Summary of the agenda for the PBAC November 2016 meeting

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

  • Fungal infection (7 medicines)
  • Schizophrenia (11 medicines)
  • Early termination of pregnancy (1 medicine)
  • Osteoporosis (12 medicines)
  • Hepatic encephalopathy (1 medicine)
  • Androgen deficiency (3 medicines)

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

 

Michael Wonder

Posted by:

Michael Wonder