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Italy’s SSN Agrees to Reimburse Secukinumab for Moderate to Severe Hidradenitis Suppurativa

Positive Phase III Sunshine and Sunrise trials showed clinically relevant reductions in inflammatory lesions alongside lower pain levels in adults unresponsive to standard therapy.

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Overview

  • The SSN has authorized reimbursement of secukinumab, a fully human IL-17A monoclonal antibody, for adults with moderate to severe hidradenitis suppurativa who have not responded to conventional systemic treatments.
  • The approval was published in the Gazzetta Ufficiale on June 30 following Sunshine and Sunrise trials demonstrating significant reductions in abscesses, nodules and skin pain.
  • Registry data published in The Lancet reported that 46% of patients achieved at least a 50% reduction in lesions by week 16 and that 70–90% of patients experienced further improvement after one year of treatment.
  • Hidradenitis suppurativa affects about 1% of the Italian population—70% of whom are women—and has historically suffered average diagnostic delays of 7–10 years and fragmented care pathways.
  • Experts and patient associations are calling for faster diagnosis, formal inclusion of HS in national chronic disease plans and the development of multidisciplinary care networks to ensure timely, coordinated treatment.