Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 380 - 399)



Dr Naysmith

  380. I want to pick up on something that Sir Michael said a moment ago. You said there were instances of successful appraisal before licensing or very early on in licensing.
  (Professor Sir Michael Rawlins) Yes.

  381. The pharmaceutical firms told us that this was very difficult and not easy to achieve. I wonder why you think they said that? This Committee wants to make positive recommendations because I like NICE, unlike one of my colleagues, and I want NICE to function better than it does now. How can we try and make sure that that does work?
  (Professor Sir Michael Rawlins) I am not quite sure why originally the pharmaceutical industry did think it would be impossible, but right from the very beginning, even before there was a board of NICE or anything, they used to tell me that it would be quite impossible to make a fair appraisal of new remedies. I found it very difficult to understand it and I argued with them in discussions about it. I think that their position is somewhat changing from what it was two years ago because I think they are realising that positive appraisals, where we are actively as it were promoting cost effective, clinically effective new treatments, are to their advantage. I suspect, to be honest with you, that the pharmaceutical industry would rather that NICE had never been started. I think it is another difficulty for them and I do understand that. If I were in the industry I suppose I would think the same sort of thing. However, I do think their position has shifted over the last couple of years and they are no longer as adamant as they were about the possibility of doing early appraisals and, as I said, we have done them and they have worked.

  382. Presumably one thing they would have against you would be that adverse indications at that stage could be the kiss of death for a particular product.
  (Professor Sir Michael Rawlins) That of course is a possibility, yes.

Sandra Gidley

  383. I have to pick up on a comment that was made when you responded to David Amess, I am afraid, because I cannot let this go. In fact, there was a change in answer. This is to Professor Rawlins. You made a very robust statement that you were tackling the postcode lottery and then that was almost retracted later on and you admitted that in some ways NICE had not tackled it. We had a submission from the ABPI which showed the take-up for taxel and the use before and after the NICE appraisal. There was not much of a shift. We all want it to work. We would love there not to be a postcode lottery and we would love the NICE recommendations to be taken up fully but life ain't like that. Question one: what audit have you made of the effect you have had on prescribing patterns? Has that work been done and have the technologies been used? We all know that some of them have been taken up, but maybe only for six patients in a health authority. Then we had the recent announcement by the Secretary of State which says "no ring-fenced money", and I would like to ask if you think there should be ring-fenced money for NICE guidance, but authorities now have a responsibility to accept the NICE guidance and prescribers can prescribe those technologies. Will that not in fact lead to another form of postcode lottery in that, okay, fine, so you have got an approved drug, but you have only got so much money in your drugs budget. Will other treatments be denied? How do you get round that because at the end of the day we all want the best for the patients?
  (Professor Sir Michael Rawlins) There are three questions there. One is that you asked if we had done an audit of prescribing. We have done some. We have had some information on prescribing primary care from the Prescription Pricing Authority, but very few of our appraisals have concerned primary care. It is secondary care. Unfortunately we do not have a robust system in the Health Service to collect data—as I am sure you are aware—on secondary care drug usage. It has different systems, in different hospitals, based almost entirely on purchase data and there are all sorts of difficulties about it. I am afraid we do not have a robust answer to that question. We have, however, commissioned independent research from Trevor Sheldon at York to undertake a very detailed review of the consequences of our appraisals. It is not a very satisfactory answer.

  384. But it is honest.
  (Professor Sir Michael Rawlins) I have been in the Health Service for 35 years now and ring-fenced money in my experience is not a terribly good idea. Ring-fenced money tends to have a habit of being used in all sorts of funny ways outside the supposed ring-fencing. I would rather not go into it in detail but you probably know what I mean. All sorts of creative fences are moved around it. It seems to me that it would be much better for the sorts of technologies that we advocate, the sorts of conditions that we make the guidelines for in the treatment of individual conditions, should be part and parcel of the general money that is available in the Health Service. It has been suggested that NICE should have a pot of £100 million a year and when we get to the end of the pot that is it. I would be very cautious about that too. The Appraisal Committee are human beings and what if it were February and there was £10 million left in the pot and they were facing a rather difficult decision (and in other health care systems in the world this difficulty had arisen) I would be rather cautious about going that route. You asked about the consequences of the directions and it is our impression, although it is only anecdotal, that in large part where there have been varying uptakes it has been because of the difficulty of the health authority's funding of a particular treatment. It has not been health professionals disagreeing with NICE advice. It has been the availability of the funding. As Mr Dillon was saying a little bit earlier in our discussions, if you want to have a standard form of access to treatment that covers England and Wales, then the inevitability is that the sorts of treatments that NICE is recommending would become available and would form a major priority. The important thing is to ensure that what we do is a real priority for the service.

  385. Will there be a postcode lottery, I was asking, for the drugs that have not undertaken appraisal?
  (Professor Sir Michael Rawlins) No.

  386. You said you had got a huge catch-up process.
  (Professor Sir Michael Rawlins) Not for the other drugs, no. For the services it might distort local priorities but not for other drugs. What I would like us to do is to appraise all new innovative pharmaceuticals but we do not need to appraise the 22nd beta-blocker or the 39th fireside diuretic. They can make their place on the market and fight on the price competition or quality competition or whatever.

Dr Taylor

  387. We are going to move on to specific drugs if we may. Relenza, the 'flu drug. We have slightly touched on this but I thought we ought to say specifically that the Drug and Therapeutic Bulletin did really complain rather that they gave you a detailed report listing all of their concerns and that was in February last year and they have never had a reply. When you us details on some of your rebuttals we would like you to include the Drug and Therapeutic Bulletin.
  (Professor Sir Michael Rawlins) I will indeed send you copies of the correspondence I had with Professor Collier, Editor of the D&TB, in particular the letter I wrote on 29 January in response to his sending me a draft article, and then he responded to that letter in April, by which time the DTB article had been published two months, with a series of questions he wanted me to answer running to nine pages. At that stage, to be honest with you, we were having a dialogue with the deaf, and I did not think it was worth spending a lot of time responding to nine pages or asking the staff of NICE to do it in view of the fact that it was two months after the publication of the original article.

  388. So you have in fact responded?
  (Professor Sir Michael Rawlins) We have in fact responded.
  (Mr Dillon) I also responded.

  389. Changing on to the colorectal drugs with absolutely unpronounceable names, that is another source of great worry because there do appear to be some really significant advances there and those are delayed, people would say. Is that fair, or is there any way round that delay?
  (Professor Sir Michael Rawlins) There were two appeals on colorectal cancers, and I chaired the second appeal last week and the decision of the Appeal Panel should be available in the next two or three weeks.

  390. So that will be out very soon?
  (Professor Sir Michael Rawlins) That will be out very soon.

Sandra Gidley

  391. Last week we had quite a vigorous debate about Herceptin. My understanding is that the drug is being appraised for use as a mono therapy and also as a combination therapy. I have been told that one set of guidances is to all intents and purposes approved and ready to go, but the whole thing is being held up because the other set of balances is not available. Would it not have been helpful to the patients out there who need the treatment to have released to some sort of interim guidance too the effect that you are happy with part of it?
  (Professor Barnett) I think you have been ill-informed, if I may say so. It is not true to say that one component of the guidance is being held up because the other part of the guidance is not available. We were asked initially to appraise two drugs, trastuzumab, which is Herceptin, and vinorelbine, for the management of advanced breast cancer. Following consultation it became obvious that the information base should be extended and, the evidence base, for those two different drugs it was quite different, not surprisingly, and therefore they were separated. The information base we were informed would take longer to collate for one of those drugs than the other and so they had been separated in their appraisal process. Both appraisals are ongoing, trastuzumab has gone through the appropriate process and the final guidance for that I hope should be out in March provided there is no appeal against the final decision.

  392. When was that finished, the appraisal process?
  (Professor Barnett) Last week, I think.

  393. Was that for use by itself?
  (Professor Barnett) That was for use in breast cancer both as a mono therapy and in combination.

  394. When did you have the results for mono therapy and when did you have the results for the combination use?
  (Professor Barnett) Both of the two components of that appraisal (trastuzumab and vinorelbine)required an additional evidence base and in particular significant consultation with both the manufacturers and professionals about the use of the drugs. They will go if you like in parallel with development. It is fairly obvious, at least to me, that the two uses of these drugs, in mono therapy and in combination, are inter-related. They are not separate components. Therefore, delivering the guidance in the best way for the oncologists who use the drugs with the two together is important. It was not one drug holding up another. In extending the evidence base for breast cancer we need to be conscious that until analysed we can't be clear about the impact of new evidence, it may be positive, it may be negative or it may support the original data.

  395. It has worried me how much this Committee seems to have been misinformed over the past couple of weeks. Does that not say in fact that maybe the bodies that are out there are not getting sufficient feedback from you as to what is happening to hold up these processes? I am a little concerned at some of the conflicting evidence we have been having.
  (Professor Barnett) I understand your concern and I would feel the same way. I think the bodies who were involved in the appraisal, the consultees themselves, were fully informed of exactly what the Appraisal Committee had in mind. I think it is the Institute's job to do that, not the Appraisal Committee's job, and on advice that is exactly what they did.

  396. So you would say that all the drug companies were happy with the length of time that the process took?
  (Professor Barnett) I do not think the drug companies are ever happy with the length of time that we take over our appraisals. What I think they are happy with is the rigour with which we address our requests.

  397. And the patients' groups are similar?
  (Professor Barnett) I think the patients' groups are unhappy too and I am not surprised because, like any patient, as a clinician I want everything yesterday, but that is not the way in my view to effectively appraise the correct use of these very complex medications in a rather tortuous pathway of care.

  398. Is there any way that can be speeded up a little? Is it right that you only have hearings every so often so that if you miss one you have to wait a few months for the next?
  (Professor Barnett) Hearings? I am not sure what you mean. The Appraisal Committees meet fortnightly.

  399. Surely that is timetabled so people know it is coming up.
  (Professor Barnett) Absolutely.

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