Summary of the agenda for the PBAC March 2015 meeting

Michael Wonder - Wonder Drug Consulting Pty Ltd

www.maestrodatabase.com

The PBAC will consider 60 submissions (39 major & 21 minor) at its next scheduled meeting in March (Table 1).

Table 1. Submissions by medicine type

Medicine category	Number	Percentage
PBS medicine or vaccine	52	87
PBS medicinal preparation*	5	8
NIP vaccine	3	5
LSDP medicine**	0	0

PBS =Pharmaceutical Benefits Scheme; NIP = National Immunisation Program; LSDP = Life Saving Drugs Program. * Blood reagent strips and nutritional supplements; ** Section 100 or LSDP

The Committee will also consider three reports from the Drug Utilisation Subcommittee (hepatitis B, Crohn’s disease and pulmonary arterial hypertension).

23 of the 60 submissions are for new medicines/vaccines (Table 2).

Table 2. Submissions by listing type

Listing type	Number	Percentage
New medicine	23	38
New vaccine	1	2
New indication	13	22
New combination product	4	7
Restriction change	4	7
New strength	4	7
New formulation	11	18
Review	0	0

Some of the 23 new medicines and four new combination products are yet to be assessed/appraised by other HTA agencies (i.e. the National Institute of Health and Clinical Excellence (NICE) in England, the Canadian Drug Expert Committee (CDEC) / Expert Review Committee (ERC) in Canada and the Institute for Quality and Efficiency in Health Care or IQWiG in Germany); these are outlined in Table 3.

Table 3. New medicines yet to be assessed/appraised by other HTA agencies

Medicine	Sponsor	Disease/condition	Submission attempt
Apremilast (Otezla)	Celgene	Psoriasis	Initial
Apremilast (Otezla)	Celgene	Psoriatic arthritis	Initial
Asuneprevir (Sunvepra)	BMS	Hepatitis C	Initial
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (Hexaxim)	Sanofi	Vaccination	Initial
Evolucumab	Amgen	Hypercholesterolaemia	Initial
Ledipasvir with sofosbuvir (Harvoni)	Gilead	Hepatitis C	Initial
Netupitant with palonosetron (Akynzeo)	Specialised Therapeutics	Nausea & vomiting	Initial
Nintedanib (Ofev)	Boehringer Ingelheim	Non small-cell lung cancer	Initial
Nintedanib (Ofev)	Boehringer Ingelheim	Idiopathic pulmonary fibrosis	Initial
Pembrolizumab (Keytruda)	MSD	Malignant melanoma	Initial
Secukinumab (Cosentyx)	Novartis	Psoriasis	Initial

9 (15%) of the 60 submissions are resubmissions; most are for new listings or new indications (Table 4).

Table 4. Resubmissions by listing type

Listing type	Number	Percentage
New listing	6	67
New indication	2	22
New combination product	1	11

This is the fifth submission for panitumumab (Vectibix) for patients with colorectal cancer. This is the third submission for follitropin alfa with lutropin alfa (Pergoveris) for female infertility and ruxolitinib phosphate (Jakavi) for patients with myelofibrosis.  The PBAC will consider a second submission for the remaining six medicines.

More than a third of all submissions are for medicines in WHO ATC main group L (Table 5).

Table 5. Medicines by WHO ATC main group

WHO ATC main group*	Number	Percentage
Alimentary	4	7
Blood	1	2
Cardiovascular	3	5
Dermatological	1	2
Genitourinary	4	7
Systemic hormonal	0	0
Anti-infective	9	15
Anti-neoplastic and immunomodulatory	24	40
Musculoskeletal	1	2
Nervous	5	8
Anti-parasitic	0	0
Respiratory	0	0
Sensory	3	5
Various**	5	8

*WHO ATC = World Health Organization Anatomical Therapeutic Chemical; **All five are medicinal preparations. 

Celgene, Novartis and Pfizer are the leading applicants with four submissions each (Table 6).

Table 6. Submissions by applicant

Sponsor	Number of submissions	Number of major submissions
Celgene	4	4
Novartis	4	3
Pfizer	4	3
Takeda	3	3
BMS	3	3

Two (5 %) of the 39 major submissions are from new applicants; submissions from all new applicants are outlined in Table 7.

Table 7. Submissions from new applicants

Sponsor	Number of submissions	Number of major submissions
Lawley	1	1
Clinect	1	1
Cortex Health	1	0

Appendix

Table 8. Submissions for new medicines

Medicine	Sponsor	Disease/condition	Submission attempt
Apremilast (Otezla)	Celgene	Psoriasis	Initial
Apremilast (Otezla)	Celgene	Psoriatic arthritis	Initial
Asuneprevir (Sunvepra)	BMS	Hepatitis C	Initial
Bendamustine hydrochloride (Ribomustin)	Janssen-Cilag	Non-Hodgkin's lymphoma	Initial
Bendamustine hydrochloride (Ribomustin)	Janssen-Cilag	Non-Hodgkin's lymphoma	Initial
Canakinumab (Ilaris)	Novartis	Juvenile idiopathic arthritis	Initial
Daclatasvir dihydrochloride (Daklinza)	BMS	Hepatitis C	Initial
Evolucumab	Amgen	Hypercholesterolaemia	Initial
Febuxostat (Adenuric)	Menarini	Gout	Resubmission
Idelalisib (Zydelig)	Celgene	Chronic lymphocytic leukaemia	Initial
Idelalisib (Zydelig)	Celgene	Non-Hodgkin's lymphoma	Initial
Lurasidone hydrochloride (Latuda)	Commercial Eyes	Schizophrenia	Resubmission
Lutropin alfa (Luveris)*	Merck Serono	Female infertility	Initial
Nintedanib (Ofev)	Boehringer Ingelheim	Non small-cell lung cancer	Initial
Nintedanib (Ofev)	Boehringer Ingelheim	Idiopathic pulmonary fibrosis	Initial
Obinutuzumab (Gazyva)	Roche	Chronic lymphocytic leukaemia	Resubmission
Pembrolizumab (Keytruda)	MSD	Malignant melanoma	Initial
Ribavirin (Ibavyr)*	Clinect	Hepatitis C	Initial
Ruxolitinib phosphate (Jakavi)	Novartis	Myelofibrosis	Resubmission
Secukinumab (Cosentyx)	Novartis	Psoriasis	Initial
Sofosbuvir (Sovaldi)	GIlead	Hepatitis C	Resubmission
Tofacitinib citrate (Xeljanz)	Pfizer	Rheumatoid arthritis	Initial
Vedolizumab (Entyvio)	Takeda	Crohn’s disease	Initial
Vedolizumab (Entyvio)	Takeda	Ulcerative colitis	Resubmission

* Listed as a component of a fixed-dose combination product but not as a discrete medicine.

Table 9. Submissions for new indications

Medicine	Sponsor	Disease/condition	Submission attempt
Apixaban (Eliquis)	BMS	Venous thromboembolism	Initial
Brentuximab vedotin (Adcetris)	Takeda	Hodgkin's lymphoma	Initial
Dapagliflozin propanediol monohydrate (Forxiga)	AstraZeneca	Type 2 diabetes mellitus	Initial
Dexamethasone (Ozurdex)	Allergan	Macular oedema	Initial
Etanercept (Enbrel)	Pfizer	Axial spondyloarthritis	Initial
Exenatide (Byetta)	AstraZeneca	Type 2 diabetes mellitus	Initial
Lignocaine (Versatis)	CSL	Pain	Initial
Panitumumab (Vectibix)	Amgen	Colorectal cancer	Resubmission
Pneumococcal polysaccharide conjugate vaccine (13 valent, adsorbed) (Prevenar 13)*	Pfizer	Vaccination	Initial
Propranolol hydrochloride (Hemangiol)	Pierre Fabre	Hemangioma	Initial
Regorafenib monohydrate (Stivarga)**	Bayer	Gastro-intestinal stromal tumour	Initial
Rituximab (MabThera)	Roche	Granulomatosis with polyangiitis	Initial
Rituximab (MabThera)	Roche	Microscopic polyangiitis	Initial
Sorafenib tosylate (Nexavar)	Bayer	Thyroid cancer	Resubmission

* Vaccine; ** Submission/s for colorectal cancer coded as new medicine.

Table 10. New combination products

Medicine	Sponsor	Disease/condition	Submission attempt
Follitropin alfa with lutropin alfa (Pergoveris)	MSD	Female infertility	Resubmission
Glycomacropeptide and essential amino acids with vitamins and minerals (PKU Glytactin RTD10, PKU Glytactin RTD15)*	Cortex Health	Nutrition	Initial
Ledipasvir with sofosbuvir (Harvoni)	Gilead	Hepatitis C	Initial
Netupitant with palonosetron (Akynzeo)	Specialised Therapeutics	Nausea and vomiting	Initial

* Medicinal preparation.

Table 11. Selected new formulations

Medicine	Sponsor	Disease/condition	Submission attempt
Aflibercept (Eylea)	Bayer	Age-related macular degeneration	Initial
Insulin glargine (Basaglar/Basaglar KwikPen)	Eli Lilly	Diabetes mellitus	Initial
Posaconazole (Noxafil)	MSD	Fungal infection	Initial
Testosterone (Testogel)	Besins	Male hypogonadism	Initial
Testosterone (Andro Forte 5)	Lawley	Androgen deficiency	Initial