Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p26
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 26/476)
Character Range: 847939–857176

recommendations in the TGA‑approved Product Information.
                                                                                                                                            A maximum of 5 repeats may be requested.
                                                                       C13582                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial 2 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
                                                                                                                                            Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
                                                                                                                                            Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS‑subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase‑5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
                                                                                                                                            The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
                                                                                                                                            Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Anakinra                                                               C5450                                                                Moderate to severe cryopyrin associated periodic syndromes (CAPS)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 5450
                                                                                                                                            Must be treated by a rheumatologist or in consultation with a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist or in consultation with a clinical immunologist.
                                                                                                                                            A diagnosis of CAPS must be documented in the patient's medical records.
Anifrolumab                                                            C15387                                                               Systemic lupus erythematosus                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                            Continuing or recommencement of treatment (within 12 months of a treatment break)
                                                                                                                                            Patient must have previously been issued with an authority prescription for this drug for this condition; AND
                                                                                                                                            Patient must be responding to treatment if they have received less than 12 months of treatment with this drug for this condition; OR
                                                                                                                                            Patient must have attained a Lupus Low Disease Activity State (LLDAS) and maintained this state while on treatment.
                                                                                                                                            Must be treated by a specialist physician experienced in the management of this condition.
                                                                                                                                            Lupus Low Disease Activity State (LLDAS) is defined as:
                                                                                                                                            (a) Total SLEDAI-2K of not greater than 4, with no major activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever); and
                                                                                                                                            (b) No new features of lupus disease activity compared with the previous assessment, and
                                                                                                                                            (c) Physician Global Assessment (PGA) of not greater than 1, and
                                                                                                                                            (d) Current prednisolone (or equivalent) dose of not greater than 7.5 mg daily, and
                                                                                                                                            (e) Well tolerated standard maintenance doses of anti-malarial and immunosuppressive drugs are allowed.
                                                                                                                                            Where