Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p178
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 178/312)
Character Range: 16570201–16579163

appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
                                                                                                                           Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.
                                                                                                                           For the purpose of administering this restriction, adequate response is defined as:
                                                                                                                           1. stability or improvement of the initial baseline measurements prior to initiating treatment with this drug;
                                                                                                                           2. relevant imaging has not shown an increase in tumour size of 20% or more.
C15479              P15479         CN15479          Cabozantinib                                                           Locally advanced or metastatic differentiated thyroid cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 15479
                                                                                                                           Continuing treatment
                                                                                                                           The condition must be refractory to radioactive iodine; OR
                                                                                                                           Patient must be deemed ineligible for treatment with radioactive iodine; AND
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST).
C15485              P15485         CN15485          Avelumab                                                               Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 15485
                                                                                                                           Maintenance therapy - Initial treatment
                                                                                                                           Patient must have received first-line platinum-based chemotherapy; AND
                                                                                                                           Patient must not have progressive disease following first-line platinum-based chemotherapy; AND
                                                                                                                           Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.
C15489              P15489         CN15489          Adalimumab                                                             Vision threatening non-infectious uveitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Recommencement of treatment
                                                                                                                           Patient must have a documented history of non-infectious uveitis that is vision threatening; AND
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have demonstrated or sustained an adequate response to treatment prior to having a break in therapy with this drug for this condition; AND
                                                                                                                           The treatment must not exceed 25 weeks under this restriction.
                                                                                                                           Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR
                                                                                                                           Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.
                                                                                                                           An adequate response to treatment is defined as:
                                                                                                                           (a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria