Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p72
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 72/312)
Character Range: 15883544–15890774

progression while receiving treatment with this drug for this condition; AND
                                                                                                                           The treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response.
C14786              P14786         CN14786          Pembrolizumab                                                          Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                           Continuing treatment - 3 weekly treatment regimen
                                                                                                                           Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing; AND
                                                                                                                           Patient must not have experienced disease recurrence; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).
C14787              P14787         CN14787          Ustekinumab                                                            Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                           Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
                                                                                                                           Patient must have an externally draining enterocutaneous or rectovaginal fistula; AND
                                                                                                                           Must be treated by a gastroenterologist (code 87).  or
                                                                                                                           Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)].  or
                                                                                                                           Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
                                                                                                                           Applications for authorisation must be made in writing and must include
                                                                                                                           (1) two completed authority prescription forms; and
                                                                                                                           (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 4 weeks old at the time of application.
                                                                                                                           Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 1 vial or pre-filled syringe of 90 mg and no repeats.
                                                                                                                           An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
                                                                                                                           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.
                                                                                                                           A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats