Summary of the agenda for the PBAC March 2015 meeting
Michael Wonder - Wonder Drug Consulting Pty Ltd
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
|
