| 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 |
| BUDESONIDE WITH GLYCOPYRRONIUM AND FORMOTEROL |
Breztri Aerosphere® |
ASTRAZENECA PTY LTD |
Severe asthma |
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 |
| ONASEMNOGENE ABEPARVOVEC |
OAV101 IT® |
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Spinal muscular atrophy (SMA) |
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 |
| 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 / CINAXADAMTASE ALFA |
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 |
| BRENTUXIMAB VEDOTIN |
Adcetris® |
TAKEDA PHARMACEUTICALS AUSTRALIA PTY. LTD. |
Hodgkin lymphoma |
Jul 2026 |
Pending PBAC outcome |
| AMINO ACID FORMULA WITH VITAMINS AND MINERALS WITHOUT VALINE, LEUCINE, ISOLEUCINE
AND SUPPLEMENTED WITH ARACHIDONIC ACID AND DOCOSAHEXAENOIC ACID |
MSUD explore5® |
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 |
| LONCASTUXIMAB TESIRINE |
Zynlonta® |
SWEDISH ORPHAN BIOVITRUM PTY LTD |
Diffuse large B-cell lymphoma (DLBCL) |
Jul 2026 |
Pending PBAC outcome |
| PEGCETACOPLAN |
Empaveli® |
SWEDISH ORPHAN BIOVITRUM PTY LTD |
Complement 3 glomerulopathy (C3G) or primary immune complex membranoproliferative
glomerulonephritis (IC-MPGN) |
Jul 2026 |
Pending PBAC outcome |
| BIRCH TRITERPENES |
Filsuvez® |
CHIESI AUSTRALIA PTY LTD |
Dystrophic or junctional epidermolysis bullosa (EB) |
Jul 2026 |
Pending PBAC outcome |
| ODEVIXIBAT |
Bylvay® |
IPSEN PTY LTD |
Alagille syndrome (ALGS) |
Jul 2026 |
Pending PBAC outcome |
| RANIBIZUMAB |
Susvimo® |
Roche Products Pty Ltd |
Neovascular (wet) age-related macular degeneration |
May 2026 |
Pending PBAC outcome |
| TUCATINIB |
TUKYSA® |
Pfizer Australia Pty Ltd |
Breast cancer |
May 2026 |
Pending PBAC outcome |
| MIGALASTAT |
Galafold® |
AMICUS THERAPEUTICS PTY LTD |
Fabry Disease |
May 2026 |
Pending PBAC outcome |
| TILDRAKIZUMAB |
Ilumya® |
SUN PHARMA ANZ PTY LTD |
Severe chronic plaque psoriasis |
Mar 2026 |
Recommended |
| USTEKINUMAB |
Ardelya® |
SANDOZ PTY LTD |
Severe chronic plaque psoriasis Severe psoriatic arthritis |
Mar 2026 |
Recommended |
| TAFAMIDIS |
Vyndamax® |
PFIZER AUSTRALIA PTY LTD |
Transthyretin amyloid cardiomyopathy (ATTR-CM) |
Mar 2026 |
Not Recommended |
| CANAKINUMAB |
Ilaris® |
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Colchicine-resistant or intolerant Familial Mediterranean Fever (crFMF) |
Mar 2026 |
Recommended |
| AVACINCAPTAD PEGOL |
Izervay® |
ASTELLAS PHARMA AUSTRALIA PTY LTD |
Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) |
Mar 2026 |
Recommended |
| DUPILUMAB |
Dupixent® |
SANOFI-AVENTIS AUSTRALIA PTY LTD |
Chronic obstructive pulmonary disease (COPD) |
Mar 2026 |
Recommended |
| LANREOTIDE |
Lacreo |
SUN PHARMA ANZ PTY LTD |
Acromegaly Functional carcinoid tumour Non-functional gastroenteropancreatic neuroendocrine
tumour (GEP-NET) |
Mar 2026 |
Recommended |
| GLYCOMACROPEPTIDE FORMULA WITH DOCOSAHEXAENOIC ACID AND LOW PHENYLALANINE |
PKU GMPro® Delight |
NUTRICIA AUSTRALIA PTY LIMITED |
Phenylketonuria (PKU) |
Mar 2026 |
Recommended |
| EFGARTIGIMOD ALFA |
Vyvgart® |
ARGENX AUSTRALIA PTY. LTD. |
Chronic inflammatory demyelinating polyneuropathy (CIDP) |
Mar 2026 |
Not Recommended |
| DURVALUMAB |
Imfinzi® |
ASTRAZENECA PTY LTD |
Gastric cancer (GC) or gastro-oesophageal junction cancer (GOJC) |
Mar 2026 |
Recommended |
| ADALIMUMAB |
Yuflyma® |
CELLTRION HEALTHCARE AUSTRALIA PTY LTD |
Moderate to severe ulcerative colitis Severe juvenile idiopathic arthritis Severe
chronic plaque psoriasis Severe Crohn disease Vision-threatening non-infectious uveitis |
Mar 2026 |
Recommended |
| ASCIMINIB |
Scemblix® |
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Chronic myeloid leukaemia (CML) |
Mar 2026 |
Recommended |
| EFGARTIGIMOD ALFA |
Vyvgart® |
ARGENX AUSTRALIA PTY. LTD. |
Generalised myasthenia gravis (gMG) |
Mar 2026 |
Recommended |
| OBINUTUZUMAB |
Gazyva® |
ROCHE PRODUCTS PTY LTD |
Lupus nephritis |
Mar 2026 |
Recommended |
| UPADACITINIB |
Rinvoq® |
ABBVIE PTY LTD |
Fistulising Crohn’s disease (FCD) |
Mar 2026 |
Recommended |
| PEGCETACOPLAN |
Empaveli® |
SWEDISH ORPHAN BIOVITRUM PTY LTD |
Complement 3 glomerulopathy (C3G) or primary immune complex membranoproliferative
glomerulonephritis (IC-MPGN) |
Mar 2026 |
Not Recommended |
| RISPERIDONE |
Uzedy® |
TEVA PHARMA AUSTRALIA PTY LTD |
Schizophrenia |
Mar 2026 |
Recommended |
| TECLISTAMAB |
Tecvayli® |
JANSSEN-CILAG PTY LTD |
Relapsed or refractory multiple myeloma (RRMM) |
Mar 2026 |
Recommended |
| SELPERCATINIB |
Retevmo® |
ELI LILLY AUSTRALIA PTY LTD |
Medullary thyroid cancer (MTC) |
Mar 2026 |
Recommended |
| NEMOLIZUMAB |
Nemluvio® |
GALDERMA AUSTRALIA PTY LTD |
Atopic dermatitis |
Mar 2026 |
Recommended |
| INOTUZUMAB OZOGAMICIN |
Besponsa® |
PFIZER AUSTRALIA PTY LTD |
Acute lymphoblastic leukaemia (ALL) |
Mar 2026 |
Advice Provided |
| ODEVIXIBAT |
Bylvay® |
IPSEN PTY LTD |
Alagille syndrome (ALGS) |
Mar 2026 |
Not Recommended |
| MEPOLIZUMAB |
Nucala® |
GLAXOSMITHKLINE AUSTRALIA PTY LTD |
Chronic obstructive pulmonary disease (COPD) |
Mar 2026 |
Recommended |
| ENZALUTAMIDE |
Xtandi® |
ASTELLAS PHARMA AUSTRALIA PTY LTD |
Non-metastatic hormone sensitive prostate cancer (nmHSPC) |
Mar 2026 |
Recommended |
| ROMIDEPSIN |
Romidepsin-Reach |
REACH PHARMACEUTICALS PTY LTD |
Relapsed or refractory peripheral T-cell lymphoma |
Mar 2026 |
Recommended |
| AMIVANTAMAB |
Rybrevant® |
JANSSEN-CILAG PTY LTD |
Non-small cell lung cancer (NSCLC) |
Mar 2026 |
Recommended |
| ADALIMUMAB |
Amgevita® |
AMGEN AUSTRALIA PTY LIMITED |
Crohn disease Ulcerative colitis Active juvenile idiopathic arthritis Complex refractory
fistulising Crohn disease Active rheumatoid arthritis Psoriatic arthritis Ankylosing
spondylitis Chronic plaque psoriasis Hidradenitis suppurativa |
Mar 2026 |
Recommended |
| RUXOLITINIB |
Jakavi® |
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Myelofibrosis Graft versus host disease Polycythemia vera |
Mar 2026 |
Recommended |
| BIRCH TRITERPENES |
Filsuvez® |
CHIESI AUSTRALIA PTY LTD |
Dystrophic or junctional epidermolysis bullosa (EB) |
Mar 2026 |
Not Applicable |
| PEGVALIASE |
Palynziq® |
BIOMARIN PHARMACEUTICAL AUSTRALIA PTY LTD |
Phenylketonuria (PKU) |
Mar 2026 |
Deferred |
| TARLATAMAB |
Imdelltra® |
AMGEN AUSTRALIA PTY LIMITED |
Extensive-stage small cell lung cancer (ES-SCLC) |
Mar 2026 |
Not Recommended |
| TRASTUZUMAB DERUXTECAN |
Enhertu® |
ASTRAZENECA PTY LTD |
Breast cancer |
Mar 2026 |
Not Recommended |
| CANNABIDIOL |
Epidyolex® |
JAZZ PHARMACEUTICALS ANZ PTY LTD |
Severe myoclonic epilepsy in infancy (Dravet syndrome) |
Mar 2026 |
Recommended |
| ENOXAPARIN |
Clexane® Safety-Lock Clexane® Forte Safety-Lock |
SANOFI-AVENTIS AUSTRALIA PTY LTD |
Prevention and treatment of thrombo-embolic disorders Haemodialysis |
Mar 2026 |
Not Applicable |
| RILUZOLE |
Teglutik® |
ASTERI PHARMA PTY LTD |
Amyotrophic lateral sclerosis |
Mar 2026 |
Advice Provided |
| INCOBOTULINUMTOXINA |
Xeomin® |
MERZ AUSTRALIA PTY LTD |
Moderate to severe spasticity of the lower limb in adults following an acute event |
Mar 2026 |
Recommended |
| LONCASTUXIMAB TESIRINE |
Zynlonta® |
SWEDISH ORPHAN BIOVITRUM PTY LTD |
Diffuse large B-cell lymphoma (DLBCL) |
Mar 2026 |
Not Recommended |
| OMALIZUMAB |
Omlyclo® |
CELLTRION HEALTHCARE AUSTRALIA PTY LTD |
Uncontrolled severe asthma Uncontrolled severe allergic asthma Severe chronic spontaneous
urticaria |
Mar 2026 |
Recommended |
| NIVOLUMAB |
Opdivo® |
BRISTOL-MYERS SQUIBB AUSTRALIA PTY LTD |
Malignant melanoma Non-Small Cell Lung Cancer (NSCLC) Renal Cell Carcinoma (RCC) Squamous
Cell Carcinoma of the Head and Neck (SCCHN) Urothelial Carcinoma (UC) Oesophageal
/ Gastro-oesophageal cancers(OC/GC) |
Mar 2026 |
Recommended |
| CICLOSPORIN |
Vevye® |
AFT PHARMACEUTICALS (AU) PTY LTD |
Dry eye disease with keratitis |
Mar 2026 |
Recommended |
| EDARAVONE |
Radicava® |
TEVA PHARMA AUSTRALIA PTY LTD |
Amyotrophic lateral sclerosis (ALS) |
Mar 2026 |
Recommended |
| ASCIMINIB |
Scemblix® |
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Chronic myeloid leukaemia (CML) |
Mar 2026 |
Not Applicable |
| ADRENALINE (EPINEPHRINE) |
Neffy® |
SEQIRUS (AUSTRALIA) PTY LTD |
Acute allergic reaction with anaphylaxis |
Mar 2026 |
Recommended |
| BUROSUMAB |
Crysvita ® |
KYOWA KIRIN AUSTRALIA PTY LTD |
Tumour induced osteomalacia (TIO) |
Mar 2026 |
Recommended |
| VORASIDENIB |
Voranigo® |
SERVIER LABORATORIES (AUST.) PTY. LTD. |
Astrocytoma or oligodendroglioma |
Mar 2026 |
Recommended |
| TOFERSEN |
Qalsody® |
BIOGEN AUSTRALIA PTY LTD |
Amyotrophic lateral sclerosis (ALS) |
Mar 2026 |
Recommended |
| TIRZEPATIDE |
Mounjaro® Mounjaro® KwikPen® |
ELI LILLY AUSTRALIA PTY LTD |
Type 2 diabetes mellitus |
Mar 2026 |
Recommended |
| TACROLIMUS |
aZematop® |
ARROTEX PHARMACEUTICALS PTY LTD |
Atopic dermatitis |
Mar 2026 |
Recommended |