Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p26
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 26/161)
Character Range: 13989012–13995166

treatment with this drug for this condition; AND
                                                                                   The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
                                                                                   Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as
                                                                                   (a) Positron emission tomography-based response lymph nodes and extralymphatic sites - a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR
                                                                                   (b) Computed tomography-based response lymph nodes and extralymphatic sites - greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable.
C13230              P13230         CN13230          Dapagliflozin                  Chronic kidney disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 13230
                                                                                   Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of:
                                                    Empagliflozin                   (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND
                                                                                   Patient must have an estimated glomerular filtration rate of between 25 to 75 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug; AND
                                                                                   Patient must have a urinary albumin to creatinine ratio of between 200 to 5000 mg/g (22.6-565 mg/mmol) inclusive prior to initiating treatment with this drug; AND
                                                                                   Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND
                                                                                   Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
                                                                                   Patient must be stabilised, for at least 4 weeks, on either:
                                                                                    (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug.
                                                                                   Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug.
C13231              P13231         CN13231          Brentuximab vedotin            Relapsed or Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND