Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p225
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 225/312)
Character Range: 16898655–16904990

greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced non-PBS-subsidised treatment with this drug for this condition where a Mayo clinic or partial Mayo clinic baseline assessment is not available; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                           Must be treated by a gastroenterologist (code 87); OR
                                                                                                                           Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
                                                                                                                           Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (1) details of the proposed prescription; 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), which includes:
                                                                                                                           (i) the completed baseline Mayo clinic or partial Mayo clinic calculation sheet prior to initiating treatment (if available) including the date of assessment; and
                                                                                                                           (ii) the date of commencement of this drug.
                                                                                                                           A patient may qualify for PBS-subsidised treatment under this restriction once only.
                                                                                                                           For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
                                                                                                                           The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
                                                                                                                           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.
                                                                                                                           Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
                                                                                                                           Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
                                                                                                                           At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
C15854              P15854         CN15854          Fluticasone propionate                                                 Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 15854
                                                                                                                           The treatment must not be a PBS benefit where this 50 microgram strength is being initiated in a patient over the age of 6.00 years; AND
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
C15856              P15856         CN15856          Esomeprazole                                                           Complex gastro-oesophageal reflux disease (GORD)