Riociguat (3, reassessment >€50m) (Adempas®) – Pulmonary arterial hypertension (PAH)

1. Characteristics

Start date 15.03.2020
Resolution 03.09.2020
INN Riociguat
Brand name Adempas®
Company MSD Sharp & Dohme GmbH
G-BA procedure ID 2020-03-15-D-528
ATC code C02KX05
ICD-10 codes I27.0Primary pulmonary hypertension, I27.28
DDD 4.5 mg O
Therapeutic area Cardiovascular diseases ORPHAN
Reason for procedure Reassessment due to turnover >€50m (orphan)
Original resolution: Riociguat (16.10.2014)
Specialties Bundling

Indication (German)

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.

Subgroup Indication Comparator
b) Erwachsene Patienten mit pulmonal arterieller Hypertonie (PAH) der WHO-Funktionsklassen (FK) II bis III Patientenindividuell optimierte medikamentöse Therapie unter Berücksichtigung der Vortherapien und des Gesundheitszustandes, unter Berücksichtigung folgender Therapien: - Endothelin-Rezeptor-Antagonisten (Ambrisentan, Bosentan, Macitentan) - Phosphodiesterase-Typ-5-Inhibitoren (Sildenafil, Tadalafil) - Prostazyklin-Analoga (Iloprost) - Selektive Prostazyklin-Rezeptor-Agonisten (Selexipag)

9. Associated procedures

Resolution INN Brand name Indication Additional benefit
Riociguat Adempas® Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTPH)
Riociguat (3, reassessment >€50m) Adempas® Pulmonary arterial hypertension (PAH)
Riociguat (2, reassessment >€50m) Adempas® Chronic thromboembolic pulmonary hypertension


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