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Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 240 - 259)



Sandra Gidley

  240. May I just ask a question about Herceptin because it is something I have been following fairly closely? Correct me if I am wrong, but my understanding was that when the Herceptin submission was put in, NICE were asked to look at two things: Herceptin by itself and Herceptin in conjunction with another drug. My understanding is that one of those—and I cannot for the life of me remember which way it is—is sitting there ready to go, the guidance is practically written, but NICE will not release it because the other guidance is not ready. What possible excuse could there be for delaying the guidance that they are happy with?
  (Mr Campbell-Morrison) That is my understanding as well. As a fellow pharmacist, I defer to you because I know you have quite a lot of knowledge about Herceptin. I do not have any explanations. It does not seem rational to me to delay guidance when you have it ready.
  (Dr Jones) This is one of those very difficult situations. This is a drug where there is incontrovertible clinical data that it works. What happens is that there are many ways of treating cancers: surgery, radiation and drugs. In these 25 per cent of women who have over-expressed this particular gene, if you add Herceptin on to a current treatment, particularly the taxanes, you get dramatic extra benefit in terms of quality and length of life. It is not a Beta-interferon situation where there are different interpretations of the clinical potential of it: there is incontrovertible data. There is a price on it. Many other countries who have already licensed it are seeing the advantage of it coming through to their patients. Is it then about the affordability of this drug to the Health Service? If the answer is yes, that to me is a political decision about whether this is a priority. If it is about whether it is cost effective, why do we not give the patient the benefit of the doubt whilst that is assessed in the real practice of patients with this condition?

Dr Naysmith

  241. Why has it been referred to NICE? What is the reason given for this?
  (Dr Jones) I presume from the witnesses we heard before our presence here, that it genuinely is the concern we all share of how on earth you make decisions on priority of spend.

  242. The reason I am pursuing this line is that this is a particularly unusual case and the ones we argue about nearly always are. How do we know for certain that a drug is performing better than other existing treatments unless you have some procedure like the NICE procedure. I know this one is unusual because I have been to a demonstration and spoken to clinicians about it. The reason for the whole process is to try to make sure not just that something is better than nothing, but that it is better than existing treatments with other competing drugs.
  (Dr Jones) That is the role the Government has given to the Medicines Control Agency, to ask whether a drug does work, whether it is effective, safe and the right quality. This drug can only be compared in a situation where you are showing the extra benefit for these patients with this unique genetic expression. The role of NICE is not to say whether it works or is going to be effective. That is proven without doubt.

  243. In this one case.
  (Dr Jones) No, it is incontrovertible. The question is whether the Health Service can see this as a cost effective way of treating this particular sub-set who have this condition and the oncologists would say it works. I think it is a clear affordability issue.
  (Dr Patterson) The Department of Health has taken a stand, through a thing called TAG, technology access group, which sits almost entirely within the Department and has few or no outsiders on it, that they are going to go with all new medicines at the time of approval and try to do a NICE assessment. With something like this where there is incontrovertible evidence, it should be relatively simple, but it still takes one to two years during which time nobody is prepared to pay for it to be given to patients. Consequently and you have this problem you have heard described. With many other cancer medicines, you have evidence maybe of response of the disease but not comparative data and maybe not survival data. Five years' survival data takes five years. The issue there is that you cannot do a definitive assessment at launch.

  Dr Naysmith: I understand what you are saying. My main point is to make it absolutely clear that here we are picking incontrovertible evidence that it works and I do not want it to be assumed that for every drug which comes up before NICE it is the same situation.

Sandra Gidley

  244. One more question on Herceptin before we move on slightly. I have also heard, I do not know whether you have any evidence that this is the case or not the case, that although there is a test available to determine whether someone would benefit from this treatment they are not even having the test because that raises questions of putting a moral responsibility on somebody to provide and fund.
  (Mr Campbell-Morrison) That is something which has a lot of moral implications. We have heard public health doctors taking advice from lawyers. If a woman goes in and has a breast tumour it is very traumatic. The doctor is going to perform a biopsy. Whether she is treated or not with Herceptin—and it would obviously be better, if that were indicated, for it to be treated if she has those markers—she is entitled to know whether she has those markers because that indicates a more aggressive disease. It is outrageous that people are not allowed to know because physicians are scared about being put in this position that you have this market, there is this drug which can treat your condition, we are not allowed to offer it, that is a terrible position to be in. I think that woman should have the right to know that she has an aggressive tumour even if she is not being treated, because then she can plan her life. She can make disposition of property, what happens to children, whether she is going to carry on working. I think that women with breast cancer in the UK need to know that.

Mr Burns

  245. With this drug, although it is new to Britain, is it being used in other countries around the world as a perfectly acceptable, tested and considered safe drug?
  (Dr Patterson) I am not an expert on Herceptin, but I can tell you the answer is yes; recently introduced in many other countries and no drug is absolutely safe. It was licensed around the world around the same time over the last two or three years.

  246. It is being used in other parts of the world.
  (Dr Patterson) Yes, as part of the standard therapy.

  247. And we are waiting for NICE to give their appraisal which has been delayed by six months so far.
  (Dr Jones) It is approved for use here in the UK by the Government authorities.

  248. The other question is on the numbers involved. Mr McKinney, you mentioned a cohort of 5,000 and then you said that it has been shown through testing that about 25 per cent would benefit from the use of this drug. Is that right?
  (Mr Fullagar) Different numbers. The total population is higher than that. The company's estimate is that those who would come into consideration for treatment are 5,000, that is the proportion of the total breast cancer patients who would potentially benefit from this treatment—

  249.—would be about 5,000 per year.
  (Mr Fullagar) Would be about 5,000 per year.

  250. On the basis of the rough ballpark figure of the cost per year for this drug, it has been worked out by someone other than myself that it would cost about £7.5 million a year which would extend and improve the quality of life of about 5,000 people. So we are talking possibly relatively small amounts of money compared to the beneficial effects it would have on 5,000 people.
  (Mr Campbell-Morrison) Yes.
  (Mr McKinney) Yes.

Jim Dowd

  251. This sounds such a strong case; words such as "incontrovertible" and "evidence" have been used. This is medically safe as far as it is possible to be. On a case as blatant as this has nobody gone to NICE to ask them what on earth they think they are doing?
  (Dr Jones) With respect, NICE have been given a task. It is not NICE's judgement.

  252. No, the words "inexplicably delayed" have been used in the evidence. Has anybody asked for that explanation?
  (Dr Jones) The process is that NICE is asked to make an appraisal. There must be a time when it has to gather the data, has to bring that to a committee, has to look at that data and make a decision. It could say it did not need to do all that, the evidence is incontrovertible that it works, off you go. That is not an appraisal.

  253. That is not my question. Has anybody sought to ask why it has been delayed six months?
  (Dr Jones) The question to ask, if I may say, is why in the first place this process was raised. If you have breast cancer or care for someone with breast cancer, what you want to know is the best way to treat the condition and the guideline in that direction, for example the Scottish SIGN approach or Royal Colleges, is a valid way forward. NICE were asked, by a process which is pretty intransparent, to look at this one and they are doing their job. I do not think we ought to blame NICE for that. NICE gets a lot of criticism when actually it is doing a pretty good job in many ways. It has faults but the process which oversees the selection and the timing of its work and the implementation of its guidance are really the issues which are in front of us.

Mr Burns

  254. Whose fault is it if it is not NICE's? Or is it no-one's fault but just the system?
  (Dr Jones) Further to the issues we heard earlier, before this blight which is occurring because of the issues of appraisal, the Health Service managers and the doctors within the Service made decisions on a case by case basis with the patient in front of them as to whether it was relevant. I believe Herceptin would be being used right now in a much greater preponderance—NICE are not saying do not use it—it would be being used much more if the system we had before had been in place. In other words people would have used their judgement to make decisions about the patients in their own patch with their own costs and affordabilities.

  255. A lot of health authorities who are ultimately responsible for the funding of health care at the moment at local levels will say—take beta-interferon for example—that they will not fund it because they are awaiting the NICE appraisal. So it is not really fair for you to say that people can use this and health authorities can fund it, because I will bet your bottom dollar, given the pressures on Health Service budgets throughout the country, that if a health authority can avoid it, particularly if they can find someone else to blame for taking that decision, they will say they are very sorry but they cannot afford this sort of level of expenditure because NICE has not done its appraisal yet. It just is not realistic out there in the Health Service today to say that health authorities should be providing the funding because they will hide behind the NICE appraisal or the awaiting of it.
  (Mr McKinney) We have been very critical of the way that whole process has worked. We had a statement from Lord Hunt in the House of Lords, we have also had the Health Service circular two years ago to say that health authorities must not or need not wait for NICE guidance before funding drug treatments. But I think you are right, this is the reality of what is happening up and down the country. They will not do it. This is one aspect of the two prongs of NICE blight. We have been very critical of health authorities. In fact we wrote to the Chairman of every health authority on colorectal drugs and other general cancer drugs to remind them of their duties and responsibilities to allow the clinicians to prescribe these drugs. No change there. Not much happened.

Dr Naysmith

  256. I have some questions which arise out of the GlaxoSmithKline evidence. Further to one of the things which is said in it—and given the exchange which has gone on already once I have asked you this question we may decide there is no role left for NICE—why do you think that NICE should not be involved in assessing affordability of technologies, drugs and so on?
  (Mr Gray) We would concur with the answer we heard earlier. Clearly different bodies have been established to ask separate questions, MCA for safety and efficacy. Clearly there is a brief for NICE to ascertain cost effectiveness through individual appraisals. In a situation where NICE deems any particular medicine or other technology to be cost effective for the system, as we heard very eloquently from the last set of witnesses, that sets up a whole set of funding questions and challenges. Do they have enough total funding to absorb this recommendation? Do they have to shift funding from elsewhere to cover the recommendation from NICE?

  257. Do you think NICE should not be involved in that sort of thing?
  (Mr Gray) We think those issues of funding are strictly the responsibility of the Minister.

  258. What is NICE's role? We have heard some critical comments from the other end of the table. What do you think NICE should be doing?
  (Mr Gray) We would concur with NICE's goals absolutely. It was set up with goals to try to address quality assessment either through guidelines or assessment of appraisal of medicines and technology, to try to do something about what was called post-code prescribing and to try to foster faster access to treatments. What we have heard from the evidence today, and certainly it is our experience, is that there is not a great deal of progress towards those goals. From our point of view, we feel that the concentration on appraisal as opposed to guideline may well have contributed to that. Going forward, looking to put greater emphasis on setting quality standards through guidelines within which local clinicians and local authorities can start to address decisions to achieve those best practice guidelines is more likely to deliver the result that NICE was set out to do.

  259. Quality was one of the things you were critical about in your submission. You mention the Appraisal Committee and say it does not have the appropriate calibre with regard to clinical expertise in evidence assessment and the appraisal process. You are saying it is not up to scratch basically.
  (Mr Gray) No, I think we may have made a slight error in the written evidence. It is not the Appraisal Committee; that seems very high standard. Where we do see problems is a great deal of variability in the assessment groups and the original assessments they provide for the Appraisal Committee to consider. To be fair, NICE themselves acknowledged that at recent board meetings. They have themselves been talking about the difficulties in recruiting enough high calibre individuals in those centres to do these assessments. Certainly obviously we know nothing about the recruitment issue, but where we notice it is in the variability of those assessments and indeed a rather high percentage of factual errors in those assessments which are obviously indicative to us of the problem which NICE have recognised.

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