Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p10
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 10/162)
Character Range: 14711340–14717816

maintaining abstinence/controlled consumption.
C13972              P13972         CN13972          Lenvatinib                                           Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 13972
                                                                                                         Continuing treatment
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                         Patient must be undergoing combination therapy consisting of:
                                                                                                          (i) pembrolizumab, (ii) lenvatinib.  or
                                                                                                         Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records.  or
                                                                                                         Patient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose.
                                                                                                         In a patient who has experienced an intolerance to pembrolizumab, details of intolerance must be documented in the patient's medical record.
C13977              P13977         CN13977          Vosoritide                                           Achondroplasia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                         Initial treatment
                                                                                                         Patient must have a diagnosis of achondroplasia, confirmed by appropriate genetic testing; 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 application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
                                                                                                         Appropriate genetic testing constitutes testing for FGFR3 gene mutation.
                                                                                                         In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X-rays and dates (date commenced treatment and date of X-ray) must be documented in the patient's medical records.
                                                                                                         Additional radiographic evidence is not required until patient has begun puberty.
                                                                                                         In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X-ray and date taken must be documented in