HTA dossier development
Assembling the evidence a health technology assessment requires: clinical effectiveness against an appropriate local comparator, safety, and the value case in a form assessors can evaluate.
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Preparing the evidence that supports assessment for Kenya's national health benefits package. Connecting regulatory approval with the case for funded access.
Kenya's Social Health Insurance Act 2023 established a new health-financing framework. Coverage is organised through the Primary Healthcare Fund, the Social Health Insurance Fund, and the Emergency, Chronic and Critical Illness Fund.
The Benefits Package and Tariffs Advisory Panel advises the Ministry of Health and the Social Health Authority on benefits and tariffs, informed by health technology assessment.
Read the Ministry of Health announcementRegistration and funding are separate decisions. This is a conceptual pathway, not a guarantee that a particular product will pass each stage.
A product outside the benefits package may compete on out-of-pocket price against a funded alternative. Planning for the evidence behind access decisions belongs alongside the regulatory strategy.
Clinical evidence, health economics and structured engagement brought together in a clear assessment case.
Assembling the evidence a health technology assessment requires: clinical effectiveness against an appropriate local comparator, safety, and the value case in a form assessors can evaluate.
Incremental cost-effectiveness analysis using Kenyan cost and epidemiological inputs, and a budget-impact model showing what inclusion would mean for the relevant fund over a defined horizon.
Structured engagement with the Ministry of Health, the Social Health Authority and the panel secretariat, sequenced so evidence arrives when it can be considered.
Kenya's HTA process is new and still taking shape. We work with the process as it currently operates, and we will tell you plainly what is established and what is not.
BPTAP now publishes an intervention-proposal form. A proposal is distinct from a guaranteed product listing or funding decision. View the official proposal channel.
A coherent evidence base spans clinical, economic and operational questions. The requirements for an individual intervention depend on the assessment and available evidence.
Begin with feasibility, build the evidence, and support engagement and the review that follows.
We establish whether the evidence base supports a submission, and what is missing.
Deliverable: a feasibility opinion and evidence gap register.
Closing the gaps: comparator selection, model construction, local data sourcing.
Deliverable: a completed economic model and dossier draft.
Structured stakeholder engagement and submission support.
Deliverable: a final dossier and an engagement record.
Responding to questions and supporting the review process to determination.
Review questions and follow-through support.