Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p111
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 111/191)
Character Range: 10732845–10740758

must include
                                                                                                                                                                                                                               (a) a completed authority prescription form(s); and
                                                                                                                                                                                                                               (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
                                                                                                                                                                                                                               The most recent PASI assessment must be no more than 1 month old at the time of application.
                                                                                                                                                                                                                               Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
                                                                                                                                                                                                                               The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.
                                                                                                                                                                                                                               It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
                                                                                                                                                                                                                               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.
                                                                                                                                                                                                                               If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
                                                                                                                                                                                                                               A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C9031               P9031          CN9031           Guanfacine                                                                                                                                                                 Attention deficit hyperactivity disorder                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 9031
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information.  or
                                                                                                                                                                                                                               Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal.  or
                                                                                                                                                                                                                               Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent.  or
                                                                                                                                                                                                                               Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously).
C9032               P9032          CN9032           Ursodeoxycholic acid                                                                                                                                                       Primary biliary cholangitis (previously known as Primary biliary cirrhosis)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 9032

C9034               P9034          CN9034           Guanfacine