Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p321
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 321/381)
Character Range: 13493212–13499801

Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
                                                                                                                                                                    The authority application must be in writing and must include
                                                                                                                                                                    1. A completed authority prescription form; AND
                                                                                                                                                                    2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
                                                                                                                                                                    3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
                                                                                                                                                                    4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
                                                                                                                                                                    5. The final adult height (in cm) of the patient's mother and father (where available); AND
                                                                                                                                                                    6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
                                                                                                                                                                    Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
                                                                                                                                                                    In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.
C12842              P12842         CN12842          Daratumumab                                                                                                     Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                    Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                                                                    Patient must have been on treatment with this drug in the subcutaneous form for this condition prior to 1 November 2021; AND
                                                                                                                                                                    Patient must have met all initial treatment PBS-eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are:
                                                                                                                                                                     (i) the condition was confirmed by histological diagnosis, (ii) the treatment is/was being used as part of triple combination therapy with bortezomib and dexamethasone, (iii) the condition progressed (see definition of progressive disease below) after one prior therapy, but not after more than two prior lines of therapies (i.e. this drug was commenced as second-line treatment), (iv) the treatment was/is not to be used in combination with another PBS-subsidised drug indicated for this condition outside of the intended combination where stated, and (v) the patient had never been treated with this drug; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving treatment with this drug for this condition.
                                                                                                                                                                    Progressive disease is defined as at least 1 of the following
                                                                                                                                                                    (a) at least a 25% increase and