Health Technology Assessment (HTA) and Reimbursement Decisions for the New Anti-IL-13 Monoclonal Antibody Lebrikizumab for Patients With Moderate to Severe Atopic Dermatitis (AD) in Europe

OBJECTIVES: Almirall applied for reimbursement to the national HTA bodies across Europe and the UK for lebrikizumab, a new anti-IL-13 monoclonal antibody approved by the EMA and the MHRA for the treatment of moderate to severe atopic dermatitis. This analysis illustrates the complexity of adapting the regulatory clinical package to local HTA requirements in three key European countries.

METHODS: In the absence of the EU having an overarching and unified approach to HTA (EU HTA), Almirall has prepared specific HTA dossiers by country, GBA/IQWIG in Germany, HAS in France and NICE in England. This bespoke approach was based on the regulatory clinical package of lebrikizumab, the PICO (Patient, Intervention, Comparator, Outcome) methodology, and the local HTA requirements.

RESULTS: GBA/IQWIG submission was based on the EMA-approved target population (patients aged 12 years and older with moderate to severe atopic dermatitis). The clinical evidence submitted was aligned with the regulatory package (ADvocates 1&2 and ADhere). A pharmacoeconomic evaluation was performed on annual cost comparisons. HAS submission aimed at obtaining reimbursement in a subgroup of patients, i.e. with failure, intolerance, or contraindication to ciclosporin, based on an additional targeted efficacy/safety clinical trial of lebrikizumab (ADvantage) performed in this population, and dedicated Matching Adjusted Indirect Comparisons in this population vs dupilumab and tralokizumab. NICE submission aimed at obtaining reimbursement for patients who are suitable for systemic treatment and who have failed at least one systemic immunosuppressant or are not suitable for these treatments. A network meta-analysis was conducted comparing lebrikizumab with biological drugs and JAKs, and a pharmacoeconomic evaluation on a cost-effective model.

CONCLUSIONS: Based on this targeted approach to meet local HTA agencies' requirements, lebrikizumab has been positively recommended for reimbursement in Germany, France, and the United Kingdom. As a result, Almirall has been able to accelerate AD patients’ access to lebrikizumab.