Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p15
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 15/162)
Character Range: 14737433–14742824

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 current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
                                                                                                         (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
                                                                                                         All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
                                                                                                         The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
                                                                                                         An assessment of a patient's response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy.
                                                                                                         Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                         If a patient fails to demonstrate a response to treatment with this drug they will not be 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.
                                                                                                         If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
                                                                                                         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 provided at the time of application.
                                                                                                         A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
C13998              P13998         CN13998          Vosoritide                                           Achondroplasia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                         Continuing treatment
                                                                                                         Patient must have received PBS subsidised vosoritide treatment for this condition; AND
                                                                                                         Patient must not have evidence of growth plate closure demonstrated by at least one of the following:
                                                                                                          i) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months; AND
                                                                                                         Must be treated by a medical specialist, experienced in the management of achondroplasia.  or
                                                                                                         Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia.
                                                                                                         At the time of authority