March 02, 2019
Outcomes of the AIFA's technical-scientific committee February 2020 meeting published
The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on February 11-14, 2020. The CTS publishes five documents of outcomes:
  • Market Authorizations (national procedures)
    • CTS expressed opinions for approximately fifty (50) Marketing Authorization procedures, most of which were positive
    • CTS expressed positive opinion for parallel import of four (4) products
  • Pre-Authorization
    • CTS expressed positive opinion for three (3) medicines to be inserted into List of Law 648/96 for selected indications
    • CTS expressed negative opinion for three (3) medicines to be inserted into List of Law 648/96 for selected indications
    • CTS is still deciding for three (3) medicines to be inserted into List of Law 648/96 for selected indications
    • There were no requests for the extension of indications to be put on the List of Law 648/96 this month
    • CTS expressed negative opinion for one (1) medicine to be inserted into the 5% fund
  • Post-marketing vigilance
  • Outcomes of CTS evaluations regarding pricing & reimbursement
    • CTS published their opinion regarding many different requests regarding the pricing & reimbursement
    • Regarding orphan drugs:
§ CTS requires more information before expressing an opinion about Zynteglo, Epidyolex, and Xermelo
§ CTS finished their part regarding Palynziq whose price is currently being negotiated by CPR
  • Regarding new pharmaceutical products:
§ CTS requires more information before expressing an opinion about Vaborem, Vitrakvi, Mulpleo, and Talzenna
§ CTS postponed the decision-making about Veyvondi
  • CTS grouping of drugs that obtained Market Authorization through the centralized procedure (via EMA) according to their delivery. Seven (7) drugs are intended to be delivered within the hospital settings, exclusively:
    • Newly-authorized drugs Evenity, Quofenix, and Rinvoq
    • Biosimilar Pegfilgrastim (Mundipharma)
    • Changes in packaging regarding Emgality, Jinarc, and Kalydeco
The CTS meetings are held monthly. The CPR meetings are usually held 7-10 days after the CTS meetings.

See all the documents with outcomes from this meeting in Italian here.

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