in Ghana.Interviewee 11  Local and international policy advocates and advisers are constantly mitigating new challenges to institutionalizing HTA.Capacity building and nurturing are ongoing, with technical and financial support provided to the ministry.

Limitations of and Opportunities Created by This Study
Recalling events, activities, and all of the players involved in the HTA agenda-setting, adoption, and implementation in Ghana is challenging.To mitigate this limitation, we used multiple data sources.
HTA implementation is ongoing; the involvement and roles of key stakeholders as well as HTA uptake may change.Follow-up analysis can compare trends in stakeholder roles, HTA uptake, and bureaucratic structures for HTA implementation.

Conclusions and Policy Implications
This paper describes the HTA policy agenda-setting, adoption, and implementation processes; key stakeholders; and administrative and bureaucratic structures created or modified to institutionalize HTA in Ghana.It also identifies the main enabling and constraining factors.Ghana's experience holds lessons for HTA policy development and implementation elsewhere, especially in low-and middle-income countries.
Several players helped effect HTA institutionalization in Ghana.The minister of health, as an agenda approver, inaugurated the HTA-TWG and HTA-SC and approved the HTA governance structure.MOH officials, together with development partners, served mainly as agenda advocates and advisers, respectively.Development partners provided technical expertise and funds.4][35] They also financially supported HTA research and activities in Kenya. 8he paper illustrates the importance of building on existing administrative and bureaucratic structures and processes to advance and maintain an agenda.HTA advocates and advisers relied on structures such as the health summit, an institutionalized policy-making process, to gain national support and legitimacy.Existing administrative capacity to accommodate new policy is important because it determines which organizational structures or policies can be actively pursued and implemented. 25Therefore, the HTA governance structures such as the HTA secretariat and the minister inaugurated HTA-TWG and HTA-SC, were possible in the Ghanaian health sector context.Having organizational and governance structures in place to undertake and use HTA to inform decisions, especially at the national level, is important. 8our implications and lessons for HTA agenda-setting, adoption, and implementation emerge from this study: • Aligning the HTA agenda with existing national health policy, such as the National Medicines Policy and institutional structures and processes, is critical to ensure early national-level buy-in.
• Incorporating a multistakeholder approach with both national and international players is important to map stakeholder expertise, roles, interest, and expectations and ensure a participatory approach to policy-making.• The context of the health system, the institutional policy-making process, and bureaucratic structures can enable or constrain the introduction of a new policy.Understanding the complex health system and how to overcome potential bureaucratic hurdles are equally important in advocating for a new policy.
• Identifying and engaging the interest of high-level policy agenda influencers, such as policy agenda approvers, advocates, and advisers, for a better understanding of HTA is vital given the ever-changing nature of national level agenda items.

Table 2 .
Organizational forms and political analyses for policy development of Health Technology Assessment and priority-setting in health in Ghana.