Posted by Michael Wonder on 24 Aug 2016
Insights from the agenda for the PBAC November 2016 meeting
24 August 2016 - Some important insights can be gleaned from the agenda.
- The PBAC is on track to consider 34 major submissions; only 20 were considered by the Committee last month
- If recommended by the PBAC, ceritinib (Zykadia) may have an impact on the current Managed Entry Scheme (MES) for crizotinib (Xalkori)
- Daiichi Sankyo is trying again for edoxaban tosylate (Lixiana); the initial two submissions were withdrawn prior to the previous meeting
- MSD is seeking to list its second biosimilar (Renflexis) and the second biosimilar for infliximab
- AbbVie has lodged a third submission for adalimumab (Humira) for use by certain patients with hidradenitis suppurativa; the agenda claims it is a major submission which is hard to fathom given it was rejected by the PBAC for the second time last month
- Roche is seeking to revise the March 2016 recommendation for tocilizumab (Actemra)
- Otsuka has lodged its first ever submission from Otsuka for tolvaptan (Jinarc) for autosomal dominant polycystic kidney disease
- Sandoz has lodged a minor submission seeking a PBS listing for the first generic competitor to GSK's Seretide (fluticasone propionate with salmeterol xinafoate)
- Rare Cancers Australia has lodged major submissions for romidepsin (Istodax) and vorinostat (Zolinza). It is the first submission for the former medicine and the second for the latter.
- The Medical Oncology Group of Australia has lodged a minor submission for goserelin acetate (Zoladex). MOGA has made submissions in the past, but never a major.
- MSD is still seeking to revise some aspects of the current MES for pembrolizumab (Keytruda)
- Janssen has lodged a major submission for ibrutinib (Imbruvica) but for a new indication
Posted by:
Michael Wonder