Pharma Value analysed the Guidelines for the compilation of the dossier supporting the application for the reimbursability and pricing of a medicine comparing them with the draft version submitted for public consultation on 16 September 2020. In case you haven't downloaded them yet, you can do so by clicking here.
Highlights
AIFA states in the introduction to the Guidelines that the Decree of the Ministry of Health and the Ministry of Economy and Finance of 2 August 2019, published in the Official Gazette of the Italian Republic No. 184 of 24 July 2020 entered into force on 8 August 2020.
Such LGs do not apply equivalents and biosimilars that fall under the 'Simplified pricing and reimbursement procedure for equivalent/biosimilar drugs' adopted as of 15 October 2020.
L'application effective implementation of the Guidelines will take place as from 1 March 2021. AIFA reserves the right to review the LGs by December 2021.
The development of aelectronic interface to enable the compilation and online filing of the Dossier. Until the final adoption, pharmaceutical companies are recommended to prepare the Dossier, in Italian language, by sending it in electronic format (word and pdf) to the e-mail boxes hta.prezzi@pec.aifa.gov.it e hta.prezzi@aifa.gov.it.
The requirement to complete the section on pharmaco-economic evaluations for all procedures related to TN1 i.e. for: New active ingredient, Orphan drug, Extension of therapeutic indications of originator drug, and Reclassification of packaging authorised in class C at the request of a party.
TN-5, a specific procedure for the 648/96, for this procedure, many points in the dossier to be filled out have been eliminated and the moment in which the company is involved has been clarified (at the request of 648).
The negotiation type TN7 was added with a specific procedure for 'Medicinal products marketed in Italy by importers'.
Some implementationsamong other new features, the request for information on the production capacity for adequate supply of the druginformation on contributions and incentives of a public nature obtained for development, patent status, methodology on quality of life assessment, use of Real World data.
Aifa clarifies the commencement and closure of proceduresmade by the Pricing and Reimbursement Committee. The procedure start date is the date of formal communication by PEC by AIFA and occurs when AIFA receives the Dossier correctly filled in with complete documentation. In some cases there may be autonomous initiation of procedures. The procedure lasts 180 days from the start of the procedure to the last opinion.
Aifa clarifies the how to suspend cnnIf the product holder does not submit an application within 30 days of the issue of the MA, AIFA sends a reminder and submits the application, assigning a deadline of 30 days for the transmission of the P&R Dossier, and if the company does not respond, suspends the Cnn.
AIFA received 43 public consultations from the various stakeholders.
