The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) announced on 30 December 2020 that it had published new guidelines for the pricing and reimbursement of medicines, which include a new streamlined procedure for generics and biosimilars.
The new guidelines were produced following public consultation:
Guidelines for compiling the dossier in support of the application refundability and price of a medicinal pursuant to D.M. 2 August 2019
(Linee guida per la compilazione del dossier a supporto della domanda di rimborsabilità e prezzo di un medicinale ai sensi del D.M. 2 agosto 2019)
Date: Version 1.0 2020
https://www.aifa.gov.it/documents/20142/1283800/Linee_guida_dossier_domanda_rimborsabilita.pdf/8249e3d6-b2fc-915d-a211-02abafb8aa6d
For generics and biosimilars the new simplified procedure applies to generics and biosimilars that have the same packaging as the originator in terms of dosage units, amount of active ingredient, pharmaceutical form, route of administration and delivery method. It does not apply to generics and biosimilars with additional indications to those of the originator, or with different packaging (dosage units, dosage and route of administration).
The new procedure simplifies the procedure for negotiation of price and class of reimbursement. This means that for generics and biosimilars whose reference products are considered essential drugs for chronic and serious diseases (Class A) or require a hospital setting and specialist supervision (Class H) and that are 100% reimbursed by the Italian National Health Service (NHS), there will be a gradual reduction in the involvement of the AIFA’s Technical Scientific Committee (Comissione Technico Scientifica) and Pricing and Reimbursement Committee (Comitato Prezzi e Rimborso).
With respect to generics and biosimilars whose reference products are considered Class C drugs, i.e. over-the-counter products, will allow the new medicine to follow the authorization phase, without any negotiation with the Health Technology Assessment and AIFA Committees.
In addition to these changes, the AIFA has also introduced specific rules for cases where the patent expiry date of the active ingredient is more than one year compared to the date of submission of the reimbursement application.
The guidelines will come into effect from 1 March 2021 in order to provide stakeholders with a suitable transition period for the compilation of new dossiers. This date also takes into consideration possible pricing and reimbursement applications already at an advanced stage and that were submitted in accordance with the previous model.
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