Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p78
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 78/191)
Character Range: 10389770–10403040

to respond to treatment with oral antispastic agents; or
                                                                                                                                                                                                                               Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
                                                                                                                                                                                                                               Patient must have chronic spasticity due to multiple sclerosis.
C6940               P6940          CN6940           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 6940
                                                                                                                                                                                                                               Patient must have failed to respond to treatment with oral antispastic agents; or
                                                                                                                                                                                                                               Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
                                                                                                                                                                                                                               Patient must have chronic spasticity due to spinal cord injury.
C6952               P6952          CN6952           Degarelix                                                                                                                                                                  Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate

C6953               P6953          CN6953           Botulinum toxin type A purified neurotoxin complex                                                                                                                         Urinary incontinence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 6953
                                                                                                                                                                                                                               Must be treated by a urologist; or
                                                                                                                                                                                                                               Must be treated by a gynaecologist; AND
                                                                                                                                                                                                                               The condition must be due to idiopathic overactive bladder; AND
                                                                                                                                                                                                                               The condition must have been inadequately controlled by therapy involving at least two alternative anti-cholinergic agents; AND
                                                                                                                                                                                                                               Patient must experience at least 14 episodes of urinary incontinence per week prior to commencement of treatment with botulinum toxin type A neurotoxin complex; AND
                                                                                                                                                                                                                               Patient must be willing and able to self-catheterise; AND
                                                                                                                                                                                                                               The treatment must not continue if the patient does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6-12 weeks after the first treatment;
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
C6976               P6976          CN6976           Degarelix                                                                                                                                                                  Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate

C6979               P6979          CN6979           Chorionic gonadotrophin                                                                                                                                                    Combined deficiency of human growth hormone and gonadotrophins
                                                                                                                                                                                                                               Patient must be male;
                                                                                                                                                                                                                               Patient must be one in whom the absence of secondary sexual characteristics indicates a lag in maturation.
C6980               P6980          CN6980           Tenofovir                                                                                                                                                                  Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 6980
                                                                                                                                                                                                                               Patient must have cirrhosis; AND
                                                                                                                                                                                                                               Patient must be nucleoside analogue naive; AND
                                                                                                                                                                                                                               Patient must have detectable HBV DNA; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                                                                               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.
C6982               P6982          CN6982           Tenofovir                                                                                                                                                                  HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 6982
                                                                                                                                                                                                                               Continuing
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised therapy for HIV infection; AND
                                                                                                                                                                                                                               The treatment must be in combination with other antiretroviral agents.
C6983               P6983          CN6983           Tenofovir                                                                                                                                                                  Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 6983
                                                                                                                                                                                                                               Patient must have cirrhosis; AND
                                                                                                                                                                                                                               Patient must have failed antihepadnaviral therapy; AND
                                                                                                                                                                                                                               Patient must