Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p87
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 87/381)
Character Range: 12084837–12095635

procedures - Streamlined Authority Code 11784
                                                                                                                                                                    Must be treated by a neurologist; AND
                                                                                                                                                                    Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with botulinum toxin type A neurotoxin; AND
                                                                                                                                                                    Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with botulinum toxin type A neurotoxin; AND
                                                                                                                                                                    Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of headache days per month after two treatment cycles (each of 12 weeks duration) in order to be eligible for continuing PBS-subsidised treatment; AND
                                                                                                                                                                    Patient must be appropriately managed by his or her practitioner for medication overuse headache, prior to initiation of treatment with botulinum toxin;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.
C11785              P11785         CN11785          Obinutuzumab                                                                                                    Follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                                                                    Maintenance therapy
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug under the rituximab refractory initial restriction; AND
                                                                                                                                                                    The condition must be CD20 positive; AND
                                                                                                                                                                    The condition must have been refractory to treatment with rituximab; AND
                                                                                                                                                                    Patient must have demonstrated a partial or complete response to PBS-subsidised re-induction treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be maintenance therapy; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
C11787              P11787         CN11787          Obinutuzumab                                                                                                    Stage II bulky or Stage III/IV follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                                                                    Maintenance therapy
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug under the previously untreated initial restriction; AND
                                                                                                                                                                    The condition must be CD20 positive; AND
                                                                                                                                                                    Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be maintenance therapy; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
C11815              P11815         CN11815          Obinutuzumab                                                                                                    Stage II bulky or Stage III/IV follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                                                                    Induction treatment
                                                                                                                                                                    The condition must be CD20 positive; AND
                                                                                                                                                                    The condition must be previously untreated; AND
                                                                                                                                                                    The condition must be symptomatic;