Two oral antivirals have so far been authorised in Italy for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not need supplemental oxygen and who are at high risk of progressing to severe COVID-19:

• Paxlovid (PF-07321332/ritonavir) by Pfizer Europe MA EEIG
• Lagevrio (molnupiravir) by Merck Sharp & Dohme

Paxlovid (PF-07321332/ritonavir) was authorised with AIFA decision No 15 dated 31 January 2022 (published in Official Gazette No 26 of 1 February 2022), transposing the relevant EU authorisation decision. By way of such AIFA decision, Paxlovid was classified as class ‘C(nn)’ (non negotiated) medicinal product for the purposes of its reimbursement by the National Health System.  Following AIFA decision No 160/2022 (published in the Official Gazette No 92 of 20 April 2022), the classification of Paxlovid for reimbursement purposes was amended from ‘Medicinal product subject to restricted medical prescription to be renewed on a case-by-case basis’ to ‘Medicinal product subject to medical prescription to be renewed on a case-by-case basis’. (AIFA Notice 692)

Lagevrio (molnupiravir) has not yet received the authorisation by the European Commission (EC). However, its distribution has been temporarily authorised in Italy by Ministry of Health Decree dated 26 November 2021 (published in Official Gazette No 295 of 13 December 2021). By decision No 1644 of 28 December 2021 (published in Official Gazette No 308 of 29 December 2021), based on the opinion of its Scientific-Technical Commission, AIFA laid down the terms and conditions of use of the antiviral for oral use molnupiravir.

The distribution of Lagevrio is handled by the Special COVID-19 Government Commissioner, pursuant to Art. 122 of Decree Law No 18 of 17 March 2020, according to the methods and procedures indicated by the above-mentioned Commissioner.

In addition, an intravenous antiviral for the treatment of COVID-19 is also authorised in Italy:

• Veklury (remdesivir) by Gilead Sciences.

Veklury (remdesivir) is the first antiviral to have been authorised by EC decision dated 3 July 2020 for the ‘treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older and weighing at least 40 kg) with pneumonia requiring supplemental oxygen.’ Such EC decision was transposed in Italy by AIFA decision 92/2020, published in Official Gazette No 250 of 9 October 2020. As a result, Veklury was classified as class C(nn) medicinal product subject to restricted medical prescription, to be used exclusively in an inpatient or similar setting.

As of 30 December 2021, following an extension of indication authorised at EU level, Veklury is now also indicated for the treatment of COVID-19 in adults who are not hospitalised for COVID-19 and who do not require supplemental oxygen, with symptoms onset of no more than 7 days and at increased risk of progressing to severe COVID-19. 

The prescription of antivirals for the treatment of COVID-19 is subject to a monitoring register and envisages the use of a sheet for medicinal products subject to monitoring. This sheet is available in the lists published on the webpage “Updated list of web-based Registries and Therapeutic Plans“. In addition, all antivirals are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national pharmacovigilance reporting system.

Please find below AIFA decisions Nos 160/2022, 15/2022, 1644/2021 and 92/2020. Two annexes with information for healthcare professionals and for patients are available for Lagevrio. The Summary of Product Characteristics (SmPC) and the Package Leaflet (PL) are available for Veklury and Paxlovid.