Reimbursement and Pricing
Preparation of a reimbursement application dossier, submission to the Authority and follow-up through the Authority for Human Medicinal Products and Medical Devices
Original Product Reimbursement Dossier
Our work on the preparation of the Original Human Medicinal Product Reimbursement Dossier starts with a project starting meeting where the process / roadmap and work schedule are determined.
The dossier requirements are determined, national and international literature is searched, medical and financial data are compiled. Before the application preparation, opinions are taken from the relevant institutions or clinical experts. If necessary, an expert advisory board is established.
Following the association of medical processes with SUT, treatment cost analysis, economic justification, budget impact analysis, epidemiological and pharmacoeconomic analysis, the application dossier is prepared in accordance with the SSI legislation, after obtaining the final opinion from the authorities.
If requested, the application is followed up, a presentation to the commission is prepared and the necessary correspondence is carried out.
Generic Product Reimbursement Dossier
Our work on the preparation of Generic Human Medicinal Product Reimbursement Dossier starts with a project starting meeting where the process and work schedule are determined. It ends with the compilation of pharmacoeconomic data, determination of application requirements and preparation of the file in accordance with the SSI legislation.
Pricing
- Performing price application based on marketing authorization
- Performing product pricing analysis
- Investigation of reference prices (domestic/foreign)
Price Update Application
Our services within the scope of price update application of registered products:
- Making the necessary calculations for the notification of price increases / decreases depending on the price change in the source country, obtaining the necessary documents, preparing the application
- Applying for 20-year status changes
- Making strategic informing and calculations for notifying TITCK of increases / decreases caused by changes in the manufacturing / import status, providing the necessary documents, preparing the application
- Determining the strategy for price change applications to be submitted to the Price Evaluation Commission (FDK) and preparing the application, following up upon request