Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p52
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 52/162)
Character Range: 14929902–14935827

on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
                                                                                                         The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
                                                                                                         Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
                                                                                                         Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
                                                                                                         If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.
                                                                                                         If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
                                                                                                         The following information must be provided by the prescriber at the time of application and documented in the patient's medical records
                                                                                                         (a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and
                                                                                                         (b) the details of prior treatment including dose and duration of treatment.
                                                                                                         The following reports must be documented in the patient's medical records where appropriate
                                                                                                         (a) pathology reports detailing C-reactive protein (CRP) level and platelet count.
                                                                                                         The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
C14096              P14096         CN14096          Choriogonadotropin alfa                              Infertility indications other than that of Assisted Reproductive Technology
                                                                                                         Patient must not be undergoing treatment with medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule; AND
                                                                                                         Patient must not be undergoing simultaneous treatment with this drug through another PBS program listing; AND
                                                                                                         Must be treated by an obstetrician/gynaecologist.  or
                                                                                                         Must be treated by a specialist in reproductive endocrinology/infertility.  or
                                                                                                         Must be treated by a urogynaecologist.  or
                                                                                                         Must be treated by an endocrinologist.  or
                                                                                                         Must be treated by a urologist.
                                                                                                         The PBS prescription, whether it is to initiate or continue treatment, must be made out under the specialist's prescriber number.
C14097              P14097         CN14097          Finerenone                                           Chronic kidney disease with Type 2 diabetes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 14097
                                                                                                         Patient