Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p37
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 37/162)
Character Range: 14857706–14863584

(less than 3.0 hertz) spike-and-wave discharges with generalised paroxysmal fast activity (sleep recording should be obtained where it is possible); AND
                                                                                                         Patient must have (as an initiating patient)/have had (as a continuing patient) more than one type of generalised seizures; AND
                                                                                                         Patient must have had at least two drop seizures (atonic, tonic or tonic-clonic) per week that are not adequately controlled with at least two other anti-epileptic drugs prior to initiating treatment with this medicine; AND
                                                                                                         The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs; AND
                                                                                                         Must be treated by a neurologist if treatment is being initiated.  or
                                                                                                         Must be treated by a neurologist if treatment is being continued or re-initiated.  or
                                                                                                         Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued.  or
                                                                                                         Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.
                                                                                                         Tonic seizures must have been recorded on video-EEG or have been clearly observed and reported by a witness.
                                                                                                         Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.
C14061              P14061         CN14061          Adalimumab                                           Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
                                                                                                         Must be treated by a paediatric rheumatologist; or
                                                                                                         Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND
                                                                                                         Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                         Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
                                                                                                         Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                         An adequate response to treatment is defined as
                                                                                                         (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                         (b) a reduction in the number of the following active joints, from at least 4, by at least 50%
                                                                                                         (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                         (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
                                                                                                         The assessment of response to treatment must be documented in the patient's medical records.
                                                                                                         At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for