16 March 2018 - The Public Summary Documents (first time rejections and deferrals) from the November 2017 PBAC meeting are now available.

Some key insights from the Public Summary Documents are outlined below:

• The PBAC decided to defer its discussion of baricitinib pending the receipt of the TGA delegate’s overview, in the context of concerns about the safety profile of baricitinib, particularly in relation to serious adverse events. The Committee considered the outcomes of the TGA’s evaluation of safety were germane to the PBAC deliberations.
  
• The PBAC did not recommend the listing for ibrutinib for patients with previously untreated chronic lymphocytic leukaemia or small lymphocytic leukaemia who are unsuitable for treatment with fludarabine-based chemoimmunotherapy. Although the PBAC accepted there is a clinical benefit in progression-free survival and overall survival for ibrutinib when compared to chlorambucil in combination with either rituximab or ofatumumab, the benefit over chlorambucil in combination with obinutuzumab was not proven. The incremental cost-effectiveness ratio presented using the blended comparator of chlorambucil in combination with rituximab, ofatumumab or obinutuzumab was considered high and optimistic.
  
• The PBAC did not recommend the listing of lenvatinib for advanced renal cell carcinoma on the basis that the clinical need and the clinical place in therapy were not adequately established. In addition, the PBAC considered that the magnitude of the clinical benefit was uncertain due to the small sample size of the key clinical trial (Study 205). The PBAC considered the cost-effectiveness of lenvatinib was unable to be established, as the clinical place in therapy and hence the appropriate comparator for the evaluation, were uncertain.
• The PBAC formed the view that the PBS is the most appropriate mechanism for subsidising the new gene therapy nusinersen for Australian patients. The PBAC considered that further information on the cost-effectiveness of treatment with nusinersen is necessary in order for it to be able to form a view on the appropriate PBS subsidy price, but that based on the information already available it is likely that a substantial reduction in the proposed price will be required.
  

The MAESTrO Database has been updated accordingly (comparator/s, clinical trial/s, primary outcomes, patient reported outcomes, type of economic evaluation, model type, model time horizon, number of model health states).

Read PBAC Public Summary Documents