Sep 26, 2019
AIFA update of innovative drugs in September 2019
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)

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