Riociguat (4) – Adempas®
Pulmonary arterial hypertension, < 18 years of age
Characteristics
| Start date | 01.07.2023 – Marketing authorisation: 31.05.2023 |
|---|---|
| Resolution | 21.12.2023 |
| INN | Riociguat |
| Brand name | Adempas® |
| Pharm. company |
Dossier: MSD SHARP & DOHME GMBH
New distributor: MSD Sharp & Dohme GmbH |
| G-BA Procedure ID | D-943 |
| ATC code | C02KX05 Antihypertensives for pulmonary arterial hypertension (C02KX) |
| ICD-10 codes (AIS) | I27.0Primary pulmonary hypertension, I27.28 |
| Alpha-ID codes (AIS) | I119869Primary pulmonary arterial hypertension, I98236Pulmonary arterial hypertension |
| Therapeutic area | Cardiovascular diseases Pulmonary arterial hypertension (PAH) |
| Reason for procedure | New therapeutic indication |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Adempas, in combination with endothelin receptor antagonists, is indicated for the treatment of children and adolescents under 18 years of age and weighing ≥ 50 kg with PAH in WHO functional classes (FC) II to III |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Paediatric patients ≥ 50 kg to < 18 years with pulmonary arterial hypertension (PAH) | Patient-individualised therapy, taking into account in particular previous therapies, severity and underlying diseases, with selection of - Endothelin receptor antagonists: bosentan, ambrisentan - Phosphodiesterase inhibitors type 5: sildenafil, tadalafil |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (PATENT-CHILD) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + no comparison |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 23.05.2023 – Neue Leitlinien |
- Clinical trials
- The PATENT-CHILD study presented in the dossier is a single-arm study investigating treatment with riociguat, in combination with endothelin receptor antagonists, in children and adolescents aged 6 to < 18 years.
Paediatric patients weighing ≥ 50 kg to < 18 years of age with pulmonary arterial hypertension (PAH)
- For paediatric patients weighing ≥ 50 kg and aged < 18 years with pulmonary arterial hypertension (PAH), the additional benefit of riociguat, in combination with endothelin receptor antagonists, compared with the appropriate comparator therapy is not proven.
- An additional benefit of riociguat, in combination with endothelin receptor antagonists, compared with the appropriate comparator therapy is not proven.
- The pharmaceutical manufacturer has not provided any data for the assessment of the additional benefit of riociguat, in combination with endothelin receptor antagonists, compared with the appropriate comparator therapy.
- Due to the lack of comparison with the appropriate comparator therapy, this study is not taken into account for the present benefit assessment.
Courtesy translation only, please refer to the German original.
Associated procedures
| Riociguat (4) | Adempas® | MSD SHARP & DOHME GMBH | Pulmonary arterial hypertension, < 18 years of age | 5–35 | 100% additional benefit not proven | |
| Riociguat (2) | Adempas® | MSD SHARP & DOHME GMBH | Chronic thromboembolic pulmonary hypertension | 920–5,460 | 100% additional benefit not proven Orphan (turnover limit) | |
| Riociguat (3) | Adempas® | MSD SHARP & DOHME GMBH | Pulmonary arterial hypertension (PAH) | 580–7,850 | 100% additional benefit not proven Orphan (turnover limit) | |
| Riociguat (1) | Adempas® | Bayer Vital GmbH | Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTPH) |
0
1,500–13,310 |
100% minor additional benefit Orphan repealed |
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