Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p89
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 89/312)
Character Range: 16027637–16035619

heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or
                                                                                                                           The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or
                                                                                                                           The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
                                                                                                                           Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.
C15051              P15051         CN15051          Dapagliflozin                                                          Chronic heart failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 15051
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                    Empagliflozin                                                          Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND
                                                                                                                           Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
                                                                                                                           The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
                                                                                                                           The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or
                                                                                                                           The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or
                                                                                                                           The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
                                                                                                                           Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.
C15063              P15063         CN15063          Cemiplimab                                                             Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 15063
                                                                                                                           Continuing treatment - 3 weekly treatment regimen
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                           The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.
C15065              P15065         CN15065          Inclisiran                                                             Familial heterozygous hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 15065
                                                                                                                           Continuing treatment with this drug or switching treatment from a monoclonal antibody