Macitentan (2) – Opsumit®
Pulmonary arterial hypertension (PAH)
Characteristics
| Start date | 15.10.2016 – Marketing authorisation: 20.12.2013 |
|---|---|
| Resolution | 06.04.2017 |
| INN | Macitentan |
| Brand name | Opsumit® |
| Pharm. company |
Dossier: Actelion Pharmaceuticals Deutschland GmbH
New distributor: JANSSEN-CILAG GmbH |
| G-BA Procedure ID | D-260 |
| ATC code | C02KX04 Antihypertensives for pulmonary arterial hypertension (C02KX) |
| ICD-10 codes (AIS) | I27.0Primary pulmonary hypertension, I27.28 |
| Alpha-ID codes (AIS) | I119436Idiopathic PAH (pulmonary arterial hypertension), I98236Pulmonary arterial hypertension |
| ORPHAcodes (AIS) | 275766Idiopathic PAH (pulmonary arterial hypertension), |
| DDD | 10 mg O |
| Therapeutic area | Cardiovascular diseases Pulmonary arterial hypertension (PAH) Orphan (turnover limit) |
| Reason for procedure |
Reassessment: Orphan turnover exceeded
Original resolution: Macitentan (1) (17.07.2014) |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with pulmonary arterial hypertension (PAH) of WHO functional class (WHO-FC) II to III | A patient-individually optimised drug therapy according to the physician's specifications, taking into account the respective approval status |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (SERAPHIN) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- The SERAPHIN trial submitted by the pharmaceutical manufacturer is a randomised, controlled, double-blind, three-arm trial comparing macitentan (3 mg² or 10 mg) with placebo.
pulmonary arterial hypertension (PAH) in adult patients with WHO/NYHA functional class II to III
- For pulmonary arterial hypertension (PAH) as long-term therapy in adult patients with WHO functional class (WHO-FC) II to III, either as monotherapy or in combination, additional benefit is not proven compared with the appropriate comparator therapy.
- For the reasons outlined, the SERAPHIN study does not allow for a comparison of macitentan with the appropriate comparator therapy and is therefore not suitable for deriving any additional benefit.
Courtesy translation only, please refer to the German original.
Associated procedures
| Macitentan (2) | Opsumit® | Actelion Pharmaceuticals Deutschland GmbH | Pulmonary arterial hypertension (PAH) | 580–7,850 | 100% additional benefit not proven Orphan (turnover limit) | |
| Macitentan (1) | Opsumit® | Actelion Pharmaceuticals Deutschland GmbH | Pulmonary arterial hypertension (PAH) |
0
580–7,850 |
100% minor additional benefit Orphan repealed |
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