Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p27
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 27/381)
Character Range: 11648198–11655543

with maximum tolerated doses of non-opioid and other opioid analgesics.  or
                                                                                                                                                                    Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.
                                                                                                                                                                    Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
C10777              P10777         CN10777          Hydromorphone                                                                                                   Severe pain
                                                                                                                                                                    Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months
                                                    Morphine                                                                                                        Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or
                                                                                                                                                                    Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.
C10802              P10802         CN10802          Tildrakizumab                                                                                                   Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                                                    Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                                                                    The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; 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 aged 18 years or older;
                                                                                                                                                                    Must be treated by a dermatologist.
                                                                                                                                                                    The most recent PASI assessment must be no more than 4 weeks old at the time of application.
                                                                                                                                                                    The authority application must be made in writing and must include
                                                                                                                                                                    (a) a completed authority prescription form(s); and
                                                                                                                                                                    (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
                                                                                                                                                                    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 response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                                                    If a patient fails to demonstrate a response to treatment