- Date 21 April 2021
- Documents : 8
- Economic analysis
- History
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DUPIXENT (dupilumab) - Dermatite atopique sévère enfant
Reason for request
Key points
Favourable opinion for reimbursement in the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy.
What therapeutic improvement?
Therapeutic improvement in the management of the condition.
Role in the care pathway?
The overall objective of treatment is to improve patients’ quality of life by treating their skin lesions and preventing the risk of secondary infections in the event of flare-ups, early relapses and xeroderma. Outside inflammatory flare-ups, all patients should be treated using adjuvant measures (hygiene, emollients) and relapses should be treated at an early stage.
As in adults and adolescents, the treatment of acute flare-ups of atopic dermatitis (AD) in children is initially based on the use of topical corticosteroids. The wet wrapping technique may be used in the event of an inadequate response.
In the event of failure of topical corticosteroid therapy, systemic immunosuppressants can be used in children. These include ciclosporin used as first-line therapy (but not recommended by the MA in children under 16 years of age) and two medicinal products without an MA in this indication: methotrexate and azathioprine. In the paediatric population, the use of these substances is based on a low level of evidence and should be time-limited due to the unfavourable long-term safety profile.
Due, in particular, to a long-term cancer risk, the use of phototherapy has a limited role in the care pathway in children in the event of failure of topical corticosteroid therapy. Topical tacrolimus has an MA in children in the event of an inadequate response to topical corticosteroid therapy. However, the Transparency Committee considered that its clinical benefit was insufficient in this age group.
Role of the medicinal product in the care pathway
In children 6 to 11 years old, DUPIXENT (dupilumab) is a second-line treatment to be reserved for severe forms of atopic dermatitis following the failure of topical corticosteroid therapy.
Clinical Benefit
Clinical Added Value
| moderate |
Considering:
despite:
as in adults and adolescents, the proprietary medicinal products DUPIXENT 200 mg and 300 mg (dupilumab) provide a moderate clinical added value (CAV III) in the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy.
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Avis économique
Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 6 Juillet 2021. L’avis économique porte sur une indication superposable à celle de la demande de remboursement et à celle de l’AMM, à savoir le traitement des enfants âgés de 6 à 11 ans souffrant de dermatite atopique (DA) sévère qui nécessite un traitement systémique. La CEESP a été en mesure de conclure sur le niveau d’efficience du produit, avec un ratio différentiel coût-résultat (RDCR) de 26 588 €/QALY sur un horizon temporel de 6 ans, versus les traitements topiques seuls. Sans la prise en compte de l’utilité des aidants, le RDCR atteint environ 42 221 €/QALY (+77%) toutes choses égales par ailleurs. À noter que la modélisation ne concerne que des enfants entre 6 ans et 11 ans, alors qu’en vie réelle, les enfants continueront très probablement leur traitement sur le long terme. L’efficience du dupilumab chez les patients initiant leur traitement dès l’âge de 6 ans et le continuant sans limite d’âge n’est pas connue.
L’impact budgétaire associé à l’introduction du dupilumab représente une augmentation des dépenses de l’assurance maladie dans l’indication de + 95% sur un horizon temporel de 5 ans.
> DUPIXENT - Avis économique (pdf)
