Coverage under the Social Health Authority flows through three funds. What that structure changes for a product that already holds Pharmacy and Poisons Board registration.
Kenya's Social Health Insurance Act 2023 replaced the National Hospital Insurance Fund with the Social Health Authority. For manufacturers, the practical question is how this changes the case for funding a registered product.
Three funds, not one
Coverage flows through three funds rather than a single pool:
- The Primary Healthcare Fund
- The Social Health Insurance Fund
- The Emergency, Chronic and Critical Illness Fund
The relevant fund affects the budget an intervention would draw on. That shapes the budget-impact case. Primary-care and critical-illness interventions can face different budget questions even when their clinical evidence is comparable.
Registration and reimbursement are separate determinations
Registration with the Pharmacy and Poisons Board establishes that a product may lawfully be sold. It establishes nothing about whether it will be paid for. Those are two determinations, made by two bodies, against two different evidence standards.
A product that clears the first and not the second may compete on out-of-pocket price against an alternative inside the benefits package. That creates a separate access question, which a regulatory timeline alone does not resolve.
What this changes about planning
The practical consequence is that evidence generation for reimbursement cannot begin after approval. A cost-effectiveness analysis needs a comparator drawn from current Kenyan practice, local cost inputs, and epidemiological data that is rarely sitting ready. Assembling that is a longer exercise than compiling a registration dossier, and it runs on a different evidence base.
Starting this work during registration gives your team more time to address gaps before an access decision is needed.
What does this mean for your product?
Discuss the evidence, requirements and next steps that apply to your situation.
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