Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p40
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 40/381)
Character Range: 11757147–11766508

least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; AND
                                                                                                                                                                    Patient must have at least one of the following if coronary artery disease is present:
                                                                                                                                                                     (i) a previous multi-vessel coronary revascularisation procedure (ii) significant stenosis in at least 2 coronary arteries (iii) a previous single vessel coronary revascularisation procedure with significant stenosis in more than 1 coronary artery; or
                                                                                                                                                                    Patient must have at least one of the following if peripheral arterial disease is present:
                                                                                                                                                                     (i) a previous peripheral/carotid artery revascularisation intervention (ii) intermittent claudication with an ankle-brachial index less than 0.9 (iii) asymptomatic carotid artery stenosis greater than 50%; AND
                                                                                                                                                                    The condition must be diagnosed by at least one of:
                                                                                                                                                                     (i) invasive (selective) angiography (ii) non-invasive imaging (i.e. CT scan, ultrasound) (iii) ankle-brachial index measurement in the case of peripheral arterial disease with intermittent claudication; AND
                                                                                                                                                                    Patient must have clinical findings/observations by the treating physician that exclude each of the following:
                                                                                                                                                                     (i) high risk of bleeding (ii) prior stroke within one month of treatment initiation (iii) prior haemorrhagic / lacunar stroke (iv) severe heart failure with a known ejection fraction less than 30% (v) New York Heart Association class III to IV heart failure symptoms (i.e. symptoms corresponding to moderate to severe limitation on physical activity, whereby any of fatigue/palpitations/dyspnoea occur upon zero to minimal activity) (vi) an estimated glomerular filtration rate less than 15 mL/minute (vii) a requirement for dual antiplatelet therapy (viii) a requirement for non-acetylsalicylic acid antiplatelet therapy (ix) a requirement for a higher dose of oral anticoagulant therapy; AND
                                                                                                                                                                    Must be treated by a specialist physician.  or
                                                                                                                                                                    Must be treated by a physician who has consulted a specialist physician.
C11015              P11015         CN11015          Obinutuzumab                                                                                                    Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 11015
                                                                                                                                                                    For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy
                                                                                                                                                                    The condition must be untreated; AND
                                                                                                                                                                    The treatment must be in combination with PBS-subsidised venetoclax.
C11017              P11017         CN11017          Venetoclax                                                                                                      Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                    First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapy
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND
                                                                                                                                                                    The treatment must cease upon disease progression.
C11057              P11057         CN11057          Beclometasone with formoterol                                                                                   Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 11057
                                                                                                                                                                    Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids;
                                                                                                                                                                    Patient must be aged 18 years