The Social Security Institution (“SSI”) has introduced a new regulation, announced on 18 March 2026, setting out the procedures and principles applicable to alternative reimbursement applications for medicines supplied from abroad.
The regulation introduces important changes to reimbursement processes carried out within the scope of patient-based access to medicines that are not licensed in Turkey or are otherwise unavailable on the market.
Scope and Purpose
As is known, the mechanism for supplying medicines from abroad allows patient-based access to products that are not licensed or not available in Turkey under certain conditions. Within this framework, the SSI’s alternative reimbursement mechanism plays a critical role in the evaluation of the financing of such products.
In this context, the “Procedures and Principles for Alternative Reimbursement Applications for Medicines Supplied from Abroad for Individual Treatment” (“Procedures and Principles”) set out in detail the application process and the information and documentation required to be included in the application dossiers.
New Requirements for Application Dossiers
The Procedures and Principles introduce a more detailed framework for the technical requirements of the application process.
In this regard, the main components required to be included in the application dossier include, among others, a letter of undertaking, an overseas medicine price offer form, information on the product’s pricing and status in other countries, summary tables of clinical data, and new treatment balance tables.
In particular, the inclusion of standardized forms and tables indicates an intention to ensure a more systematic and comparable assessment of applications.
Expansion of the Scope of Data Requirements
The new regulation expands the scope of data required to be submitted within application dossiers.
Accordingly, companies are expected to provide, in addition to analyses on the estimated prevalence and patient population in Turkey for the relevant indication, projections on the potential budget impact if the product is included within the reimbursement scheme.
Risk Sharing and the Undertaking Mechanism
Another key aspect introduced by the Procedures and Principles is the set of obligations imposed on companies through the mandatory undertaking to be included in the application dossier.
In this respect, companies are required to commit to ensuring uninterrupted supply of the products and to assume certain financial obligations arising from potential price differences.
This reflects a mechanism whereby financial risks under the alternative reimbursement framework are, to a certain extent, shared between the public authority and the companies.
General Assessment
This development indicates that alternative reimbursement applications will be assessed not only on the basis of clinical efficacy and medical need, but also in light of budget impact and patient population data.
Accordingly, the scope of application dossiers is expanding, and it is becoming increasingly important for companies to prepare their data sets in a more holistic and structured manner.