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Italy simplifies over-the-counter generics price and reimbursement Posted 26/03/2021

The Italian Drugs and Medicines Agency (Agenzia Italiana del Farmaco, AIFA) has simplified its price and reimbursement procedure for class C generic/biosimilar medicines. As of February 2021, generic/biosimilar versions of over-the-counter class C reference products will automatically be classified as class C products.

The details of this simplified procedure were first announced in December 2020 [1].
It does not apply to generic/hybrid/biosimilar medicines that include any additional therapeutic indications compared with the reference medicinal product. This also removes the need for negotiations with the Health Technology Assessment (HTA) Department and with AIFA’s Technical Scientific advisory Committee (CTS) and the Price and Reimbursement Committee (CPR).

The new simplified approach applies to products with package interchangeability with reference products. Here, the packages have the same quantity of active ingredient, pharmaceutical form, route of administration, methods of release and dosage units, which leads to automatic inclusion in class C for reimbursement purposes. However, any generic/hybrid/biosimilar medicines featuring packages differing in strength, pharmaceutical form, number of dosage units and methods of release, from those of the reference medicinal product, are designated to class ‘C Non-Negotiated’ (C(nn)) and cannot be automatically included in class C.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Italy publishes new guidelines on pricing and reimbursement of generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 26]. Available from: www.gabionline.net/Guidelines/Italy-publishes-new-guidelines-on-pricing-and-reimbursement-of-generics-and-biosimilars

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