Our Services

Market access is a collection of processes encompassing licensing, pricing and reimbursement functions. From the perspective of the public authority, market access involves the application, evaluation and decision-making processes through which a product — whose efficacy and safety have been demonstrated through clinical trials and approved by international regulatory authorities — is licensed in Turkey, priced for sale in open pharmacies, and ultimately, through a reimbursement decision, becomes publicly or privately financed for citizen use under health coverage.

Innovative medicines are evaluated at numerous commission and technical committee meetings between the initial marketing authorisation application and the reimbursement decision. In addition to efficacy and safety parameters, the priority of the relevant therapeutic area and the need for the medicine under evaluation within that area (unmet need) are assessed by the clinicians serving as commission and committee members.

The reimbursement decision is finalised by the Reimbursement Upper Committee following the recommendation formed by the relevant reimbursement sub-committee, which is informed by the technical committee assessment.

Both the sub-committee and the upper committee include experts in public finance and funding outside of health and social security institutions. In this context, the systematic preparation, publication and communication of the disease, indication and the advantages and benefits provided by the product under evaluation is of great importance.

KH Consulting conducts Policy Studies for Market Access with the aim of making a positive contribution to the evaluation by conveying the disease, indication and product to relevant stakeholders as effectively as possible in licensing, pricing and reimbursement processes.

Policy Studies for Market Access are refined through Advisory Board Meetings held with the participation of specialty societies working in the relevant therapeutic area, following an initial study designed by KH Consulting. The report is ultimately published upon approval by the executive bodies of the relevant specialty societies.

These policy studies, which may vary by disease, indication and product, consist of 3 phases:

A reimbursement application is a series of processes that requires coordinated work across different specialised fields and is completed with the publication of the relevant product in the Health Implementation Communiqué (SUT) upon the successful completion of the 3 Phases outlined below.

KH Consulting provides consultancy services for the phases of the reimbursement process defined above, across different therapeutic areas, diseases and indications. This consultancy service may be provided for all 3 Phases as a whole or for a selected individual phase.

Certain verifiable data and analyses are required in the preparation of a reimbursement application. The services provided by KH Consulting in this scope are presented below:

Adaptation of pharmacoeconomic models developed by the global management of pharmaceutical companies to Turkey using local data is carried out with KH Consulting's expertise.

To obtain the local data required for the Turkish adaptation of the model, a preliminary study is conducted with a clinician or clinicians (proposed by the company or KH Consulting) experienced in the use of the molecule/drug in the relevant indication.

This study is fundamentally based on identifying resource utilisation (specialist visits, consultations, intensive care, hospitalisation, laboratory and diagnostic tools, medication and care) related to disease and adverse event management during the use of the molecule/drug in the relevant indication. A final study is conducted with another clinician experienced in the use of the molecule/drug for validation. Micro-models are prepared for disease and adverse event management, and the validated resource utilisation figures are costed using current SUT prices.

The global model is updated with the obtained local data and costs, and the analyses and sensitivity tests required for the Turkish adaptation are performed. Finally, the definitive report for the model adaptation and the text and annexes to be included in Section III of the reimbursement dossier are prepared.

KH Consulting develops dynamic and actionable solutions for Patient Associations in environments where changing conditions, practices and SUT rules negatively impact patients' and caregivers' access to medication:

KH Consulting conducts Field and Market Research to support the GMP, licensing and reimbursement processes of innovative molecules and to contribute to Phase IV studies.

KH Consulting conducts focus group studies with subject-matter experts on the topics listed below.

KH Consulting conducts analyses to determine the most appropriate and effective position for innovative products in the relevant therapeutic area and market — within the context of existing products, competitive conditions and SUT constraints — prior to GMP and/or licensing processes.

Product positioning studies are conducted with the participation of competent academics in the relevant therapeutic area and with standing before the public authority.

Updating health policies in line with country and regional needs, prioritising public health and preventive medicine, operating healthcare organisations effectively and efficiently, and using health technology assessment systems in the allocation of scarce resources are important conditions for improving the health status of societies and individuals.

KH Consulting focuses on the following areas in project consultancy within the healthcare sector: