Summary
of the agenda for the PBAC July 2014 meeting
Michael Wonder - Wonder Drug Consulting Pty Ltd
The PBAC will consider 50 submissions (27 major & 23 minor) at its
next scheduled meeting in July (Table 1).
Table 1. Submissions by medicine type
Medicine
category
|
Number
|
Percentage
|
PBS medicine or vaccine
|
41
|
82
|
PBS medicinal preparation*
|
7
|
14
|
NIP vaccine
|
2
|
4
|
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
18 of the 50 submissions are for new medicines/vaccines (Table 2).
Table 2.
Submissions by listing type
Listing type
|
Number
|
Percentage
|
New PBS medicine/vaccine
|
18
|
36
|
New indication
|
9
|
18
|
New combination product
|
5
|
10
|
New NIP vaccine
|
1
|
2
|
Restriction change
|
5
|
10
|
New strength
|
1
|
2
|
New formulation
|
10
|
20
|
Review cost-effectiveness
|
1
|
2
|
Some of the 13 new medicines and five 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. Interestingly, they are confined to two
disease areas; obstructive respiratory disease (chronic obstructive pulmonary
disease and asthma) and pulmonary arterial hypertension.
Table 3. New medicines yet
to be assessed/appraised by other HTA agencies (NICE, CDEC/ERC, IQWiG)
Medicine
|
Sponsor
|
Disease/condition
|
Submission attempt
|
Empagliflozin
(Jardiance)
|
Boehringer
Ingelheim
|
Type
2 diabetes mellitus
|
Initial
|
Obinutuzumab (Gazyva)
|
Roche
|
Chronic lymphocytic leukaemia
|
Initial
|
Olodaterol
(Striverdi Respimat)
|
Boehringer
Ingelheim
|
Chronic obstructive pulmonary disease
|
Initial
|
Pomalidomide
(Pomalyst)*
|
Celgene
|
Multiple myeloma
|
Initial
|
Simeprevir
sodium (Olysio)*
|
Janssen-Cilag
|
Hepatitis
C
|
Initial
|
Sofosbuvir
(Sovaldi)*
|
Gilead
|
Hepatitis C
|
Initial
|
Umeclidinium bromide (Incruse Ellipta)
|
GSK
|
Chronic obstructive pulmonary disease
|
Initial
|
Vedolizumab (Entyvio)
|
Takeda
|
Ulcerative colitis
|
Initial
|
* These medicines are under assessment in Canada/Germany but the CDEC/IQWiG
is yet to publish an appraisal.
14 (28%) of the 50 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
|
5
|
36
|
New indication
|
8
|
57
|
New combination product
|
1
|
7
|
New vaccine
|
1
|
7
|
Restriction change
|
1
|
7
|
New strength
|
0
|
0
|
New formulation
|
20
|
0
|
More than a quarter 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
|
5
|
10
|
Blood
|
0
|
0
|
Cardiovascular**
|
2
|
4
|
Dermatological
|
0
|
0
|
Genitourinary
|
1
|
2
|
Systemic hormonal
|
0
|
0
|
Anti-infective
|
4
|
8
|
Anti-neoplastic and immunomodulatory
|
15
|
30
|
Musculoskeletal
|
3
|
6
|
Nervous
|
6
|
12
|
Anti-parasitic
|
1
|
2
|
Respiratory
|
5
|
10
|
Sensory
|
2
|
4
|
Various***
|
6
|
12
|
*WHO ATC = World Health Organization Anatomical Therapeutic
Chemical; **The WHO is yet to allocate an ATC code to riociguat; it is been
assumed that it will come under ATC main group C; **All two are medicinal
preparations.
Novartis is the leading applicant with six submissions (Table 6).
Table 6. Submissions by applicant
Sponsor
|
Number of submissions
|
Number of major
submissions
|
Novartis (excludes Vaccines &
Diagnostics Unit)
|
5
|
1
|
GSK
|
3
|
2
|
Lundbeck
|
3
|
2
|
Vitaflo
|
3
|
0
|
Submissions
from new applicants are outlined in Table 7.
Table
7. Submissions from new applicants
Sponsor
|
Number of submissions
|
Number of major
submissions
|
Merz
|
1
|
1
|
SWR
International
|
1
|
0
|
Table 8. Submissions for new medicines
Medicine
|
Sponsor
|
Disease/condition
|
Submission attempt
|
Alemtuzumab
(Lemtrada)
|
Genzyme
|
Multiple
sclerosis
|
Initial
|
Brentuxumab
vedotin (Adcetris)
|
Takeda
|
Non-Hodgkin’s
lymphoma
|
Resubmission
|
Collagenase clostridium histolyticum
(Xiaflex)
|
Actelion
|
Dupuytren’s contracture
|
Resubmission
|
Empagliflozin
(Jardiance)
|
Boehringer
Ingelheim
|
Type
2 diabetes mellitus
|
Initial
|
Glycine with carbohydrate (Glycine500)
|
Vitaflo
|
Nutrition
|
Initial
|
Ingenol mebutate (Picato)
|
Leo
|
Actinic
keratosis
|
Resubmission
|
Lisdexamfetamine dimesylate (Vyvanse)
|
Shire
|
Attention deficit hyperactivity disorder
|
Resubmission
|
Lixisenatide (Lyxumia)
|
Sanofi
|
Type
2 diabetes mellitus
|
Initial
|
Obinutuzumab (Gazyva)
|
Roche
|
Chronic lymphocytic leukaemia
|
Initial
|
Olodaterol
(Striverdi Respimat)
|
Boehringer
Ingelheim
|
Chronic obstructive pulmonary disease
|
Initial
|
Perampernel
(Fycompa)
|
Eisai
|
Epilepsy
|
Initial
|
Pomalidomide
(Pomalyst)
|
Celgene
|
Multiple myeloma
|
Initial
|
Ruxolitinib phosphate (Jakavi)
|
Novartis
|
Myelofibrosis
|
Resubmission
|
Simeprevir sodium (Olysio)
|
Janssen-Cilag
|
Hepatitis C
|
Initial
|
Sofosbuvir (Sovaldi)
|
Gilead
|
Hepatitis C
|
Initial
|
Umeclidinium bromide (Incruse Ellipta)
|
GSK
|
Chronic obstructive pulmonary disease
|
Initial
|
Vedolizumab (Entyvio)
|
Takeda
|
Ulcerative colitis
|
Initial
|
Vortioxetine
hydrobromide (Brintellix)
|
Lundbeck
|
Depression
|
Initial
|
Table 9. Submissions for new indications
Medicine
|
Sponsor
|
Disease/condition
|
Submission attempt
|
Abiraterone
acetate (Zytiga)
|
Janssen-Cilag
|
Prostate
cancer
|
Initial
|
Adalimumab
(Humira)
|
AbbVie
|
Ulcerative
colitis
|
Resubmission
|
Fluticasone furoate with vilanterol
trifenatate (Breo Ellipta)
|
GSK
|
Chronic obstructive pulmonary disease
|
Resubmission
|
Inflximab
(Remicade)
|
Janssen-Cilag
|
Ulcerative
colitis
|
Resubmission
|
Panitumumab
(Vectibix)
|
Amgen
|
Colorectal
cancer
|
Resubmission
|
Ranibizumab
(Lucentis)
|
Novartis
|
Macular
oedema (DME)*
|
Resubmission
|
Ranibizumab
(Lucentis)
|
Novartis
|
Macular
oedema (RVO)*
|
Resubmission
|
Sorafenib
tosylate (Nexavar)
|
Bayer
|
Thyroid
cancer
|
Initial
|
Vildagliptin,
vildagliptin with metformin hydrochloride (Galvus/Galvumet)
|
Novartis
|
Type
2 diabetes mellitus
|
Resubmission
|
* DME = diabetic macular edema; RVO = retinal vein occlusion
Table 10. New combination products
Medicine
|
Sponsor
|
Disease/condition
|
Submission attempt
|
Dapagliflozin propanediol monohydrate
with metformin hydrochloride (Xigduo)
|
AstraZeneca
|
Type
2 diabetes mellitus
|
Initial
|
Ezetimibe with rosuvastatin calcium
(Rosuzet)
|
MSD
|
Hypercholesterolaemia
|
Initial
|
Indacaterol with glycopyrronium bromide
(Ultibro Breezhaler)
|
Novartis
|
Chronic
obstructive pulmonary disease
|
Resubmission
|
Mifepristone with misoprostol (MS-2
step)
|
Marie
Stopes Health
|
Contraception
|
Initial
|
Umeclidinium bromide with vilanterol
trifenatate (Anoro Ellipta)
|
GSK
|
Chronic
obstructive pulmonary disease
|
Initial
|
Table 11. “Selected” new formulations*
Medicine
|
Sponsor
|
Disease/condition
|
Submission attempt
|
Incobotulinumtoxin
A
|
Merz
|
Muscle
spasticity
|
Initial
|
