Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p58
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 58/69)
Character Range: 592727–599287

have previously received PBS‑subsidised treatment with this drug for this condition; OR
                                                                                                                Patient must have previously received inpatient treatment with this drug for this condition in the public hospital setting; AND
                                                                                                                Patient must not receive PBS‑subsidised treatment with this drug for this condition if it is no longer determined to be clinically beneficial by the treating clinician.
                                                                                                                According to the TGA‑approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.
C15094              P15094         Cemiplimab                                                                   Stage IV (metastatic) non‑small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 15094
                                                                                                                Initial treatment ‑ 3 weekly treatment regimen
                                                                                                                Patient must not have previously been treated for this condition in the metastatic setting; OR
                                                                                                                The condition must have progressed after treatment with tepotinib; AND
                                                                                                                Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for non‑small cell lung cancer; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c‑ROS proto‑oncogene 1 (ROS1) gene arrangement in tumour material; AND
                                                                                                                The treatment must not exceed a total of 7 doses under this restriction.
C15163              P15163         Dostarlimab                                                                  Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 15163
                                                                                                                Initial treatment covering the first 6 treatment cycles
                                                                                                                Patient must have deficient mismatch repair (dMMR) endometrial cancer, as determined by immunohistochemistry test; AND
                                                                                                                The condition must be unsuitable for at least one of the following: (i) curative surgical resection, (ii) curative radiotherapy; AND
                                                                                                                The treatment must be initiated in combination with platinum‑containing chemotherapy; AND
                                                                                                                The condition must be, at treatment initiation with this drug, either: (i) untreated with systemic therapy, (ii) treated with neoadjuvant/adjuvant systemic therapy, but the cancer has recurred or progressed after more than 6 months from the last dose of systemic therapy; AND
                                                                                                                Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for this condition; AND
                                                                                                                Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation.
C15196              P15196         Dostarlimab                                                                  Advanced, metastatic or