Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p112
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 112/191)
Character Range: 10739661–10749830

permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously).
C9032               P9032          CN9032           Ursodeoxycholic acid                                                                                                                                                       Primary biliary cholangitis (previously known as Primary biliary cirrhosis)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 9032

C9034               P9034          CN9034           Guanfacine                                                                                                                                                                 Attention deficit hyperactivity disorder                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 9034
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Must be treated by a paediatrician or psychiatrist; AND
                                                                                                                                                                                                                               The condition must be or have been diagnosed according to the DSM-5 criteria; AND
                                                                                                                                                                                                                               Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; or
                                                                                                                                                                                                                               Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; or
                                                                                                                                                                                                                               Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; or
                                                                                                                                                                                                                               Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously);
                                                                                                                                                                                                                               Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.
C9063               P9063          CN9063           Certolizumab pegol                                                                                                                                                         Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment - balance of supply
                                                    Golimumab                                                                                                                                                                  Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND
                                                    Secukinumab                                                                                                                                                                Must be treated by a rheumatologist.  or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                    Ustekinumab

C9064               P9064          CN9064           Adalimumab                                                                                                                                                                 Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
                                                    Bimekizumab                                                                                                                                                                Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or
                                                    Etanercept                                                                                                                                                                 Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 16 weeks