Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p42
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 42/312)
Character Range: 15702510–15708673

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.
C14659              P14659         CN14659          Certolizumab pegol                                                     Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 1 (new patient)
                                                                                                                           The condition must be either radiologically (plain X-ray) confirmed:
                                                                                                                            (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
                                                                                                                           Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have at least 2 of the following:
                                                                                                                            (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
                                                                                                                           Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
                                                                                                                           Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, 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 application must include details of the NSAIDs trialled, their doses and duration of treatment.
                                                                                                                           If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.
                                                                                                                           If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
                                                                                                                           If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
                                                                                                                           The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application
                                                                                                                           (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and
                                                                                                                           (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP)