June 29, 2020
Outcomes of the AIFA's technical-scientific committee June 2020 meeting published
The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on June 9-12, 2020. The CTS published six types of outcome documents:

  • Market Authorizations (national procedures)
    • CTS expressed opinions for approximately sixty (60) Marketing Authorization procedures, most of which were positive
    • CTS expressed positive opinion for parallel import of more than ten (10) products
  • Pre-Authorization
    • Drug list 648/96
      • CTS postponed decision-making for eight (8) medicines
      • CTS made negative decisions for ten (10) medicines
      • CTS made positive decisions for six (6) medicines
      • CTS is still discussing two (2) medicines
    • AIFA 5% list
      • All four (4) drugs are still being discussed
  • Post-marketing vigilance
  • HTA and pharmaco-economics
    • Regarding orphan drugs:
      • CTS is reviewing Waylivra, Onivyde, and Givlaari
      • Sent to CPR for pricing decision: Xermelo, Epidyolex
  • CTS grouping of drugs that obtained Market Authorization through the centralized procedure (via EMA). Sixteen (16) opinions were published
  • Monitoring registries opinions:
    • Registry schemes to be assessed / approved by the CTS:
      • Postponed: VITRAKVI
      • Approved: WAYLIVRA, REVLIMID, TALZENNA, LYNPARZA, MVASI, KADCYLA (after additional discussions)
The CTS meetings are held monthly. The CPR meetings are usually held 7-10 days after the CTS meetings.

See all the details in Italian here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.
This website uses cookies to ensure you get the best experience on our website. By carrying on browsing, you are giving your consent for us to set cookies.

Learn more
Ok, I agree
Close
Subscribe to newsletter
Subscribe to our newsletter to get regular updates from us on the changes of reimbursement systems (>100 reimbursement stakeholders in 12 EU countries)