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AIFA ends Managed Entry Agreement procedures in HOLOCLAR registry from 31 October 2026

🇮🇹 AIFA · Mon 02 Nov 2026

Italy's medicines agency says risk-sharing procedures are no longer active for HOLOCLAR's registered indication, but treatments first dispensed before the cut-off stay under the existing arrangements.

The Italian Medicines Agency (AIFA) has told users of its monitored-medicines registries that, from 31 October 2026, Managed Entry Agreement (MEA) procedures are no longer active in the HOLOCLAR registry. The notice was published on 2 November 2026 by AIFA's Monitoring Registries Office.

The closure applies to the indication listed in the registry: treatment of adults with moderate to severe limbal stem cell deficiency, whether unilateral or bilateral, caused by physical or chemical ocular burns. AIFA reproduces the definition of severity, which requires superficial corneal neovascularisation in at least two quadrants, central corneal involvement and severe impairment of visual acuity. It also notes that the biopsy needs at least 1–2 mm² of undamaged limbal tissue.

AIFA sets out a transition rule. The risk-sharing procedures remain active for treatments whose first dispensing took place before 31 October 2026. Packs dispensed after 30 October 2026 are reimbursable only if they belong to a treatment first dispensed before that date.

The notice does not give a reason for the closure. It points readers to AIFA's table of the current status of reimbursement procedures and lists Determina Pres/1423/2026 on HOLOCLAR as a related document. AIFA also posted a separate notice on 2 November about the closure of the HOLOCLAR monitoring registry, whose content is not covered in this item.

What it means for your team

  • Market-access teams should check which patients have a first dispensing date before 31 October 2026, as only those treatments stay under MEA rules.
  • Packs dispensed after 30 October 2026 for treatments started on or after the cut-off are not reimbursable under the notice's rule.
  • Teams should consult AIFA's 'current status of reimbursement procedures' table and Determina Pres/1423/2026 for the full picture, since the notice gives no rationale.

Official source: AIFA ↗

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

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