PBAC Public Summary Documents – July 2023

Page last updated: 1 March 2024

Public Summary Documents relating to the July 2023 PBAC meeting.

• Abiraterone and methylprednisolone: Pack containing 120 tablets abiraterone (as acetate) 125 mg and 30 tablets methylprednisolone 4 mg; Yonsa Mpred®
• Acalabrutinib: Tablet 100 mg; Calquence®
• Adalimumab: Injection 40 mg in 0.4 mL pre-filled pen, Injection 40 mg in 0.4 mL pre-filled syringe, Injection 80 mg in 0.8 mL pre-filled syringe; Ardalicip®
• Atogepant: Tablet 60 mg; Aquipta®
• Avacopan: Capsule 10 mg; Tavneos®
• Cabotegravir: Suspension for injection, 600 mg in 3 mL; Apretude® - September 2023
• Calcipotriol with betamethasone: Foam containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g; Enstilar®
• Dapagliflozin: Tablet 10 mg; Forxiga®
• Daunorubicin with cytarabine: Powder for I.V. infusion containing daunorubicin 44 mg and cytarabine 100 mg; Vyxeos®
• Dupilumab: Injection 200 mg in 1.14 mL single dose pre filled syringe, Injection 300 mg in 2 mL single dose pre filled syringe; Dupixent®
• Durvalumab: Solution concentrate for I.V. infusion 120 mg in 2.4 mL vial, Solution concentrate for I.V. infusion 500 mg in 10 mL vial; Imfinzi®
• Enoxaparin: Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre filled syringe, Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre filled syringe, Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre filled syringe, Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre filled syringe, Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre filled syringe, Injection containing enoxaparin sodium 120 mg (12,000 I.U. anti-Xa) in 0.8 mL pre filled syringe, Injection containing enoxaparin sodium 150 mg (15,000 I.U. anti-Xa) in 1 mL pre filled syringe; ExaraneTM Exarane ForteTM
• Esketamine: Nasal spray solution 28 mg in 0.2 mL; Spravato®
• Ixekizumab: Injection 80 mg in 1 mL single dose pre-filled pen, Taltz®
• Lumacaftor with ivacaftor: Sachet containing granules, lumacaftor 150 mg with ivacaftor 188 mg, Sachet containing granules, lumacaftor 75 mg with ivacaftor 94 mg, Sachet containing granules, lumacaftor 100 mg with ivacaftor 125 mg; Orkambi®
• Mavacamten: Capsule 2.5 mg, Capsule 5 mg, Capsule 10 mg, Capsule 15 mg; Camzyos®
• Mirikizumab: Solution concentrate for I.V. infusion 300 mg in 15 mL, Solution for injection 100 mg in 1 mL pre filled pen; Omvoh®
• Mobocertinib: Capsule 40 mg; Exkivity®
• Molnupiravir: Capsule 200 mg; Lagevrio® - November 2023
• Nivolumab (non-small cell lung cancer): Injection concentrate for I.V. infusion 40 mg in 4 mL vial, Injection concentrate for I.V. infusion 100 mg in 10 mL vial; Opdivo®
• Nivolumab (gastro-oesophageal cancer): Injection concentrate for I.V. infusion 40 mg in 4 mL, Injection concentrate for I.V. infusion 100 mg in 10 mL; Opdivo®
• Nusinersen: Solution for injection 12 mg in 5 mL; Spinraza®
• Olipudase alfa: Powder for I.V. infusion 20 mg; Xenpozyme®
• Onasemnogene abeparvovec: Solution for injection, customised based on patient weight; Zolgensma®
• Patisiran: Solution concentrate for I.V. infusion 10 mg in 5 mL; Onpattro® - September 2023
• Pembrolizumab: Solution concentrate for I.V. infusion 100 mg in 4 mL; Keytruda®
• Pomalidomide: Capsule 1 mg, Capsule 2 mg; PomolideTM
• Ravulizumab (PNH): Solution concentrate for I.V. infusion 300 mg in 3 mL, Solution concentrate for I.V. infusion 1,100 mg in 11 mL; Ultomiris®
• Sacituzumab govitecan: Powder for injection 180 mg; Trodelvy®
• Secukinumab: Solution for injection 300 mg in 2 mL pre-filled syringe, Solution for injection 150 mg in 1 mL pre-filled syringe, Solution for injection 150 mg in 1 mL pre-filled pen, Solution for injection 300 mg in 2 mL pre-filled pen; Cosentyx®
• Selpercatinib: Capsule 40 mg, Capsule 80 mg; Retevmo®
• Somapacitan: Injection 5 mg in 1.5 mL pre-filled pen, Injection 10 mg in 1.5 mL pre-filled pen Injection 15 mg in 1.5 mL pre-filled pen; Sogroya®
• Sonidegib: Capsule 200 mg; Odomzo®
• Tafamidis: Capsule 61 mg; Vyndamax®
• Tagraxofusp: Solution concentrate for I.V. infusion 1 mg in 1 mL; Elzonris®
• Tirzepatide: Injection 2.5 mg in 0.5 mL pre-filled pen, Injection 5 mg in 0.5 mL pre-filled pen, Injection 7.5 mg in 0.5 mL pre-filled pen, Injection 10 mg in 0.5 mL pre-filled pen, Injection 12.5 mg in 0.5 mL pre-filled pen, Injection 15 mg in 0.5 mL pre-filled pen; Mounjaro®
• Trientine: Capsule containing trientine dihydrochloride 250 mg (equivalent to 166.7 mg trientine); Trientine Dr.Reddy
• Upadacitinib: Tablet 15 mg, Tablet 30 mg, Tablet 45 mg; Rinvoq®
• Ustekinumab: Solution concentrate for I.V. infusion 130 mg in 26 mL, Solution for injection 90 mg in 1 mL pre-filled syringe; Stelara®
• Varicella zoster virus recombinant vaccine: Injection [1 vial] & adjuvant substance diluent [0.5 mL vial]; Shingrix®

The following Public Summary Document was finalised out-of-session between March 2023 and July 2023 meetings.

• Interim Report of the Post-market Review of Opioid Dependence Treatment Program medicines – OOS 2023

The following Public Summary Documents have been updated:

July 2022 PBAC meeting

• Trastuzumab deruxtecan: Powder for I.V. infusion 100 mg; Enhertu®Trastuzumab deruxtecan: Powder for I.V. infusion 100 mg; Enhertu®

November 2022 PBAC meeting

• Budesonide with Glycopyrronium and Formoterol: Pressurised inhalation containing budesonide 160 micrograms with glycopyrronium 7.2 micrograms and formoterol fumarate dihydrate 5 micrograms per dose, 120 doses; Breztri Aerosphere® DFP-EvoCap
• Fremanezumab: Solution for injection 225 mg in 1.5 mL single dose pre-filled syringe, Solution for injection 225 mg in 1.5 mL single dose autoinjector; Ajovy®
• Olaparib: Tablet 100 mg, Tablet 150 mg; Lynparza®

December 2022 PBAC meeting

• Zoledronic acid: Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL; APO-Zoledronic Acid®

March 2023 PBAC meeting

• Budesonide: Tablet 500 micrograms (orally disintegrating), Tablet 1 mg (orally disintegrating); Jorveza®Budesonide: Tablet 500 micrograms (orally disintegrating), Tablet 1 mg (orally disintegrating); Jorveza®
• Niraparib: Capsule 100 mg; Zejula®
• Ravulizumab(aHUS): Solution concentrate for I.V. infusion 300 mg in 3 mL vial, Solution concentrate for I.V. infusion 1.1 g in 11 mL vial; Ultomiris®
• Relatlimab and nivolumab: Solution concentrate for I.V. infusion containing 80 mg relatlimab and 240 mg nivolumab in 20 mL vial; Opdualag®