Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p22
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 22/38)
Character Range: 69960–75404

caused by neurological or musculoskeletal disease,
                                                       5. Heart failure, coronary artery disease, cardiomyopathies,
                                                       6. Obesity (BMI greater than 30 kg/m 2),
                                                       7. Diabetes type I or II, requiring medication for glycaemic control,
                                                       8. Renal impairment (eGFR less than 60mL/min),
                                                       9. Cirrhosis, or
                                                       10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
                                                       Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
                                                       For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
                                                       Access to this drug through this restriction is permitted irrespective of vaccination status.
                                                       Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
                                                       Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
                                                       This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.
C16158  P16158  CN16158  Dapagliflozin with metformin  Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 16158
                                                       Patient must have cardiovascular disease; OR
                                                       Patient must be at high risk of a cardiovascular event; OR
                                                       Patient must identify as Aboriginal or Torres Strait Islander.
                                                       Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.
C16162  P16162  CN16162  Dapagliflozin with metformin  Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 16162
                                                       The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                       Patient must have cardiovascular disease; OR
                                                       Patient must be at high risk of a cardiovascular event; OR
                                                       Patient must identify as Aboriginal or Torres Strait Islander.
                                                       Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.
C16164  P16164  CN16164  Dapagliflozin                 Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 16164
                                                       The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                       The treatment must be in combination with metformin; unless contraindicated/intolerant; AND
                                                       Patient must have cardiovascular disease; OR
                                                       Patient must be at high risk of