Sunday, 11 January 2015

2014 PBAC submissions and outcomes – therapeutic areas

Michael Wonder - January 2015

www.maestrodatabase.com

Submissions
The PBAC considered 170 submissions in 2014 of which 168 were prepared and lodged by the pharmaceutical industry (sponsors of medicines and medicinal preparations).
88 (52%) of the 133 submissions were major submissions and 82 (48%) were minor submissions.
Outcomes
The 170 submissions yielded 244 outcomes.  The number of PBAC outcomes from a given PBAC meeting or analysis period may be greater than the number of submissions for the same meeting or analysis period as some submissions may have contained multiple requests and/or multiple patient populations.
Of the 244 outcomes, 157 (64%) were recommendations, 57 (23%) were rejections and 30 (12%) were deferrals.
Therapeutic areas
The therapeutic area with the highest number of outcomes in 2014 was the antineoplastic and immunomodulatory group with 89 outcomes (53 recommendations with a success rate of 59%).
The therapeutic areas with the highest success rates were:
  • ·      Parasitic (2 recommendations and no rejections or deferrals)
  • ·      Systemic hormonal (1 recommendation and no rejections or deferrals)
  • ·      Cardiovascular (20 recommendations and 1 rejection)

© Wonder Drug Consulting Pty Ltd, 2015.

PBAC 2014 outcomes by therapeutic area

Therapeutic area (WHO ATC main group)
Number of recommendations
Number of rejections
Number of deferrals
Total number of outcomes
Success rate (%)
Alimentary
13
7
2
22
59
Blood
3
1
0
4
75
Cardiovascular
20
1
0
21
95
Dermatology
1
1
0
2
50
Genito-urinary
8
1
0
9
89
Systemic hormonal
1
0
0
1
100
Anti-infective
15
7
1
23
65
Anti-neoplastic and immunomodulatory
53
17
19
89
59
Musculoskeletal
8
1
1
10
80
Nervous
9
7
0
16
56
Parasitic
2
0
0
2
100
Respiratory
11
5
0
16
69
Sensory
7
2
2
11
64
Various
14
0
4
18
78

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  1. 2014 PBAC submissions and outcomes by therapeutic area

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