4 September 2017 - The PBAC will consider 66 submissions at its next scheduled meeting in early November.

40 (61%) of the 66 submissions are major submissions; the PBAC has not considered 40 or more submissions at a given meeting for many years. The PBAC considered 39 major submissions in March 2015.

46 (70%) of the 66 submissions are initial submissions; the remaining 20 are resubmissions.  The PBAC will consider four medicines for the fourth time.

61 (92%) of the 66 submissions are for PBS medicines/gene therapies; the remaining five submissions are for PBS medicinal preparations.  The agenda does not include a submission for a NIP vaccine or a LSDP medicine.

22 (33%) of the 66 submissions are for a new medicine.

There appear to be eight TGA-PBAC parallel process submissions; this number will be confirmed in due course.

There appears to be only one PBAC/MSAC co-dependency submission; this will also be confirmed in due course.

The most commonly represented therapeutic areas are:

• Endocrinology - 16 submissions
  
• Haematology - 15 submissions
  
• Immunology - 14 submissions
  
• Oncology - 13 submissions
  

The agenda includes a number of 'firsts':

• The first submission for a radiopharmaceutical - Radium Ra 223 dichloride (Xofigo) for patients with prostate cancer (minor submission)
  
• The first submission for a gene therapy - nusinersen sodium (Spinraza) for patients with spinal muscular atrophy (major submission)
  
• The first major submission from Sun Pharma (sonedegib phosphate - Odomzo) and Orpharma (sodium phenylbutyrate - Pheburane)

The applicants/pharmaceutical companies with the highest number of submissions up for review are the 'usual suspects':

• Janssen-Cilag - 5 submissions
  
• Novartis - 4 submissions
  
• MSD - 4 submissions
  
• Roche - 4 submissions
  
• Pfizer - 3 submissions
  

A more detailed analysis is available upon request.