Riociguat (3) – Adempas®
Pulmonary arterial hypertension (PAH)
Characteristics
| Start date | 15.03.2020 – Marketing authorisation: 27.03.2014 |
|---|---|
| Resolution | 03.09.2020 |
| INN | Riociguat |
| Brand name | Adempas® |
| Pharm. company |
Dossier: MSD SHARP & DOHME GMBH
New distributor: MSD Sharp & Dohme GmbH |
| G-BA Procedure ID | D-528 |
| 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 |
| ORPHAcodes (AIS) | 275766Primary pulmonary arterial hypertension, |
| DDD | 4.5 mg O |
| Therapeutic area | Cardiovascular diseases Pulmonary arterial hypertension (PAH) Orphan (turnover limit) |
| Reason for procedure |
New therapeutic indication
–
Orphan turnover exceeded
Original resolution: Riociguat (1) (16.10.2014) |
| Specialty | Bundling Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| b) | Adult patients with pulmonary arterial hypertension (PAH) of WHO functional classes (FC) II to III | Patient-individually optimised drug therapy taking into account previous therapies and health status, taking into account the following therapies: - Endothelin receptor antagonists (ambrisentan, bosentan, macitentan). - Phosphodiesterase type 5 inhibitors (sildenafil, tadalafil) - Prostacyclin analogues (iloprost) - Selective prostacyclin receptor agonists (selexipag) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (PATENT-1) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT (off-label) |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- For the assessment of the additional benefit of riociguat, indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) in WHO functional classes (FC) II to III, to improve physical performance, the pharmaceutical manufacturer submitted the Phase III PATENT-1 randomised, double-blind, placebo-controlled, parallel-group trial, which formed the basis for marketing authorisation.
- In addition, the pharmaceutical manufacturer submitted the single-arm Phase III PATENT-2 extension study.
Adult patients with pulmonary arterial hypertension (PAH) in WHO functional classes (FC) II to III
- An additional benefit is not proven.
- Consequently, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of riociguat compared with the appropriate comparator therapy.
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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