14 December 2018 - The outcomes from the November 2018 PBAC meeting are now available but not in full.

Submissions

• 50 submissions were considered by the PBAC; 46 relate to the listing of a medicine or medicinal preparation on the Pharmaceutical Benefits Scheme; the remaining four relate to the listing of a vaccine on the National Immunisation Program
  
• 29 (58%) were major submissions
  
• 40 (80%) were initial submissions and 10 (20%) were resubmissions
  
• 10 (20%) submissions were for a ‘new medicine’
  
• 7 (14%) submissions included a CEA/CUA. The type of economic evaluation in some submissions is as yet unknown.
  
• 22 (44%) submissions were for medicines in WHO ATC Group L (anti-neoplastic and immunomodulating agents), 5 (10%) were for medicines in WHO ATC Group M (musculoskeletal) and 7 (11%) were for medicines in WHO ATC Group N (nervous system)
• Two submissions appear to have been withdrawn
  
• The PBAC considered a few minor submissions that were not included in the published agenda
  

Outcomes

• The 50 submissions yielded 59 outcomes; 33 (56%) recommendations, 20 (34%) rejections & 6 (10%) deferrals. Insofar as some submissions included multiple requests; the number of outcomes exceeds the number of submissions.
  
• 5 of the 10 submissions for a new medicine considered by the PBAC were recommended
  
• The 7 submissions that are known to have included a CEA/CUA yielded 7 outcomes; 2 (29%) recommendations and 3 (43%) rejections
  
• 8 of the 20 rejections were for medicines in WHO ATC Group L (some of these rejections are for a medicine that is not used by patients with cancer)
  
• The 11 resubmissions yielded 11 outcomes of which 8 (73%) were recommendations
  

Insights

• The reason why the submission for pembrolizumab (Keytruda) for use in combination with platinum-based chemotherapy and pemetrexed disodium heptahydrate for the treatment of patients with EGFR wild-type ALK translocation negative non-squamous non-small-cell lung cancer was rejected is unclear as the PBAC outcome is blank. It is unclear why the outcome has not been made public.
  
• Four medicines were recommended with a risk share agreement
  
• Two medicines were recommended on the basis of a comparison with the least costly alternative
  
• No medicines were recommended with a managed access program
• The PBAC considered only one submission for a new biosimilar medicine
• The PBAC considered only one submission with a co-dependent technology

Read PBAC outcomes