EBGLYSS (lebrikizumab) - atopic dermatitis

Opinions on drugs - Posted on Sep 24 2024

Reason for request

First listing

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.”

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:

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,
in adolescents 12 years and older

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:

a favourable opinion for inclusion of EBGLYSS 125 mg/ml (lebrikizumab) solution for injection in pre-filled syringe or pre-filled pen (pack of 2) in both the list of covered drugs for outpatients and the list of covered drugs for inpatients approved for use 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 contraindi cation to ciclosporin and at the MA dosages,
an unfavourable opinion for inclusion in both the list of covered drugs for outpatients and the list of covered drugs for inpatients approved for use in the treatment of mod erate to severe atopic dermatitis in adults with inadequate response to topical treatments and who are ciclosporin-naive, in the absence of comparative data.