Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p88
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 88/191)
Character Range: 10507393–10518141

in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
                                                                                                                                                                                                                               The treatment must be limited to a maximum duration of 12 weeks.
C7621               P7621          CN7621           Balsalazide                                                                                                                                                                Ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 7621
                                                                                                                                                                                                                               Patient must have had a documented hypersensitivity reaction to a sulphonamide.  or
                                                                                                                                                                                                                               Patient must be intolerant to sulfasalazine.
C7695               P7695          CN7695           Glatiramer                                                                                                                                                                 Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 7695
                                                                                                                                                                                                                               Initial treatment
                                                    Interferon beta-1b                                                                                                                                                         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, with 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
                                                    Peginterferon beta-1a                                                                                                                                                      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).
                                                                                                                                                                                                                               Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C7699               P7699          CN7699           Ocrelizumab                                                                                                                                                                Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 7699
                                                                                                                                                                                                                               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); AND
                                                                                                                                                                                                                               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.
C7714               P7714          CN7714           Alemtuzumab                                                                                                                                                                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