Summary of the agenda for the PBAC July 2018 meeting
Summary of the agenda for the PBAC July 2018 meeting
The PBAC will consider 57 submissions (30 major & 27 minor) at its next scheduled meeting in July (Table 1).
Technology category
|
Number
|
Percentage
|
PBS medicine or vaccine
|
54
|
95
|
PBS medicinal preparation*
|
1
|
2
|
NIP vaccine
|
2
|
3
|
LSDP medicine**
|
0
|
0
|
PBS = Pharmaceutical Benefits Scheme; NIP = National Immunisation Program; LSDP = Life Saving Drugs Program. * Nutritional supplements; ** Section 100 or LSDP
The Committee will also consider six reports from the Drug Utilisation Subcommittee (DUSC) for medicines for:
· Age-related macular degeneration & macular oedema (3 medicines)
· Malignant melanoma (7 medicines)
· Attention deficit-hyperactivity disorder (5 medicines)
· Muscle spasticity/blepharospasm (3 medicines)
· Gastro-oesophageal reflux disease (5 medicines)
· Fungal infection (1 medicine)
13 (23%) of the 57 submissions are for a new medicine (Table 2).
Table 2. Submissions by listing type
Listing type
|
Number
|
Percentage
|
New medicine
|
13
|
23
|
New vaccine
|
0
|
0
|
New gene therapy
|
0
|
0
|
New biosimilar medicine
|
5
|
9
|
New indication
|
19
|
33
|
New combination product
|
3
|
6
|
Restriction change
|
5
|
9
|
New strength
|
3
|
5
|
New formulation
|
9
|
16
|
Review
|
0
|
0
|
17 (30%) of the 57 submissions are resubmissions; most are for a new medicine or a new indication (Table 3).
Table 3. Resubmissions by listing type
Listing type
|
Number
|
Percentage
|
New medicine
|
7
|
41
|
New indication
|
7
|
41
|
New combination product
|
2
|
12
|
New formulation
|
1
|
6
|
Just under a quarter of all submissions are for oncology medicines (Table 4).
Table 4. Submissions by therapeutic area
Therapeutic area
|
Number*
|
Percentage
|
Cardiovascular disease
|
1
|
2
|
Dermatology
|
0
|
0
|
Endocrinology
|
4
|
7
|
Gastroenterology
|
3
|
5
|
Genetic disease
|
2
|
3
|
Haematology
|
7
|
12
|
Hepatology
|
0
|
0
|
Immunology
|
12
|
21
|
Infectious disease
|
4
|
7
|
Musculoskeletal
|
1
|
2
|
Nephrology
|
1
|
2
|
Neurology
|
1
|
2
|
Nutrition
|
1
|
2
|
Obstetrics/Gynaecology
|
0
|
0
|
Oncology
|
13
|
23
|
Ophthalmology
|
1
|
2
|
Otolaryngology
|
0
|
0
|
Paediatrics
|
5
|
9
|
Psychiatry/Psychology
|
1
|
2
|
Respiratory disease
|
0
|
0
|
Rheumatology
|
0
|
0
|
Sleep
|
0
|
0
|
Urology
|
0
|
0
|
MSD is the leading applicant (Table 5).
Table 5. Submissions by applicant
Sponsor
|
Number of submissions
|
Number of major submissions
|
MSD
|
8
|
6
|
Amgen
|
4
|
3
|
Pfizer
|
4
|
1
|
BMS
|
3
|
3
|
Novartis
|
3
|
1
|
Roche
|
3
|
1
|
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