Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p181
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 181/312)
Character Range: 16590017–16599724

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, significant symptoms/morbidity are defined as, but not limited to:
                                                                                                                           1. head and neck PN that can compromise the airway or great vessels;
                                                                                                                           2. paraspinal PN that can cause myelopathy;
                                                                                                                           3. brachial or lumbar plexus PN that can cause nerve compression and loss of function;
                                                                                                                           4. PN that can result in major deformity or significant disfiguring (e.g. orbital PN);
                                                                                                                           5. PN of the extremity that can cause limb hypertrophy or loss of function; and
                                                                                                                           6. painful PN.
                                                                                                                           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.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (1) details of the proposed prescription; and
                                                                                                                           (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
C15500              P15500         CN15500          Durvalumab                                                             Unresectable Stage III non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 15500
                                                                                                                           Initial treatment
                                                                                                                           Patient must have received platinum based chemoradiation therapy; AND
                                                                                                                           The condition must not have progressed following platinum based chemoradiation therapy; AND
                                                                                                                           Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                           Patient must be untreated with immunotherapy at commencement of this drug; AND
                                                                                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.
C15509              P15509         CN15509          Larotrectinib                                                          Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The condition must be either: (i) non-small cell lung cancer, (ii) soft tissue sarcoma, (iii) glioma, (iv), glioneuronal tumour, (v) glioblastoma; AND
                                                                                                                           The treatment must cease to be a PBS benefit upon radiographic progression; AND
                                                                                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           Where radiographic progression is observed, mark any remaining repeat prescriptions with the word 'cancelled'.
C15510              P15510         CN15510          Lenvatinib                                                             Locally advanced or metastatic differentiated thyroid cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 15510
                                                                                                                           Initial treatment
                                                                                                                           The condition must be refractory to radioactive iodine; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must have symptomatic progressive disease prior to treatment; OR
                                                                                                                           Patient must have progressive disease