On 30 December 2020 AIFA approved the document containing the provisions required by art. 2 of Ministerial Decree of 2 August 2019, “Criteria and procedures according to which the Italian Medicines Agency negotiates prices of medicines reimbursed by the National Health Service” (Official Journal No. 185 of 24 July 2020), for the submission of applications for negotiation.

The criteria and the procedures set out in the new GuideLines will apply starting from 1 March 2021, and they will replace the old CIPE resolution.

Pharma Value decided to make a comparison between the GuideLines and the CIPE resolution to analyze the main differences and similarities so to highlight how many and which of the required information remain the same and what the differences are.

Read our analysis and let us know your feedback