AIFA informs that pursuant to Resolution of the Technical-Scientific Director No. 88/2025 of 23/12/2025, the ‘Guidelines for compiling the dossier supporting the Health Technology Assessment of a medicinal product for the purposes of pricing and reimbursement borne by the National Health Service’ have been updated.

This document has been drawn up with the aim of providing a comprehensive framework for the Health Technology Assessment (HTA) of a medicinal product, in order to support informed decisions regarding its reimbursement and price borne by the NHS. The Dossier, drafted in accordance with these Guidelines, provides the data and information necessary to assess the implications of the introduction of a medicinal product on the market at the expense of the NHS, from different perspectives and in line with the key dimensions of HTA: clinical effectiveness, safety, economic, social and organisational impact.

The changed regulatory framework has made it necessary to update the Guidelines in light of the provisions of Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment, amending Directive 2011/24/EU, as well as the Implementing Acts adopted by the European Commission and the technical and procedural guidelines adopted by the HTA Coordination Group.

This version of the Guidelines also takes into account the amendments made pursuant to Decree-Law No. 169 of 8 November 2022, coordinated with Conversion Law No. 196 of 16 December 2022 (Official Gazette - General Series - No. 301 of 27 December 2022) which, pursuant to Article 3, abolished the Technical-Scientific Advisory Committee (CTS) and the Pricing and Reimbursement Committee (CPR), assigning their functions to the Scientific and Economic Committee for Medicines (CSE).

Furthermore, this update to the Guidelines incorporates the changes made by Resolution No. Pres/966/2025, in which AIFA identified the criteria for classifying innovative medicines and anti-infective agents for multi-resistant germ infections (pursuant to Law No. 207 of 30 December 2024, Article 1, paragraphs 281-292) which have access to the resources of the fund established pursuant to Article 1, paragraph 401, of Law No. 232 of 11 December 2016 (Innovative Medicines Fund). The definition of innovativeness, its assessment and the granting of innovative medicinal product status is now decided by the CSE as part of a multidimensional assessment process. This assessment is based on three main dimensions: therapeutic need, added therapeutic benefit and quality of scientific evidence; the supporting elements for which are prepared by the pharmaceutical company as part of the request for innovativeness related to the submission of the dossier.

Moreover, it should be noted that these Guidelines refer to the standard procedures of application for reimbursement and pricing for medicinal products falling under negotiation types TN-1 to TN-7, as described in detail in the document attached to the Resolution. As for the so-called simplified procedures (TN-8), the description of the requirements necessary to submit the Dossier will be published on the AIFA institutional portal in a specific document.

Finally, the section on the economic and financial impact of the medicinal product has been updated, redefining the methods for applying pharmacoeconomic analyses (cost-effectiveness analysis, cost-utility analysis) and budget impact analyses (BIA).

The “Guidelines for compiling the dossier supporting the Health Technology Assessment of a medicinal product for the purposes of pricing and reimbursement by the National Health Service” will enter into effect on 1 April 2026 in order to provide pharmaceutical companies with a reasonable period of time to adapt to the new requirements for compiling applications for reimbursement and pricing of medicinal products.

Resolution No. 88/2025 of the Technical-Scientific Director and the Guidelines can be accessed in the ‘Related links’ box.

Published on: 24 December 2025