Summary of agenda for the PBAC November 2013 meeting

Michael Wonder - Wonder Drug Consulting

The PBAC will consider 47 submissions (30 major & 17 minor) at its next scheduled meeting in November (Table 1).

Table 1. Submissions by medicine type

Medicine category	Number	Percentage
PBS medicine or vaccine	38	81
PBS medicinal preparation*	8	17
NIP vaccine	1	2
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

10 of the 47 submissions are for new medicines/vaccines (Table 2).

Table 2. Submissions by listing type

Listing type	Number	Percentage
New medicine/vaccine	10	21
New indication	14	30
New combination product	2	4
Restriction change*	5	11
New strength	3	6
New formulation	12	26
Review cost-effectiveness	1	2

15 (32%) of the 47 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	27
New indication	7	47
New combination product	0	0
Restriction change	1	7
New strength	0	0
New formulation	3	20

This will be the fourth submission for three medicines: plerixafor (Mozobil) for multiple myeloma and lymphoma, tapentadol hydrochloride (Palexia SR) for pain and sorafenib tosylate (Nexavar) for renal cell carcinoma.  It will be the second submission for the remaining ten medicines.  It will be the third submission for exenatide (Bydureon) for type 2 diabetes mellitus and panitumumab (Vectibix) for colorectal cancer.

Almost a quarter of all submissions are for medicines in WHO ATC main group L (Table 4).

Table 4. Medicines by WHO ATC main group

WHO ATC main group*	Number	Percentage
Alimentary	6	13
Blood	1	2
Cardiovascular	1	2
Dermatological	3	6
Genitourinary	0	0
Systemic hormonal	1	2
Anti-infective	5	11
Anti-neoplastic and immunomodulatory	12	26
Musculoskeletal	2	4
Nervous	3	6
Anti-parasitic	0	0
Respiratory	1	2
Sensory	4	9
Various**	8	17

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

Nutricia is the leading applicant with six submissions (Table 5).

Table 5. Submissions by applicant

Sponsor	Number of submissions	Number of major submissions
Nutricia	6*	0
Novartis	5	5
Amgen	3	3
MSD	3	2

Table 6. Submissions for new medicines

Medicine	Sponsor	Submission attempt
Axitinib (Inlyta)	Pfizer	Initial
Clobetasol propionate (Clobex)	Galderma	Initial
Crizotinib (Xalkon)	Pfizer	Initial
Dolutegravir (Tivicay)	ViiV	Initial
Eribulin mesylate (Halaven)	Eisai	Resubmission
Glycopyrronium bromide (Seebri Breezhaler)	Novartis	Initial
Ingenol mebutate (Picato)	Leo	Resubmission
Multicomponent meningococcal Group B vaccine (Bexsero)	Novartis	Initial
Plerixifor (Mozobil)	Sanofi	Resubmission
Tapentadol hydrochloride (Palexia SR)	CSL	Resubmission

Table 7. Submissions for new indications

Medicine	Sponsor	Submission attempt
Adalimumab (Humira)	AbbVie	Initial
Bevacizumab (Avastin)	Roche	Initial
Botulinum toxin (Botox)	Allergan	Initial
Denosumab (Prolia)	Amgen	Initial
Infliximab (Remicade)	Janssen-Cilag	Resubmission
Panitumumab (Vectibix)	Amgen	Resubmission
Quetiapine fumarate (Seroquel)	AstraZeneca	Resubmission
Ranibizumab (Lucentis)	Novartis	Resubmission
Ranibizumab (Lucentis)	Novartis	Resubmission
Sorafenib tosylate (Nexavar)	Bayer	Resubmission
Tocilizumab (Actemra)	Roche	Initial

Table 8. New combination products

Medicine	Sponsor	Submission attempt
Alogliptin with metformin hydrochloride (Nesina Met)	Takeda	Initial
Ezetimibe with rosuvastatin calcium (Rosuzet Combination Pack)	MSD	Initial

Table 9. “Selected” new formulations

Medicine	Sponsor	Submission attempt
Exenatide (Bydureon)	BMS	Resubmission
Saxagliptin hydrochloride with metformin hydrochloride (Kombiglyze XR)	BMS	Initial
Sitagliptin phosphate monohydrate with metformin hydrochloride (Janumet XR)	MSD	Initial
Tobramycin (Tobi Podhaler)	Novartis	Resubmission