Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p86
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 86/191)
Character Range: 10483910–10497365

Authority Required procedures - Streamlined Authority Code 7471
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have disease progression; AND
                                                                                                                                                                                                                               The treatment must be as monotherapy.
                                                                                                                                                                                                                               A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
C7483               P7483          CN7483           Varenicline                                                                                                                                                                Nicotine dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures - Streamlined Authority Code 7483
                                                                                                                                                                                                                               Continuation of a short-term (12 weeks or 24 weeks) course of treatment
                                                                                                                                                                                                                               The treatment must be as an aid to achieving abstinence from smoking; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have previously received treatment with this drug during this current course of treatment; AND
                                                                                                                                                                                                                               Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.
C7484               P7484          CN7484           Tetracosactide                                                                                                                                                             Hypsarrhythmia and/or infantile spasms

C7487               P7487          CN7487           Sorafenib                                                                                                                                                                  Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 7487
                                                                                                                                                                                                                               Continuing treatment beyond 3 months
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; 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.
                                                                                                                                                                                                                               A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
C7488               P7488          CN7488           Methotrexate                                                                                                                                                               Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 7488
                                                                                                                                                                                                                               Patient must be unsuitable for administration of an oral form of methotrexate for this condition.
C7491               P7491          CN7491           Sonidegib                                                                                                                                                                  Metastatic or locally advanced basal cell carcinoma (BCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment or Continuing treatment – balance of supply
                                                    Vismodegib                                                                                                                                                                 Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete maximum of 16 weeks of treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete maximum of 16 weeks of treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
C7518               P7518          CN7518           Methotrexate                                                                                                                                                               Severe psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 7518
                                                                                                                                                                                                                               The condition must not have adequately responded to topical treatment; AND
                                                                                                                                                                                                                               Patient must be unsuitable for administration of an oral form of methotrexate for this condition.
C7526               P7526          CN7526           Pralatrexate                                                                                                                                                               Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The condition must be relapsed or chemotherapy refractory; AND
                                                                                                                                                                                                                               Patient must not develop progressive disease whilst receiving PBS-subsidised treatment