| ARIPIPRAZOLE |
Abilify Asimtufii® |
LUNDBECK AUSTRALIA PTY LTD |
Schizophrenia |
Nov 2026 |
Pending PBAC outcome |
| BAXDROSTAT |
Baxfendy® |
ASTRAZENECA PTY LTD |
Hypertension |
Nov 2026 |
Pending PBAC outcome |
| GLYCOMACROPEPTIDE AND ESSENTIAL AMINO ACID FORMULA WITH VITAMINS, MINERALS, AND LOW
IN TYROSINE AND PHENYLALANINE |
Tylactin Build 20® |
CORTEX HEALTH PTY LTD |
Tyrosinaemia |
Nov 2026 |
Pending PBAC outcome |
| RANIBIZUMAB |
Raniviz® |
ACTOR PHARMACEUTICALS PTY LTD |
Branch retinal vein occlusion with macular oedema Central retinal vein occlusion with
macular oedema Proliferative diabetic retinopathy and/or diabetic macular oedema Subfoveal
choroidal neovascularisation |
Nov 2026 |
Pending PBAC outcome |
| ENFORTUMAB VEDOTIN |
PADCEV® |
ASTELLAS PHARMA AUSTRALIA PTY LTD |
Muscle-invasive bladder cancer (MIBC) |
Nov 2026 |
Pending PBAC outcome |
| FREMANEZUMAB |
Ajovy® |
TEVA PHARMA AUSTRALIA PTY LTD |
Treatment-resistant migraine |
Nov 2026 |
Pending PBAC outcome |
| AVACINCAPTAD PEGOL |
Izervay® |
ASTELLAS PHARMA AUSTRALIA PTY LTD |
Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) |
Nov 2026 |
Pending PBAC outcome |
| PEMBROLIZUMAB |
Keytruda SC® |
MERCK SHARP & DOHME (AUSTRALIA) PTY LTD |
Cancer |
Nov 2026 |
Pending PBAC outcome |
| IVOSIDENIB |
Tibsovo® |
SERVIER LABORATORIES (AUST.) PTY. LTD. |
Acute myeloid leukaemia (AML) |
Nov 2026 |
Pending PBAC outcome |
| AFLIBERCEPT |
Eylea® |
BAYER AUSTRALIA LTD |
Branch retinal vein occlusion (BRVO) with macular oedema Central retinal vein occlusion
(CRVO) with macular oedema |
Nov 2026 |
Pending PBAC outcome |
| GLYCOMACROPEPTIDE AND ESSENTIAL AMINO ACIDS WITH VITAMINS AND MINERALS |
PKU Build 20® |
CORTEX HEALTH PTY LTD |
Phenylketonuria (PKU) |
Nov 2026 |
Pending PBAC outcome |
| CANNABIDIOL |
Epidyolex® |
JAZZ PHARMACEUTICALS ANZ PTY LTD |
Seizures associated with tuberous sclerosis complex (TSC) |
Nov 2026 |
Pending PBAC outcome |
| MIFEPRISTONE AND MISOPROSTOL |
MS-2 Step® |
MS Health Pty Ltd |
Management of miscarriage |
Nov 2026 |
Pending PBAC outcome |
| NUSINERSEN |
Spinraza® |
BIOGEN AUSTRALIA PTY LTD |
Spinal muscular atrophy (SMA) |
Nov 2026 |
Pending PBAC outcome |
| TEZEPELUMAB |
Tezspire® |
ASTRAZENECA PTY LTD |
Chronic rhinosinusitis with nasal polyps (CRSwNP) |
Nov 2026 |
Pending PBAC outcome |
| VADADUSTAT |
Vafseo® |
STADA PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Anaemia associated with intrinsic renal disease |
Nov 2026 |
Pending PBAC outcome |
| DENOSUMAB |
- Denolia®
- Deskelta®
- Dexeva®
- Dostiva®
|
ACCORD HEALTHCARE PTY. LTD. |
Osteoporosis Bone metastases Giant cell tumour of bone |
Nov 2026 |
Pending PBAC outcome |
| BUDESONIDE |
Jorveza® |
DR FALK PHARMA AUSTRALIA PTY LTD |
Eosinophilic oesophagitis |
Nov 2026 |
Pending PBAC outcome |
| AUMOLERTINIB |
Velarion® |
Glenmark Pharmaceuticals (Australia) Pty Limited |
Non-small cell lung cancer (NSCLC) |
Nov 2026 |
Pending PBAC outcome |
| APIXABAN |
Axoran® |
ACTOR PHARMACEUTICALS PTY LTD |
Prevention of stroke or systemic embolism Prevention of recurrent venous thromboembolism
Deep vein thrombosis Pulmonary embolism Prevention of venous thromboembolism |
Nov 2026 |
Pending PBAC outcome |
| ACORAMIDIS |
Attruby® |
DKSH HEALTHCARE AUSTRALIA PTY LIMITED |
Transthyretin amyloid cardiomyopathy (ATTR-CM) |
Nov 2026 |
Pending PBAC outcome |
| EPCORITAMAB |
Epkinly® |
ABBVIE PTY LTD |
Relapsed or refractory (R/R) follicular lymphoma (FL) |
Nov 2026 |
Pending PBAC outcome |
| SOTAGLIFLOZIN |
Inpefa® |
VIATRIS PTY LTD |
Heart failure |
Nov 2026 |
Pending PBAC outcome |
| GLYCOMACROPEPTIDE AND ESSENTIAL AMINO ACIDS WITH VITAMINS AND MINERALS |
PKU Restore® |
CORTEX HEALTH PTY LTD |
Phenylketonuria (PKU) |
Nov 2026 |
Pending PBAC outcome |
| SECUKINUMAB |
Cosentyx® |
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Severe chronic plaque psoriasis Ankylosing spondylitis Severe psoriatic arthritis
Non-radiographic axial spondyloarthritis Moderate to severe hidradenitis suppurativa |
Nov 2026 |
Pending PBAC outcome |
| IMIQUIMOD |
|
INOVA PHARMACEUTICALS (AUSTRALIA) PTY LIMITED |
Superficial basal cell carcinoma (BCC) |
Nov 2026 |
Pending PBAC outcome |
| PEMBROLIZUMAB |
Keytruda® |
MERCK SHARP & DOHME (AUSTRALIA) PTY LTD |
Muscle-invasive bladder cancer (MIBC) eligible for cisplatin-based chemotherapy |
Nov 2026 |
Pending PBAC outcome |
| METRELEPTIN |
Myalepta® |
CHIESI AUSTRALIA PTY LTD |
Lipodystrophy |
Nov 2026 |
Pending PBAC outcome |
| NERANDOMILAST |
Jascayd® |
BOEHRINGER INGELHEIM PTY LTD |
Progressive pulmonary fibrosis (PPF) |
Nov 2026 |
Pending PBAC outcome |
| SPARSENTAN |
Filspari® |
SEQIRUS (AUSTRALIA) PTY LTD |
Immunoglobulin A nephropathy (IgAN) |
Nov 2026 |
Pending PBAC outcome |
| TORIPALIMAB |
Zytorvi® |
Dr Reddy's Laboratories (Australia) Pty Ltd |
Oesophageal squamous cell carcinoma (OSCC) |
Nov 2026 |
Pending PBAC outcome |
| HYALURONIC ACID |
- Opticalm Intensive®
- Opticalm Fast®
- Opticalm Ultra®
|
ARO INVESTMENTS PTY LIMITED |
Severe dry eye syndrome |
Nov 2026 |
Pending PBAC outcome |
| TAFAMIDIS |
Vyndamax® |
PFIZER AUSTRALIA PTY LTD |
Transthyretin amyloid cardiomyopathy (ATTR-CM) |
Nov 2026 |
Pending PBAC outcome |
| ZOLBETUXIMAB |
Vyloy® |
ASTELLAS PHARMA AUSTRALIA PTY LTD |
Gastric or gastroesophageal junction (G/GOJ) cancer |
Nov 2026 |
Pending PBAC outcome |
| DURVALUMAB |
Imfinzi® |
ASTRAZENECA PTY LTD |
Non-small cell lung cancer (NSCLC) |
Nov 2026 |
Pending PBAC outcome |
| DATOPOTAMAB DERUXTECAN |
Datroway® |
ASTRAZENECA PTY LTD |
Breast cancer |
Nov 2026 |
Pending PBAC outcome |
| PLOZASIRAN |
Redemplo® |
LUCID HEALTH CONSULTING PTY LTD |
Familial chylomicronaemia syndrome (FCS) |
Nov 2026 |
Pending PBAC outcome |
| EFGARTIGIMOD ALFA |
Vyvgart® |
ARGENX AUSTRALIA PTY. LTD. |
Chronic inflammatory demyelinating polyneuropathy (CIDP) |
Nov 2026 |
Pending PBAC outcome |
| RANIBIZUMAB |
Susvimo® |
ROCHE PRODUCTS PTY LTD |
Subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration
(AMD) |
Nov 2026 |
Pending PBAC outcome |
| EVOLOCUMAB |
Repatha® |
AMGEN AUSTRALIA PTY LIMITED |
Non-familial hypercholesterolaemia Familial heterozygous hypercholesterolaemia Familial
homozygous hypercholesterolaemia |
Nov 2026 |
Pending PBAC outcome |
| SEPIAPTERIN |
SEPHIENCE® |
PTC THERAPEUTICS AUSTRALIA PTY LIMITED |
Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) |
Nov 2026 |
Pending PBAC outcome |
| GLYCOMACROPEPTIDE AND ESSENTIAL AMINO ACIDS WITH VITAMINS AND MINERALS |
PKU Glytactin RTD 15® |
CORTEX HEALTH PTY LTD |
Phenylketonuria (PKU) |
Nov 2026 |
Pending PBAC outcome |
| SEMAGLUTIDE |
Wegovy® |
NOVO NORDISK PHARMACEUTICALS PTY. LIMITED |
Established atherosclerotic cardiovascular disease (eASCVD) with obesity |
Nov 2026 |
Pending PBAC outcome |
| GLYCOMACROPEPTIDE AND ESSENTIAL AMINO ACIDS WITH VITAMINS AND MINERALS |
Camino Pro Bettermilk® |
CORTEX HEALTH PTY LTD |
Phenylketonuria (PKU) |
Nov 2026 |
Pending PBAC outcome |
| GLYCOMACROPEPTIDE AND ESSENTIAL AMINO ACIDS WITH VITAMINS AND MINERALS |
Tylactin RTD® |
CORTEX HEALTH PTY LTD |
Tyrosinaemia |
Nov 2026 |
Pending PBAC outcome |
| PEMBROLIZUMAB |
Keytruda® |
MERCK SHARP & DOHME (AUSTRALIA) PTY LTD |
Muscle-invasive bladder cancer (MIBC) ineligible for cisplatin-based chemotherapy |
Nov 2026 |
Pending PBAC outcome |
| NERANDOMILAST |
Jascayd® |
BOEHRINGER INGELHEIM PTY LTD |
Idiopathic pulmonary fibrosis (IPF) |
Nov 2026 |
Pending PBAC outcome |
| LENIOLISIB |
Joenja® |
PHARMING AUSTRALIA PTY LTD |
Activated PI3K delta syndrome (APDS) |
Nov 2026 |
Pending PBAC outcome |
| SOTATERCEPT |
Winrevair® |
MERCK SHARP & DOHME (AUSTRALIA) PTY LTD |
Pulmonary arterial hypertension (PAH) |
Nov 2026 |
Pending PBAC outcome |
| RANIBIZUMAB |
|
GENERIC HEALTH PTY LTD |
Branch retinal vein occlusion with macular oedema Central retinal vein occlusion with
macular oedema Proliferative diabetic retinopathy and/or diabetic macular oedema Subfoveal
choroidal neovascularisation |
Nov 2026 |
Pending PBAC outcome |
| CANNABIDIOL |
Epidyolex® |
JAZZ PHARMACEUTICALS ANZ PTY LTD |
Dravet syndrome (DS) Lennox-Gastaut syndrome (LGS) |
Nov 2026 |
Pending PBAC outcome |
| TAPINAROF |
Vtama® |
ORGANON PHARMA PTY LTD |
Atopic dermatitis |
Nov 2026 |
Pending PBAC outcome |
| GLYCOMACROPEPTIDE AND ESSENTIAL AMINO ACIDS WITH VITAMINS AND MINERALS |
PKU Build 10® |
CORTEX HEALTH PTY LTD |
Phenylketonuria (PKU) |
Nov 2026 |
Pending PBAC outcome |
| GLYCOMACROPEPTIDE AND ESSENTIAL AMINO ACIDS WITH VITAMINS AND MINERALS |
PKU Glytactin RTD 15 Lite® |
CORTEX HEALTH PTY LTD |
Phenylketonuria (PKU) |
Nov 2026 |
Pending PBAC outcome |
| TRASTUZUMAB DERUXTECAN |
Enhertu® |
ASTRAZENECA PTY LTD |
Breast cancer |
Nov 2026 |
Pending PBAC outcome |
| DROSPIRENONE |
Slindelle® |
BESINS HEALTHCARE AUSTRALIA PTY LTD |
Contraception Endometriosis associated pelvic pain (EAPP) |
Nov 2026 |
Pending PBAC outcome |
| ADALIMUMAB |
Amgevita® |
AMGEN AUSTRALIA PTY LIMITED |
Immune-mediated inflammatory disease |
Nov 2026 |
Pending PBAC outcome |