WHAT IS CANADA’S DRUG AGENCY REIMBURSEMENT RECOMMENDATION FOR EBGLYSS?: Canada’s Drug Agency (CDA-AMC) recommends that Ebglyss should not be reimbursed by public drug plans for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. WHY DID CDA-AMC MAKE THIS RECOMMENDATION? • Evidence from 3 clinical trials demonstrated that, in the short-term, Ebglyss treatment improved the severity of AD and reduced itch symptoms compared with placebo in adults and adolescents with moderate to severe AD. However, based on the evidence reviewed in the initial meeting and the reconsideration meeting, the Canadian Drug Expert Committee (CDEC) could not determine whether lebrikizumab would address the unmet needs of patients because of the uncertainty around the benefit of lebrikizumab versus appropriate comparators and in patients who received prior dupilumab or Janus kinase (JAK) inhibitor treatment. • No evidence was submitted that directly compared Ebglyss to currently available treatments for AD. The indirect evidence submitted had limitations that impacted the certainty of the evidence, and it was unclear if the estimates were valid. • The safety of Ebglyss relative to other treatments for AD is unknown because no comparative evidence was submitted. In addition, longer-term safety and efficacy was uncertain because of limitations of the study designs and analysis with the available evidence.
WHAT IS AD? AD is a condition that affects the skin and causes dry, red skin that is extremely itchy. Constant scratching causes the skin to split and bleed, which can lead to infections. Oozing and weeping sores occur in more severe forms. Severe AD can be physically incapacitating and cause anxiety or depression. AD affects around 20% of children, and up to 10% of adults in high-income countries. UNMET NEEDS IN AD: There is a potential need for additional treatment options that effectively reduce the severity and symptoms of AD, particularly in patients whose disease did not adequately respond to, or were deemed unsafe to receive, other biologics or JAK inhibitors. HOW MUCH DOES EBGLYSS COST? Treatment with Ebglyss is expected to cost approximately $35,657 per patient in the first year and approximately $24,397 per patient in subsequent years.
