PBS updates

Kuvan (Sapropterin)

sapropterin dihydrochloride 100 mg soluble tablet, 30 · ORAL · PBS code 12579C

AUTHORITY_REQUIRED

What it costs

AU$776.15 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: 2021-07-01.
  • • Repeats: 0.
  • • 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

Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)


Initial treatment - responsiveness testing


The treatment must be for the purpose of ascertaining the patient's response to treatment over a period of 7 days, with the intent to then use the drug to control phenylalanine levels under the treatment phase: First continuing treatment, Indication: Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU); AND

Patient must have a baseline blood phenylalanine level above 250 micromol/L prior to commencing treatment with this drug despite best efforts to rely on dietary modifications to control phenylalanine levels; AND

Must be treated by a metabolic physician; AND

Patient must be undergoing treatment with this drug for the first time; AND

Patient must not be undergoing treatment with this drug under this Treatment phase, more than once per lifetime following completion of this authority application; AND

Patient must not be undergoing simultaneous treatment with this drug under another PBS-listing (apply under either listing type, but not both simultaneously); AND

Patient must be one of: (i) planning conception, (ii) pregnant.

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.