NUCALA (mépolizumab) - Asthme sévère à éosinophiles pour les enfants de 6 ans et plus et les adolescents

Key points

Positive opinion on the reimbursement of NUCALA (mepolizumab) as an additional treatment for severe refractory eosinophilic asthma in children aged six years and over and in adolescents meeting the following criteria

• a blood eosinophil level ≥ 150/μL within the last 12 months;

AND

• at least two asthma exacerbation episodes requiring oral corticosteroid treatment (≥ 3 days each) in the last 12 months despite basic treatment with a combination of high-dose inhaled corticosteroids and a long-acting bronchodilator (LABA);
• OR treatment with oral corticosteroids for at least 6 months in the last 12 months.

Not recommended for reimbursement in other clinical situations for the additional treatment of severe refractory eosinophilic asthma in children aged 6 years and over and adolescents.

Therapeutic improvement?

A therapeutic advance in the management of severe refractory eosinophilic asthma in children aged six years and older and adolescents.

Role in therapeutic strategy?

As in adults, the aim of the pharmacological management of asthma in children aged six years and older and in adolescents is to maintain sustained control of the disease, including: reduction of symptoms, prevention of exacerbations, reduction of limitations in daily life, and limitation of adverse effects due to pharmacological treatments.

Treatment is adapted to the severity of the disease. International consensus has identified five levels of severity with escalation of therapy in case of non-control or partial control of asthma. Severe asthma corresponds to levels 4 and 5:

• tier 4 – asthma requiring basic treatment with a combination of medium-dose ICS and LABA (preferred basic treatment);
• tier 5 – tier 4 asthma requiring basic treatment with a combination of high-dose ICS and LABA, with the addition of biologic treatment if necessary, depending on the asthma phenotype.

Escalation of therapy for severe asthma in children over six years of age and adolescents involves oral corticosteroids and biotherapies as a last resort. However, in paediatrics, oral corticosteroids can only be occasionally used as a short course of treatment due to the risk of adverse effects. Among the biotherapies, omalizumab (XOLAIR) for severe allergic asthma, mepolizumab (NUCALA) for severe refractory eosinophilic asthma and dupilumab (DUPIXENT) for severe asthma associated with type-2 inflammation are currently approved for use in children aged six and over in France.

Role of the medicinal product:

According to the recommendations of the European Respiratory Society/American Thoracic Society (ERS/ATS) and the European Academy of Allergy and Clinical Immunology (EAACI), the eosinophil count should be ≥ 150/μL for the initiation of NUCALA (mepolizumab) therapy. This level should be ≥ 150/μL or ≥ 300/μL for the initiation of NUCALA (mepolizumab) therapy according to the GINA.

The Committee defines children aged six years and over and adolescents who may benefit from NUCALA (mepolizumab) in the following manner:

• patients with a blood eosinophil level ≥ 150/μL in the last 12 months;

AND

• patients with at least two asthma exacerbation episodes requiring oral corticosteroid treatment (≥ 3 days each) in the last 12 months despite basic treatment with a combination of high-dose inhaled corticosteroids and a long-acting bronchodilator (LABA);
• OR patients treated with oral corticosteroids for at least six of the last 12 months.

 Children aged 6 years and older and adolescents whose asthma is not controlled due to inadequate basic treatment, compliance problems, comorbidities or unmanaged aggravating risk factors, are not included.

Due to the lack of a direct comparison between NUCALA (mepolizumab) and the biotherapies (DUPIXENT [dupilumab] and XOLAIR [omalizumab]), the role of NUCALA (mepolizumab) among the other available biotherapies for severe asthma still needs to be clarified.