Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p38
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 38/381)
Character Range: 11740555–11749151

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; AND
                                                                                                                                                                    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         CN10988          Methoxsalen                                                                                                     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; AND
                                                                                                                                                                    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         CN10989          Methoxsalen                                                                                                     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 with