Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p21
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 21/161)
Character Range: 13954317–13960418

(the latest version is located on the website specified in the Administrative Advice).
C13175              P13175         CN13175          Sonidegib                      Metastatic or locally advanced basal cell carcinoma (BCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                    Vismodegib                     The condition must be inappropriate for surgery; AND
                                                                                   The condition must be inappropriate for curative radiotherapy; AND
                                                                                   Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; or
                                                                                   Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND
                                                                                   Patient must not receive more than 16 weeks of 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) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and
                                                                                   (b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and
                                                                                   (c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate.
                                                                                   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 due to cumulative prior radiotherapy dose; or
                                                                                   (iv) Progressive disease despite prior irradiation of locally advanced BCC.
                                                                                   Inappropriate for curative radiotherapy is defined as
                                                                                   (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
                                                                                   (ii) Limitations