KALYDECO RAISED AT SENATE ESTIMATES

Thank You Senator Nick Xenophon

Estimates of government expenditure are referred to Senate committees as part of the annual budget cycle. This opportunity to examine the operations of government plays a key role in the parliamentary scrutiny of the executive.

On Monday 2 June at the Hearing of the Community Affairs Legislation Committee which comprises the Health Portfolio, Senator Nick Xenophon raised the issue of Kalydeco. A transcript of this particular discussion is below. For the full record of this meeting go to http://bit.ly/SenateEst2Jun2014.

Senator XENOPHON: Let us go to the issue of the stalemate between the government and the manufacture of the cystic fibrosis drug, Kalydeco. I will truncate these questions given the time constraints. I am asking these questions on behalf of my constituent Leah Johnston's eight-year-old son who, along with 199 other Australians with cystic fibrosis, is in desperate need of this drug. My understanding is that the PBAC provided a recommendation to reimburse Kalydeco through the PBS and that that was in late 2013. Is that correct?

Ms McNeill: That is correct. They first recommended it in November 2013. The company put a subsequent application in to the March 2014 meeting and that was again recommended.

Senator XENOPHON: I have written to the minister about this, but where are we at in terms of Kalydeco being allowed through the PBS onto the market for these 199 Australians who are in desperate need of this drug?

Ms McNeill: The department is working quite furiously on this particular matter. We appreciate your concerns and we are working constructively with the pharmaceutical company in this regard. We met with them last week and we are meeting with them again this week. We have been exchanging information to progress this as quickly as possible since the recommendation in March.

Senator XENOPHON: What is the time frame? There are some very desperate parents worried about their children. Every day counts. How quickly can this be approved, in your view?

Ms McNeill: I am working as hard as I can, as are my staff, with the pharmaceutical company. In the end, it is also a matter for the pharmaceutical company to show us how they can meet the recommendation of the PBAC so that we can give that advice to government and list it.

Senator XENOPHON: So you are hopeful of some resolution of this in the next few weeks?

Ms McNeill: I am working hard to try and do so.

Senator DI NATALE: Are you just negotiating on price at the moment? Is that where you are up to?

Ms McNeill: No, it is not just about price.

Senator DI NATALE: Okay. What are the other issues?

Ms McNeill: There are other issues with respect to the recommendation and how you assess the clinical effectiveness to record that, to maintain the ongoing access under the pay-for-performance arrangement—so, what types of tests, what clinical hurdle, would meet the evidence base that shows that drug continues to work and how well it is working, both working with the company and getting advice from clinicians themselves as to what it is to use this drug in practice and how best to monitor that ongoing effectiveness of the drug.

Senator XENOPHON: Is it the case that Australia is one of the last developed nations to fund this drug?

Ms McNeill: Yes.

Senator XENOPHON: Why is that? You cannot tell me why that is?

Ms McNeill: We were one of the last countries to have the drug brought here for consideration for reimbursement.

Prof. Halton: Let us be clear about this. The drug company have to bring forward a proposal. They did not do that in the same time frame as they did in other countries. And they also have to meet the requirements of the PBAC which are not all, as Senator Di Natale rightly asked, in respect of price. The reality is that we have to, as we are obliged to legally, get an adequate response from the company in respect of these matters, and we are trying to get that as fast as we can.

Senator XENOPHON: Okay, but we are still one of the last developed countries to have this drug approved for public funding. Is that right?

Ms McNeill: But, again, Senator, we were one of the last countries to have the drug brought here for consideration.

Senator XENOPHON: Right. Thank you.

Senator SMITH: Ms McNeill, if there is anything that we might be able to do as individual senators to encourage the company to respond to queries from the department, we would be very keen to do because it is an issue of concern to all senators. Just going back to two points you made, if I may, one was about the time frame for listing new medicines on the PBS, and in your earlier remarks you mentioned that it is now four weeks faster than it was previously. Can you share with us: what was the average time for the listing of new medicines on the PBS under the previous government? Do you record that figure?

(NB - Felicity McNeill is Pharmaceutical Benefits Division - First Assistant Secretary - Department of Health)

Click HERE to download this transcript as a PDF.