Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p20
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 20/476)
Character Range: 805206–814638

disease modifying therapy for this condition; AND
                                                                                                                                            Patient must be ambulatory (without assistance or support).
                                                                                                                                            Must be treated by a neurologist.
                                                                                                                                            Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
                                                                       C9589               P9589                                            Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 9589
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not show continuing progression of disability while on treatment with this drug; AND
                                                                                                                                            Patient must not receive more than one PBS‑subsidised treatment per year; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
                                                                                                                                            Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
                                                                                                                                            Must be treated by a neurologist.
                                                                       C9636               P9636                                            Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 9636
                                                                                                                                            Initial treatment
                                                                                                                                            The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
                                                                                                                                            The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
                                                                                                                                            Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS‑subsidised disease modifying therapy for this condition; AND
                                                                                                                                            Patient must be ambulatory (without assistance or support).
                                                                                                                                            Must be treated by a neurologist.
                                                                                                                                            Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
Ambrisentan                                                            C11229                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Triple therapy ‑ Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
                                                                                                                                            The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) PBS‑subsidised selexipag (referred to as 'triple therapy'); OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of either: (i) PBS‑subsidised selexipag with one endothelin receptor antagonist, (ii) PBS‑subsidised selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
                                                                                                                                            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.
                                                                                                                                            The authority application for selexipag must be approved prior