Spotlight: medicine and medical device pricing and reimbursement in Italy

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Pricing and reimbursement

The prices of medicines reimbursed by the NHS must be negotiated and agreed upon with AIFA according to the price and reimbursement (P&R) procedure that is regulated by the Ministry of Health's decree of 2 August 2019. The Decree defines the procedure to be followed to obtain AIFA's price and reimbursement decision on a given product.

A pharmaceutical company applying for P&R negotiation must follow the AIFA's guidelines, issued in accordance with the abovementioned Decree, on how to prepare the P&R dossier supporting the P&R application, which are effective from 1 March 2021.

In order to speed up the access to the market of medicines authorised by the EMA, a legal provision was introduced in 2012 under which centrally approved medicines, within 60 days from the date of the publication of their MA in the EU Official Journal, must be automatically placed in a new class of medicines called C-nn (medicines whose price has not been negotiated with AIFA yet). Therefore, these medicines may be commercialised before the completion of their P&R negotiation with AIFA. The negotiation of the P&R can take place later, provided that the pharmaceutical company decides to apply for the reimbursement of the price from the NHS. This, in effect, ensures the faster availability of new medicines on the market. However, as long as an agreement with AIFA has not been reached, the cost of C-nn medicines is fully borne by the patients or by the hospital where the latter deems it can bear the cost.

If a pharmaceutical company does not apply for P&R negotiation within 30 days from the release of the MA at EU level, AIFA urges the company to file this application within the following 30 days. If the company does not do so, its medicine is no longer under the C-nn class, and thus it can no longer be marketed in Italy, unless the competent authorities allow its use because of relevant public health interests.

AIFA must give priority to the assessment of the applications for P&R concerning orphan drugs, medicines whose exceptional therapeutic and social importance has been acknowledged by AIFA and must make a decision within 100 days from the application date. The negotiated prices of reimbursed innovative medicines are usually associated with some form of conditional reimbursement agreement entered into by AIFA and pharmaceutical companies (managed entry agreements, MEAs) whose aim is to ensure access to new medicines for all patients, at the same time avoiding unnecessary expenses for the NHS.

MEAs can be either 'financial-based' (i.e., aimed at managing budget impact) or 'performance-based' (aimed at managing the use in real life or at providing evidence regarding uncertain decisions).

On the other hand, the price of non-reimbursable medicines is freely decided by their MAHs.

The price of medical devices is freely decided by their manufacturers.