Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p53
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 53/312)
Character Range: 15764117–15770119

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.
C14686              P14686         CN14686          Certolizumab pegol                                                     Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                           Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                           The condition must be either radiologically (plain X-ray) confirmed:
                                                                                                                            (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; 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 a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND
                                                                                                                           Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or
                                                                                                                           Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or
                                                                                                                           Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; 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 authority application must be made in writing and must include
                                                                                                                           (1) a completed authority prescription form; and
                                                                                                                           (2) a