Opsynvi (Macitentan + tadalafil)
Macitentan 10 mg + tadalafil 40 mg tablet, 30 · ORAL · PBS code 14785E
AUTHORITY_REQUIREDWhat it costs
AU$2552.08 PBS-determined price per 30 units
Most patients pay only the standard PBS co-payment, not the full price above — up to AU$25.00 per script (general) or AU$7.70 (concession/Safety Net) in 2026. The figure above is what the PBS pays the pharmacy; the Australian Government subsidises the rest. Always confirm the current amount with your pharmacist.
- • First listed on the PBS: 2025-05-01.
- • Repeats: 5.
- • PBS program: HB.
Eligibility criteria for subsidised access
The following is the government's own wording from the PBS Schedule, shown unchanged.
Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1
Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must be dual combination therapy as a fixed dose combination consisting of: (i) macitentan, (ii) tadalafil; or
The treatment must be part of triple combination therapy as a fixed dose combination consisting of: (i) macitentan, (ii) tadalafil, (iii) one prostanoid; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing continuing treatment of existing PBS-subsidised macitentan and tadalafil as part of combination therapy (dual or triple therapy, excluding selexipag) where macitentan and tadalafil and their doses in the combination remain unchanged from the previous authority application.
This treatment is not PBS-subsidised for the use as initial therapy
For the purposes of PBS subsidy, a prostanoid is one of: (a) epoprostenol, (b) iloprost
Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as 'combination' therapy.
Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1
Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (triple therapy with selexipag)
The treatment must be part of triple combination therapy consisting of: (i) macitentan, (ii) tadalafil, (iii) selexipag; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing continuing treatment of existing PBS-subsidised macitentan and tadalafil as part of combination therapy (triple therapy with selexipag) where macitentan and tadalafil and their doses in the combination remain unchanged from the previous authority application.
This treatment is not PBS-subsidised for the use as initial therapy
The authority application for selexipag must be approved prior to the authority application for this agent.
Sponsor: Janssen-Cilag Pty Ltd ABN 47 000 129 975
Not medical advice. Voxsanity republishes public PBS data in plain English. PBS listing status and criteria can change; always confirm current subsidised availability with your doctor or pharmacist.
Source: Pharmaceutical Benefits Scheme (PBS), © Commonwealth of Australia. Data used and redistributed under permission; not modified from its original wording where displayed verbatim.