PBAC Public Summary Documents - March 2018

Page last updated: 9 November 2018

Public Summary Documents relating to the March 2018 PBAC meeting.

• Abatacept: 125mg SC injection (auto-injector and pre-filled syringe) and 250mg vial for IV infusion; Orencia®
• Adrenaline: I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector; AdrenaJect®
• Adrenaline: I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector; Emerade®
• Amino acid formula with vitamins and minerals without valine, leucine and isoleucine: Oral liquid, 87 mL, 30 (MSUD Cooler 10); oral liquid, 130 mL, 30 (MSUD Cooler 15); oral liquid, 174 mL, 30 (MSUD Cooler 20); MSUD Cooler® 10, MSUD Cooler® 15, MSUD Cooler® 20. Amino acid formula with vitamins and minerals without phenyalanine and tyrosine: oral liquid, 87 mL, 30 (TYR Cooler 10); oral liquid, 130 mL, 30 (TYR Cooler 15); oral liquid, 174 mL, 30 (TYR Cooler 20); TYR Cooler® 10, TYR Cooler® 15, TYR Cooler® 20. Amino acid formula with vitamins and minerals without methionine: oral liquid, 87 mL, 30 (HCU Cooler 10); oral liquid, 130 mL, 30 (HCU Cooler 15); oral liquid, 174 mL, 30 (HCU Cooler 20); HCU Cooler® 10, HCU Cooler® 15, HCU Cooler® 20
• Apomorphine: Injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen; Movapo®pen
• Apremilast: Pack containing 4 tablets of 10 mg, 4 tablets of 20 mg and 19 tablets of 30; Tablet 30 mg; Otezla®
• Asfotase alfa rch: Injection, 18 mg in 0.45 mL, 28 mg in 0.7 mL, 40 mg in 1 mL and 80 mg in 0.8 mL, vial; Strensiq®
• Baricitinib: Tablet 2 mg, Tablet 4 mg; Olumiant®
• Bictegravir + emtricitabine + tenofovir alafenamide fixed dose combination: Tablet containing tenofovir alafenamide 25 mg with emtricitabine 200 mg and bictegravir 50 mg; Biktarvy® - Updated 26 October 2018
• Benralizumab: 30 mg in 1 mL injection; Fasenra®
• Benralizumab: 30 mg in 1 mL solution for injection prefilled syringe; Fasenra®
• Biosimilar medicines: considering brand equivalence /substitution
• Botulinum toxin type A purified neurotoxin complex: Lyophilised powder for injection, 100 units; Botox®
• Calcipotriol with betamethasone dipropionate: Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g; Daivobet®
• Carfilzomib: Powder for I.V. infusion 10 mg; Kyprolis®
• Cetuximab: Solution for I.V. infusion 100 mg in 20 mL, Solution for I.V. infusion 500 mg in 100 mL; Erbitux®
• Cladribine: Tablet, 10 mg; Mavenclad®
• Dexamethasone: Intravitreal injection 700 micrograms; Ozurdex®
• Eculizumab: Solution concentrate for I.V. infusion 300 mg in 30 mL; Soliris®
• Ertugliflozin: Tablet containing 5 mg ertugliflozin, Tablet containing 15 mg ertugliflozin; Steglatro®; ertugliflozin with metformin: Tablet containing 2.5 mg ertugliflozin with 500 mg metformin hydrochloride, Tablet containing 2.5 mg ertugliflozin with 1 g metformin hydrochloride, Tablet containing 7.5 mg ertugliflozin with 500 mg metformin hydrochloride, Tablet containing 7.5 mg ertugliflozin with 1 g metformin hydrochloride; Segluromet®
• Etanercept: Injection 50 mg in 1 mL single use auto-injector, 4, Injection 50 mg in 1 mL single use pre-filled syringes, 4; Erelzi®
• Evolocumab: Injection 420 mg in 3.5 mL single use pre-filled cartridge, Injection 140 mg in 1 mL single use pre-filled pen; Repatha®
• Filgrastim: Injection 120 micrograms in 0.2 mL single use pre‑filled syringe, Injection 300 micrograms in 0.5 mL single use pre‑filled syringe, Injection 480 micrograms in 0.5 mL single use pre‑filled syringe; Nivestim® - Updated 9 November 2018
• Follitropin alfa: Injection 75 I.U. in 0.125 mL pre-filled pen, Injection 150 I.U. in 0.25 mL pre-filled pen, Injection 225 I.U. in 0.375 mL pre-filled pen, Injection 300 I.U. in 0.5 mL pre-filled pen, Injection 450 I.U. in 0.75 mL pre-filled pen; Bemfola®
• Grazoprevir with elbasvir: Tablet containing grazoprevir 100 mg with elbasvir 50 mg; Zepatier®
• Guselkumab: Injection 100 mg in 1 mL single use pre-filled syringe; Tremfya® - Updated 26 October 2018
• Hydromorphone hydrochloride: Oral liquid, 1 mg/mL; Dilaudid®
• Ibrutinib: Capsule 140 mg; Imbruvica®
• Inactivated influenza vaccine (surface antigen), adjuvanted, suspension for injection, 15mcg in 0.5mL, Fluad®
• Inactivated trivalent influenza vaccine (Split Virion) suspension for injection, 180mcg single dose in 0.5mL, Fluzone® High-Dose,
• Insulin degludec with insulin aspart: Injections, cartridges, 70 units-30 units per mL, 3 mL, 5, Injections, pre-filled pen, 70 units-30 units per mL, 3 mL, 5; Ryzodeg®
• Insulin glargine with lixisenatide: Injections (human analogue), cartridges, insulin glargine 100 units per mL with lixisenatide 50 microgram per mL, 3 mL, 5; Injections (human analogue), cartridges, insulin glargine 100 units per mL with lixisenatide 33 microgram per mL, 3 mL, 5; Soliqua®
• Irinotecan (nanoliposomal): 43 mg in 10 mL Injection; Onivyde®
• Lenalidomide: Capsule, 5 mg, 10 mg and 15 mg; Revlimid®
• Lenvatinib: Capsule 4 mg (as mesilate), Capsule 10 mg (as mesilate); Lenvima®
• Liraglutide: Injection, 3 mL pre-filled, multi-dose, disposable pen, 6 mg/mL; 2 pen pack; Victoza®
• Meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and Y (infants): Pre-filled syringe, 0.5mL; Nimenrix®
• Meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and Y(adolescents): Pre-filled syringe, 0.5mL; Nimenrix®
• Mepolizumab: Powder for injection 100 mg; Nucala®
• Nandrolone decanoate: Injection 50 mg in 1 mL ampoule; Deca-Durabolin®
• Nicotine: Gum 2 mg, Gum 4 mg, Lozenge 2 mg, Lozenge 4 mg; Nicotinell®
• Nivolumab: 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®
• Obinutuzumab: Solution for I.V. infusion, 1000 mg in 40 mL; GAZYVA® - Updated 9 November 2018
• Olaparib: Tablet 150 mg, Tablet 100 mg; Lynparza™
• Omalizumab: prefilled syringe, 150 mg/mL; Xolair®
• Palbociclib: Capsules, 75 mg, 100 mg, 125 mg; Ibrance®
• Pegfilgrastim: Injection 6 mg in 0.6 mL, single use pre-filled syringe; Neulasta®
• Pembrolizumab (melanoma): Powder for injection 50 mg, solution concentrate for I.V. infusion 100 mg in 4 mL; Keytruda®
• Pembrolizumab (NSCLC): Powder for injection 50 mg, solution concentrate for I.V. infusion 100 mg in 4 mL; Keytruda®
• Perfluorohexyloctane: Eye drops containing perfluorohexyloctane 1 mL per mL, 3 mL; NovaTears®
• Pirfenidone: Tablet 267 mg, 90, Tablet 801 mg, 90; Esbriet® - March 2018
• Pneumococcal polysaccharide conjugate 13-valent adsorbed vaccine: Pre-filled syringe, 0.5 mL; Prevenar 13®
• Protein hydrosylate formula with medium chain triglycerides: Oral powder 450 g (Aptamil Gold + Pepti-Junior); Aptamil Gold + Pepti-Junior®
• Quetiapine: Tablet 25 mg (as fumarate); Multiple Brands - Updated 26 October 2018
• Ramucirumab: 100 mg in 10 mL vial, 500 mg in 50 mL vial; Cyramza®
• Ranibizumab: 2.3 mg/0.23 mL, 0.23 mL vial and 1.65 mg/0.165 mL, pre-filled syringe; Lucentis® - Updated 9 November 2018
• Ranibizumab: 2.3 mg/0.23 mL, 0.23 mL vial and 1.65 mg/0.165 mL, pre-filled syringe; Lucentis® - Updated 9 November 2018
• Ranolazine: Tablet (modified release), 375 mg, 500 mg, 750 mg; Ranexa®
• Regorafenib: Tablet 40 mg (as monohydrate); Stivarga®
• Ribociclib: Tablet, 200 mg; Kisqali®
• Rituximab: Solution for I.V. infusion 100 mg in 10 mL, 2 vials, Solution for I.V. infusion 500 mg in 50 mL, 1 vial; Riximyo®
• Rituximab: Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL; Mabthera SC
• Sapropterin: Tablet (soluble) containing sapropterin dihydrochloride 100 mg; Kuvan®
• Sodium phenylbutyrate: Sugar-coated spheres, 483 mg sodium phenylbutyrate per gram; Pheburane®
• Sofosbuvir with velpatasvir and voxilaprevir: 400mg/100mg/100mg tablets; VOSEVI® - Updated 26 October 2018
• Tiotropium: Solution for oral inhalation 2.5 µg per actuation, 60; Spiriva® Respimat®
• Tolvaptan: Pack containing 28 tablets 15 mg and 28 tablets 45 mg, Pack containing 28 tablets 30 mg and 28 tablets 60 mg, Pack containing 28 tablets 30 mg and 28 tablets 90 mg; JINARC®
• Tramadol hydrochloride with paracetamol: Tablet containing tramadol hydrochloride 37.5 mg with paracetamol 325 mg; Zaldiar®
• Trifluridine with tipiracil: Tablet, 15 mg trifluridine with 6.14 mg tipiracil, 20 mg trifluridine with 8.19 mg tipiracil; Lonsurf®
• Triglycerides, long chain with glucose polymer: Oral liquid 250 mL, 18, Oral liquid, 1L, 6; ProZero®