Ultra Pharma
Ultra Pharma / Services / Stage 03

Health product assessment and national benefit listing

Preparing the evidence that supports inclusion in Kenya's national health benefits package, so an approved product becomes a funded one.

01What changed

A new panel decides what SHA covers

Kenya's Social Health Insurance Act 2023 replaced the National Hospital Insurance Fund with the Social Health Authority. Coverage now flows through three funds: the Primary Healthcare Fund, the Social Health Insurance Fund, and the Emergency, Chronic and Critical Illness Fund.

The Ministry of Health established the Benefits Package and Tariffs Advisory Panel to guide what those funds cover and at what tariff. The panel was gazetted through Gazette Notice No. 5044 of 23 April 2025 and inaugurated in May 2025, chaired by Prof. Walter Jaoko, with its secretariat at the Centre for Epidemiological Modelling and Analysis at the University of Nairobi. Its method is health technology assessment.

Body
Benefits Package and Tariffs Advisory Panel
Gazetted
Notice No. 5044, 23 April 2025
Inaugurated
26 May 2025
Chair
Prof. Walter Jaoko
Secretariat
CEMA, University of Nairobi
Method
Health technology assessment
The access chain
  1. Registered
  2. Assessed
  3. Listed
  4. Funded

Registration clears the first step. The three that follow are decided by health technology assessment.

Policy & Health EconomicsBPTAP Advisory Context

A product outside the benefits package competes on out-of-pocket price against a funded alternative. In a market where most patients are covered through SHA, that is a decisive commercial disadvantage, and it is invisible on a regulatory timeline because it sits entirely after approval.

02Market Reality

Registration establishes that a product may be sold. It does not establish that anyone will pay for it.

03What we do

Our HTA and Reimbursement Services

Navigating the intersection of health economics, clinical evidence, and regulatory requirements to achieve national benefit listing.

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.

Cost-effectiveness and budget-impact modelling

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.

Stakeholder engagement and SHA liaison

Structured engagement with the Ministry of Health, the Social Health Authority and the panel secretariat, sequenced so evidence arrives when it can be considered.

Regulatory Advisory: 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.

  1. 01Clinical effectiveness against a comparator in current Kenyan practice
  2. 02Safety profile and adverse-event data
  3. 03Incremental cost-effectiveness analysis with local cost inputs
  4. 04Budget-impact model against the relevant fund
  5. 05Local epidemiological and disease-burden data
  6. 06Equity and access considerations
  7. 07Implementation feasibility within existing service delivery
04The Evidence

Seven things an assessment looks for

A successful listing requires a rigorous presentation of data across clinical, economic, and operational domains to prove value to the Social Health Authority.

05How we work

Phases of Engagement

A structured workflow taking your product from initial feasibility modelling through to formal panel submission and the review process that follows.

Phase 1

Feasibility assessment

We establish whether the evidence base supports a submission, and what is missing.

Deliverable: a feasibility opinion and evidence gap register.

Phase 2

Evidence generation

Closing the gaps: comparator selection, model construction, local data sourcing.

Deliverable: a completed economic model and dossier draft.

Phase 3

Engagement

Structured stakeholder engagement and submission support.

Deliverable: a final dossier and an engagement record.

Phase 4

Follow-through

Responding to questions and supporting the review process to determination.

End-to-end review determination

06Next step

Start with a feasibility assessment

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