Advice on price dossiers and reimbursement
The definition of the price of a drug is an essential aspect of the corporate strategy. The price dossier should be drafted considering specific requirements, and then submitted to the Authority according to an established timetable.
The Italian Medicine Agency (AIFA) is the official body charged with the negotiation of the reimbursement and price of medicinal products with pharmaceutical companies.
In particular, the AIFA Technical Scientific Advisory Commission (CTS) evaluates the clinical and therapeutic value of a drug, while the AIFA Committee for prices and reimbursement (CPR) analyses the price proposals taking the CTS assessment into account.
The price and reimbursement of medicinal products are defined through a HTA (Health Technology Assessment) process, assessing the cost-effectiveness and sustainability profile of every single drug.
The process starts with the submission of a dedicated dossier, including pharmacological and economic evaluations supporting the applied price. In their evaluations, AIFA will also consider the available literature as well as the decisions of other countries for the same product. AIFA evaluates the dossier analysing the costs compared to other available options as well as the potential economic impact of the drug reimbursement.
The process ends with a negotiation between the agency and the company, followed by the release of a product classification and reimbursement decree.
Di Renzo Regulatory Affairs has highly qualified regulatory experts, that can assist pharmaceutical companies in the following activities:
- Preparation of the price dossier to be submitted to AIFA
- Price negotiation at the AIFA
- Assistance in the Health Technology Assessment (HTA) procedures
- Assistance for price and reimbursement in other EU Member States
Thanks to its international cooperation with several consultants in the EU countries, Di Renzo Regulatory Affairs can also take care of price and reimbursement procedures in other Member States.
Foto di Myriams-Fotos da Pixabay
