Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p119
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 119/312)
Character Range: 16213348–16219986

the first administered dose, once in a lifetime.
C15199              P15199         CN15199          Risankizumab                                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; OR
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; OR
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; OR
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; OR
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; OR
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND
                                                                                                                           The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                           The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.
                                                                                                                           Must be treated by a dermatologist.
C15201              P15201         CN15201          Evolocumab                                                             Non-familial hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 15201
                                                                                                                           Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran; AND
                                                                                                                           The treatment must be in conjunction with dietary therapy and exercise; AND
                                                                                                                           Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug