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. 2019 Jul 1;34(4):696–707. doi: 10.3904/kjim.2019.185

Table 4.

Korean FDA approval and reimbursement by the Korean Health Insurance System for pulmonary arterial hypertension-targeted therapeutics

Mechanism of action Name of drug Route of delivery Korean FDA approval Reimbursed by NHIS Reimbursed for NYHA functional classes
II III IV
ERA Ambrisentan PO × ×
Bosentan PO ×
Macitentan PO × ×
PDE-5 inhibitor Sildenafil PO ×
Tadalafil PO × × × × ×
Vardenafil PO × × × × ×
Prostacyclin analogues Epoprostenol IV × × × × ×
Iloprost INH ×
IV × × × × ×
Treprostinil SC ×
INH × × × × ×
IV ×
PO × × × × ×
Beraprost PO No clear criteria
Selexipag PO × ×
sGC stimulator Riociguat PO × × × ×

FDA, Food and Drug Administration; NHIS, National Health Insurance Service; NYHA, New York Heart Association; ERA, endothelin receptor antagonist; PO, per oral; PDE-5, phosphodiesterase 5; IV, intravenous; INH, inhaled; SC, subcutaneous; sGC, soluble guanylyl cyclase.