Summary of the agenda for the PBAC July 2015 meeting

The PBAC will consider 49 submissions (28 major & 21 minor) at its next scheduled meeting in July (Table 1).

Table 1. Submissions by medicine type

Medicine category	Number	Percentage
PBS medicine or vaccine	43	88
PBS medicinal preparation*	2	4
NIP vaccine	4	8
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 five reports from the Drug Utilisation Subcommittee for medicines for

• ·      Attention deficit hyperactivity disorder (3 medicines)
• ·      Age-related macular degeneration (3 medicines)
• ·      Benign prostatic hyperplasia (2 medicines)
• ·      Angioedema (1 medicine)
• ·      Idiopathic thombocytopaenic purpura (2 medicines)

9 of the 49 submissions are for new medicines/vaccines (Table 2).

Table 2. Submissions by listing type

Listing type	Number	Percentage
New medicine	9	19
New vaccine	1	2
New indication	14	29
New combination product	5	10
Restriction change	9	18
New strength	3	6
New formulation	8	16
Review	0	0

16 (33%) of the 49 submissions are resubmissions; most are for new listings or new indications (Table 3).

Table 3. Resubmissions by listing type

Listing type	Number	Percentage
New listing	4	25
New indication	7	44
New combination product	1	6
New vaccine	1	6
New formulation	3	19

This is the fourth submission for exenatide (Bydureon) for patients with diabetes mellitus. This is the third submission for adailimumab (Humira) for ulcerative colitis, sorafenib tosylate (Nexavar) for patients with thyroid cancer and trastuzumab (Herceptin) for patients with gastric cancer.  The PBAC will consider a second submission for the remaining ten medicines.

Just under 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	12	24
Blood	1	3
Cardiovascular	2	6
Dermatological	0	0
Genitourinary	1	2
Systemic hormonal	0	0
Anti-infective	7	15
Anti-neoplastic and immunomodulatory	13	27
Musculoskeletal	1	2
Nervous	3	6
Anti-parasitic	0	0
Respiratory	5	10
Sensory	1	2
Various**	3	6

*WHO ATC = World Health Organization Anatomical Therapeutic Chemical; **Two of the three are medicinal preparations. 

AbbVie, AstraZeneca, Janssen-Cilag and Sanofi are the leading applicants with four submissions each (Table 6).

Table 6. Submissions by applicant

Sponsor	Number of submissions	Number of major submissions
AbbVie	4	3
AstraZeneca	4	2
Janssen-Cilag	4	2
Sanofi (including Genzyme)	3	4

Appendix

Table 7. Submissions for new medicines

Medicine	Sponsor	Disease/condition	Submission attempt
Bendamustine hydrochloride (Ribomustin)	Janssen-Cilag	Non-Hodgkin's lymphoma	Resubmission
Bendamustine hydrochloride (Ribomustin)	Janssen-Cilag	Non-Hodgkin's lymphoma (mantle cell lymphoma)	Resubmission
Carglumic acid (Carbaglu)	Emerge Health	Hyperammonaemia	Initial
Eliglustat tartrate (Cerdelga)	Genzyme	Gaucher disease	Initial
Ibrutinib (Imbruvica)	Janssen-Cilag	Chronic lymphocytic leukaemia	Initial
Ibrutinib (Imbruvica)	Janssen-Cilag	Non-Hodgkin's lymphoma	Initial
Nadroparin calcium (Fraxiparin, Fraxiparin Forte)	Aspen	Venous thromboembolism	Initial
Nitisinone (Orfadin)	Menarini	Tyrosinaemia	Resubmission
Nivolumab (Opdivo)	BMS	Malignant melanoma	Initial
Ponatinib hydrochloride (Iclusig)	Specialised Therapeutics	Chronic myeloid leukaemia	Resubmission
Ponatinib hydrochloride (Iclusig)	Specialised Therapeutics	Acute lymphoblastic leukaemia	Resubmission
Ribavirin (Ibavyr)*	Clinect	Hepatitis C	Resubmission

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

Table 8. Submissions for new indications

Medicine	Sponsor	Disease/condition	Submission attempt
Adalimumab (Humira)	AbbVie	Ulcerative colitis	Resubmission
Diphtheria, tetanus and acellular pertussis vaccine (Triplacel)*	Sanofi	Vaccination	Initial
Pneumococcal polysaccharide conjugate vaccine (13 valent, adsorbed) (Prevenar 13)*	Pfizer	Vaccination	Resubmission
Riociguat (Adempas)	Bayer	Pulmonary arterial hypertension	Resubmission
Saxagliptin hydrochloride with metformin hydrochloride XR (Kombiglyze XR)	AstraZeneca	Type 2 diabetes mellitus	Initial
Saxagliptin hydrochloride (Onglyza)	AstraZeneca	Type 2 diabetes mellitus	Initial
Simeprevir sodium (Olysio)	Janssen-Cilag	Hepatitis C	Initial
Sitagliptin phosphate monohydrate (Januvia)	MSD	Type 2 diabetes mellitus	Initial
Sitagliptin phosphate monohydrate with metformin hydrochloride (Janumet, Janumet XR)	MSD	Type 2 diabetes mellitus	Initial
Sorafenib tosylate (Nexavar)	Bayer	Thyroid cancer	Resubmission
Tiotropium bromide monohydrate (Spiriva Respimat)	Boehringer Ingelheim	Asthma	Initial
Trastuzumab (Herceptin)	Roche	Gastric cancer	Resubmission
Ustekinumab (Stelara)	Janssen-Cilag	Psoriatic arthritis	Resubmission

* Vaccine

Table 9. New combination products

Medicine	Sponsor	Disease/condition	Submission attempt
Aclidinium bromide with eformoterol fumarate dehydrate (Bretaris Genuair)	Menarini	Chronic obstructive pulmonary disease	Initial
Brinzolamide with brimonidine tartrate (Simbrinza)	Alcon	Glaucoma	Initial
Brinzolamide with brimonidine tartrate (Simbrinza)	Alcon	Ocular hypertension	Initial
Netupitant with palonosetron (Akynzeo)	Specialised Therapeutics	Nausea and vomiting	Resubmission
Ombitasvir with paritaprevir and ritonavir (Viekira Pak)	AbbVie	Hepatitis C	Initial
Ombitasvir with paritaprevir and ritonavir and ribavirin (Viekira Pak-RBV)	AbbVie	Hepatitis C	Initial
Tiotropium bromide monohydrate with olodaterol hydrochloride (Spiolto Respimat)	Boehringer Ingelheim	Chronic obstructive pulmonary disease	Initial

Table 10. Selected new formulations

Medicine	Sponsor	Disease/condition	Submission attempt
Exenatide (Bydureon)	AstraZeneca	Diabetes mellitus	Resubmission
Infliximab (Inflectra)	Hospira	Ankylosing spondylitis, Crohn’s disease, rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis	Initial
Insulin glargine (Basaglar, Basaglar KwikPen)	Eli Lilly	Diabetes mellitus	Resubmission