New Systemic Treatment Option Recommended for Patients Aged 12 and Over
The National Institute for Health and Care Excellence (NICE) has recommended Almirall's Ebglyss (lebrikizumab) as a treatment for moderate to severe atopic dermatitis in patients aged 12 and above who weigh at least 40 kg. This recommendation applies only if the patient's condition has not responded to at least one systemic immunosuppressant or if such treatments are deemed unsuitable, and if dupilumab or tralokinumab would otherwise be considered.
Clinical Trial Insights
Almirall's pivotal clinical trials—ADvocate 1, ADvocate 2, ADhere, and ADvantage—played a key role in this recommendation. These Phase 3 trials, which were double-blind and randomized, compared lebrikizumab with a placebo in individuals aged 12 and older with moderate to severe atopic dermatitis. Notably, the ADvantage trial included participants whose condition was inadequately controlled with ciclosporin or for whom ciclosporin was not appropriate. The ADhere and ADvantage trials were highlighted for their relevance to clinical practice, as they allowed the use of topical corticosteroids in combination with lebrikizumab, unlike the monotherapy trials ADvocate 1 and 2.
The primary outcome across these trials was achieving an EASI 75 score at week 16, indicating at least a 75% improvement from baseline. Results showed that lebrikizumab significantly outperformed the placebo in reaching this milestone in both monotherapy and combination settings. However, it is important to note that these trials did not compare lebrikizumab with other biological medicines or JAK inhibitors.
Economic Evaluation
The economic model submitted by Almirall consisted of a hybrid approach: a short-term decision tree for the first year capturing treatment initiation and a long-term Markov model from year two onwards. This model, which assumed a lifetime horizon of up to 100 years, applied a 3.5% discount rate for both costs and quality-adjusted life years (QALYs). The model started with patients receiving either lebrikizumab or comparator treatments, with those responding to treatment continuing and those not responding moving to best supportive care.
NICE's guidelines suggest a cautious approach when the incremental cost-effectiveness ratio (ICER) exceeds £20,000 per QALY gained. The committee considered patient and clinical expert feedback regarding the severity of atopic dermatitis and the need for additional treatment options. Despite some uncertainties in the network meta-analysis and treatment outcome derivation, the committee concluded that lebrikizumab's cost-effectiveness was within the acceptable range compared to current biological treatments like dupilumab and tralokinumab.
Final Recommendation
NICE has concluded that lebrikizumab is a cost-effective treatment option for moderate to severe atopic dermatitis in patients 12 years and older who meet specific criteria. This recommendation provides a new systemic treatment alternative for individuals whose condition has not adequately responded to other systemic immunosuppressants or for whom such treatments are unsuitable.
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