HTA in Emerging Markets: Lessons from South Africa’s Pharmacoeconomic Guidelines

South Africa’s journey toward institutionalised Health Technology Assessment (HTA) offers practical lessons for low- and middle-income countries (LMICs) wrestling with how to make fair, evidence-based choices about medicines and other health technologies. In 2013, South Africa published formal Guidelines for Pharmacoeconomic Submissions to provide a transparent, consistent way for manufacturers and evaluators to present cost-effectiveness evidence, a landmark step in the region’s move from ad-hoc decisions toward methodical priority-setting.

Below we take a look at the most useful lessons from South Africa’s experience, sketch a case study of how the guidelines are being used, and give a short, localised example showing how an LMIC (here framed for Kenya and other similar contexts) could adapt these lessons to strengthen benefit-package decisions.

Why South Africa matters for other LMICs

1. A formal method reduces ad-hoc decisions: Before the guidelines, pricing and coverage decisions were inconsistent across hospitals and provinces; the pharmacoeconomic rules created a common format for submissions and evaluation, improving transparency.

2. HTA is being embedded into broader policy (NHI): South Africa explicitly ties HTA to National Health Insurance reforms and is building institutional structures (advisory committees, methods guides, and an HTA workplan) to use HTA for benefits design. That shows how HTA can move from a technical exercise into routine policy.

3. Guidelines evolve into operational methods: The pharmacoeconomic submission rules (2013) were an early, focused instrument; later, the Department of Health published more detailed HTA methods guidance and review frameworks to cover a wider set of technologies and functions. Countries can start small and iterate. 

Case study: What the 2013 pharmacoeconomic guidelines changed

1. Standard submission template: Manufacturers must present epidemiology, comparator choice, model structure, cost inputs, and sensitivity analyses in a defined way, making it easier for reviewers to compare dossiers.

2. Decision context: The guidelines made the role of pharmacoeconomic evidence explicit for pricing committees and formulary reviews, not necessarily binding, but influential. Stakeholders (government, industry, clinicians) now work from a known evidence baseline. 

3. Implementation challenges: Capacity constraints, data gaps (local costs, outcomes), and the complexity of dual public–private systems have slowed full realisation. South Africa’s ongoing work focuses on building institutional capacity and tailoring methods to local data realities. 

Practical lessons for LMICs (actionable)

1. Start with a clear, narrow remit: South Africa began with pharmacoeconomic submissions for medicines before broadening to full HTA methods. LMICs can start with high-impact product categories (e.g., high-cost antivirals, vaccines) to demonstrate value.

2. Prescribe submission standards, not a single 'perfect' model: Require transparent model structure, comparator choice, local unit costs where possible, and sensitivity analyses, but allow pragmatic approaches where data are scarce. The goal is comparability and reproducibility, not methodological perfection.

3. Invest in capacity and data in parallel: Guidelines are only useful if reviewers can interpret models and auditors can test assumptions. Pair guideline roll-out with training for ministry analysts, academic partners, and hospital pharmacists; parallel investments in basic costing and outcome measurement are essential. 

4. Use HTA to inform, not to freeze decisions: In mixed systems, HTA is most effective when its outputs (e.g., incremental cost-effectiveness ratios, budget-impact analyses, equity impact statements) feed into deliberative committees that consider feasibility, equity, and budget constraints.

5. Create a staged institutional roadmap: South Africa’s move from guidance → methods → HTA unit demonstrates a phased path: start with administrative rules, publish a methods guide, create an advisory committee, then establish an independent or semi-independent agency. Each step must be matched by sustainable funding and clear decision mandates.

Localised example: Relevance to Kenya (or a similar LMIC)

Scenario: The Ministry of Health must decide whether to include a new long-acting diabetes medicine in the national primary-care formulary. Clinical trials show improved HbA1c control and fewer hospitalisations, but the drug is substantially pricier than standard treatment.

How to use South Africa’s lessons, step by step:

1. Require a standard submission. Ask the manufacturer to submit a pharmacoeconomic dossier that follows a national template: model structure, comparator (current standard of care), local unit costs, and a 5-year budget-impact analysis. If Kenya does not yet have a national template, adapt South Africa’s submission checklist as a stopgap.

2. Run a rapid HTA. The ministry’s HTA secretariat (or a technical working group at the university) conducts a rapid review: check the model’s transparency, test key assumptions with local cost data, and rerun the model using country-specific resource use. If local data are missing, perform plausible scenario analyses and threshold analyses (e.g., what price would make the medicine cost-effective at a chosen willingness-to-pay).

3. Present findings to a deliberative committee. Provide the committee a succinct package: (a) base-case incremental cost-effectiveness ratio (ICER) with local inputs, (b) budget impact for the next 3–5 years, (c) equity implications (which populations benefit), and (d) implementation considerations (cold chain, training). The committee weighs clinical benefit, affordability, and distributional concerns. 

4.     Negotiate conditional access. If the committee finds clinical value but budgets are constrained, negotiate managed entry: volume-based discounts, price caps tied to outcomes, or restricted listing to high-risk groups while local monitoring systems collect real-world effectiveness and utilisation data. South Africa’s transparent submission system makes such negotiations evidence-based and credible.

Pitfalls to avoid

• Treating guidelines as a one-time product. Without regular revision and capacity building, guidance becomes irrelevant as new methods and data emerge. South Africa’s continued method development illustrates the need for iteration.

  
  

• Imposing impractical requirements. Mandating complex country-specific inputs before local data systems exist will choke submissions and widen inequity. Be pragmatic: allow international evidence supplemented by local scenario analyses. 

Editors Note

South Africa’s pharmacoeconomic guidelines show that LMICs do not need a perfect HTA system to start reaping benefits of more rational, transparent decision-making. The practical sequence is clear: publish pragmatic submission rules, build local review capacity, embed HTA outputs into deliberative processes, and iterate the methods as data and institutions mature.

If your country is beginning this journey, consider publishing a simple pharmacoeconomic checklist this year, pair it with a small HTA unit or academic secretariat, and use pilot decisions (e.g., for high-cost medicines or vaccines) to prove the model.