Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p216
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 216/312)
Character Range: 16842454–16848571

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
                                                                                                                           Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must not receive more than 20 weeks of treatment under this restriction.
                                                                                                                           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 16 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.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (1) details of the proposed prescription(s); 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 to complete a three month course of antibiotics.
                                                                                                                           The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.
                                                                                                                           Details of two completed prescriptions should be submitted with every initial application for this drug.
                                                                                                                           One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.
                                                                                                                           Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
C15812              P15812         CN15812          Secukinumab                                                            Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written 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