Riociguat (2) – Adempas®
Chronic thromboembolic pulmonary hypertension
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-527 |
| ATC code | C02KX05 Antihypertensives for pulmonary arterial hypertension (C02KX) |
| ICD-10 codes (AIS) | I27.20Pulmonary hypertension NOS |
| Alpha-ID codes (AIS) | I108910Pulmonary hypertension in chronic thromboembolism |
| ORPHAcodes (AIS) | 70591Pulmonary hypertension in chronic thromboembolism |
| DDD | 4.5 mg O |
| Therapeutic area | Cardiovascular diseases Chronic thromboembolic pulmonary hypertension (CTEPH) Orphan (turnover limit) |
| Reason for procedure |
New therapeutic indication
–
Orphan turnover exceeded
Original resolution: Riociguat (1) (16.10.2014) |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with - inoperable CTEPH, - persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients in WHO functional classes (FC) II to III with unresectable CTEPH, persistent or recurrent CTEPH after surgical treatment. | Best-Supportive-Care |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (CHEST-1) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- To assess the additional benefit of riociguat for the treatment of adult patients in WHO functional classes (FC) II to III with inoperable CTEPH, or persistent or recurrent CTEPH following surgical treatment, to improve physical performance, the pharmaceutical manufacturer submitted the randomised, double-blind, placebo-controlled Phase III CHEST-1 trial, which formed the basis for marketing authorisation.
- In addition, the pharmaceutical manufacturer submitted the single-arm Phase III CHEST-2 extension study.
Adult patients in WHO functional classes (FC) II to III with inoperable CTEPH, or persistent or recurrent CTEPH following surgical treatment
- The 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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