Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p257
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 257/476)
Character Range: 2434981–2441276

of therapy) of prior optimised nasal polyp medicine treatment,
                                                                                                                                            (d) details (date and treatment) of nasal polyp surgery; or
                                                                                                                                            (e) if applicable, details of surgical exception including serious comorbid disease (e.g. cardiovascular, stroke) making the risk of surgery unacceptable,
                                                                                                                                            (f) the eosinophil count and date,
                                                                                                                                            (g) two of the following, measured within the past 12 months: (i) baseline bilateral endoscopic nasal polyp score, (ii) baseline nasal obstruction VAS score, (iii) baseline overall VAS score.
                                                                       C15353                                                               Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.
                                                                                                                                            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 or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                            The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                                            Patient must be aged 12 years or older.
                                                                                                                                            An adequate response to this biological medicine is defined as:
                                                                                                                                            (a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,
                                                                                                                                            OR
                                                                                                                                            (b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.
                                                                                                                                            All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
                                                                                                                                            The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be