When applying for pricing and reimbursement, the applicants can also apply for 'innovativeness assessment.' Drugs that apply for 'innovativeness assessment' are usually prioritized for assessment by the technical-scientific commission (CTS) of the Italian Drugs Agency (AIFA). Furthermore, the drugs that obtain innovative status are funded from specific national funds. The potentially/conditionally innovative medicines are financed from the regional budgets, like regular pharmaceutical care.
On September 13, 2019, AIFA has published the last report of the innovativeness assessment. In period July-September 2019, the results of the innovativeness assessment of five therapies have been published:
- PERJETA (pertuzumab) – not innovative for the requested condition
- KYMRIAH (tisagenlecleucel; CAR-T cell therapy) – innovative for two conditions
- CRYSVITA (burosumab) – conditional innovativeness for one conditio
- IMFINZI (durvalumab) – innovative for one condition
See everything about the innovative drugs in Italy here
- Excel file with the details of the innovativeness assessment
- The updated file of all innovative and conditionally/potentially innovative medicines (according to Law 189/2012)
- The updated file of all innovative oncological and non-oncological drugs which are funded from specific national budgets (according to Law 189/2012)
to our newsletter delivered every second week not to miss important reimbursement information.