What the SHA benefits package means for a registered product

Kenya's Social Health Insurance Act 2023 replaced the National Hospital Insurance Fund with the Social Health Authority. The change is often described as an administrative one. It is not. It restructured how money reaches a provider, and in doing so it created a second gate that sits entirely after regulatory approval.

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

For a manufacturer this matters because the fund a product would be reimbursed from determines which budget its inclusion competes against, and therefore which budget-impact argument has to be made. A product used in primary care and a product used in critical illness are not making the same case, even where the 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 is legal to sell and commercially exposed: it competes on out-of-pocket price against an alternative inside the benefits package. In a market where most patients are covered through SHA, that is a decisive disadvantage, and it is invisible on a regulatory timeline because it sits after the point most launch plans stop tracking.

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.

Firms that treat the two as sequential discover the gap at the point when it is most expensive to close.