Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p214
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 214/312)
Character Range: 16830285–16837169

version is located on the website specified in the Administrative Advice) which includes:
                                                                                                                           (i) the Hurley stage grading; and
                                                                                                                           (ii) the AN count.
                                                                                                                           Details of two completed prescriptions should be submitted with every initial application for this drug.
                                                                                                                           One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.
C15807              P15807         CN15807          Secukinumab                                                            Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                           Initial 1 (new patient) or 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 this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; OR
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; OR
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND
                                                                                                                           The treatment must provide no more than the balance of up to 20 weeks treatment.
                                                                                                                           Must be treated by a dermatologist.
C15808              P15808         CN15808          Migalastat                                                             Fabry disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           Patient must have at least one of: (i) documented deficiency of alpha-galactosidase enzyme activity in blood, (ii) presence of genetic mutations known to result in deficiency of alpha-galactosidase enzyme activity; AND
                                                                                                                           Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant; AND
                                                                                                                           Patient must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2; AND
                                                                                                                           Patient must be male with Fabry-related renal disease confirmed by at least one of the following: (i) abnormal albuminuria of more than 20 mcg/min, as determined by 2 separate samples at least 24 hours apart, (ii) abnormal proteinuria of more than 150 mg/24 hours, (iii) albumin:creatinine ratio greater than upper limit of normal in 2 separate samples at least 24 hours apart, (iv) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; OR
                                                                                                                           Patient must be female with Fabry-related renal disease confirmed by at least one of the following: (i) proteinuria of more than 300 mg/24 hours with clinical evidence of progression, (ii) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; OR
                                                                                                                           Patient must have Fabry-related cardiac disease