Institutionalizing Health Technology Assessment in South Africa—An Opportunity in National Health Insurance

ABSTRACT While South Africa has some experience in various forms of health technology assessment (HTA), it is currently fragmented across numerous players. Additionally, there is a lack of systematic and consistently applied HTA processes that inform priority-setting and budget allocations. To address this, the country is journeying toward more institutionalized use of HTA. This will begin with the establishment of a Ministerial Advisory Committee on HTA for National Health Insurance (NHI) and will gradually embed HTA processes in decision-making. The goal is to create an independent HTA agency. Although these reforms will be intrinsically linked to the wider health financing reforms envisaged under NHI, such as formulating the benefits package, they will also assist in strengthening South Africa’s health system. As a country facing a highly constrained fiscal environment, with limited space for additional funding for the health sector, evidence-based priority-setting will be critical to ensure that value for money is achieved in the government’s investments in health care services in NHI.


Introduction
HTA approaches have been implemented in the South African public sector in the selection of essential medicines.The Essential Medicines List (EML) informs the procurement of essential medicines in the public sector, while the Prescribed Minimum Benefits determines entitlements in the private sector.
HTA aims to provide a transparent, regularly updated link between emerging technologies and the foundational evidence and values guiding their integration.HTA streamlines decision pathways by avoiding redundancy and double counting.It is feasible to incorporate dynamic feedback on real-world effectiveness, allowing corrective action when deviations from optimal clinical performance are identified.This information can also be used to review the quality and appropriateness of the original funding decision.HTA will encompass initial appraisal, alignment to policy goals, and ongoing audit of realworld local and regional effectiveness.
In this commentary, as representatives of the National Departments of Health and Treasury of South Africa, National Essential Medicines List Committee and HTA Technical Work Group, we review the historical development of HTA in South Africa and share the potential strategies for formalizing HTA using existing structures and processes while providing a vision for the positioning of HTA under the recently approved National Health Insurance (NHI) Bill.

The History of HTA in South Africa
Players with different mandates are involved in HTA processes and include private sector funders, large hospital groups, nonprofit organizations, academia, and national and provincial public sector guideline developers and advisory committees. 1 The policy directions of these players align with those of their funders.This work is imperfectly coordinated, often duplicated, and frequently lacks transparency.Specifically, the sharing of HTA work done in the private sector may be limited due to intellectual property concerns.The costing assumptions used in economic models may also differ considerably between public and private entities.
Over the past two decades, in the public health sector, South Africa has incrementally increased the use of HTA processes in the selection of essential medicines through the ministerially appointed National Essential Medicines List Committee (NEMLC).
The application of HTA for developing the National EML has focused predominantly on the evaluation of medicines and has been under-resourced in terms of the appropriately skilled human resources despite the growth and strengthening of the rigor of the methodological process in the country.Its current location in the National Department of Health (NDoH) potentially opens decisions to political influences and to being over-ridden by provincial health authorities.
The public sector medicines selection has moved from an era of subjective round-table decision-making by opinion leaders, to the application of a sound evidence-based methodology which prioritizes topics for assessment.The HTA Methods Guide provides guidance for gathering, producing and reporting evidence on clinical efficacy, safety, cost-effectiveness and affordability, as well as factors such as equity, feasibility and acceptability. 2  Over the past 3 years, the committees were able to develop approximately 20 medicine reviews informing changes to the national EML with a greater policy demand for HTA analysis and faster turnaround time during and following the COVID-19 period.
These governance processes have been strengthened with the updating and application of policies and standard operating procedures (e.g., conflict of interest, confidentiality, appeals, and stakeholder engagement).These processes have supported the successful application of HTA in the context of the review of essential medicines in the South African public health sector by promoting transparency and understanding of HTA processes.As more private sector players with a wider range of primary interests become involved in the review of the EML processes, the resilience of these processes will be tested and may require adaptation.
While there has been progress on incorporating HTA processes into decisions around medicines and vaccines, similar assessments for other technologies and interventions such as equipment, health care education, and diagnostics have been very limited.Additionally, the precise placement of HTA in final decision-making is not clearly articulated in the NHI Bill.
The Department of Health's in-house capacity to perform HTA needs to be strengthened through the transfer of skills, information sharing, collaboration, mentorship, and leveraging academic institutions and HTA networks, both locally and internationally.
This medicine-focused HTA methodology forms the foundation of the draft HTA Strategic Plan.The national Standard Treatment Guidelines and EML are considered fundamental in defining the health benefits packages that would be covered by the NHI fund, most notably for primary health care.However, alignment will be needed across clinical guidelines developed in the public and private health sectors using a standardized HTA methodology.

Designing an Evidence Informed NHI Strategy
South Africa spends 8.4% of its gross domestic product (GDP) on the health care system with poor outcome indicators.Half of this spend is in the public sector on the majority of the population (84%) across provinces.Even within the public sector, there is potential inequity between provinces due to differences in implementation of nationally set policies.Additionally, decision-making at the policy level is sometimes not transparent, making it difficult to determine the nature and weighting of values used in final resource allocations.These discrepancies in financing and resource allocation policies result in inequitable care both between public and private sectors and also between provinces in the public sector.
NHI seeks to bridge the gap between the current private-and state-funded health care sectors, through the establishment of the NHI Fund (NHIF).The new NHIF will purchase services from both the public and private sectors, with the intention of providing equitable access to quality health care services for all South Africans, regardless of socio-economic status or location.As South Africa moves toward strategic purchasing under NHI, the need for a reliable and trusted process for evaluating all components of the health system will grow.
Demand for health care services is always increasing, placing increasing pressures on existing health budgets.Implementation of NHI provides an opportunity to strengthen priority-setting to make efficient resource allocation decisions.
Following South Africa's National Assembly approval of the NHI Bill in June 2023, it was then adopted by the National Council of Provinces in December 2023.Once assented to by the President, the Bill will become an Act of Parliament, after which the proposed major health financing reforms will be implemented.
HTA will play an important role in maximizing the impact of NHI spend and will assist in maintaining political and public support for NHI.There will be a need to transition from implicit to explicit decision-making processes to ensure consistent, equitable, transparent, and fair access to health technologies.HTA will ultimately inform the availability and use of interventions for health promotion, disease prevention, diagnosis, treatment, and rehabilitation, which in turn will determine the cost of the health services in the health benefits packages utilizing these interventions.
South Africa, through a short-term HTA Technical Working Group, developed an HTA Strategic Plan which provides a framework for strengthening HTA, building on existing processes, and providing recommendations for the positioning of HTA under NHI. 3 It is envisioned that an HTA model that starts small and develops based on the usefulness of its output is a feasible and sensible use of scarce health resources.This model should be designed for capacity development and mentorship, starting at a national level and then expanding, with further changes over time as resources are acquired.
Given the level of effort needed to design the benefits packages, decision-making will be supported by a formal framework for priority-setting.Effectiveness and feedback on outcomes to inform future decisions are important, and post-implementation surveillance should be considered.
Key players need to embrace the core values underpinning the proposed HTA Strategic Plan, which includes incrementally promoting and embedding an HTA process, where feasible, into all health technology decisions; building and transferring HTA skills across the country; ensuring transparency and acceptability of decisions by introducing a culture of robust, resilient, evidence-todecision type framework use, performing HTA, when required, to guide appropriate allocation of resources; and ensuring growth and scalability of the HTA model.

Positioning of HTA in NHI
In terms of the NHI Bill, the Benefits Advisory Committee (BAC) will advise the Minister on prioritysetting to inform the decision-making processes of the NHIF.The BAC will also be responsible for the development of detailed and cost-effective treatment guidelines. 4AC on HTA will serve as a precursor to the HTA agency that must regularly review the range of health interventions and technology by using the best available evidence on cost-effectiveness, allocative, productive, and technical efficiency and HTA. 4 Furthermore, the reference to HTA under the Healthcare Services Coverage section in the Bill indicates the intention to use HTA to determine costeffectiveness not only with health products but also with all health interventions. 4lthough policy developments for NHI and HTA in South Africa are ongoing at the time of writing, HTA may be operationalized as follows: • Short term: MAC on HTA for NHI will be established, and supported by the NHI branch within the NDoH.MAC will design the HTA policy, engage with stakeholders, and promote HTA processes.Their role will also be to develop proof of concepts, piloting HTA methodologies and processes for all types of health technologies, and transfer skills and capacity for conducting HTA.• Medium-term: Greater use will be made of skilled national HTA resources using facilitatory and contracting approaches, with further engagement with stakeholders for all types of health technologies.HTA service providers will be evaluated, graded, and capacity to conduct HTA assessments will be strengthened where needed.Technical contributions from appropriate partners, including academic institutions, will be an important component.• Long term: HTA processes will be entrenched and embedded in decision-making, as a national agency once the NHI Bill comes into full effect, with a vision of a mature, sustainable independent HTA entity serving as an authority for all health technologies.An independent agency could give national credibility to the entity, improving the independence of its decisions.The agency could have more powers to develop and utilize a highpowered network of academic and other institutions to do HTAs and could be more transparent in its evaluations compared to an HTA unit in the NHIF.However, this approach is costly and requires extensive administrative infrastructure.

Conclusion
While South Africa has experience with various forms of HTA across both the public and private health care sectors, the fragmented processes across various players have not yielded the health outcomes commensurate with the funding expended in providing health care services.
As the country faces a highly constrained fiscal environment, the establishment of NHI provides the opportunity to embed and formalize HTA to support decision-making for the use of all health interventions for the health sector.
Following approval of the NHI Bill, the draft HTA Strategic Plan will require widespread stakeholder consultation.Buy-in is needed from key players in terms of the core values that underpin the strategy and for an HTA model designed for incremental growth.
Ultimately, transparent decision-making and coordination among all stakeholders involved in HTA processes across the public and private sectors, strong governance, leadership, and the political will to invest in human resources will facilitate the uptake of a formalized HTA process in South Africa.