Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p209
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 209/312)
Character Range: 16798157–16804395

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.
C15796              P15796         CN15796          Adalimumab                                                             Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                           Subsequent continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; 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 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised 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.
                                                                                                                           A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.
                                                                                                                           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 the Hidradenitis Suppurativa Clinical Response (HiSCR) result.
C15799              P15799