Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p32
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 32/161)
Character Range: 14029097–14034840

eyelid, eye; or requirement for limb amputation or free tissue transfer); or
                                                                                   (iii) Medical contraindication to surgery.
                                                                                   (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
                                                                                   (ii) Limitations due to location of tumour; or
                                                                                   (iii) Limitations due to cumulative prior radiotherapy dose; or
                                                                                   (iv) Progressive disease despite prior irradiation of locally advanced BCC.
                                                                                   Inappropriate for curative radiotherapy is defined as
                                                                                   (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
                                                                                   (ii) Limitations due to location of tumour; or
                                                                                   (iii) Limitations due to cumulative prior radiotherapy dose; or
                                                                                   (iv) Progressive disease despite prior irradiation of locally advanced BCC.
                                                                                   For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records.
C13282              P13282         CN13282          Somatrogon                     Short stature and slow growth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                   Recommencement of treatment as a reclassified patient
                                                                                   Patient must be undergoing treatment that is simultaneously:
                                                                                    (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone; AND
                                                                                   Patient must have had a lapse in growth hormone treatment; 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 no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND
                                                                                   Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or
                                                                                   Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND
                                                                                   Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
                                                                                   Patient must not have an active tumour