Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p160
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 160/162)
Character Range: 15470616–15477318

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.
                                                                                                         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.
C14563              P14563         CN14563          Fremanezumab                                         Treatment-resistant migraine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 14563
                                                                                                         Continuing treatment
                                                                                                         Must be treated by a neurologist; or
                                                                                                         Must be treated by a general practitioner in consultation with a neurologist; AND
                                                                                                         Patient must not be undergoing concurrent treatment with the following PBS benefits:
                                                                                                          (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must have achieved and maintained at least 50% reduction from baseline in the number of migraine headache days per month; AND
                                                                                                         Patient must continue to be appropriately managed for medication overuse headache.
                                                                                                         Patient must have the number of migraine headache days per month documented in their medical records.
C14567              P14567         CN14567          Adalimumab                                           Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 14567
                                                                                                         First continuing treatment
                                                                                                         Must be treated by a rheumatologist; or
                                                                                                         Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                                         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.
                                                                                                         An adequate response to treatment is defined as
                                                                                                         an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
                                                                                                         AND either of the following
                                                                                                         (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                         (b) a reduction in the number of the following active joints, from at least 4, by at least 50%
                                                                                                         (i) elbow, wrist,