FAQs

Which group was recommended by the PBAC?

The PBAC gave a positive recommendation to those who have at least one copy of the F508del mutation age 12+, 2200 people in Australia.

Following a positive recommendation the drug company choses whether to proceed, with several additional processes that need to be completed before a medication is added to the PBS.

So when will Trikafta be available?

As above, there's a process to be followed following a PBAC recommendation where contracts are negotiated with the Health Department. On this occasion, the recommendation came with the text:

"The PBAC considered that ELX/TEZ/IA could be brought within an acceptable incremental cost effectiveness ratio range with a price reduction, and in the context of accepting the resubmission's proposed patient estimates as reflecting the upper end of the range of likely use."

What has happened in the past?

Past Vertex medications have taken 2, 8 and 12 months from a positive recommendation to PBS listing (the 2 month listing did not have a recommendation mentioning a lower price being needed). On two occasions Vertex have provided interim access when a date for PBS listing has been set.

What is the timeframe moving forward?

Federal Health Minister Greg Hunt has guaranteed he will work as fast as possible to have Trikafta listed on the PBS:

“I hope that they are able to recommend it and if they do, we will move again at lightning speed to make sure it’s listed.”

And from Vertex:

“While there is still considerable work to do by all stakeholders in order to reach an agreement given the conditions related to the recommendation set out by the PBAC, we are committed to doing all we can to move the process along and have already initiated the next step.”

The main challenge now is that the Federal Budget is being approved in March, closely followed by a Federal Election when the Government will be in caretaker mode so action may not occur for several months. We need to push to make sure we don't have to wait a minute longer to get access to Trikafta through the PBS.