Presentation (CTI)

OBJECTIVES: Biologics have expanded options for patients with moderate-to-severe atopic dermatitis (AD) with inadequate response to conventional therapies. Lebrikizumab, an interleukin-13 inhibitor, is EMA-approved for adolescents ≥12 years (≥40 kg) and adults with moderate-to-severe AD when topical treatments cannot be used or are insufficient. This research compares reimbursed populations for lebrikizumab in AD across Europe and identifies differences in reimbursement access criteria.
METHODS: A targeted review of HTA and payer decision documents was conducted across 16 European countries that completed local HTA processes for lebrikizumab by May 2026 (Austria, Belgium, Czech, England, Finland, France, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Scotland, Spain, Sweden, Switzerland). The clinical and pre-treatment requirements for accessing lebrikizumab were compared with the EMA approved indication. Data were analysed descriptively.
RESULTS: Of the 16 countries assessed, 14 had more restrictive reimbursement criteria than the EMA label (excluding Germany and Netherlands). Over half (n=9/16) had additional clinical requirements and over two-thirds (n=13/16) had additional pre-treatment requirements. Restricting to severe populations was observed (n=9/16); with four countries (n=4/9) specifying severe AD using country-specific Eczema Area and Severity Index thresholds (Belgium, Italy, Poland, Spain). Of the countries with pre-treatment requirements (n=13/16), 12/13 restricted to adults not adequately controlled by systemic immunosuppressive therapy and 7/13 countries also applied this to adolescents (England, Ireland, Poland, Portugal, Scotland, Spain, Switzerland). Five (n=5/13) countries required pre-treatment with ciclosporin A (Belgium, France, Italy, Poland, Spain), four (n=4/13) required intensive local therapy to be exhausted (Austria, Czech, Ireland and Switzerland) and three (n=3/13) specified time periods for pre-treatments (Belgium, Ireland and Switzerland).
CONCLUSIONS: Patient access to lebrikizumab for moderate-to-severe AD varies across Europe, reflecting heterogeneity in national access and treatment frameworks. This highlights the opportunity for a more harmonised approach to access, ensuring that patients with AD have equal and consistent availability of biologics across different health care systems.