Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p189
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 189/191)
Character Range: 11365552–11373509

treatment, within the timeframes specified below.
                                                                                                                                                                                                                               Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
                                                                                                                                                                                                                               An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                                                                                                                               Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                                                                                                                               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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                                                                                                               A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. 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.
C9828               P9828          CN9828           Terbutaline                                                                                                                                                                Bronchospasm                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 9828
                                                                                                                                                                                                                               Patient must be unable to achieve co-ordinated use of a metered dose inhaler containing a short-acting beta-2 agonist.  or
                                                                                                                                                                                                                               Patient must have developed a clinically important product-related adverse event during treatment with another short-acting beta-2 agonist.
                                                                                                                                                                                                                               Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.
C9831               P9831          CN9831           Ciclosporin                                                                                                                                                                Management of transplant rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 9831
                                                                                                                                                                                                                               The treatment must be used by organ or tissue transplant recipients.
C9914               P9914          CN9914           Sirolimus                                                                                                                                                                  Management of renal allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 9914
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                                                                                                                                                                                               Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
                                                                                                                                                                                                                               The treatment must be under the supervision and direction