30 April 2018 - The Department of Health has published a revised agenda for the July 2018 PBAC meeting on the PBS website.

While the website notes the page was updated yesterday (30 April 2018), it does not note that the initial agenda (published on 27 April 2018) has been revised. The revised agenda lists the technologies in alphabetic order (not the case for the initial agenda) and now includes a major submission from Novartis for erenumab (Aimovig) for the prevention of migraine.

The PBAC will now consider 58 submissions (31 major & 27 minor) at its next scheduled meeting in July.

MAESTrO Database has analysed the (revised) agenda and has identified some interesting insights:

• The agenda includes five (minor) submissions for a new biosimilar medicine; two submissions for adalimumab, one for insulin glargine, one for pegfilgrastim and one for rituximab. While the Amgen for adalimumab (Amgevita) requests a PBS listing for all patient populations, the submission from MSD (Hadlima) requests a PBS listing only for patients with rheumatoid arthritis.
  
• Submissions for the PD-1s are prominent; there are three submissions for nivolumab (Opdivo), three submissions for pembrolizumab (Keytruda) and one submission for avelumab (Bavencio).
  
• There are five submissions for four orphan drugs: cerliponase alfa (Brineura) for certain patients with neuronal ceroid lipofuscinosis, crizotinib (Xalkori) for certain patients with non-small-cell lung cancer, lumacaftor with ivacaftor (Orkambi) for certain patients with cystic fibrosis (two submissions) and teduglutide (Revestive) for certain patients with short bowel syndrome.
  
• The TGA-PBAC parallel process seems to be alive and well; MAESTrO Database estimates that 16 of the 58 submissions have been lodged under this process.
  
• Three submissions are associated with a co-dependent technology; interestingly all are for medicines for patients with non-small-cell lung cancer: crizotinib (Xalkori), pembrolizumab (Keytruda) and osimertinib mesylate (Tagrisso).
  
• MSD is the leading applicant with eight submissions (six major). Other prominent applicants are Amgen with four submissions (three major), Novartis with four submissions (two major), Pfizer with four submissions (one major), BMS with three submissions (three major) and Roche with three submissions (one major).
  
• While Servier has lodged its sixth submission for trifluridine with tipiracil hydrochloride (Lonsurf) for use by patients with colorectal cancer; Celgene has not lodged another submission for apremilast (Celgene) for use by patients with psoriasis which has been considered by the PBAC five times (four rejections and a deferral). Has Celgene given up (at least for the time being)? Celgene has not done well of late; apremilast has been considered by the PBAC seven times for two diseases (psoriasis and psoriatic arthritis) without success (six rejections and a deferral).
  
• There are first time submissions from two companies; Celltrion (rituximab) and KMC Health Care (levocarnitine). It is unclear if KMC Health Care is the sponsor of levocarnitine (Metabolics L-Carnitine).
  

Read revised agenda for July 2018 PBAC meeting