Kuvan (Sapropterin)
sapropterin dihydrochloride 500 mg powder for oral liquid, 30 sachets · ORAL · PBS code 11983Q
AUTHORITY_REQUIREDWhat it costs
AU$3880.75 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: 2020-05-01.
- • Repeats: 5.
- • PBS program: GE.
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
Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
First continuing treatment
Must be treated by a metabolic physician; or
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND
Patient must have previously received PBS-subsidised treatment under the Initial treatment - responsiveness testing restriction with this drug for this condition; AND
Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing.
Blood phenylalanine levels must be based on measurements taken during stable periods of the condition.
Dietary phenylalanine intake must be maintained at a constant level.
Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1
Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Subsequent continuing
Must be treated by a metabolic physician; or
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must be undergoing regular phenylalanine testing and assessment of adherence to dietary modifications.
Sponsor: BioMarin Pharmaceutical Australia Pty Ltd ABN 69 159 743 496
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.