Mepolizumab (2) – Nucala®

Bronchial asthma, ≥ 6 to < 18 years

Characteristics

Start date 01.10.2018 – Marketing authorisation: 27.08.2018
Resolution 22.03.2019
INN Mepolizumab
Brand name Nucala®
Pharm. company GlaxoSmithKline GmbH & Co. KG
G-BA Procedure ID D-390
ATC code R03DX09 Other systemic drugs for obstructive airway diseases (R03DX)
ICD-10 codes (AIS) J45.0, J45.1, J45.8, J45.9Other and unspecified asthma
Alpha-ID codes (AIS) I16367Bronchial asthma, I5235Predominantly allergic bronchial asthma, I5238Non-allergic bronchial asthma, I5245Mixed form of bronchial asthma
DDD 3.6 mg P
Therapeutic area Respiratory system diseases Asthma
Reason for procedure New therapeutic indication
Specialty ACT change Combination therapy

Therapeutic indication of the resolution

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.
Subpopulation Indication Comparator
Children and adolescents aged ≥ 6 to < 18 years with severe refractory eosinophilic asthma Continuation of the optimised therapy of severe asthma according to stage 5 of the NVL Asthma 2018 and additionally escalation with omalizumab, provided that the criteria necessary for the use of omalizumab are fulfilled.

Studies and Results

No. of studies
(best subpopulation) 		3 (MENSA, MUSCA, SIRIUS)
Study design
(best subpopulation) 		Evidence transfer
Meta analysis
(best subpopulation) 		no
ACT change 11.12.2018 – Aktualisierung der Leitlinien (EBM)

  • Clinical trials
    • The MENSA trial is a randomised, placebo-controlled, double-blind Phase III trial with a 32-week treatment duration.
    • The randomised, placebo-controlled, double-blind Phase III SIRIUS trial enrolled 135 patients aged 12 years and over (including 2 adolescents) with severe refractory eosinophilic asthma were enrolled; at the time of enrolment, they were already receiving regular treatment with oral (systemic) corticosteroids (OCS) in addition to high-dose ICS and a further control medication.
    • The single-arm, open-label COSMOS study is a joint follow-up study of the MENSA and SIRIUS trials.
    • The COSMEX study is a follow-up to the COSMOS study, which enrolled 339 patients with life-threatening or severe debilitating asthma who had demonstrated clinical benefit following prior treatment with mepolizumab.
    • In the single-arm, open-label OSMO study, 145 patients aged 12 years and over (including 2 adolescents) with severe eosinophilic asthma were treated with mepolizumab over a period of 32 weeks.
    • Study 200363 is a single-arm, open-label Phase II study of mepolizumab, which exclusively enrolled children aged ≥ 6 to < 12 years with severe eosinophilic asthma.

Children and adolescents aged ≥ 6 to < 18 years with severe refractory eosinophilic asthma

  • The additional benefit is not proven.
  • For this reason, the G-BA concludes that additional benefit from mepolizumab is not proven for children and adolescents aged ≥ 6 to < 18 years with severe refractory eosinophilic asthma.
  • Overall, only very few adolescents and no children were included in the comparative studies submitted (MENSA, MUSCA and SIRIUS).
  • Extrapolating the results from adult patients to paediatric patients with severe refractory eosinophilic asthma is fraught with considerable uncertainty due to differences in pathogenesis and the resulting suitability of omalizumab as an appropriate escalation option.
  • Due to the significant uncertainties mentioned above, it is not possible to perform evidence transfer from the results of adults in the directly comparative studies MENSA, SIRIUS and MUSCA to adolescents and children.
  • The data presented are therefore not suitable for determining any additional benefit of mepolizumab for children and adolescents aged ≥ 6 to < 18 years with severe eosinophilic asthma.

Courtesy translation only, please refer to the German original.

Associated procedures



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