PBS updates

Kuvan (Sapropterin)

sapropterin dihydrochloride 100 mg soluble tablet, 30 · ORAL · PBS code 11676M

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: 2019-05-01.
  • • 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

Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)


Initial treatment - responsiveness testing


Must be treated by a metabolic physician; AND

Patient must be untreated with this drug; or

Patient must have completed prior responsiveness testing on only 1 occasion - this occurred when the patient was less than 1 month of age, but this benefit is for a second attempt at responsiveness testing in a patient aged at least 1 month old; AND

Patient must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age; or

Patient must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age; AND

The treatment must be for the purpose of initial responsiveness testing for a period of 24 hours in a patient less than one month of age; or

The treatment must be for the purpose of initial responsiveness testing for a period of 7 days in a patient aged more than one month.

Dietary phenylalanine intake must be maintained at a constant level.

Patients or their parent/guardian should be assessed for their ability to comply with the sapropterin protocol and PKU diet prior to conducting initial responsiveness testing.

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.