EBGLYSS (lebrikizumab) - atopic dermatitis
Reason for request
Summary of opinion
- 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.
No clinical added value of the new EBGLYSS (lebrikizumab) 125 mg/ml solution for injection in pre filled pen and pre-filled syringe (pack of 2) forms compared to the pre-filled pen and pre-filled syringe (pack of 1) forms already listed.
- In adolescents ≥ 12 years (weighing at least 40 kg)
Favourable opinion for reimbursement in the MA indication “treatment of moderate to severe atopic dermatitis in adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.”
No clinical added value of the new EBGLYSS (lebrikizumab) 125 mg/ml solution for injection in pre filled pen and pre-filled syringe (pack of 2) forms compared to the pre-filled pen and pre-filled syringe (pack of 1) forms already listed.
Clinical Benefit
Substantial |
The Committee considers that the clinical benefit of EBGLYSS 125 mg/ml (lebrikizumab) solution for injection in pre-filled syringe or pre-filled pen (pack of 2) is substantial:
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Insufficient |
The Committee considers that the clinical benefit of EBGLYSS 125 mg/ml (lebrikizumab) solution for injection in pre-filled syringe or pre-filled pen (pack of 2) is insufficient to justify public funding in view of the available aternatives in the other situations covered by the MA in adults. |
Clinical Added Value
no clinical added value |
The Committee issues:
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