Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p122
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 122/161)
Character Range: 14452648–14460340

the continuing restriction.
                                                                                   The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
                                                                                   Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                   If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
C13558              P13558         CN13558          Lorlatinib                     Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.
C13561              P13561         CN13561          Vericiguat                     Chronic heart failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 13561
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; 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.
C13562              P13562         CN13562          Vericiguat                     Chronic heart failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   Must be treated by a cardiologist; or
                                                                                   Must be treated by a medical practitioner who has been directed to prescribe this medicine by a cardiologist; AND
                                                                                   Patient must be symptomatic with NYHA classes II, III or IV; AND
                                                                                   Patient must have a documented left ventricular ejection fraction (LVEF) of less than 45%; AND
                                                                                   The condition must be stabilised following a decompensation event that required at least one of:
                                                                                    (i) hospitalisation in the past 6 months, (ii) intravenous diuretic therapy in the past three months; AND
                                                                                   Patient must not have clinical signs of fluid overload;