Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p1
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 1/161)
Character Range: 13826705–13833967

1  Circumstances, purposes and conditions
  The following table sets out:
 (a) circumstances for circumstances codes, for the purposes of section 13 and 23; and
 (b) purposes for purposes codes, for the purposes of sections 15 and 16; and
 (c) for the purposes of section 19, information relating to how authorisation is obtained when the circumstances or conditions for writing a prescription include an authorisation requirement.

Circumstances Code  Purposes Code  Conditions Code  Listed Drug                    Circumstances and Purposes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Authority Requirements (part of Circumstances; or Conditions)

C13006              P13006         CN13006          Ponatinib                      Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                   Subsequent continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must have maintained a major cytogenic response of less than 35% Philadelphia positive bone marrow cells at 12 month intervals.  or
                                                                                   Patient must have maintained a peripheral blood level of BCR-ABL of less than 1% on the international scale at 12 month intervals.
                                                                                   A pathology report demonstrating the patient's cytogenetic response or a peripheral blood level of BCR-ABL must be documented in the patient's medical records.
C13007              P13007         CN13007          Lapatinib                      Metastatic (Stage IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                                                   Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND
                                                                                   The treatment must be in combination with capecitabine; AND
                                                                                   Patient must have received prior therapy with a taxane for at least 3 cycles; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; or
                                                                                   Patient must have developed intolerance to treatment with a taxane of a severity necessitating permanent treatment withdrawal; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; or
                                                                                   Patient must have experienced disease progression following treatment with trastuzumab emtansine in whom disease had relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; or
                                                                                   Patient must have experienced disease relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; AND
                                                                                   The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND
                                                                                   The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
                                                                                   Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must