Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p42
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 42/69)
Character Range: 483457–490229

in the patient's medical records. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.
                                                                                                                A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single‑agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner.
                                                                                                                A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease.
C13774              P13774         Daratumumab                                                                  Newly diagnosed systemic light chain amyloidosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                Continuing treatment from week 25 onwards (administered once every four weeks)
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition.
                                                                                                                Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND
                                                                                                                Patient must be undergoing continuing treatment that does not extend treatment duration beyond whichever comes first: (i) disease progression, (ii) 96 cumulative weeks from the first administered dose, once in a lifetime.
C13839              P13839         Nivolumab                                                                    Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 13839
                                                                                                                Maintenance treatment
                                                                                                                Patient must have previously received of up to maximum 4 doses of PBS‑subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
                                                                                                                The treatment must be as monotherapy for this condition; AND
                                                                                                                Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this PBS indication.
                                                                                                                Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
                                                                                                                The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C13900              P13900         Nivolumab                                                                    Adjuvant treatment of stage II or III oesophageal cancer or gastro‑oesophageal junction cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                The condition must have histological evidence confirming a diagnosis of a least one of: (i) adenocarcinoma, (ii) squamous cell cancer; document this evidence in the patient's medical records; AND
                                                                                                                The condition must have been treated with neoadjuvant