Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p20
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 20/312)
Character Range: 15581071–15588798

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.
                                                                                                                           A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
C14600              P14600         CN14600          Etanercept                                                             Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Initial 2 treatment (Whole body) - Change of treatment
                                                                                                                           Must be treated by a dermatologist; AND
                                                                                                                           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 this drug more than once during the current treatment cycle; AND
                                                                                                                           Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND
                                                                                                                           The treatment must be as systemic monotherapy; or
                                                                                                                           The treatment must be in combination with methotrexate; AND
                                                                                                                           Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction;
                                                                                                                           Patient must be under 18 years of age.
                                                                                                                           An adequate response to treatment is defined as
                                                                                                                           A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
                                                                                                                           In relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because
                                                                                                                           (i) there is an absence of an adequate response to that treatment; or
                                                                                                                           (ii) there was an intolerance to that treatment; or
                                                                                                                           (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above.
                                                                                                                           The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient's medical records.
C14603              P14603         CN14603          Etanercept                                                             Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
                                                                                                                           Must be treated by a rheumatologist; or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                                                           Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND
                                                                                                                           Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must not have