Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p26
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 26/162)
Character Range: 14795207–14800609

most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                         Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND
                                                                                                         Patient must not receive more than 24 weeks of treatment under this restriction;
                                                                                                         Patient must be at least 18 years of age.
                                                                                                         Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
                                                                                                         Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
                                                                                                         At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
                                                                                                         An application for the continuing treatment 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 treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                         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 with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                         A patient may re-trial this drug after a minimum of 5 years have elapsed 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.
C14021              P14021         CN14021          Selinexor                                            Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Initial treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week
                                                                                                         The condition must be confirmed by a histological diagnosis; AND
                                                                                                         Patient must be undergoing triple combination therapy limited to:
                                                                                                          (i) this drug, (ii) bortezomib, (iii) dexamethasone; or
                                                                                                         Patient must be undergoing dual combination therapy limited to:
                                                                                                          (i) this drug, (ii) dexamethasone; AND
                                                                                                         Patient must have progressive disease after at least one prior therapy; AND
                                                                                                         Patient must not have previously received