Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p19
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 19/476)
Character Range: 795589–805963

to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle.
Adefovir                                                               C4490                                                                Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4490
                                                                                                                                            Patient must not have cirrhosis; AND
                                                                                                                                            Patient must have failed antihepadnaviral therapy; AND
                                                                                                                                            Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
                                                                                                                                            Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.
                                                                       C4510                                                                Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4510
                                                                                                                                            Patient must have cirrhosis; AND
                                                                                                                                            Patient must have failed antihepadnaviral therapy; AND
                                                                                                                                            Patient must have detectable HBV DNA.
                                                                                                                                            Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.
Alemtuzumab                                                            C6847               P6847                                            Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 6847
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not show continuing progression of disability while on treatment with this drug; AND
                                                                                                                                            Patient must not receive more than one PBS‑subsidised treatment per year; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
                                                                                                                                            Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
                                                                                                                                            Must be treated by a neurologist.
                                                                       C7714               P7714                                            Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 7714
                                                                                                                                            Initial treatment
                                                                                                                                            The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
                                                                                                                                            The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
                                                                                                                                            Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS‑subsidised disease modifying therapy for this condition; AND
                                                                                                                                            Patient must be ambulatory (without assistance or support).
                                                                                                                                            Must be treated by a neurologist.
                                                                                                                                            Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
                                                                       C9589