Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p164
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 164/381)
Character Range: 12588188–12594994

doses available under any of the initial treatment phases.
C12336              P12336         CN12336          Adalimumab                                                                                                      Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 1 (new patient)
                                                                                                                                                                    Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND
                                                                                                                                                                    Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; or
                                                                                                                                                                    Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or
                                                                                                                                                                    Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be limited to a maximum duration of 16 weeks; AND
                                                                                                                                                                    Must be treated by a dermatologist.
                                                                                                                                                                    Assessment of disease severity must be no more than 4 weeks old at the time of application.
                                                                                                                                                                    An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
                                                                                                                                                                    Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                                                    At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient) or Initial 2 (recommencement of treatment) - balance of supply
                                                                                                                                                                    The authority application must be made in writing and must include
                                                                                                                                                                    (1) a completed authority prescription form; and
                                                                                                                                                                    (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes
                                                                                                                                                                    (i) the Hurley stage grading; and
                                                                                                                                                                    (ii) the AN count; and
                                                                                                                                                                    (iii) the name of the antibiotic/s received for two separate courses each of three months; or
                                                                                                                                                                    (iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable