Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p175
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 175/381)
Character Range: 12672442–12678790

vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
                                                                                                                                                                    If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with teriparatide is initiated.
                                                                                                                                                                    If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with teriparatide is initiated.
                                                                                                                                                                    Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.
                                                                                                                                                                    Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be documented in the patient's medical record.
C12493              P12493         CN12493          Upadacitinib                                                                                                    Chronic severe atopic dermatitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Continuing or resuming treatment with this drug of the whole body
                                                                                                                                                                    Patient must have received PBS-subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the whole body; AND
                                                                                                                                                                    Patient must have achieved an adequate response prior to this first continuing treatment authority application; or
                                                                                                                                                                    Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; or
                                                                                                                                                                    Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND
                                                                                                                                                                    Must be treated by a dermatologist; or
                                                                                                                                                                    Must be treated by a clinical immunologist; AND
                                                                                                                                                                    Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication:
                                                                                                                                                                     chronic severe atopic dermatitis).
                                                                                                                                                                    For the purposes of this restriction, an adequate response to treatment is