20 August 2018 - Highest recommendation rate for a scheduled PBAC meeting in modern times.

MAESTrO Database has conducted a detailed analysis of the outcomes for the July 2018 PBAC meeting. The analysis reveals some interesting findings.

• The recommendation rate (81%) is the highest rate since the PBAC has published its outcomes in full (2003). It is important to note that the rate is calculated using the number of submission requests rather than the number of submissions. A single submission for a medicine (biosimilar medicine) for multiple indications/patient populations will yield multiple outcomes. The high recommendation rate will please many people. Nonetheless, there are some interesting, some might say disturbing, findings.
  
• Several medicines associated with multiple resubmissions were finally recommended: lumacaftor with ivacaftor for cystic fibrosis (4 submissions), pembrolizumab for non-small cell lung cancer (4 submissions), lanreotide acetate for pancreatic neuroendocrine tumour (5 submissions), tolvaptan for polycystic kidney disease (4 submissions) and trifluridine with tipiracil hydrochloride for colorectal cancer (6 submissions).
• The PBAC recommended the listing of three biosimilar medicines (two submissions for adalimumab and one for insulin glargine) and deferred another (pegfilgrastim).  The submission for another biosimilar medicine (rituximab) was withdrawn.
  
• Five submissions were recommended on the basis of a comparison with the lowest cost alternative: carmellose sodium/hypromellose sodium for drey eyes, guselkumab for psoriasis, ixekizumab for psoriatic arthritis, tildrakizumab for psoriasis and mesalazine for Criohn's disease and ulcerative colitis.
  
• Five submissions were recommended with a risk sharing agreement (RSA): guanfacine hydrochloride for attention deficit hyperactivity disorder, lanreotide acetate for pancreatic neuroendocrine tumour, midostaurin for acute myeloid leukaemia, tolvaptan for polycystic kidney disease and trifluridine with tipiracil hydrochloride for colorectal cancer. Interestingly, none of the recommended PD-1s are associated with a  RSA. This might chance with the publication of the public summary documents.
  
• One medicine was recommended with a Managed Access Program (MAP) - lumacaftor with ivacaftor (Orkambi) for cystic fibrosis
• The PBAC considered three submissions with a co-dependent technology; suprisingly all are for medicines for patients with non-small cell lung cancer. Two were recommended (crizotinib and pembrolizumab) and the third (osimertinib mesylate) was deferred.
• The PBAC considered seven submissions for a programmed death receptor-1 antagonist yielding 8 outcomes (5 recommendations).