On October 15, 2020, the Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”) published a new simplified pricing and reimbursement procedure for generics and biosimilars. The procedure simplifies the negotiation and assessment procedures to be carried out by the AIFA.
This simplified procedure applies exclusively to generics and biosimilars with the same packaging as the originator medicines in terms of dosage units, quantity of active ingredient, pharmaceutical form, administration method and modalities of release.
1. Simplified procedure: main features
The simplified procedure provides for a minor participation of the AIFA Technical Scientific Committee (Comitato Tecnico Scientifico – “CTS“) and of the Prices and Reimbursement Committee (Comitato Prezzi e Rimborso – “CPR“), in order to streamline the evaluation process and the preliminary investigation phases. As a result, the entire procedure will be quicker.
Steps in the procedure differ depending on whether the generic or biosimilar medicine is based on an originator medicine included in class A or class H (medicines covered by the National Health Service), or in class C.
(A) If the originator medicine belongs to class A or class H
In this case, in order to benefit from the simplified procedure, a pharmaceutical company shall submit a dossier supporting the application for reimbursement, classification, and price, along with a price proposal in accordance with the price reduction provided by the Ministerial Decree of April 4, 2013 (hereinafter the “Scaglioni Decree”).
The launch of the simplified procedure is reported to pharmaceutical companies via certified e-mail after an administrative check. Subsequently, the competent AIFA office (health technology assessment and pharma-economics ) may inform the company of any further conditions that must be met for the negotiation procedure to be concluded.
If the pharmaceutical company accepts all the negotiating conditions proposed by the AIFA, the generic or biosimilar medicine is then assessed directly by the Board of Directors (Consiglio di Amministrazione – “CdA”) for approval. In this case, CTS and CPR assessments are not required. Therefore, a pricing and reimbursement determination will be issued following the CdA’s assessment.
However, if the pharmaceutical company does not propose a price pursuant to the Scaglioni Decree, the ordinary negotiation procedure shall apply.
(B) If the originator medicine belongs to class C
With regard to generic and biosimilar medicines based on originator medicines in class C, the simplified procedure provides that a medicine is automatically classified as class C without any negotiation and without prior classification in CNN (non-negotiated medicines class).
2. Special cases and derogation from the simplified procedure
The measure adopted by the AIFA regulates special cases in which the patent for the active ingredient of the originator medicine will expire more than one year after the date of application for the simplified price and reimbursement procedure. By way of example, the measure provides that, in this case, if the pharmaceutical company producing the generic or biosimilars in question decides to propose a price in accordance with the Scaglioni Decree, the negotiation agreement will be stipulated with a safeguard clause that allows the negotiation procedure to be restarted in the event of a change in the reference market (e.g., variation in the price of the originator).
As for derogations, the simplified procedure cannot be applied to a medicine whose originator medicine is included in a monitoring register, is subject to a managed entry agreement, and/or has one or more therapeutic indications included in the list referenced in Law no. 648/1996. In such cases, the ordinary negotiation procedure – including CTS and CPR evaluations – shall apply.
 Medicines included in classes A and H are considered essential and their cost is covered completely by the National Health Service (“NHS”). Medicines in class H may be used exclusively in hospitals.
 The cost of medicines included in class C is covered by patients.
 Under the Scaglioni Decree, the price of generic or biosimilar medicines shall be based on the price of the originator medicine minus a percentage discount; the criteria to be used are set forth in the Scaglioni Decree.