Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p264
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 264/476)
Character Range: 2476265–2484367

treatment
                                                                                                                                            Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; OR
                                                                                                                                            Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication; OR
                                                                                                                                            The treatment must be in combination with peginterferon alfa‑2a only if used in combination with another drug; AND
                                                                                                                                            Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND
                                                                                                                                            Patient must not have previously received PBS‑subsidised treatment with this drug for this PBS indication.
                                                                                                                                            Must be treated by a haematologist; OR
                                                                                                                                            Must be treated by a medical physician working under the supervision of a haematologist.
                                                                                                                                            Patient must be aged 18 years or over.
                                                                       C10988              P10988                                           Erythrodermic stage III‑IVa T4 M0 Cutaneous T‑cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 10988
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have received PBS‑subsidised treatment with this drug for this PBS indication; AND
                                                                                                                                            Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication; OR
                                                                                                                                            The treatment must be in combination with peginterferon alfa‑2a only if used in combination with another drug; AND
                                                                                                                                            Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule.
                                                                                                                                            Must be treated by a haematologist; OR
                                                                                                                                            Must be treated by a medical physician working under the supervision of a haematologist.
                                                                                                                                            A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS‑subsidy. Response only needs to be demonstrated after the first six months of treatment
                                                                       C10989              P10989                                           Erythrodermic stage III‑IVa T4 M0 Cutaneous T‑cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 10989
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have received PBS‑subsidised treatment with this drug for this PBS indication; AND
                                                                                                                                            Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication; OR
                                                                                                                                            The treatment must be in combination with peginterferon alfa‑2a only if used in combination