Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p45
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 45/312)
Character Range: 15718825–15726014

response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                           Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                           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.
C14668              P14668         CN14668          Infliximab                                                             Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                           Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
                                                                                                                           Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                           The treatment must have both:
                                                                                                                            (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; 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.
                                                                                                                           The authority application must be made in writing and must include
                                                                                                                           (1) a completed authority prescription form; and
                                                                                                                           (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                           An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 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.
                                                                                                                           All measurements provided must be no more than 1 month old at the time of application.
C14670              P14670         CN14670          Adalimumab                                                             Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with