22 August 2016 - The publication of the outcomes from the PBAC July 2016 meeting presents another opportunity to study the working of the Committee.

• The PBAC considered just 44 submissions; this is the lowest number since the July 2012 meeting when there were just 38 submissions. The meeting average is much higher.
• Only 20 major submissions were considered, the smallest number for quite a while.  The PBAC considered 19 major submissions in July 2012.
• The overall success rate was 73% which is higher than in recent times. This can be explained, at least part, by the lower number of major submissions.
• Talimogene laherparepvec (Imlygic) was the first cellular therapy ever to be considered by the PBAC; it was rejected but not because it was not suitable for listing on the PBS
• The recommendation for Brenzys, the biosimilar for etanercept, for all seven diseases/conditions, does not come as a big surprise. 

  The PBAC considered the Enbrel and Brenzys brands of etanercept could be marked as equivalent in the Schedule of Pharmaceutical Benefits (‘a’ flagged), for the purposes of substitution by the pharmacist at the point of dispensing for all the circumstances (restrictions) that both brands are listed against.  

  In forming its view on brand substitution (‘a’ flagging), the PBAC considered a range of factors including advice from the TGA's Advisory Committee on Prescription Medicines.

• Idelalisib (Zydelig) was recommended at the fourth attempt for three diseases: chronic lymphocytic leukaemia, small lymphocytic lymphoma (a form of non-Hodgkin's lymphoma) and follicular lymphoma.  Idelalisib is the first tyrosine kinase inhibitor (TKI) to be recommended by the PBAC for these diseases.  The other TKI in the race, ibrutinib (Imbruvica) was deferred by the PBAC in March and appears not to have been considered by the Committee in July. Idelalisib has had some recent safety concerns; the EMA has updated its label to exclude first-line use.  Ibutinib has already been approved by the FDA for first-line use.
• Blinatomumab (Blincyto) was recommended for the treatment of patients with relapsed or refractory Philadelphia chromosome negative B-precursor acute lymphocytic leukaemia on the basis of acceptable cost-effectiveness over standard care chemotherapies, to be achieved in the context of a managed entry framework (MES).  This is the fourth medicines to be recommended by the PBAC in the context of a MES. The initial price for blinatumomab will be established based on respecifying of the base case of the submitted model and may be reduced in time when the results of the ongoing Tower Trial become available. Insofar as blinatomumab does not have any immediate competitors, the MES may go full term.
• Grazoprevir with elbasvir (Zepatier) was recommended for six of the seven proposed patient populations with chronic hepatitis C virus infection; the Committee considered that there were insufficient data to recommend the combination for use by patients with genotype 3.  If and when listed, Zepatier will compete with sofosbuvir (SovaldI; genotypes 1, 4 & 6), sofosbuvir with ledipasvir (Harvoni; genotypes 1, 4 & 6), ombitasvir with paritaprevir and ritonavir and dasabuvir sodium monohydrate +/- ribavirin (Viekira Pak/Viekira Pak-RBV; genotype 1), simemprevir sodium (Olysio; genotype 1) and daclatasvir dihydrochloride (Daklinza; genotype 1).
• The recommendations for ixekizumab (Taltz) for use by patients with plaque psoriasis and progesterone (Utrogestan) for luteal support as part of an assisted reproductive technology treatment program for infertile women are interesting insofar as that the PBAC stated that should be cost-minimised to the least costly comparator.
• The PBAC could not publish the outcome for nivolumab (Opdivo) for use by patients with renal cell carcinoma (RCC) because it is yet to be approved by the TGA for this indication. BMS must surely be hoing it doesn't take as long as it has for insulin degludec (Tresiba) and mometasone furoate with eformoterol fumarate dihydrate (Zenhale) which have been oustanding since 2013.  This is most unlikelya as Opdivo has already been approved by the FDA & the EMA/EC for use by patients with RCC.