Baricitinib (4) – Olumiant®

Atopic dermatitis, ≥ 2 until < 17 years

Characteristics

Start date 15.11.2023 – Marketing authorisation: 18.10.2023
Resolution 02.05.2024
INN Baricitinib
Brand name Olumiant®
Pharm. company Lilly Deutschland GmbH
G-BA Procedure ID D-989
ATC code L04AF02 IMMUNOSUPPRESSANTS (L04A)
ICD-10 codes (AIS) L20.0Besnier´s prurigo, L20.8Other atopic dermatitis, L20.9Atopic dermatitis, unspecified
Alpha-ID codes (AIS) I19541Neurodermatitis, I28531Prurigo Besnier, I9918Atopic dermatitis
Therapeutic area Skin diseases Atopic dermatitis (AD)
Reason for procedure New therapeutic indication
Specialty Bundling

Therapeutic indication of the resolution

Treatment of moderate to severe atopic dermatitis in children and adolescents aged 2 to 17 years who are eligible for systemic therapy
Subpopulation Indication Comparator
a) Children from 2 to 11 years of age with moderate atopic dermatitis who are eligible for systemic therapy A therapy regimen optimized for the individual patient depending on the severity of the disease and taking into account the previous therapy, taking into account the following therapies: – topical glucocorticoids of classes 1 to 3 – topical calcineurin inhibitors
b) Children from 2 to 11 years of age with severe atopic dermatitis who are eligible for systemic therapy Dupilumab (possibly in combination with TCS and/or TCI)
c) Adolescents aged 12 to 17 years with moderate to severe atopic dermatitis who are eligible for systemic therapy Dupilumab (possibly in combination with TCS and/or TCI)

Studies and Results

No. of studies
(best subpopulation) 		0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. non-ACT + no ITC)
Reason for dividing into subpopulations (G-BA) Patient eligibility

  • Clinical trials
    • In the BREEZE-AD-PEDS trial, which formed the basis for marketing authorisation, a randomised comparison with placebo was conducted over 16 weeks.

a) Children aged 2 to 11 years with moderate atopic dermatitis who are eligible for systemic therapy

  • For children aged 2 to 11 years with moderate atopic dermatitis who are eligible for systemic therapy, the additional benefit is not proven.
  • No relevant study was identified for the assessment of the additional benefit of baricitinib compared with the appropriate comparator therapy.
  • An additional benefit of baricitinib over the appropriate comparator therapy is not proven.
  • The G-BA defined the appropriate comparator therapy as a treatment regimen optimised for the individual patient depending on the severity of the condition and taking into account prior treatment, taking into account topical glucocorticoids of classes 1 to 3 and topical calcineurin inhibitors.

b) Children aged 2 to 11 years with severe atopic dermatitis who are eligible for systemic therapy

  • For children aged 2 to 11 years with severe atopic dermatitis who are eligible for systemic therapy, the additional benefit is not proven.
  • No relevant study was identified for the assessment of the additional benefit of baricitinib compared with the appropriate comparator therapy.
  • An additional benefit of baricitinib compared with the appropriate comparator therapy is not proven.
  • The G-BA has designated treatment with dupilumab (where appropriate, in combination with TCS and/or TCI) as the appropriate comparator therapy.

c) Adolescents aged 12 to 17 with moderate to severe atopic dermatitis who are eligible for systemic therapy

  • For adolescents aged 12 to 17 with moderate to severe atopic dermatitis who are eligible for systemic therapy, the additional benefit is not proven.
  • No relevant study was identified for the assessment of the additional benefit of baricitinib compared with the appropriate comparator therapy.
  • An additional benefit of baricitinib over the appropriate comparator therapy is not proven.
  • The G-BA has designated treatment with dupilumab (where appropriate, in combination with TCS and/or TCI) as the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.

Associated procedures



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