AIFA opens monitoring registry for Voranigo as SSN reimbursement starts for IDH-mutant glioma
Italy's medicines agency has activated the web registry and published clinical forms for vorasidenib, with reimbursed use for grade 2 IDH-mutant astrocytoma or oligodendroglioma starting 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 with National Health Service (SSN) reimbursement.
The change follows the entry into force of Determination PRES/1518/2026, announced in Official Gazette No 258 of 5 November 2026. The determination is available as a PDF alongside the notice.
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 or over weighing at least 40 kg. Eligible patients must have been treated with surgery alone and must not need radiotherapy or chemotherapy immediately.
AIFA states that prescriptions for the 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 therapeutic plans, which is reached through the related-links box on the AIFA page. The notice was issued by AIFA's monitoring registries office.
In Italy, monitoring registries are used to manage reimbursed access to selected medicines, with prescribing tied to defined clinical criteria.
What it means for your team
- Market-access teams: the SSN reimbursement for Voranigo applies from 6 November 2026 and is limited to the indication defined in Determination PRES/1518/2026.
- Regulatory and commercial operations: check the published monitoring forms and the determination to align prescriber and centre guidance with the registry's eligibility criteria.
- Hospital and prescriber support teams: reimbursed prescribing is tied to the clinical form's eligibility and appropriateness criteria, so registry access and use should be confirmed before treatment is started.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
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