Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p41
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 41/381)
Character Range: 11764876–11778706

with formoterol                                                                                   Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 11057
                                                                                                                                                                    Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids;
                                                                                                                                                                    Patient must be aged 18 years or older.
C11066              P11066         CN11066          Dolutegravir with lamivudine                                                                                    HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 11066
                                                                                                                                                                    Continuing or change of treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised therapy for HIV infection.
C11069              P11069         CN11069          Venetoclax                                                                                                      Chronic lymphocytic leukaemia (CLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND
                                                                                                                                                                    The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment under this restriction with this drug for this condition, whichever comes first.
C11070              P11070         CN11070          Protein formula with vitamins and minerals, and low in potassium, phosphorus, calcium, chloride and vitamin A   Chronic renal failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 11070
                                                                                                                                                                    Patient must be a child aged 3 years or older;
                                                                                                                                                                    Patient must require treatment with a low protein and a low phosphorus diet.  or
                                                                                                                                                                    Patient must require treatment with a low protein, low phosphorus and low potassium diet.
C11077              P11077         CN11077          Levetiracetam                                                                                                   Partial epileptic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 11077
                                                                                                                                                                    The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or
                                                                                                                                                                    Patient must be a woman of childbearing potential; AND
                                                                                                                                                                    Patient must be unable to take a solid dose form of levetiracetam; AND
                                                                                                                                                                    The treatment must not be given concomitantly with brivaracetam, except for cross titration.
C11081              P11081         CN11081          Lamotrigine                                                                                                     Epileptic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 11081
                                                                                                                                                                    The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs.  or
                                                                                                                                                                    Patient must be a woman of childbearing potential.
C11089              P11089         CN11089          Ixekizumab                                                                                                      Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)
                                                    Secukinumab                                                                                                     Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                                                    Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                                                                    The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
                                                                                                                                                                     (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are