Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p113
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 113/312)
Character Range: 16175193–16183432

of HCM.
                                                                                                                           (5) The details of the LVOT gradient report. State all the following:
                                                                                                                           (a) the date, unique identifying number/code or provider number of the report;
                                                                                                                           (b) the measured LVOT gradient;
                                                                                                                           (c) how the LVOT gradient was measured (rest, Valsalva manoeuvre or exercise).
                                                                                                                           (6) NYHA status.
                                                                                                                           (7) The current beta-blocker or non-dihydropyridine calcium channel blocker (either diltiazem or verapamil only) therapy if applicable.
                                                                                                                           (8) Prior beta-blocker or non-dihydropyridine calcium channel blocker trials, including:
                                                                                                                           (a) if the patient is currently taking beta-blocker therapy, state the previous therapy with non-dihydropyridine calcium channel blocker that was trialled confirming that it was not effective;
                                                                                                                           (b) if the patient is currently taking non-dihydropyridine calcium channel blocker therapy, state the previous therapy with beta-blocker that was trialled confirming that it was not effective;
                                                                                                                           (c) if there is contraindication or intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information, specify the details.
                                                                                                                           All results and reports must be documented in the patient's medical records.
C15177              P15177         CN15177          Evolocumab                                                             Familial heterozygous hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 15177
                                                                                                                           Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran; AND
                                                                                                                           The treatment must be in conjunction with dietary therapy and exercise; AND
                                                                                                                           Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication.
C15184              P15184         CN15184          Palbociclib                                                            Locally advanced or metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; OR
                                                                                                                           Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND
                                                                                                                           The condition must be hormone receptor positive; AND
                                                                                                                           The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
                                                                                                                           The condition must be inoperable; AND
                                                                                                                           Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
                                                                                                                           The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with a non-steroidal aromatase inhibitor; OR
                                                                                                                           The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND
                                                                                                                           The treatment must not be in combination with another