Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p31
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 31/161)
Character Range: 14023574–14029699

(IPSS) score.
                                                                                   The following reports must be documented in the patient's medical records
                                                                                   (a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and
                                                                                   (b) full blood examination report; and
                                                                                   (c) pathology report detailing the cytogenetics demonstrating intermediate-2 or high-risk disease according to the International Prognostic Scoring System (IPSS).
                                                                                   No more than 3 cycles will be authorised under this restriction in a patient's lifetime.
C13268              P13268         CN13268          Vismodegib                     Metastatic or locally advanced basal cell carcinoma (BCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                   The condition must remain inappropriate for surgery; AND
                                                                                   The condition must remain inappropriate for curative radiotherapy; AND
                                                                                   Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.
                                                                                   The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include
                                                                                   (a) Confirmation from the treating doctor that the disease has not progressed; and
                                                                                   (b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy.
                                                                                   The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
                                                                                   All reports must be documented in the patient's medical records.
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (i) A completed authority prescription form; and
                                                                                   (ii) 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).
                                                                                   Inappropriate for surgery is defined as
                                                                                   (i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
                                                                                   (ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
                                                                                   (iii) Medical contraindication to surgery.
                                                                                   (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
                                                                                   (ii) Limitations due to location of tumour; or
                                                                                   (iii) Limitations