Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p64
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 64/381)
Character Range: 11927476–11935936

severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
                                                                                                                                                                    The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient's medical records.
                                                                                                                                                                    If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                                                    A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C11524              P11524         CN11524          Adalimumab                                                                                                      Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 11524
                                                                                                                                                                    Subsequent continuing treatment
                                                                                                                                                                    Must be treated by a gastroenterologist (code 87); or
                                                                                                                                                                    Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                                                                                    Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                                                                                    Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND
                                                                                                                                                                    Patient must have demonstrated an adequate response to treatment with this drug for this condition.
                                                                                                                                                                    An adequate response is defined as
                                                                                                                                                                    (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
                                                                                                                                                                    (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
                                                                                                                                                                    The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
                                                                                                                                                                    Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
                                                                                                                                                                    A maximum of 24 weeks treatment will be authorised under this restriction.
C11529              P11529         CN11529          Adalimumab                                                                                                      Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 11529
                                                                                                                                                                    Subsequent continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                                                                                                    Patient must have demonstrated a response to treatment with this drug for this condition; AND
                                                                                                                                                                    Must be treated by a dermatologist.
                                                                                                                                                                    A response to treatment is defined as
                                                                                                                                                                    Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline