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NEMLUVIO (nemolizumab) - Atopic dermatitis in adults and in adolescents ≥ 12 years.
Reason for request
Inclusion on list
- In Adults :
Favourable opinion for reimbursement only in “the treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy, in the event of inadequate response, intolerance or contraindication to ciclosporin.”
Unfavourable opinion for reimbursement in adults with inadequate response to topical therapies and who are ciclosporin-naive, in the absence of comparative data.
- In adolescents ≥ 12 years
Favourable opinion for reimbursement only in “the treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy.
Clinical Benefit
| Substantial |
The clinical benefit of NEMLUVIO 30 mg (nemolizumab) solution for injection in pre-filled pen is substantial only in the treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy, in the event of inadequate response, intolerance or contraindication to ciclosporin, and in the MA indication in adolescents 12 years and older. |
| Insufficient |
The clinical benefit of NEMLUVIO 30 mg (nemolizumab) solution for injection in pre-filled pen is insufficient to justify public funding in view of the available alternatives in the other situations covered by the MA in adults, in the absence of comparative data versus ciclosporin. |
Clinical Added Value
| no clinical added value |
In adults within the reimbursement scope retained by the Committee (in the event of inadequate response, intolerance or contraindication to ciclosporin): NEMLUVIO 30 mg (nemolizumab) solution for injection in pre-filled pen provides no clinical added value (CAV V) in the care pathway for the treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy, in the event of inadequate response, intolerance or contraindication to ciclosporin, which includes other interleukin inhibitors (dupilumab, tralokinumab and lebrikizumab) and JAK inhibitors (baricitinib, upadacitinib and abrocitinib). In adolescents ≥ 12 years NEMLUVIO 30 mg (nemolizumab) solution for injection in pre-filled pen provides no clinical added value (CAV V) in the care pathway for the treatment of moderate to severe atopic dermatitis in adolescents (≥ 12 years) who are candidates for systemic therapy, which includes other interleukin inhibitors (dupilumab, tralokinumab and lebrikizumab) and JAK inhibitors (upadacitinib and abrocitinib). |
| Not applicable |
