Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p180
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 180/312)
Character Range: 16584394–16590549

the airway or great vessels;
                                                                                                                           2. paraspinal PN that can cause myelopathy;
                                                                                                                           3. brachial or lumbar plexus PN that can cause nerve compression and loss of function;
                                                                                                                           4. PN that can result in major deformity or significant disfiguring (e.g. orbital PN);
                                                                                                                           5. PN of the extremity that can cause limb hypertrophy or loss of function; and
                                                                                                                           6. painful PN.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (1) details of the proposed prescription; and
                                                                                                                           (2) 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).
C15491              P15491         CN15491          Selumetinib                                                            Neurofibromatosis type 1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                           Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                           Patient must have previously received treatment with this drug for this condition prior to 1 August 2024; OR
                                                                                                                           Patient must have previously received treatment with another mitogen-activated protein kinase (MEK) inhibitor for this condition prior to 1 August 2024; AND
                                                                                                                           Patient must have met all other PBS eligibility criteria that a non-'Grandfather' patient would ordinarily be required to meet, meaning that at the time non-PBS-subsidised supply of a MEK inhibitor (including selumetinib) was commenced, the patient: (i) had PN that caused/was likely to cause at least one of: (a) significant symptoms/morbidity, (b) disability, (c) disfigurement, (d) impairment of normal body function; (ii) had PN for which complete PN resection could not be performed either: (a) safely, (b) without causing unacceptable morbidity; (iii) had either a: (a) Karnofsky, (b) Lansky Performance Score of at least 70%; (iv) was aged between 2 to 18 years; (v) was able to swallow the whole capsule form if received non-PBS supply with selumetinib; AND
                                                                                                                           Patient must be tolerating treatment; AND
                                                                                                                           Patient must have achieved either: (i) stabilisation of disease, (ii) adequate response to treatment, if have received at least 12 months of treatment.
                                                                                                                           Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation.
                                                                                                                           At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) 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.
                                                                                                                           Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.
                                                                                                                           For the purpose of administering this restriction, significant symptoms/morbidity are defined