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AIFA opens monitoring registry for Nucala in reimbursed COPD indication from 31 October

🇮🇹 AIFA · Mon 02 Nov 2026

Italy's medicines agency has activated the web registry and published monitoring forms for mepolizumab in uncontrolled eosinophilic COPD, following a determination announced in the Official Gazette.

The Italian Medicines Agency (AIFA) has announced that Nucala (mepolizumab) can be used through an AIFA monitoring registry from 31 October 2026. The notice, published on 2 November by AIFA's Monitoring Registries Office, follows the entry into force of Determination Pres/1411/2026, announced in Official Gazette no. 253 of 30 October 2026.

The registry covers the indication admitted to reimbursement: add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils. Nucala is to be given together with an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist.

AIFA states that prescriptions for indications reimbursed by the National Health Service 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, reachable through the related links box on the AIFA page.

The web registry itself has been available on the platform since 31 October. AIFA has asked regional contacts to log in to the system and enable the authorised healthcare centres. The determination is available on the AIFA site as a PDF.

By way of context, monitoring registries are used in Italy to manage access to certain reimbursed medicines, with prescribing tied to defined clinical criteria.

What it means for your team

  • Market-access teams should note that reimbursed Nucala use in eosinophilic COPD in Italy now runs through the AIFA monitoring registry, with eligibility criteria in the published clinical form.
  • Regulatory and compliance staff at the marketing authorisation holder should check Determination Pres/1411/2026 for the full conditions of reimbursement.
  • Regional contacts need to enable authorised centres on the platform before prescribers can use the registry.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

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