Our highlights:
These LGs do not apply to equivalent and biosimilar drugs that fall under the 'Simplified Pricing and Reimbursement Procedure for Equivalent/Biosimilar Drugs' adopted on 15/10/2020.
Effective implementation of the LGs will take place as of 1 March 2021, with the possibility of revision by December 2021.
The obligation to fill out the section on pharmaco-economic evaluations is for all procedures of new active substance, orphan drug, extension of therapeutic indications of originator drug and reclassification of authorised packaging into class C at the request of a party;
È a specific procedure has been added for 648/96 only and the moment when the company is involved (at the request of 648) is clarified;
The main implementations compared to the September draft concern the required information on production capacity for adequate supply of the drug, information on public subsidies and incentives obtained for development, the patent status of the patent, the methodology on quality of life assessment, and the use of Real World data.
There were 43 public consultations received by AIFA, which can be downloaded here in the next 30 days https://bit.ly/3aRkHKF
