AIFA opens monitoring registry for Voranigo as SSN reimbursement starts for IDH-mutant grade 2 glioma
Italy's medicines agency has activated the web registry and published clinical forms for vorasidenib, with reimbursed use under the national health service possible from 6 November 2026.
The Italian Medicines Agency (AIFA) has activated the web-based monitoring registry for Voranigo (vorasidenib) and published the associated monitoring forms. From 6 November 2026, the medicine can be used in Italy under national health service (SSN) reimbursement.
The change follows the entry into force of Determination PRES/1518/2026, announced in Gazzetta Ufficiale no. 258 of 5 November 2026. AIFA's Monitoring Registries Office issued the notice on 6 November.
The reimbursed indication covers Voranigo as monotherapy for grade 2 astrocytoma or oligodendroglioma that is predominantly non-enhancing and carries an IDH1 R132 or IDH2 R172 mutation. It applies to adults and adolescents aged 12 years or older weighing at least 40 kg. Eligible patients have been treated with surgery alone and do not need radiotherapy or chemotherapy immediately.
AIFA states that prescriptions for the SSN-reimbursed indication must follow the eligibility and prescribing-appropriateness criteria set out in the clinical form. The form can be downloaded as a .zip file from the list of active registries and treatment plans, reached through the related links box on the AIFA page. The determination itself is available as a PDF.
What it means for your team
- Market-access teams: reimbursed access in Italy is tied to the AIFA monitoring registry and the eligibility criteria in the clinical form, so the reimbursed population is narrower than a general description of the product.
- Hospital pharmacy and prescribing centres need to work through the registry and use the published clinical form to prescribe under SSN reimbursement.
- Regulatory and access teams should read Determination PRES/1518/2026 and the clinical form for the exact conditions of use.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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