PBS updates

Kuvan (Sapropterin)

sapropterin dihydrochloride 100 mg soluble tablet, 30 · ORAL · PBS code 12569M

AUTHORITY_REQUIRED

• • First listed on the PBS: 2021-07-01.
• • 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

Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)

Pre-conception through to when pregnancy first becomes known

Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%; AND

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 not be undergoing treatment with this drug under this Treatment phase, following completion of this authority application, for more than 13 cumulative months (assuming 1 month consists of 30 days); AND

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

Patient must be actively trying to conceive.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)

Existing pregnancy to birth

Patient must be pregnant; AND

Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%; AND

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 not be undergoing further treatment with this drug as a PBS benefit, post-partum in the absence of actively trying to conceive a subsequent child/a known subsequent pregnancy; AND

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

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.