This document outlines details of PBS-subsidised ambrisentan, bosentan, epoprostenol, iloprost, macitentan, riociguat, selexipag, sildenafil, and tadalafil for patients with pulmonary arterial hypertension (PAH). Monotherapy, dual therapy, and triple therapy treatment options are available.
For information on how to process a PBS Authority, see Processing Complex Authority Required Listings.
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Pulmonary arterial hypertension (PAH) - monotherapy quick reference
Pulmonary arterial hypertension (PAH) - dual or triple therapy quick reference (excluding selexipag)
Pulmonary arterial hypertension (PAH) - triple therapy quick reference (including selexipag)
Pulmonary arterial hypertension (PAH) - monotherapy quick reference
Table 1
Restrictions | Authority level and section | PA assessment | Processing system | Prescriber type | Prescriber self-serve |
Initial 1 (new patients) PB070 form | Written Electronic S100: ambrisentan bosentan epoprostenol iloprost macitentan riociguat sildenafil tadalafil | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Initial 2 (change) | Telephone Electronic S100: ambrisentan bosentan epoprostenol iloprost macitentan riociguat sildenafil tadalafil | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Continuing | Telephone Electronic S100: ambrisentan bosentan epoprostenol iloprost macitentan riociguat sildenafil tadalafil | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Cessation | Telephone Electronic S100: bosentan 62.5mg | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Pulmonary arterial hypertension (PAH) - dual or triple therapy quick reference (excluding selexipag)
Table 2
Restrictions | Authority level and section | PA assessment | Processing system | Prescriber type | Prescriber self-serve |
Initial 1 (excluding selexipag, for previously untreated patients) PB303 form | Written Electronic S100: Dual therapy a combination of either: one ERA and one PDE-5i ambrisentan bosentan macitentan with: sildenafil tadalafil or one ERA and one prostanoid ambrisentan bosentan macitentan with: epoprostenol iloprost or one PDE-5i and one prostanoid sildenafil tadalafil with: epoprostenol iloprost Triple therapy a combination of: one ERA, one PDE-5i and one prostanoid ambrisentan bosentan macitentan with: epoprostenol iloprost and: sildenafil tadalafil | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Initial 2 (excluding selexipag, for previously treated) | Telephone Electronic S100: Dual therapy a combination of either: one ERA and one PDE-5i ambrisentan bosentan macitentan with: sildenafil tadalafil or one ERA and one prostanoid ambrisentan bosentan macitentan with: epoprostenol iloprost Triple therapy a combination of: one ERA, one PDE-5i and one prostanoid ambrisentan bosentan macitentan with: epoprostenol iloprost and: sildenafil tadalafil | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Initial 3 (excluding selexipag, for change of treatment) | Telephone Electronic S100: Dual therapy a combination of either: one ERA and one PDE-5i ambrisentan bosentan macitentan with: sildenafil tadalafil or one ERA and one prostanoid ambrisentan bosentan macitentan with: epoprostenol iloprost or one PDE-5i and one prostanoid sildenafil tadalafil with: epoprostenol iloprost Triple therapy a combination of: one ERA, one PDE-5i and one prostanoid ambrisentan bosentan macitentan with: epoprostenol iloprost and: sildenafil tadalafil | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Continuing (dual or triple therapy, excluding selexipag) | Telephone Electronic S100: Dual therapy a combination of either: one ERA and one PDE-5i ambrisentan bosentan macitentan with: sildenafil tadalafil or one ERA and one prostanoid ambrisentan bosentan macitentan with: epoprostenol iloprost or one PDE-5i and one prostanoid sildenafil tadalafil with: epoprostenol iloprost Triple therapy a combination of: one ERA, one PDE-5i and one prostanoid ambrisentan bosentan macitentan with: epoprostenol iloprost and: sildenafil tadalafil | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Cessation | Telephone Electronic S100: bosentan 62.5mg | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Pulmonary arterial hypertension (PAH) - triple therapy quick reference (including selexipag)
Table 3
Restrictions | Authority level and section | PA assessment | Processing system | Prescriber type | Prescriber self-serve |
Initial (titration) | Telephone Electronic S100: selexipag | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Initial (after dose titration) | Telephone Electronic S100: selexipag | No | OPA | Must be treated and prescribed by a: - physician with expertise in the management of PAH
| Yes |
Initial/Continuing | Telephone Electronic S100: ambrisentan bosentan macitentan sildenafil tadalafil Note: the initial authority application for selexipag must be approved prior to the authority approval for treatment with the second and/or third agents as triple therapy or dual therapy in lieu of triple therapy | No | OPA | Must be treated and prescribed by a: - physician with expertise in management of PAH
| Yes |
Continuing | Telephone Electronic S100: selexipag | No | OPA | Must be treated and prescribed by a: - physician with expertise in management of PAH
| Yes |
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