Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p289
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 289/476)
Character Range: 2678291–2688014

disease or metastatic disease; AND
                                                                                                                                            The condition must be World Health Organisation (WHO) grade 1 or 2; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
                                                                                                                                            WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.
                                                                       C10077                                                               Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 10077
                                                                                                                                            The condition must be unresectable locally advanced disease or metastatic disease; AND
                                                                                                                                            The condition must be World Health Organisation (WHO) grade 1 or 2; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
                                                                                                                                            WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.
Omalizumab                                                             C7046                                                                Severe chronic spontaneous urticaria                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Must be treated by a clinical immunologist; OR
                                                                                                                                            Must be treated by an allergist; OR
                                                                                                                                            Must be treated by a dermatologist; OR
                                                                                                                                            Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).
                                                                                                                                            Patient must have demonstrated a response to the most recent PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.
                                                                       C7055                                                                Severe chronic spontaneous urticaria                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Must be treated by a clinical immunologist; OR
                                                                                                                                            Must be treated by an allergist; OR
                                                                                                                                            Must be treated by a dermatologist; OR
                                                                                                                                            Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU).
                                                                                                                                            The condition must be based on both physical examination and patient history (to exclude any factors that may be triggering the urticaria); AND
                                                                                                                                            Patient must have experienced itch and hives that persist on a daily basis for at least 6 weeks despite treatment with H1 antihistamines; AND
                                                                                                                                            Patient must have failed to achieve an adequate response after a minimum of 2 weeks treatment with a standard therapy; AND
                                                                                                                                            Patient must not receive more than 12 weeks of treatment under this restriction.
                                                                                                                                            A standard therapy is defined as a combination of therapies that includes H1 antihistamines at maximally tolerated doses in accordance with clinical guidelines, and one of the following:
                                                                                                                                            1) a H2 receptor antagonist (150 mg twice per day); or