Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p207
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 207/312)
Character Range: 16783579–16793125

with this drug is/was initiated in a child; OR
                                                                                                                           Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing for solid tumours (of certain specified types) with confirmed NTRK gene fusion which either includes: (i) mammary analogue secretory carcinoma of the salivary gland, (ii) secretory breast carcinoma.
                                                                                                                           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.
                                                                                                                           Where radiographic progression is observed, mark any remaining repeat prescriptions with the word 'cancelled'.
C15782              P15782         CN15782          Ganciclovir                                                            Cytomegalovirus infection and disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 15782
                                                                                                                           Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.
                                                    Valganciclovir

C15784              P15784         CN15784          Ganciclovir                                                            Cytomegalovirus infection and disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 15784
                                                                                                                           Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.
                                                    Valganciclovir

C15787              P15787         CN15787          Migalastat                                                             Fabry disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                           Grandfather arrangement (transition from LSDP-funded Fabry disease therapy)
                                                                                                                           Patient must have previously received treatment with this drug for this condition funded under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 September 2024; OR
                                                                                                                           Patient must have previously received treatment with Enzyme Replacement Therapy for this condition funded under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 September 2024; AND
                                                                                                                           Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant prior to commencing treatment with this drug; AND
                                                                                                                           Patient must have/have had an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2prior to commencing treatment with this drug.
                                                                                                                           Must be treated by a physician with expertise in the management of Fabry disease.
                                                                                                                           Patient must be at least 12 years of age.
                                                                                                                           A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
                                                                                                                           Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient's medical records.
                                                                                                                           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).
C15788              P15788         CN15788          Adalimumab                                                             Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                           Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years), or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
                                                                                                                           Patient must have received insufficient therapy with