14 April 2022 - The Public Summary Documents (first time decisions not to recommend, deferrals and other matters) from the December 2021 PBAC meeting are now available.

Don't get too excited. There is only one new public summary document it is for the Category 2 submission from Vertex Pharmaceuticals to address the requirements of the Managed Access Program for the supply of lumacaftor with ivacaftor and tezacaftor and ivacaftor for the treatment of patients with cystic fibrosis patients homozygous for the F508 deletion mutation.

Having said that, the sponsor comments (Vertex Pharmaceuticals) are definitely worth a read. "We note that the PBAC has made comments beyond that required of the Managed Access Program, without adequate data or methodology supporting such conclusions."

Read PBAC Public Summary Document