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In brief

On November 25, 2021, the AIFA published two new simplified negotiation procedures for (i) the negotiation of generic or biosimilar drugs and reimbursement applications for the extension of indications already reimbursed for the originator, and (ii) the reimbursement of new packages for changes in the primary packaging.


In regards to the pricing and reimbursement procedure for generic and biosimilar drugs, the new simplified procedure, which envisages an automatic negotiation mechanism, provides that companies wishing to use said mechanism must submit an application for classification and reimbursement, and the relevant dossier, with a price proposal in line with the reduction provided for by the Ministerial Decree of April 4, 2013 (the so-called “Decreto Scaglioni”). Following the submission, and the relevant administrative checks, the Health Technology Assessment Department (“HTAD”) may request further conditions to the company in order to conclude the negotiation procedure and, in case of acceptance, the drug is submitted to the Board of Directors for approval, without further steps to be discharged before the Technical Scientific Committee (“CTS”) and the Pricing and Reimbursement Committee (“CPR”). Generic and biosimilar drugs whose originator is classified in class C are automatically registered in the same class from their authorization, without any negotiation step before the HTAD, the CTS, the CPR and without prior classification in CNN.

With regard to reimbursement applications for the extension of indications already reimbursed for the originator, the simplified procedure provides that if the price proposed for the drug for which the extension of indications is requested is already aligned to the reference price or to the applicable lowest price, the indication already reimbursed for the originator is automatically extended to the generic or biosimilar, with immediate publication of the relevant decision in the Official Journal.

Lastly, the procedure for the reimbursement of new packages due to a modification in the primary packaging applies to cases where said packaging is made of a different material or is of a different type compared to the existing one for packages with the same dosage forms and the same number of dosage units. In this case, if the price proposed for the new package is aligned with the current price of the corresponding package already on the market, the procedure will be submitted to the Board of Directors for approval at the first meeting available. If the proposed price is not aligned, the HTAD will notify the applicant and, upon acceptance of the alignment to the current price, the procedure will be submitted to the Board of Directors. Conversely, in case of non-acceptance, the standard negotiation procedure will apply.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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