Reason for request
- Key points
Favourable opinion for reimbursement in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high-dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
- What therapeutic improvement?
Slight therapeutic improvement.
- Role in the care pathway?
The main objective of pharmacological treatment of asthma in adults and adolescents is to ensure durable maintenance of asthma control, including the reduction of symptoms, the prevention of exacerbations, the improvement of respiratory function, the reduction of restrictions in everyday activities and the limitation of adverse reactions related to pharmacological treatments.
The GINA defines fives treatment steps, with severe asthma corresponding to step 4 (disease requiring the use of maintenance treatment by a combination of moderate or high-dose ICS and LABA, potentially supplemented with one or more other bronchodilators or anti-inflammatories, and step 5 (disease not controlled by step 4 treatment, requiring maintenance treatment, add-on treatment with oral or injectable corticosteroids or monoclonal antibody therapy with anti-IgE [omalizumab] in the event of allergic asthma or anti-IL5 [benralizumab, mepolizumab, reslizumab] in the event of eosinophilic asthma or anti-IL4 [dupilumab] in the event of asthma associated with type 2 inflammation).
Role of the medicinal product in the care pathway
DUPIXENT (dupilumab) is a new therapeutic alternative in patients with severe asthma. Patients whose asthma is not controlled due to inappropriate maintenance treatment, treatment compliance problems, comorbidities or untreated exacerbating risk factors do not fall within this scope.
In the absence of any direct comparison between DUPIXENT and biologic therapies (CINQAERO, FASENRA, NUCALA, XOLAIR), the role of DUPIXENT among the other biologic therapies available in severe asthma remains to be specified.
The clinical benefit of DUPIXENT is substantial in the indication “in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised FeNO (see section 5.1 of the SPC), who are inadequately controlled with high-dose ICS plus another medicinal product for maintenance treatment."
Clinical Added Value
DUPIXENT provides a minor clinical added value (CAV IV), like CINQAERO, FASENRA, NUCALA and XOLAIR, in the treatment of severe asthma with type 2 inflammation in adults and adolescents 12 years and older who are inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment.