PBAC Public Summary Documents – November 2022

Page last updated: 27 October 2023

Public Summary Documents relating to the November 2022 PBAC meeting.

• Abiraterone and Methylprednisolone: Pack containing 120 tablets abiraterone (as acetate) 125 mg and 60 tablets methylprednisolone 4 mg; Yonsa® Mpred™
• Adalimumab: Injection 20 mg in 0.2 mL pre-filled syringe, 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 pen, Injection 80 mg in 0.8 mL pre-filled syringe; Humira® and Upadacitinib: Tablet 15 mg; Rinvoq®
• Amino Acid Formula with Vitamins and Minerals without Phenylalanine: Oral gel 85 g, 30 (PKU Squeezie); PKU Squeezie®
• Amino Acid Synthetic Formula Supplemented with Long Chain Polyunsaturated Fatty Acids, Medium Chain Triglycerides, 2’- Fucosyllactose and Lacto-N-Neotetraose: Oral powder 400 g; Alfamino®
• Asciminib: Tablet 20 mg, Tablet 40 mg; Scemblix®
• Avatrombopag: Tablet 20 mg; Doptelet®
• 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 - OOS June 2023
• Darolutamide: Tablet 300 mg; Nubeqa® - May 2023
• Deucravacitinib: Tablet 6 mg; Sotyktu®- March 2023
• Dostarlimab: Solution concentrate for I.V. infusion 500 mg in 10 mL; Jemperli®- March 2023
• Dupilumab: Injection 300 mg in 2 mL single dose autoinjector, Injection 200 mg in 1.14 mL single dose autoinjector; Dupixent®
• Elexacaftor with Tezacaftor and with Ivacaftor, and Ivacaftor: Pack containing 56 tablets elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 tablets ivacaftor 150 mg, Pack containing 56 tablets elexacaftor 50 mg with tezacaftor 25 mg and with ivacaftor 37.5 mg and 28 tablets ivacaftor 75 mg; Trikafta® - March 2023
• Empagliflozin: Tablet 10 mg; Jardiance® – OOS 2022
• Enfortumab Vedotin: Powder for I.V. infusion 20 mg, Powder for I.V. infusion 30 mg; Padcev® - OOS February 2023
• Etanercept: Injection 50 mg in 1 mL single use auto-injector, 4; Nepexto®
• 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® - OOS August 2023
• Glycomacropeptide Formula with Long Chain Polyunsaturated Fatty Acids and Docosahexaenoic Acid and Low in Phenylalanine: Oral liquid, 237 mL, 15 (PKU Sphere Liquid); PKU Sphere Liquid
• Infliximab: Solution for injection 120 mg in 1 mL pre-filled pen, Solution for injection 120 mg in 1 mL pre-filled syringe; Remsima® SC
• Lanreotide: Injection 60 mg (as acetate) in single dose pre-filled syringe, Injection 90 mg (as acetate) in single dose pre-filled syringe, Injection 120 mg (as acetate) in single dose pre-filled syringe; Mytolac®
• Lenacapavir: Tablet 300 mg, Pack containing 2 injection sets 463.5 mg in 1.5 mL; Sunlenca®
• Mavacamten: Capsule 2.5 mg, Capsule 5 mg, Capsule 10 mg, Capsule 15 mg; Camzyos®
• Mepolizumab: Injection 100 mg in 1 mL single dose pre-filled pen; Nucala®
• Midazolam: Oromucosal solution in pre-filled syringe 2.5 mg in 0.25 mL, Oromucosal solution in pre-filled syringe 5 mg in 0.5 mL, Oromucosal solution in pre-filled syringe 7.5 mg in 0.75 mL, Oromucosal solution in pre-filled syringe 10 mg in 1 mL; Zyamis®
• Mobocertinib: Capsule 40 mg; Exkivity®
• Nivolumab: Injection concentrate for I.V. infusion 40 mg in 4 mL, Injection concentrate for I.V. infusion 100 mg in 10 mL; Opdivo®
• Nivolumab plus Ipilimumab: Nivolumab: Injection concentrate for I.V. infusion 100 mg in 10 mL, Injection concentrate for I.V. infusion 40 mg in 4 mL; Opdivo®. Ipilimumab: Injection concentrate for I.V. infusion 200 mg in 40 mL, Injection concentrate for I.V. infusion 50 mg in 10 mL; Yervoy®
• Olaparib: Tablet 100 mg, Tablet 150 mg; Lynparza® - July 2023
• Onasemnogene Abeparvovec: Solution for injection, customised based on patient weight; Zolgensma®
• Ozanimod: Capsule 920 micrograms, Pack containing 4 capsules 230 micrograms and 3 capsules 460 micrograms: Zeposia®
• Patiromer: Sachet, 8.4 g powder for oral liquid, Sachet, 16.8 g powder for oral liquid; Veltassa®
• Pembrolizumab (cervical cancer): Solution concentrate for I.V. infusion 100 mg in 4 mL; Keytruda®
• Pembrolizumab (urothelial carcinoma): Solution concentrate for I.V. infusion 100 mg in 4 mL; Keytruda®
• Pneumococcal Polysaccharide Conjugate Vaccine, 20-Valent Adsorbed: 0.5 mL pre-filled syringe; Prevenar 20®
• Polatuzumab Vedotin: Powder for I.V. infusion 30 mg, Powder for I.V. infusion 140 mg; Polivy®
• Risedronic Acid: Tablet (enteric coated) containing risedronate sodium 35 mg; Actonel® EC- March 2023
• Selinexor: Tablet 20 mg; Xpovio®
• Selumetinib: Capsule 10 mg, Capsule 25 mg; Koselugo®
• Upadacitinib (nr-axSpA): Tablet 15 mg; Rinvoq® - March 2023

The following Section 19A Public Summary Documents were finalised out-of-session between July 2022 and November 2022 PBAC meetings.

• Dulaglutide: Injection 1.5 mg in 0.5 mL single dose pre-filled pen (s19A); Trulicity® (Netherlands) – OOS 2022
• Semaglutide: Solution for injection 2 mg in 1.5 mL pre-filled pen (s19A), Solution for injection 4 mg in 3 mL pre-filled pen (s19A); Ozempic® (UK) – OOS 2022

The following Public Summary Documents have been updated:

July 2022 PBAC meeting

• Risankizumab: Solution concentrate for I.V. infusion 600 mg in 10 mL, Injection 360 mg in 2.4 mL in pre-filled cartridge; Skyrizi®
• Ruxolitinib: Tablet 5 mg, Tablet 10 mg; Jakavi®
• Upadacitinib (ulcerative colitis): Tablet 15 mg, Tablet 30 mg, Tablet 45 mg; Rinvoq®
• Vosoritide: Powder for injection 0.4 mg with diluent, Powder for injection 0.56 mg with diluent, Powder for injection 1.2 mg with diluent; Voxzogo®