26 February 2020
Today PHARMAC announced their decision to fund Kalydeco for people with cystic fibrosis with the G551D mutation.
This follows a consultation process, in which CFNZ along with clinicians, DHBs and Kalydeco for Kiwis, submitted feedback. This feedback was well received, taken on board and acted upon. Read the feedback, and PHARMAC’s comments and considerations here.
As Kalydeco (ivacaftor) is yet to receive Medsafe approval and until Kalydeco is listed on the Pharmaceutical Schedule, PHARMAC has set up an easily navigable ‘exceptional circumstances’ application process from 1 March so that people who are eligible can access Kalydeco.
“The regulatory updates required for ivacaftor tablets will take more time than initially expected. Vertex, the supplier of ivacaftor, will be submitting the necessary changes to Medsafe as soon as possible for ivacaftor tablets and granules, and Medsafe will then need time to assess this information. We want to ensure that ivacaftor meets the requirements of Medsafe to be supplied in New Zealand and we will not be listing ivacaftor tablets or granules on the Pharmaceutical Schedule before Medsafe approval,” writes PHARMAC.
From 1 March 2020 PHARMAC will consider applications under exceptional circumstances for people with CF who meet the funding criteria, prior to Kalydeco being listed on the Pharmaceutical Schedule. All CF clinicians will have been notified of the process and will be discussing what this means for you.
PHARMAC has outlined what they’re doing now, changes made to the original proposal, and their response to the community’s input in a notification statement, here.