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
|
