In these days of quarantine, Pharma Value wants to share with you some useful content for those working in regulatory and market access and for those who, in this time of health emergency, want to better understand how a drug gets to patients.
The scheme represents the Italian transposition of the European Marketing Authorisation and the process of reclassification, pricing and reimbursement of a drug.
The drugs that are reimbursed by the SSN are those that meet the criteria of the CIPE 2001 resolution (e.g. drugs useful for the prevention/treatment of relevant diseases/symptoms for which no effective therapy exists).
AIFA, supported by two collegial bodies, the Technical-Scientific Commission and the Price and Reimbursement Committee, decides whether to allow a drug to be reimbursed, to whom and how to dispense it, negotiates the price of the drug centrally by asking, as a monopsonist - the sole purchaser against a plurality of sellers - for a discount from the pharmaceutical companies.
Only at the end of this complex process, if an agreement is reached between the parties, is the drug reimbursed by the SSN.
Sources:
AIFA Organisation Regulations 2016
CIPE Resolution 2001
Art.11 and 12 Law no.189/2012
