EBGLYSS (lebrikizumab) - Atopic dermatitis

Opinions on drugs - Posted on Jun 18 2024

Reason for request

First listing

Summary of opinion

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 in adults with inadequate response to topical therapies and who are ciclosporin-naïve, in the absence of comparative data.

Clinical Benefit

Substantial

The Committee deems that the clinical benefit of EBGLYSS 125 mg/ml (lebrikizumab) solution for injection in pre-filled syringe or 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,
in adolescents 12 years and older (body weight ≥ 40 kg) in the MA indication and at the MA dosages.

Insufficient

The Committee deems that the clinical benefit of EBGLYSS 125 mg/ml (lebrikizumab) solution for injection in pre-filled syringe or pen is insufficient to justify public funding cover in view of the available alternatives in the other situations covered by the MA in adults.

Clinical Added Value

no clinical added value

Within the reimbursement scope retained by the Committee (in the event of inadequate response, intolerance or contraindication to ciclosporin):

EBGLYSS (lebrikizumab) 125 mg/ml solution for injection 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 JAK inhibitors (baricitinib, upadacitinib and abrocitinib).

In adolescents ≥ 12 years

EBGLYSS (lebrikizumab) 125 mg/ml solution for injection provides no clinical added value (CAV V) in the care pathway for the treatment of moderate to severe atopic dermatitis in adolescents 12 years and older (body weight ≥ 40 kg) who are candidates for systemic therapy, which includes two interleukin inhibitors (dupilumab and tralokinumab) and one JAK inhibitor (upadacitinib).

Not applicable