Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p176
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 176/312)
Character Range: 16555883–16564400

require single maintenance and reliever therapy.
                                                                                                                           Patient must be at least 18 years of age.
C15471              P15471         CN15471          Nivolumab                                                              Resectable non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 15471
                                                                                                                           The condition must be at least one of: (i) node positive, (ii) at least 4 cm in size; AND
                                                                                                                           The treatment must be for neoadjuvant use in a patient preparing for surgical resection; AND
                                                                                                                           Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                           The treatment must be in combination with platinum-based chemotherapy.
                                                                                                                           Patient must not be undergoing treatment with more than 3 PBS-subsidised doses of this drug per lifetime for this indication.
                                                                                                                           In non-squamous type NSCLC where any of the following is known to be present, this drug must not be a PBS benefit: (i) activating epidermal growth factor receptor (EGFR) gene mutation, (ii) anaplastic lymphoma kinase (ALK) gene rearrangement.
C15473              P15473         CN15473          Adalimumab                                                             Vision threatening non-infectious uveitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Balance of Supply
                                                                                                                           Patient must have received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition to complete one of the following: (i) 25 weeks for initial treatment; (ii) 25 weeks for recommencement treatment; (iii) 24 weeks for continuing treatment; (iv) 24 weeks for transitioning from non-PBS to PBS-subsidised treatment.
C15474              P15474         CN15474          Adalimumab                                                             Vision threatening non-infectious uveitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           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; 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; OR
                                                                                                                           Patient must have failed to achieve an adequate response to at least one immunosuppressive agent in patients for whom corticosteroids are not clinically appropriate; OR
                                                                                                                           Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to corticosteroid and immunomodulatory therapy; AND
                                                                                                                           The treatment must not exceed 25 weeks under this restriction.
                                                                                                                           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.
                                                                                                                           Vision threatening disease is defined as at least 1 of the following:
                                                                                                                           (a) A decrease in visual acuity of at least 10 letters using an ETDRS chart or equivalent;
                                                                                                                           (b) A 2-step increase