Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p147
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 147/161)
Character Range: 14578251–14583561

to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.
                                                                                   Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records
                                                                                   (a) the level of serum monoclonal protein; or
                                                                                   (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
                                                                                   (c) the serum level of free kappa and lambda light chains; or
                                                                                   (d) bone marrow aspirate or trephine; or
                                                                                   (e) if present, the size and location of lytic bone lesions (not including compression fractures); or
                                                                                   (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
                                                                                   (g) if present, the level of hypercalcaemia, corrected for albumin concentration.
                                                                                   As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented 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.
C13753              P13753         CN13753          Leflunomide                    Severe active rheumatoid arthritis
                                                                                   Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or
                                                                                   Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND
                                                                                   The treatment must be initiated by a physician.
C13769              P13769         CN13769          Brolucizumab                   Subfoveal choroidal neovascularisation (CNV)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                                                   Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND
                                                                                   The condition must