Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p204
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 204/381)
Character Range: 12879006–12891014

P12599         CN12599          Tiotropium                                                                                                      Severe asthma
                                                                                                                                                                    Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of:
                                                                                                                                                                     (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND
                                                                                                                                                                    The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated;
                                                                                                                                                                    Patient must be at least 18 years of age.
                                                                                                                                                                    Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.
C12603              P12603         CN12603          Beclometasone with formoterol and glycopyrronium                                                                Severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 12603
                                                                                                                                                                    Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of:
                                                    Fluticasone furoate with umeclidinium and vilanterol                                                             (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique;
                                                                                                                                                                    Patient must be at least 18 years of age.
                                                    Indacaterol with glycopyrronium and mometasone                                                                  Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.

C12604              P12604         CN12604          Ivermectin                                                                                                      Human sarcoptic scabies                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 12604
                                                                                                                                                                    The condition must be established by clinical and/or parasitological examination;
                                                                                                                                                                    Patient must identify as Aboriginal or Torres Strait Islander;
                                                                                                                                                                    Patient must weigh 15 kg or over;
                                                                                                                                                                    Patient must be 5 years of age or older.
C12607              P12607         CN12607          Budesonide                                                                                                      Mild to moderate Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 12607
                                                                                                                                                                    The condition must affect the ileum.  or
                                                                                                                                                                    The condition must affect the ascending colon.  or
                                                                                                                                                                    The condition must affect the ileum and ascending colon.
                                                                                                                                                                    The total duration of therapy should be no more than 12 weeks in any single course.
C12619              P12619         CN12619          Cabotegravir                                                                                                    HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 12619
                                                                                                                                                                    Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND
                                                                                                                                                                    The treatment must be in combination with rilpivirine tablets; AND
                                                                                                                                                                    Patient must intend to proceed to treatment with intramuscular administration of cabotegravir and rilpivirine.
C12636              P12636         CN12636          Cabotegravir and rilpivirine                                                                                    HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 12636
                                                                                                                                                                    Patient must have previously received PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
C12656              P12656         CN12656          Sacituzumab