Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p222
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 222/312)
Character Range: 16881889–16889069

AND
                                                                                                                           The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only.
                                                                                                                           Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR
                                                                                                                           Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.
                                                                                                                           HER2-low is defined as an immunohistochemical (IHC) score of 1+ or an IHC score of 2+ and a negative result on in situ hybridization (ISH).
                                                                                                                           Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription:
                                                                                                                           1) Evidence of HER2-low status
                                                                                                                           2) Details of prior drug regimens prescribed for the patient
                                                                                                                           3) Cardiac function test results
C15836              P15836         CN15836          Venetoclax                                                             Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply of first-line therapy
                                                                                                                           Patient must have received non-PBS-subsidised treatment with ibrutinib for this condition prior to 1 October 2024; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment for this condition; AND
                                                                                                                           The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses).
                                                                                                                           A patient may qualify for PBS-subsidised treatment under this restriction once only.
                                                                                                                           For continuing PBS-subsidised treatment, a 'Grandfathered' patient must qualify under the next relevant treatment phase.
                                                                                                                           A patient may also qualify for treatment under this listing if they have previously received non-PBS-subsidised treatment with venetoclax for this condition prior to 1 October 2024 from Cycle 4.
C15851              P15851         CN15851          Etrasimod                                                              Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 1 (new patient)
                                                                                                                           Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
                                                                                                                           Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
                                                                                                                           Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent