Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p201
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 201/312)
Character Range: 16745496–16751752

or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                           Patient must not receive more than 16 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.
                                                                                                                           A response to treatment is defined as:
                                                                                                                           Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
                                                                                                                           To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                           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), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (1) details of the proposed prescription; 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.
C15767              P15767         C15767           Secukinumab                                                            Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have demonstrated a response to treatment with this drug for this condition.
                                                                                                                           Must be treated by a dermatologist.
                                                                                                                           A response to treatment is defined as:
                                                                                                                           Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
                                                                                                                           An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation