2 November 2018 - One new medicine and six new indications headline this month's major PBS & LSDP listings.

The following medicines were listed on the PBS/LSDP yesterday:

• Dexamethasone (Ozurdex) - new indication (x2)
  
• Evolocumab (Repatha) - new indication
  
• Migalastat hydrochloride (Galafold) - new listing (LSDP)
  
• Pembrolizumab (Keytruda) - new indication
  
• Ranibizumab (Lucentis) - new indication (x2)
  

Their listing timelines are as follows:

• Period (mean) from date of TGA registration to date of PBS/LSDP listing = 745 days
  
• Period (mean) from date of initial PBAC submission to date of PBS/LSDP listing = 624 days
  
• Period (mean) from date of PBAC outcome to date of PBS/LSDP listing = 238 days
  

Migalastat hydrochloride (Galafold) has been considered by the PBAC three times; one deferral and two rejections.  The Public Summary Document for the most recent submission (November 2017) makes no mention of the PBAC's discussion of its possible listing on the Life Savings Drugs Program.

It is unclear if the listing of migalastat hydrochloride on the LSDP should be included in the dataset that will form the baseline dataset for the Department of Health's objective to reduce the period from PBAC recommendation to PBS/LSDP listing by two months. Some would argue that it should.