Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p123
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 123/312)
Character Range: 16240626–16247012

(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.
C15213              P15213         CN15213          Risankizumab                                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                           Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                           Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
                                                                                                                           Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
                                                                                                                           The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                           Patient must not receive more than 28 weeks of treatment under this restriction.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           Must be treated by a dermatologist.
                                                                                                                           An adequate response to treatment is defined as:
                                                                                                                           A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
                                                                                                                           An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
                                                                                                                           To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                           Where a