Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p44
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 44/161)
Character Range: 14081930–14086837

(3) The patient's weight (kg);
                                                                                   (4) The patient's growth velocity in response to the preceding supply of drug (cm/year; extrapolated for time on treatment);
                                                                                   (5) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.
                                                                                   Height, growth velocity and weight measurements must not be more than three months old at the time of application.
                                                                                   Document growth improvements in the patient's medical records.
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (i) A completed authority prescription form; and
                                                                                   (ii) 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).
C13294              P13294         CN13294          Somatrogon                     Short stature associated with biochemical growth hormone deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                   Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                   Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime; AND
                                                                                   The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following:
                                                                                    (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
                                                                                   Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or
                                                                                   Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or
                                                                                   Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of