3 March 2017 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the PBAC November 2016 meeting are now available.

Some interesting insights from these documents are noted below:

• Ivacaftor (Kalydeco) granules were recommended by the PBAC on 25 January 2017 and listed on the PBS on 7 February 2017. This has to be a record!
  
• Janssen will continue to engage with the PBAC and Department of Health to work towards a resolution for ibruitinib (Imbruvica). The fifth submission, which proposed a reduction in the total expenditure caps compared to the previous submission, and would effectively reduce the incremental cost/QALY gained in the event that usage exceeded the level of the new caps, was rejected on the basis that the cost-effectiveness of ibrutinib remained unacceptably high and uncertain. The PBAC remained of the view that, at a total net cost to the PBS of more than $100 million over the first 5 years of listing ibrutinib, there would be a significant opportunity cost to the Commonwealth.
  
• The second submission for apremilast (Otezla) for moderate to severe plaque psoriasis was rejected on the basis that the evidence presented did not support the claims of superior comparative efficacy or safety versus cyclosporin and that the cost effectiveness of apremilast was uncertain and unacceptable at the requested price. The resubmission claimed apremilast as being superior in terms of comparative effectiveness and safety compared with cyclosporin. The clinical claim was based on a real-world, non-randomised US study of comparative persistence rates and supportive analyses of persistence from medicine access programs in Australia, Canada and Germany. The PBAC considered that the applicability of the non-randomised US persistence data presented in the submission to the likely PBS use of apremilast was unclear. The cost-utility analysis approach to the economic modelling was considered to be uninformative.
• The resubmission for daclizumab (Zinbryta) claimed non-inferiority in terms of comparative efficacy and safety compared to fingolimod hydrochloride but superior efficacy and similar safety compared to interferon β-1a. The PBAC formed the view that the evidence in the submission supported a conclusion that daclizumab is likely to be superior to interferon β-1a and may be non-inferior to fingolimod hydrochloride with regards to comparative efficacy, but may be inferior to interferon β-1a with regards to comparative safety.
  
• The major submission for Technivie (when used in combination with ribavirin) initially proposed a PBS listing on a cost-effectiveness and cost-utility basis compared with ‘no treatment’. In the end, the PBAC recommended the listing of paritaprevir with ritonavir and ombitasvir (in combination with ribavirin) for treatment naïve and treatment experienced genotype 4 chronic hepatitis C vivus infection on a cost- minimisation basis with grazoprevir with elbasvir with or without ribavirin.
  
• The submission for pegvisomant (Somavert) presented a cost-utility analysis compared with pasireotide diaspartate, octreotide acetate and lanreotide acetate. 2.5 The pre-PBAC response changed the basis on which listing for pegvisomant was being sought to a cost-minimisation to pasireotide (excluding cost offsets for diabetes).

Read PBAC Public Summary Documents