Summary of the agenda for the PBAC March 2019 meeting
The PBAC will consider 58 submissions (29 major & 29 minor) at its next scheduled meeting in March (Table 1).
Technology category
|
Number
|
Percentage
|
PBS medicine/vaccine/gene therapy
|
56
|
96
|
PBS medicinal preparation*
|
1
|
2
|
NIP vaccine
|
1
|
2
|
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 consider two reports from the Drug Utilisation Subcommittee (DUSC) for medicines for:
· Non-Hodgkin’s lymphoma (1 medicine)
· Haemolytic uraemic syndrome (1 medicine)
The PBAC will also consider matters relating to the post-market review of medicines for pulmonary arterial hypertension (8 medicines).
9 (16%) of the 58 submissions are for a new medicine (Table 2).
Table 2. Submissions by listing type
Listing type
|
Number
|
Percentage
|
New medicine
|
9
|
16
|
New vaccine
|
0
|
0
|
New cellular therapy
|
0
|
0
|
New gene therapy
|
0
|
0
|
New biosimilar medicine
|
2
|
3
|
New indication
|
20
|
34
|
New combination product
|
2
|
3
|
Restriction change
|
11
|
19
|
New strength
|
2
|
3
|
New formulation
|
12
|
21
|
Review
|
0
|
0
|
18 (32%) of the 58 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
|
6
|
33
|
New indication
|
9
|
50
|
New combination product
|
1
|
6
|
New formulation
|
2
|
11
|
Just under a third of all submissions are for oncology medicines (Table 4).
Table 4. Submissions by therapeutic area
Therapeutic area
|
Number*
|
Percentage
|
Cardiovascular disease
|
2
|
3
|
Dermatology
|
0
|
0
|
Endocrinology
|
5
|
9
|
Gastroenterology
|
3
|
5
|
Genetic disease
|
2
|
3
|
Haematology
|
7
|
12
|
Hepatology
|
0
|
0
|
Immunology
|
5
|
9
|
Infectious disease
|
2
|
3
|
Musculoskeletal
|
2
|
3
|
Nephrology
|
0
|
0
|
Neurology
|
2
|
3
|
Nutrition
|
1
|
2
|
Obstetrics/Gynaecology
|
1
|
2
|
Oncology
|
17
|
29
|
Ophthalmology
|
1
|
2
|
Otolaryngology
|
0
|
0
|
Paediatrics
|
2
|
3
|
Psychiatry/Psychology
|
2
|
3
|
Respiratory disease
|
3
|
5
|
Rheumatology
|
0
|
0
|
Sleep
|
0
|
0
|
Urology
|
0
|
1
|
Toxicity
|
1
|
2
|
Roche is the leading applicant (Table 5).
Table 5. Submissions by applicant
Sponsor
|
Number of submissions
|
Number of major submissions
|
Roche
|
6
|
3
|
Pfizer
|
4
|
1
|
MSD
|
3
|
2
|
BMS
|
3
|
1
|
Ipsen
|
3
|
1
|
Sanofi
|
3
|
2
|
Insights
- The PBAC will consider two submissions for a new biosimilar medicine (trastuzumab)
- The PBAC will consider resubmissions for two medicines rejected many years ago; bevacizumab (Avastin) for brain cancer (rejected in 2010) and darbepoetin alfa (Aranesp) for chemotherapy-induced neutropenia (last rejected in 2008).
- The PBAC will consider first ever submissions from Indivior and iCare Pharma Distributors
- Boehringer Ingelheim has lodged a minor submission requesting that Spiriva not be ‘a’ flagged with Teva Pharmaceuticals’ Braltas.
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