Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p288
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 288/312)
Character Range: 17292885–17300847

The treatment must be initiated within 5 days of symptom onset.
                                                                                                                           Patient must be both: (i) at least 50 years of age, (ii) at high risk.
                                                                                                                           For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions:
                                                                                                                           1. The patient is in residential aged care,
                                                                                                                           2. The patient has disability with multiple comorbidities and/or frailty,
                                                                                                                           3. Neurological conditions, including stroke and dementia and demyelinating conditions,
                                                                                                                           4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or 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