Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p205
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 205/312)
Character Range: 16772514–16778368

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.
C15779              P15779         CN15779          Secukinumab                                                            Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                           Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                           Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 June 2024; AND
                                                                                                                           Patient must have had a Hurley stage II or III with an abscess and inflammatory nodule (AN) count greater than or equal to 3 prior to starting treatment with this drug for this condition; AND
                                                                                                                           Patient must have demonstrated a response to treatment by achieving Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment if the patient has been treated with this drug for this condition for 16 weeks or longer; AND
                                                                                                                           Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of non-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 non-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 non-PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                           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