Baricitinib (3) – Olumiant®

Polyarticular juvenile idiopathic Arthritis, RF+ or RF− polyarticular and expanded oligoarticular, ≥ 2 years

Characteristics

Start date 15.11.2023 – Marketing authorisation: 15.09.2023
Resolution 02.05.2024
INN Baricitinib
Brand name Olumiant®
Pharm. company Lilly Deutschland GmbH
G-BA Procedure ID D-988
ATC code L04AF02 IMMUNOSUPPRESSANTS (L04A)
ICD-10 codes (AIS) M08.00Unspecified juvenile rheumatoid arthritis of unspecified site, M08.3Juvenile rheumatoid polyarthritis (seronegative), M08.90Juvenile arthritis, unspecified, unspecified site, M08.99Juvenile arthritis, unspecified, multiple sites
Alpha-ID codes (AIS) I119798Juvenile idiopathic arthritis, I126529Juvenile rheumatoid factor-negative polyarthritis, I128130Juvenile rheumatoid factor-positive polyarthritis, I130694Juvenile idiopathic arthritis in several locations
Therapeutic area Musculoskeletal system diseases Juvenile idiopathic arthritis / Enthesitis-related arthritis
Reason for procedure New therapeutic indication
Specialty Bundling

Therapeutic indication of the resolution

Baricitinib is used for the treatment of active juvenile idiopathic arthritis in patients aged 2 years and older who have previously had an inadequate response or intolerance to one or more conventional synthetic or biologic DMARDs:

– Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular). Baricitinib can be used as monotherapy or in combination with methotrexate.
Subpopulation Indication Comparator
a) Children and adolescents aged 2 years and older with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have had an inadequate response to or are intolerant of one or more conventional synthetic DMARDs A bDMARD (adalimumab or etanercept or golimumab or tocilizumab) in combination with MTX; if necessary as monotherapy, taking into account the respective approval status in the event of MTX intolerance or unsuitability
b) Children and adolescents aged 2 years and older with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have had an inadequate response to or are intolerant of one or more biological DMARDs A bDMARD (abatacept or adalimumab or etanercept or golimumab or tocilizumab) in combination with MTX; if necessary as monotherapy, taking into account the respective approval status in the event of MTX intolerance or unsuitability depending on the previous therapy

Studies and Results

No. of studies
(best subpopulation) 		0 (no data submitted)
Study design
(best subpopulation) 		no data submitted
Reason for dividing into subpopulations (G-BA) Previous treatment

  • Clinical trials
    • In the pivotal I4V-MC-JAHV (JUVE-BASIS) trial, all patients initially received baricitinib for 12 weeks, followed by a double-blind treatment phase lasting up to 32 weeks, during which patients who responded were randomised to receive either further treatment with baricitinib or a placebo.

a) Children and adolescents aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to, or are intolerant of, one or more conventional synthetic DMARDs

  • For children and adolescents aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to one or more conventional synthetic DMARDs or have been unable to tolerate them; the additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any data for either patient population to assess the additional benefit of baricitinib compared with the appropriate comparator therapy.
  • In agreement with the pharmaceutical manufacturer, no suitable studies could be identified for a comparison of baricitinib with the appropriate comparator therapy.
  • In the pivotal I4V-MC-JAHV (JUVE-BASIS) trial, all patients initially received baricitinib for 12 weeks, followed by a double-blind treatment phase lasting up to 32 weeks, during which patients who responded were randomised to receive either further treatment with baricitinib or placebo. In accordance with the pharmaceutical manufacturer’s approach as set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of comparison with the appropriate comparator therapy.

b) Children and adolescents aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to, or are intolerant of, one or more biological DMARDs

  • For children and adolescents aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to one or more biological DMARDs or have been unable to tolerate them; the additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any data for either patient population to assess the additional benefit of baricitinib compared with the appropriate comparator therapy.
  • In agreement with the pharmaceutical manufacturer, no suitable studies could be identified for a comparison of baricitinib with the appropriate comparator therapy.
  • In the pivotal I4V-MC-JAHV (JUVE-BASIS) trial, all patients initially received baricitinib for 12 weeks, followed by a double-blind treatment phase lasting up to 32 weeks, during which patients who responded were randomised to receive either further treatment with baricitinib or placebo. In accordance with the pharmaceutical manufacturer’s approach as set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of comparison with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.

Associated procedures



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