Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p296
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 296/312)
Character Range: 17351512–17358588

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.
                                                                                                                           For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.
                                                                                                                           Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records.
C16201              P16201         CN16201          Molnupiravir                                                           SARS-CoV-2 infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 16201
                                                                                                                           The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND
                                                                                                                           Patient must have received a positive nucleic acid test result; OR
                                                                                                                           Patient must have received a positive rapid antigen test (RAT) result; AND
                                                                                                                           Patient must have at least one sign or symptom attributable to COVID-19; AND
                                                                                                                           Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
                                                                                                                           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.