Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p29
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 29/38)
Character Range: 103274–108146

(prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND
                                                       The treatment must not exceed two cycles of consolidation therapy under this restriction.
                                                       This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
                                                       The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.
                                                       Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams.
C16200  P16200  CN16200  Molnupiravir                  SARS-CoV-2 infection                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 16200
                                                       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 each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.
                                                       For the purpose of administering this restriction, high risk is defined as the presence of at least one 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
                                                       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
                                                       11. Past COVID-19 infection episode resulting in hospitalisation.
                                                       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