Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p213
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 213/312)
Character Range: 16824754–16831041

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.
                                                                                                                           This restriction is intended for induction dosing only.
C15806              P15806         CN15806          Secukinumab                                                            Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                           Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                           Patient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines 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.
                                                                                                                           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 a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
                                                                                                                           To demonstrate a response to treatment the application 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 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.
                                                                                                                           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.
                                                                                                                           Details of two completed prescriptions should be submitted with every initial application for this drug.
                                                                                                                           One prescription