Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p39
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 39/381)
Character Range: 11748571–11757737

beyond 6 months of treatment for the first time; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or
                                                                                                                                                                    The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND
                                                                                                                                                                    Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND
                                                                                                                                                                    Must be treated by a haematologist.  or
                                                                                                                                                                    Must be treated by a medical physician working under the supervision of a haematologist.
                                                                                                                                                                    A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment
C10992              P10992         CN10992          Rivaroxaban                                                                                                     Chronic stable atherosclerotic disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 10992
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be in combination with aspirin, but not with any other anti-platelet therapy.
C10995              P10995         CN10995          Venetoclax                                                                                                      Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                    Dose modification
                                                                                                                                                                    The treatment must be for dose titration purposes.
C11013              P11013         CN11013          Rivaroxaban                                                                                                     Chronic stable atherosclerotic disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 11013
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The treatment must be in combination with aspirin, but not with any other anti-platelet therapy; AND
                                                                                                                                                                    Patient must have a diagnosis of coronary artery disease in addition to at least one of the following risk factors:
                                                                                                                                                                     (i) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (ii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iii) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; or
                                                                                                                                                                    Patient must have a diagnosis of peripheral artery disease in addition to at least one of the following risk factors:
                                                                                                                                                                     (i) concomitant coronary artery disease (ii) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (iii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iv) diabetes mellitus combined with at 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