Reimbursement and pricing of medicines: AIFA’s new rules effective 1 April 2026

AIFA has also issued a separate document governing simplified and fast‑track procedures applicable to certain categories of medicines.

The update was prompted by changes in the European regulatory landscape, notably the introduction of common Health Technology Assessment (HTA) procedures under Regulation (EU) 2021/2282 and the Commission’s implementing acts, including those on Joint Clinical Assessment (JCA) for human medicines. These EU rules are being phased in progressively from January 2025.

The new AIFA Guidelines

Criteria and procedures for determining a medicine’s reimbursement and price are set out in the Decree of the Ministry of Health of 2 August 2019, in force since August 2020. Under that Decree, negotiation is initiated by an application from the sponsor, accompanied by a product dossier containing scientific evidence on the added therapeutic value versus comparators and the relevant economic assessments (projected sales volumes, budget‑impact on the National Health Service, etc.).

AIFA’s Guidelines provide detailed instructions on the information to be submitted for each dossier section, methodological clarifications and the international standards to be followed. The 2020 Guidelines have been replaced by the new Guidelines for the compilation of the dossier to support HTA of a medicinal product for the purposes of reimbursement and pricing by the NHS[1], adopted by AIFA Determination of 23 December 2025 and applicable to dossiers submitted from 1 April 2026.

The new Guidelines reflect AIFA’s reorganised structure and the consolidation of functions previously assigned to the Prices and Reimbursement Committee (Comitato Prezzi e Rimborso – CPR) and the Technical‑Scientific Advisory Commission (Commissione consultiva tecnico‑scientifica – CTS) into the current Scientific and Economic Commission for Medicines (Commissione Scientifica ed Economica del Farmaco – CSE). The negotiation must now conclude within 180 days, counted from the application submission to the date of the CSE’s final opinion.

References to innovativeness now incorporate AIFA Presidential Determination No. 966 of July 2025, which sets new classification criteria based on therapeutic need, added therapeutic benefit and the quality of the evidence provided.

In line with the EU HTA framework, the Guidelines allow certain clinical‑study summary sections to be optional at submission when a joint clinical assessment at EU level already exists. In practice, the AIFA dossier may rely on EU‑level assessments to avoid full duplication.

The European HTA framework

The update also responds to Regulation (EU) 2021/2282 (the HTA Regulation) and its implementing acts. The Regulation, which began to apply in January 2025 to certain categories of medicines, establishes common rules and methodologies for Joint Clinical Assessment (JCA), Joint Scientific Consultation (JSC), Horizon Scanning, and the development of common methodologies and procedures. It introduces a single‑submission mechanism whereby developers submit the information and evidence required for JCA once at EU level.

The Regulation’s phased scope covers oncology and ATMPs from 12 January 2025, orphan medicines from 13 January 2028, and all other centrally authorised medicines from 13 January 2030.

Simplified and fast‑track P&R procedures

The new Guidelines address ordinary P&R procedures (negotiation types TN 1–7). AIFA adopted a separate Document on simplified negotiation procedures for price and reimbursement[2] by Determination of 24 March 2026, which updates and rationalises existing simplified routes applicable to generics, biosimilars, parallel imports and certain vaccines.

Procedures are divided into simplified and fast‑track procedures:

• Simplified procedures (TN‑8) do not require CSE evaluation; they are approved by AIFA’s Board of Directors and published in the Gazzetta Ufficiale. They apply to generics and biosimilars, extensions of already reimbursed indications, new pack sizes due to primary packaging changes, parallel imports and automatic re‑negotiations of previously agreed conditions.
• Fast‑track procedures still involve CSE review but are expedited through the use of predefined, standardised opinions and pre‑validated negotiation parameters. These routes are intended for cases such as dosage or unit‑dose changes, new fixed‑dose combinations, re‑negotiations for shortage medicines, medicines subject to spending caps, and certain vaccine or class‑C classifications.

Applicants must use AIFA’s standard application form and state in the cover letter their intention to request simplified or fast‑track treatment, specifying the chosen route. Access is not automatic and is granted by AIFA after verification of eligibility.

[1] Linee guida per la compilazione del Dossier a supporto dell’Health Technology Assesment di un medicinale ai fini della rimborsabilità e del prezzo a carico del SSN, https://www.aifa.gov.it/documents/20142/3214492/Linee_guida_dossier_domanda_rimborsabilita_vers-2-2025.pdf.   

[2] Documento di armonizzazione delle procedure di semplificazione dell’iter negoziale di prezzo e rimborso, https://www.aifa.gov.it/documents/20142/1142605/Documento_armonizzazione_procedure_semplificazione_P-R.pdf.