Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p171
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 171/312)
Character Range: 16521165–16528346

The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
C15446              P15446         CN15446          Adalimumab                                                             Vision threatening non-infectious uveitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must demonstrated or sustained an adequate response to treatment with this drug for this condition; AND
                                                                                                                           The treatment must not exceed 24 weeks under this restriction per authority application.
                                                                                                                           Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR
                                                                                                                           Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.
                                                                                                                           An adequate response to treatment is defined as:
                                                                                                                           (a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or
                                                                                                                           (b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or
                                                                                                                           (c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or
                                                                                                                           (d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only)
                                                                                                                           The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
C15450              P15450         CN15450          Adalimumab                                                             Vision threatening non-infectious uveitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                           Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2024; AND
                                                                                                                           Patient must have non-infectious uveitis that is vision threatening with the diagnosis confirmed by an ophthalmologist, rheumatologist, or immunologist; AND
                                                                                                                           Patient must have failed to achieve an adequate response to corticosteroid therapy in combination with at least 1 immunosuppressive agent prior to commencing non-PBS-subsidised treatment; OR
                                                                                                                           Patient must have flared when corticosteroid therapy was tapered to a dose of less than or equal to 7.5 mg per day of prednisone or equivalent while on immunomodulatory therapy prior to commencing non-PBS-subsidised treatment; OR
                                                                                                                           Patient must have failed to achieve an adequate response to prior conventional immunomodulatory therapy in patients for whom corticosteroids