Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p133
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 133/161)
Character Range: 14504550–14511277

withdrawal of treatment.
                                                                                   If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
C13624              P13624         CN13624          Leuprorelin                    Central precocious puberty
                                                                                   Initial treatment
                                                                                   Must be treated by a paediatric endocrinologist; or
                                                                                   Must be treated by an endocrinologist specialising in paediatrics;
                                                                                   Patient must be of an age that is prior to their 10th birthday if female; or
                                                                                   Patient must be of an age that is prior to their 11th birthday if male;
                                                                                   Patient must have had onset of signs/symptoms of central precocious puberty prior to their 8th birthday if female.  or
                                                                                   Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9th birthday if male.
C13625              P13625         CN13625          Natalizumab                    Clinically definite relapsing-remitting multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 13625
                                                                                   Must be treated by a neurologist; AND
                                                                                   The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                   Patient must be ambulatory (without assistance or support); 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
                                                                                   The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord.  or
                                                                                   Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
                                                                                   The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
                                                                                   Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
                                                                                   For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
C13646              P13646         CN13646          Etanercept                     Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                   Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                   Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                   Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
                                                                                   Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
                                                                                   The treatment must be as