Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p199
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 199/312)
Character Range: 16733534–16740505

treatment with this drug for this condition prior to 1 September 2024; AND
                                                                                                                           Patient must have had a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records if not already documented; AND
                                                                                                                           Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
C15759              P15759         CN15759          Alectinib                                                              Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Initial treatment
                                                    Brigatinib                                                             The treatment must be as monotherapy; AND
                                                                                                                           The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
                                                    Ceritinib                                                              Patient must have a WHO performance status of 2 or less; AND
                                                                                                                           Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.
C15764              P15764         CN15764          Adalimumab                                                             Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 1 (new patient)
                                                                                                                           Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND
                                                                                                                           Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                                           Must be treated by a dermatologist.
                                                                                                                           Assessment of disease severity must be no more than 4 weeks old at the