Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p256
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 256/476)
Character Range: 2429696–2435682

by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP.
                                                                                                                                            Patient must have a diagnosis of CRSwNP confirmed by at least one of: (i) nasal endoscopy, (ii) computed tomography (CT) scan, with the results documented in the patient's medical records; OR
                                                                                                                                            Patient must have a diagnosis of CRSwNP from at least two physicians of the above mentioned prescriber types; AND
                                                                                                                                            Patient must have undergone surgery for the removal of nasal polyps; OR
                                                                                                                                            Patient must have the written advice from at least two physicians of the above mentioned prescriber types demonstrating inappropriateness for surgery; AND
                                                                                                                                            Patient must have, despite optimised nasal polyp therapy, at least two of: (i) bilateral endoscopic nasal polyp score of at least 5 (out of a maximum score of 8, with a minimum score of 2 in each nasal cavity), (ii) nasal obstruction visual analogue scale (VAS) score greater than 5 (out of a maximum score of 10), (iii) overall symptom VAS score greater than 7 (out of a maximum score of 10); AND
                                                                                                                                            Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; OR
                                                                                                                                            Patient must have had a 12 month break in PBS‑subsidised treatment with a biological medicine 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 any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND
                                                                                                                                            Patient must have failed to achieve adequate control with optimised nasal polyp therapy which has been documented; AND
                                                                                                                                            Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            Optimised nasal polyp therapy includes:
                                                                                                                                            (a) adherence to intranasal corticosteroid therapy for at least 2 months, unless contraindicated or not tolerated
                                                                                                                                            (b) if required, nasal irrigation with saline
                                                                                                                                            Where the patient has a contraindication or intolerance to intranasal corticosteroid therapy, document the reasons for the contraindication or intolerance in the patient's medical file.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (a) a completed authority prescription form,
                                                                                                                                            (b) 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),
                                                                                                                                            (c) details (date of commencement and duration 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)