Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p4
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 4/381)
Character Range: 11412166–11425206

for this condition; AND
                                                                                                                                                                    The condition must be unresectable locally advanced disease or metastatic disease; AND
                                                                                                                                                                    The condition must be World Health Organisation (WHO) grade 1 or 2; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
                                                                                                                                                                    WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
C10076              P10076         CN10076          Sapropterin                                                                                                     Hyperphenylalaninaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Must be treated by a metabolic physician; AND
                                                                                                                                                                    Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.
                                                                                                                                                                    Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.
C10077              P10077         CN10077          Lanreotide                                                                                                      Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 10077
                                                                                                                                                                    The condition must be unresectable locally advanced disease or metastatic disease; AND
                                                    Octreotide                                                                                                      The condition must be World Health Organisation (WHO) grade 1 or 2; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
                                                                                                                                                                    WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
C10093              P10093         CN10093          Fingolimod                                                                                                      Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10093
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not show continuing progression of disability while on treatment with this drug; AND
                                                                                                                                                                    Patient must have demonstrated compliance with, and an ability to tolerate this therapy;
                                                                                                                                                                    Patient must weigh 40 kg or less.
C10095              P10095         CN10095          Prednisolone with phenylephrine                                                                                 Severe eye inflammation
                                                                                                                                                                    Patient must have had a cataract removed in the treated eye; or
                                                                                                                                                                    Patient must be scheduled for cataract surgery in the treated eye;
                                                                                                                                                                    Patient must identify as Aboriginal or Torres Strait Islander.
C10116              P10116         CN10116          Dolutegravir with abacavir and lamivudine                                                                       HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 10116
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised therapy for HIV infection.
C10119              P10119         CN10119          Nivolumab                                                                                                       Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                    Initial