Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p33
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 33/381)
Character Range: 11694756–11702795

between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C10890              P10890         CN10890          Oxycodone                                                                                                       Severe pain
                                                                                                                                                                    Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months
                                                                                                                                                                    Patient must have cancer pain; or
                                                                                                                                                                    The treatment must be for post-operative pain following a major operative procedure; AND
                                                                                                                                                                    Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics.  or
                                                                                                                                                                    Patient must be unable to use non-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.
C10891              P10891         CN10891          Morphine                                                                                                        Cancer pain
                                                                                                                                                                    Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months
                                                                                                                                                                    Patient must have cancer pain; AND
                                                                                                                                                                    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.
C10901              P10901         CN10901          Guselkumab                                                                                                      Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 3, Face, hand, foot (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 be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
                                                                                                                                                                     (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
                                                                                                                                                                    The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                                                                    Patient must not receive more than 20 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 PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
                                                                                                                                                                    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