Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p206
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 206/312)
Character Range: 16777739–16783983

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 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 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.
                                                                                                                           Assessment of disease severity must not have been more than 4 weeks old at the time treatment with this drug was initiated.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (a) details of the proposed prescription; and
                                                                                                                           (b) 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
                                                                                                                           (v) the Hidradenitis Suppurativa Clinical Response (HiSCR) result if the patient has received 16 weeks or more of treatment.
                                                                                                                           A patient may qualify for PBS-subsidised treatment under this restriction once only.
                                                                                                                           For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
C15781              C15781         CN15781          Larotrectinib                                                          Solid tumours with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing for solid tumours (of any type) with confirmed NTRK gene fusion where treatment with this drug is/was initiated in a child; OR
                                                                                                                           Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing for solid tumours (of certain specified types) with confirmed NTRK gene fusion which either includes: (i) mammary analogue