Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p52
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 52/312)
Character Range: 15756628–15764511

therapy for gastro-oesophageal cancer; AND
                                                                                                                           Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first:
                                                                                                                            (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs;
                                                                                                                           Patient must be in one of the three population subsets described below.
                                                                                                                           Population 1
                                                                                                                           Conditions gastric cancer, gastro-oesophageal junction cancer, oesophageal adenocarcinoma
                                                                                                                           Concomitant therapies chemotherapy containing at least a fluoropyrimidine drug plus a platinum drug
                                                                                                                           Line of treatment first-line drug treatment
                                                                                                                           Additional clinical finding HER2 negative
                                                                                                                           Population 2
                                                                                                                           Condition oesophageal squamous cell carcinoma (can be recurrent)
                                                                                                                           Concomitant therapies chemotherapy containing at least a fluoropyrimidine drug plus a platinum drug
                                                                                                                           Line of treatment first-line drug treatment
                                                                                                                           Additional clinical finding unresectable
                                                                                                                           Population 3
                                                                                                                           Condition oesophageal squamous cell carcinoma (can be recurrent)
                                                                                                                           Line of treatment second-line drug treatment after chemotherapy containing at least a fluoropyrimidine drug plus a platinum drug
                                                                                                                           Additional clinical finding unresectable
C14683              P14683         CN14683          Adalimumab                                                             Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 14683
                                                                                                                           First continuing treatment
                                                    Etanercept                                                             Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment under this restriction;
                                                                                                                           Patient must be at least 18 years of age;
                                                                                                                           Must be treated by a rheumatologist.  or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
                                                                                                                           An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following
                                                                                                                           (a) an ESR measurement no greater than 25 mm per hour; or
                                                                                                                           (b) a CRP measurement no greater than 10 mg per L; or
                                                                                                                           (c) an ESR or CRP measurement reduced by at least 20% from baseline.
                                                                                                                           Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
                                                                                                                           The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
                                                                                                                           If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                           A patient