During the February session of Senate Estimates, Dr Richard Di Natale questioned the Department of Health about the potential review of the Life Saving Drugs Program.
Senator DI NATALE: Can you give me an update on the review of the Life Saving Drugs Program?
Ms McNeill: That is still being progressed and a decision on that is imminent.
Senator DI NATALE: You have nothing else to say on that, except the decision is imminent.
Ms McNeill: Yes.
Senator DI NATALE: Can you tell me about the last changes to the Life Saving Drugs Program in 1999 which inserted the word 'substantial', basically meaning a drug would need to demonstrate substantial life extension. I still do not understand what that means. Can you give me some clarity about its meaning?
Ms McNeill: That is a decision that is made by the clinicians when they assess the clinical evidence that is put forward for a particular drug. Since that change in the criteria for the Life Saving Drugs Program we have had drugs listed under that criterion.
Senator DI NATALE: What factors did you consider when you were assessing whether substantial life extension?
Ms McNeill: That is not assessed by me; that is assessed by medical practitioners. I am but a mere humble public servant.
Senator DI NATALE: But they must have some guidelines about it. What I as a medical practitioner consider substantial and what a colleague might consider substantial could vary wildly. What is the framework they use to assess that?
Ms McNeill: The guidelines for assessment of the Life Saving Drugs Program are as you have seen and as quoted, and it is published on the internet. That is then used as the basis of a submission that is put together by a drug company, by their health technology team, and that is then assessed by the university assessors. That is then provided to the Pharmaceutical Benefits Advisory Committee, which comprises 18 members—many of whom are experts in a variety of fields; it also has consumer representatives, and that is why we have a balance of views from the medical profession as to the evaluation of that evidence and whether the submission that is put forward meets that criteria. As I pointed out earlier, we have had drugs listed on the Life Saving Drugs Program, under that criteria, since it was introduced.
Senator DI NATALE: That is right; you have also had drugs that have not been listed, and I am just trying to determine why you give some a substantial extension of life and not others. I cannot see any rationale for those decisions.
Ms McNeill: Those drugs have not been recommended for the Life Saving Drugs Program under the old criteria as well.
Senator DI NATALE: That is correct, but I am asking you under the new criteria what it is that allows one drug to demonstrate substantial extension of life and another drug does not.
Ms McNeill: The recommendations that are put forward by the Pharmaceutical Benefits Advisory Committee are published in public summary documents; all analyses that they have done of all drugs that have sought listing under that program are publicly available on the internet, with the reasons for the evaluation of that evidence, the reasons for reconsideration of that evidence and what evidence they are looking for in the future to reconsider those drugs.
Senator DI NATALE: In the review that is being done at the moment, has there been any comparison with the way life saving drugs programs work in other settings internationally?
Ms McNeill: As I said, a decision whether to proceed with that review is imminent.
Senator DI NATALE: You do not want to speculate? You do not want to reflect on the process that was used to arrive at that decision? Were some international markets considered as part of that review?
Ms McNeill: That is a matter for the government to determine—if the review should proceed, and what the terms of reference for that review should be.
Senator DI NATALE: If the review should proceed? So the decision is not about the outcome of the review?
Ms McNeill: No, it is about whether or not the review will proceed.
Senator DI NATALE: The review was announced I think by the previous government?
Ms McNeill: That is correct.
Senator DI NATALE: Then it was underway?
Ms McNeill: No—they announced their intention to undertake the review in the process that had been agreed with Medicines Australia, draft terms of reference were provided to stakeholders in consultation to determine if those terms were appropriate, that feedback was then provided, some additional work was done, those terms of references have now been provided to government and it is a matter for the new government to determine whether or not that review should proceed.
Senator DI NATALE: Well, start—effectively all we have got is some terms of reference, is that right?
Ms McNeill: We have draft terms of reference.
Senator DI NATALE: So the government has some draft terms of reference, and is going to make a decision about whether the review should be initiated?
Ms McNeill: That is correct. No decision has been made on whether to proceed with the review, but work has been done on those terms of reference since that time.
Senator CAROL BROWN: Are the terms of reference complete, and have they been provided to the minister? Where is it up to?
Ms McNeill: A decision on whether to proceed with that is imminent.
Senator CAROL BROWN: So, the draft terms of reference are with the minister?
Prof. Halton: It is now at the decision-for-government stage.
Senator DI NATALE: Should a decision not to proceed be made, effectively we are left with the status quo, which is that we have this substantial life extension clause in the current process.
Prof. Halton: This is really all in the decision-for-government category; there is really not a lot more we can say.
Senator DI NATALE: If the government decides not to proceed with the review, then we get the status quo?
Prof. Halton: Government can do anything it wants in terms of changing the criteria or proceeding with the review or whatever. It is essentially now over to the government.
Senator DI NATALE: It sounds like it is imminent.