Policy Studies for Market Access

Innovative medicines are evaluated in numerous commission and technical committee meetings throughout the process from licensing application to reimbursement decision; in addition to efficacy and safety parameters, the priority of the relevant therapeutic area and the need for the medicine under evaluation (unmet need) are assessed by clinician members of the commissions and committees.

The reimbursement decision is finalized by the reimbursement upper committee, following the recommendation prepared by the relevant reimbursement sub-committee based on the technical committee assessment.

Both the sub-committee and the upper committee are formed with the participation of senior officials specialized in public finance and funding, beyond health and social security institutions. In this context, preparing, publishing and communicating the advantages provided by the disease, indication and product of the medicine under evaluation with a systematic approach is of great importance.

Market access is a concept covering licensing, pricing and reimbursement processes. With the application, evaluation and decision-making processes defined by the public authority, market access is the licensing in Türkiye of a product whose efficacy and safety have been proven by clinical research and approved by international authorities to become a commercial product; its pricing so that it can be sold in community pharmacies; and finally, with the reimbursement decision, its use by citizens under health insurance becoming financeable by public or private insurance.

Phases

Phase I: Descriptive Analysis Study

Epidemiology
Disease Burden
Diagnostic Methods
Early Diagnosis and Prevention
Current Treatment Options
New Treatment Options and Approaches

Phase II: Roadmap Study

Complication and Treatment Cost Analysis
Survival and Quality of Life Analysis

Phase III: Disease Control Program Design

Policy Studies for Market Access are matured in Advisory Board Meetings held with the participation of specialty societies working in the relevant therapeutic area, after the preliminary study designed by Omega Araştırma, and finally the report approved by the specialty society managements is published.

These policy studies, which may differ on a disease, indication and product basis, consist of 3 phases.

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