Document ID: chunk:federal_register_of_legislation:F2024L01736:schedule:1:p3
Version: federal_register_of_legislation:F2024L01736
Segment Type: schedule
Provision Reference: sch 1 (pt 3/6)
Character Range: 8966–12469

muscular atrophy PBS Authority Application Form which includes the following:
              (i) confirmation of genetic diagnosis of SMA; and
              (ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)
              The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.
              The approved Product Information recommended dosing is as follows:
              (i) 16 days to less than 2 months of age: 0.15 mg/kg
              (ii) 2 months to less than 2 years of age: 0.20 mg/kg
              (iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg
              (iv) 2 years of age and older weighing 20 kg or more: 5 mg
              In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:
              1 unit where (i) applies;
              2 units where (ii) applies;
              3 units where (iii) applies;
              3 units where (iv) applies.

 1.                    Schedule 3, entry for Vedolizumab
         1.            omit:
   C16170     Moderate to severe chronic pouchitis                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
              Initial 2 treatment (Recommencement of treatment after a break in biological medicine)
              Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
              Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition; AND
              Patient must not receive more than 14 weeks of treatment under this restriction.
              Must be treated by a gastroenterologist (code 87); OR
              Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
              Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
              The treatment must be initiated in combination with standard of care antibiotic.
              The assessment of a patient's response to this initial course of treatment must be made after the third dose of vedolizumab so there is adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14.
              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.
              Application for authorisation of initial treatment must be in writing and must include:
              (a) details of the proposed prescription; and
              (b) 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 following: