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Italian Medicines Agency Agenzia Italiana del Farmaco

Innovative medicinal products

Innovative medicinal products

The definition of innovation, its assessment and the granting of the status of innovative medicine are the responsibility of AIFA and its Scientific-Technical Committee. This status implies the assessment of three basic elements: therapeutic need, added therapeutic value and robustness of the scientific evidence submitted by the company together with the request for innovation.
AIFA has provided that the assessment of innovation must be performed through a single model for all medicines, also allowing, if necessary, the use of additional specific indicators.

Criteria for the classification of innovative medicinal products and innovative oncological medicinal products

With Resolution No. 1535/2017, AIFA has identified the criteria for the classification of innovative medicinal products and innovative oncological medicinal products pursuant to Article 1, paragraph 402 of Law No. 232 of 11 December 2016.

Elenco farmaci innovativi

An updated list of medicines is available which, according to the Scientific-Technical Committee, meet the requirement of full or conditional therapeutic innovation, pursuant to Article 10, paragraph 2 of Law no. 189/2012, as defined by Article 1, paragraph 1, of the State-Regions Agreement of 18 November 2010 (Rep. Atti n.197/CSR).
The list contains the innovative products to be made immediately available to patients, even without formal inclusion in the regional hospital therapeutic schedules.
The reference to the inclusion in the list is published In the Official Gazette for each individual specialty, relating to the indication reimbursed by the National Health Service.
This list also includes the details of the products having access to the Fund for innovative oncological and non-oncological medicines (Article 1, paragraphs 402, 403 and 404, of the Law 11 December 2016, no. 232 and subsequent amendments).
The above list includes the assessment reports for recognition of innovation, by therapeutic indication, in accordance with the provisions of AIFA Resolution no. 1535/2017.
Reports are also published of medicines that have obtained negative results in the innovation assessment. 

List of innovative drugs by single indication

As a conclusion of the “Revision and validation procedure of the lists of therapeutic indications for innovative drugs by pharmaceutical companies”, started on 11/03/2022 and ended on 25/03/2022, AIFA has drawn up a list of medicines (reported below) to which the requirement of (full) therapeutic innovation has been recognized, for at least one indication.

The list provides all the innovative indications and the indications eligible for reimbursement, by specific packaging, with an impact on expenditure in the year 2021.

The information in the list was previously shared with the companies holding the marketing authorization prior to this publication.

The list was drafted in the context of the 2021 Monitoring and Payback procedure of pharmaceutical expenditure, and contains neither indications with an effective date following 31/12/2021 nor indications not reimbursed by the NHS (National Health Service).

In cases where the AIFA Scientific-Technical Commission has recognized the requirement of therapeutic innovation for part of the authorized indication, it has been necessary to separate the innovative part of the indication from the non-innovative one, only for the purpose of monitoring expenditure.

Finally, the period of innovation of the indication has always been indicated for each medicine, even in the event that a package has been marketed after the starting date of the innovation effectiveness.

Innovativi per singola indicazione

Innovative medicinal products subject to monitoring

The Agency publishes the lists of innovative medicinal products subject to monitoring in accordance with the 2017 Budget Law. There are different tables for oncological and non-oncological medicinal products and they are constantly updated following the authorisations published in the Official Journal.

innovative_medicinal_products_subject_to_monitoring_10.04.2019

Uffici di riferimento

Reference offices

HTA & Pharmaceutical Economy Division

Francesco Trotta

f.trotta@aifa.gov.it

Monitoring Registers Office

Pierluigi Russo

p.russo@aifa.gov.it

Health Budget Monitoring and Regional Relations Office

Francesco Trotta (ad interim)

f.trotta@aifa.gov.it

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