Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p128
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 128/381)
Character Range: 12353083–12364305

must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of migraine days per month; AND
                                                                                                                                                                    Patient must continue to be appropriately managed for medication overuse headache.
                                                                                                                                                                    Patient must have the number of migraine days per month documented in their medical records.
C12035              P12035         CN12035          Panitumumab                                                                                                     Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 12035
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; or
                                                                                                                                                                    Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of treatment with first-line pembrolizumab for dMMR mCRC; AND
                                                                                                                                                                    Patient must not have progressive disease; AND
                                                                                                                                                                    The treatment must be as monotherapy; or
                                                                                                                                                                    The treatment must be in combination with chemotherapy; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
                                                                                                                                                                    Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
                                                                                                                                                                    Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.
C12045              P12045         CN12045          Cetuximab                                                                                                       Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 12045
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must have RAS wild-type metastatic colorectal cancer; AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less; AND
                                                                                                                                                                    The condition must have failed to respond to first-line chemotherapy; or
                                                                                                                                                                    The condition must have progressed following first-line treatment with pembrolizumab for dMMR mCRC; AND
                                                                                                                                                                    The treatment must be as monotherapy; or
                                                                                                                                                                    The treatment must be in combination with chemotherapy; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
                                                                                                                                                                    Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.
                                                                                                                                                                    Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.
C12049              P12049         CN12049          Infliximab                                                                                                      Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more 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
                                                                                                                                                                    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; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                                                    Patient must have had a break in treatment of 5 years or more