With Determination DTS No. 88/2025 of 23 December 2025, AIFA published an update to the ‘Guidelines for the preparation of the dossier supporting the Health Technology Assessment (HTA) of a medicinal product for the purposes of reimbursement and pricing under the National Health Service.
The update reflects the most recent developments in the regulatory framework, both at the European level — with the harmonisation of HTA assessment processes — and at the national level, following the reorganisation of AIFA’s decision‑making structures, which assigned to the Scientific and Economic Commission for Medicines (CSE) the responsibilities previously held by the Technical‑Scientific Commission (CTS) and the Pricing and Reimbursement Committee (CPR), as well as the introduction of new criteria for recognising the innovativeness of medicinal products.
The updated Guidelines apply to the ordinary negotiation procedures for the reimbursement and pricing of medicinal products, corresponding to types TN‑1 to TN‑7. The simplified procedures, TN‑8, will instead be governed by a dedicated document, which will be published on AIFA’s institutional portal.
The new provisions will enter into force on 1 April 2026, providing pharmaceutical companies with a transition period to adapt the content and structure of their dossiers to the new regulatory expectations.
For an immediate overview of the main changes introduced by the new Guidelines, the following focus can be consulted: Guidelines for reimbursement application dossiers as of 1 April
