Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p149
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 149/161)
Character Range: 14588871–14596594

administered dose, once in a lifetime.
C13839              P13839         CN13839          Nivolumab                      Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 13839
                                                                                   Maintenance treatment
                                                                                   Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
                                                                                   The treatment must be as monotherapy for this condition; AND
                                                                                   Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this PBS indication.
                                                                                   Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
                                                                                   The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C13867              P13867         CN13867          Ruxolitinib                    Moderate to severe chronic graft versus host disease (cGVHD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 13867
                                                                                   Continuing treatment
                                                                                   Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must have responding disease at 24 weeks compared with baseline, demonstrated by either a:
                                                                                    (i) partial response, (ii) complete response; AND
                                                                                   The treatment must be the sole PBS-subsidised treatment for this condition with the exception of:
                                                                                    (i) corticosteroids, (ii) calcineurin inhibitors; AND
                                                                                   Must be treated by a haematologist.  or
                                                                                   Must be treated by an oncologist with allogeneic bone marrow transplantation experience.  or
                                                                                   Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
                                                                                   Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib.
                                                                                   (a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy.
                                                                                   (b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies.
                                                                                   The assessment of response must be documented in the patient's medical records.
                                                                                   Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.
                                                                                   This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
C13868              P13868         CN13868          Sapropterin                    Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                   Initial treatment - responsiveness testing
                                                                                   The treatment must