Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p213
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 213/476)
Character Range: 2116693–2123119

and used to assess all future responses to treatment.
                                                                                                                                            The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
                                                                                                                                            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.
                                                                       C14701                                                               Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 14701
                                                                                                                                            Subsequent continuing treatment
                                                                                                                                            Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
                                                                                                                                            Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
                                                                                                                                            Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
                                                                                                                                            An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
                                                                                                                                            (a) an ESR measurement no greater than 25 mm per hour; or
                                                                                                                                            (b) a CRP measurement no greater than 10 mg per L; or
                                                                                                                                            (c) an ESR or CRP measurement reduced by at least 20% from baseline.
                                                                                                                                            Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
                                                                                                                                            The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
                                                                                                                                            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