24 August 2016 - The PBAC will consider 66 submissions (34 major & 32 minor) at its next scheduled meeting in November.
Table 1. Submissions by medicine type
Medicine category |
Number |
Percentage |
PBS medicine or vaccine |
60 |
91 |
PBS medicinal preparation* |
6 |
9 |
NIP vaccine |
0 |
0 |
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 five reports from the Drug Utilisation Subcommittee (DUSC) for medicines for
13 of the 66 submissions are for new medicines/vaccines (Table 2).
Table 2. Submissions by listing type
Listing type |
Number |
Percentage |
New medicine |
13 |
20 |
New vaccine |
0 |
0 |
New indication |
20 |
30 |
New combination product |
4 |
6 |
Restriction change |
11 |
17 |
New strength |
3 |
5 |
New formulation |
13 |
20 |
Review |
2 |
3 |
21 (32%) of the 66 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 |
7 |
33 |
New indication |
10 |
48 |
New combination product |
1 |
5 |
New formulation |
2 |
9 |
Review |
1 |
5 |
Just under a third of all submissions are for medicines in WHO ATC main group L (Table 4).
Table 4. Submissions by therapeutic area
Therapeutic area |
Number* |
Percentage |
Cardiovascular disease |
3 |
5 |
Dermatology |
1 |
2 |
Endocrinology |
2 |
3 |
Gastroenterology |
2 |
3 |
Genetic disease |
2 |
3 |
Haematology |
13 |
20 |
Hepatology |
3 |
5 |
Immunology |
6 |
9 |
Infectious disease |
1 |
1 |
Musculoskeletal |
0 |
0 |
Neurology |
4 |
6 |
Nutrition |
9 |
14 |
Obstetrics/Gynaecology |
1 |
2 |
Oncology |
14 |
21 |
Ophthalmology |
0 |
0 |
Paediatrics |
0 |
0 |
Respiratory disease |
6 |
9 |
Rheumatology |
0 |
0 |
Sleep |
0 |
0 |
MSD and Vitaflo are the leading applicants (Table 5).
Table 5. Submissions by applicant
Sponsor |
Number of submissions |
Number of major submissions |
MSD |
5 |
3 |
Vitaflo |
5 |
0 |
Roche |
4 |
1 |