| 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 |
| TRIPTORELIN |
Diphereline® |
IPSEN PTY LTD |
Treatment with gonadotrophin releasing hormone (GnRH) agonist |
Nov 2026 |
Pending PBAC outcome |
| AMINO ACID FORMULA WITH VITAMINS AND MINERALS WITHOUT VALINE, LEUCINE AND ISOLEUCINE |
MSUD express 15® |
VITAFLO AUSTRALIA PTY LIMITED |
Short-chain Enoyl co-A Hydratase (ECHS1) deficiency and 3-Hydroxyisobutyryl co-A Hydrolase
(HIBCH) deficiency |
Jul 2026 |
Pending PBAC outcome |
| AFLIBERCEPT |
Eydenzelt® |
CELLTRION HEALTHCARE AUSTRALIA PTY LTD |
Branch retinal vein occlusion with macular oedema; Central retinal vein occlusion
with macular oedema; Diabetic macular oedema; Subfoveal choroidal neovascularisation
due to age-related macular degeneration |
Jul 2026 |
Pending PBAC outcome |
| ANIFROLUMAB |
Saphnelo® |
ASTRAZENECA PTY LTD |
Systemic lupus erythematosus (SLE) |
Jul 2026 |
Pending PBAC outcome |
| BLINATUMOMAB |
Blincyto® |
AMGEN AUSTRALIA PTY LIMITED |
Acute lymphoblastic leukaemia (ALL) Precursor B-cell ALL (Pre-B-cell ALL) |
Jul 2026 |
Pending PBAC outcome |
| AZACITIDINE |
- Azacitidine Accord®
- Azacitidine Dr Reddy’s®
- Azacitidine Euglia® Azacitidine Juno® Azacitidine MSN® Azacitidine Sandoz®
- Azacitidine SXP®
|
LICENSED STERILE COMPOUNDERS OF AUSTRALIA LIMITED |
Acute Myeloid Leukemia; Myelodysplastic syndrome; Chronic Myelomonocytic Leukemia |
Jul 2026 |
Pending PBAC outcome |
| DUPILUMAB |
Dupixent® |
SANOFI-AVENTIS AUSTRALIA PTY LTD |
Chronic severe atopic dermatitis |
Jul 2026 |
Pending PBAC outcome |
| ELTROMBOPAG |
Revolade® |
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Severe aplastic anaemia Severe thrombocytopenia |
Jul 2026 |
Pending PBAC outcome |
| DELGOCITINIB |
Anzupgo® |
LEO PHARMA PTY LTD |
Chronic hand eczema (CHE) |
Jul 2026 |
Pending PBAC outcome |
| ETONOGESTREL |
Implanon NXT® |
ORGANON PHARMA PTY LTD |
Contraception |
Jul 2026 |
Pending PBAC outcome |
| USTEKINUMAB |
Steqeyma® |
CELLTRION HEALTHCARE AUSTRALIA PTY LTD |
Severe chronic plaque psoriasis; Severe psoriatic arthritis; Severe Crohn disease;
Complex refractory fistulising Crohn disease; Moderate to severe ulcerative colitis |
Jul 2026 |
Pending PBAC outcome |
| ONASEMNOGENE ABEPARVOVEC |
OAV101 IT® |
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Spinal muscular atrophy (SMA) |
Jul 2026 |
Pending PBAC outcome |
| TEPROTUMUMAB |
Tepezza® |
AMGEN AUSTRALIA PTY LIMITED |
Thyroid eye disease (TED) |
Jul 2026 |
Pending PBAC outcome |
| GUSELKUMAB |
Tremfya® |
JANSSEN-CILAG PTY LTD |
Severe Crohn disease (CD) |
Jul 2026 |
Pending PBAC outcome |
| PROGESTERONE |
Utrogestan® |
BESINS HEALTHCARE AUSTRALIA PTY LTD |
Unexplained threatened miscarriage |
Jul 2026 |
Pending PBAC outcome |
| DEPEMOKIMAB |
Exdensur® |
GLAXOSMITHKLINE AUSTRALIA PTY LTD |
Uncontrolled severe eosinophilic asthma |
Jul 2026 |
Pending PBAC outcome |
| EPCORITAMAB |
Epkinly® |
LICENSED STERILE COMPOUNDERS OF AUSTRALIA LIMITED |
Relapsed or refractory diffuse large B-cell lymphoma |
Jul 2026 |
Pending PBAC outcome |
| CLOZAPINE |
Clozaril® |
VIATRIS PTY LTD |
Schizophrenia |
Jul 2026 |
Pending PBAC outcome |
| SEBELIPASE ALFA |
Kanuma® |
ALEXION PHARMACEUTICALS PTY LIMITED |
Late-onset lysosomal acid lipase deficiency (LAL-D) |
Jul 2026 |
Pending PBAC outcome |
| VUTRISIRAN |
Amvuttra® |
MEDISON PHARMA AUSTRALIA PTY LIMITED |
Transthyretin amyloid cardiomyopathy (ATTR-CM) |
Jul 2026 |
Pending PBAC outcome |
| EVOLOCUMAB |
Repatha® |
AMGEN AUSTRALIA PTY LIMITED |
Non-familial hypercholesterolaemia; Familial heterozygous hypercholesterolaemia; Familial
homozygous hypercholesterolaemia |
Jul 2026 |
Pending PBAC outcome |
| PEGZILARGINASE |
Loargys® |
ILLUMINATE HEALTH CONSULTING PTY LIMITED |
Arginase 1 deficiency (ARG1-D) |
Jul 2026 |
Pending PBAC outcome |
| BELANTAMAB MAFODOTIN |
Blenrep® |
GLAXOSMITHKLINE AUSTRALIA PTY LTD |
Relapsed and/or refractory multiple myeloma (MM) |
Jul 2026 |
Pending PBAC outcome |
| AMINO ACID FORMULA WITH VITAMINS AND MINERALS WITHOUT LYSINE AND LOW IN TRYPTOPHAN |
- GA1 Anamix Infant®
- GA1 Anamix Junior®
|
NUTRICIA AUSTRALIA PTY LTD |
Pyridoxine‑Dependent Epilepsy (PDE) |
Jul 2026 |
Pending PBAC outcome |
| MIFEPRISTONE AND MISOPROSTOL |
MS-2 Step® |
MS HEALTH PTY LTD |
Termination of an intra-uterine pregnancy |
Jul 2026 |
Pending PBAC outcome |
| DARATUMUMAB |
Darzalex SC® |
LICENSED STERILE COMPOUNDERS OF AUSTRALIA LIMITED |
Newly diagnosed systemic light chain amyloidosis; Untreated multiple myeloma; Relapsed
and/or refractory multiple myeloma |
Jul 2026 |
Pending PBAC outcome |
| DONIDALORSEN |
Zirdawny® |
OTSUKA AUSTRALIA PHARMACEUTICAL PTY. LTD |
Hereditary angioedema |
Jul 2026 |
Pending PBAC outcome |
| PIRTOBRUTINIB |
Jaypirca® |
ELI LILLY AUSTRALIA PTY LTD |
Chronic lymphocytic leukaemia (CLL) Small lymphocytic lymphoma (SLL) |
Jul 2026 |
Pending PBAC outcome |
| ELEXACAFTOR WITH TEZACAFTOR AND WITH IVACAFTOR, AND IVACAFTOR |
Trikafta® |
VERTEX PHARMACEUTICALS (AUSTRALIA) PTY. LTD. |
Cystic fibrosis |
Jul 2026 |
Pending PBAC outcome |
| FINERENONE |
Kerendia® |
BAYER AUSTRALIA LTD |
Heart failure |
Jul 2026 |
Pending PBAC outcome |
| ESTRADIOL WITH PROGESTERONE |
Bijuva® |
THERAMEX AUSTRALIA PTY LTD |
Vasomotor symptoms in post-menopausal women |
Jul 2026 |
Pending PBAC outcome |
| TEPLIZUMAB |
Tzield® |
SANOFI-AVENTIS AUSTRALIA PTY LTD |
Type 1 diabetes (T1D) |
Jul 2026 |
Pending PBAC outcome |
| USTEKINUMAB |
Yesintek® |
GENERIC HEALTH PTY LTD |
Severe chronic plaque psoriasis; Severe psoriatic arthritis; Severe Crohn disease;
Complex refractory fistulising Crohn disease; Moderate to severe ulcerative colitis |
Jul 2026 |
Pending PBAC outcome |
| AMIVANTAMAB |
Rybrevant SC® |
JANSSEN-CILAG PTY LTD |
Non-small cell lung cancer (NSCLC) |
Jul 2026 |
Pending PBAC outcome |
| BEMPEDOIC ACID BEMPEDOIC ACID WITH EZETIMIBE |
|
SEQIRUS (AUSTRALIA) PTY LTD |
Hypercholesterolaemia |
Jul 2026 |
Pending PBAC outcome |
| ATEZOLIZUMAB |
Tecentriq SC® |
LICENSED STERILE COMPOUNDERS OF AUSTRALIA LIMITED |
Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular
carcinoma; Extensive-stage small cell lung cancer; Resected early stage (Stage II
to IIIA) non-small cell lung cancer; Locally advanced or metastatic non-small cell
lung cancer; Stage IV (metastatic) non-small cell lung cancer |
Jul 2026 |
Pending PBAC outcome |
| BRIVARACETAM |
Briviact® |
UCB AUSTRALIA PROPRIETARY LIMITED |
Intractable focal onset seizures |
Jul 2026 |
Pending PBAC outcome |
| AMINO ACID FORMULA WITH VITAMINS AND MINERALS WITHOUT VALINE, LEUCINE AND ISOLEUCINE |
- MSUD Anamix Infant®
- MSUD Anamix Junior®
- MSUD Lophlex LQ 20®
- MSUD Maxamum®
|
NUTRICIA AUSTRALIA PTY LTD |
Short-chain enoyl-CoA hydratase (ECHS1) deficiency |
Jul 2026 |
Pending PBAC outcome |
| ACALABRUTINIB |
Calquence® |
ASTRAZENECA PTY LTD |
Mantle cell lymphoma (MCL) |
Jul 2026 |
Pending PBAC outcome |
| ELACESTRANT |
Orserdu® |
A.MENARINI AUSTRALIA PTY LIMITED |
Breast cancer |
Jul 2026 |
Pending PBAC outcome |
| TISLELIZUMAB |
Tevimbra® |
BEONE MEDICINES AUS PTY LTD |
Gastro-oesophageal cancer |
Jul 2026 |
Pending PBAC outcome |
| APADAMTASE ALFA WITH CINAXADAMTASE ALFA (RECOMBINANT ADAMTS13) |
Adzynma® |
TAKEDA PHARMACEUTICALS AUSTRALIA PTY. LTD. |
Congenital thrombotic thrombocytopenic purpura (cTTP) |
Jul 2026 |
Pending PBAC outcome |
| METHOXSALEN |
Uvadex® |
HEALTH TECHNOLOGY ANALYSTS PTY LIMITED |
Cutaneous T-cell lymphoma (CTCL) Chronic graft versus host disease (cGVHD) |
Jul 2026 |
Pending PBAC outcome |
