Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p79
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 79/381)
Character Range: 12031675–12043032

PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                                                                                                    Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
                                                                                                                                                                    Patient must have a total PCDAI score of 40 points or less; AND
                                                                                                                                                                    Patient must not receive more than 24 weeks of treatment under this restriction;
                                                                                                                                                                    Patient must be aged 6 to 17 years inclusive;
                                                                                                                                                                    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)].  or
                                                                                                                                                                    Must be treated by a paediatrician.  or
                                                                                                                                                                    Must be treated by a specialist paediatric gastroenterologist.
                                                                                                                                                                    The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
                                                                                                                                                                    The PCDAI assessment must be no more than 4 weeks old at the time of application.
                                                                                                                                                                    Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
C11746              P11746         CN11746          Clonazepam                                                                                                      For use in patients receiving palliative care

C11753              P11753         CN11753          Buprenorphine                                                                                                   Severe disabling pain                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                                                                    Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or
                                                    Morphine                                                                                                        Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance; AND
                                                                                                                                                                    Patient must be undergoing palliative care.
                                                    Oxycodone

                                                    Oxycodone with naloxone

C11755              P11755         CN11755          Obinutuzumab                                                                                                    Follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                                                                    Re-induction treatment
                                                                                                                                                                    Patient must not have previously received PBS-subsidised obinutuzumab; AND
                                                                                                                                                                    The condition must be CD20 positive; AND
                                                                                                                                                                    The condition must be refractory to treatment with rituximab for this condition; AND
                                                                                                                                                                    The condition must be symptomatic; AND
                                                                                                                                                                    The treatment must be for re-induction treatment purposes only; AND
                                                                                                                                                                    The treatment must be in combination with bendamustine; AND
                                                                                                                                                                    The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.
                                                                                                                                                                    The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.
                                                                                                                                                                    A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under
                                                                                                                                                                    i) the previously untreated induction treatment restriction; or
                                                                                                                                                                    ii) the rituximab-refractory re-induction restriction.
C11759              P11759         CN11759          Adalimumab                                                                                                      Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                                                                    Must be treated by a gastroenterologist (code 87); or
                                                                                                                                                                    Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or