National Institute for Health and Clinical Excellence - Health Committee Contents


Examination of Witnesses (Questions 620 - 638)

THURSDAY 18 OCTOBER 2007

MR STEVE WINYARD AND DR RAFIQ HASAN

  Q620  Mr Scott: The obvious optimal option is to make sure that people do not have to go blind in one eye before receiving the drug. That may require give and take on all sides?

  Dr Hasan: Absolutely.

  Mr Winyard: I do not think RNIB has a view on drug pricing policy; it is way out of our area.

  Q621  Dr Naysmith: We have looked at a number of systems in different countries. Some allow discussion about price whilst the evaluation is going on. That does not happen under current NICE guidelines. I know that you do not speak for the whole of the drug industry, but does Novartis prefer that kind of system?

  Dr Hasan: There are strengths and weaknesses in every system. Clearly, the systems in France, Germany, Spain and Italy are very different, but, to give you a little insight, for Lucentis it is pretty uniform across the whole of Europe. For example, in France and Germany patients do not face the same barriers to uptake that we see in the UK. They see the value that the product delivers and they are happy to reimburse it at that price. When we take those sorts of pricing decisions clearly we need to think about the investment in terms of research and development, but the value we deliver with that particular product is clearly a factor we take into account. If one looks at the price of Lucentis versus other cancer medicines, for example, it is very similar, but to restore somebody's sight is a significant benefit.

  Q622  Chairman: My PCT pays for the treatment of wet AMD with Lucentis. It also pays for Avastin which is not licensed for this treatment, but if the consultant and patient agree that can go ahead. I am led to believe that it is enormously cheaper than Lucentis. Notwithstanding that you have a vested interest in the drug produced by your company, that gives us a dilemma. I know of an individual who is receiving treatment with Avastin which is successful and has been having injections every few weeks. This week that patient has been told that no more injections are needed. It is believed that eyesight has improved since the patient has been on Avastin. Clearly, that is more affordable for my PCT which has many other calls on its budget; the drug is more affordable than Lucentis. How do we as taxpayers take a steer on this? Mr Winyard must debate this in the RNIB every day, because if it comes down to money that issue is out there at the moment.

  Mr Winyard: It is a debate. As I said in my introductory remarks, we very much follow the lead of the Royal College of Ophthalmologists which broadly is that if clinicians and individual patients on the basis of informed consent regard Avastin as the solution that is what those patients receive. The Royal College also says that the quality of data available for Avastin is not the same as it is for Lucentis and therefore it does not recommend an Avastin-only service. It does not want to see Primary Care Trusts simply running an Avastin-only service.

  Q623  Chairman: It is a very difficult question for the taxpayer. Nobody wants to get this licensed and therefore it will not be at a competitive level with Lucentis. Everybody accepts, however, that it is less expensive than Lucentis. It seems to me that in those circumstances there is a real dilemma. Why is not somebody going ahead with it? It is quite right to say that in this country there is no comparable data because none has been collected and nobody wants to get it licensed for that particular form of treatment. Data has to be collected for that purpose. I understand that in America it is the drug of choice for the treatment of wet AMD. I do not know whether or not that is true.

  Dr Hasan: We would challenge that assertion.

  Q624  Chairman: But these are the matters that come across our radar in relation to these issues. There are real dilemmas in treatment. I am on your side, in that I believe that what NICE says about the treatment of wet AMD is illogical. That does not mean we should not question the cost to the taxpayer.

  Dr Hasan: Our position is that Avastin has not been designed, manufactured or approved for use in wet AMD.

  Q625  Chairman: In the UK?

  Dr Hasan: Anywhere in the world. Being a physician myself, for the past 15 years the whole medical profession has been concerned about evidence-based medicine and the need to provide the evidence—randomised controlled trials, the robust gold standard of data—to prove that the product works. That is what the Medicines and Healthcare Products Regulatory Agency is about; it is there to safeguard public safety and assess evidence. Our position has always been: if you provide high quality evidence for Avastin we are happy to consider it.

  Q626  Dr Naysmith: There are quite a few medicines in use that were not designed for the purpose for which they are currently used, and you must know many examples.

  Dr Hasan: I accept that, but as a physician I would use those types of medicines in a situation where I had no licensed alternative. For example, most medicines in children are used off label, but there is no evidence or licensed product to say that that could be used as a preference, whereas clearly in this scenario there are products that have undergone rigorous randomised clinical trials involving thousands of patients to prove the benefit and safety of injecting such a product in the eye. However, in the case of Avastin we just do not know the risks. There are lots of uncertainties and unknowns.

  Mr Winyard: RNIB is on record as saying that it wants a trial to take place. We support the IVAN trial and want to see it move ahead quickly. Similarly, in the States there will be a trial. If the data that comes forward shows that Avastin is safe and effective that is wonderful; it will be a much cheaper product and more people can be treated.

  Q627  Chairman: Quite clearly, it will not interact in the way this particular drug does in terms of QALYs in relation to NICE. That is one of the issues that we are looking at. Mr Winyard, you said earlier—I should like you to confirm it—that having to wait to go blind in one eye is a major risk. The likelihood is that the eyes would not react in the same way to this type of treatment and one could lose sight in the eye that would react to Lucentis in a positive way. Is that clinically sound?

  Dr Hasan: Absolutely.

  Q628  Chairman: What we hear NICE is likely to do is completely illogical in those circumstances.

  Mr Winyard: That is right.

  Q629  Chairman: We can all make guesses at what the wider test would be. As somebody who is only slightly visually impaired, I just cannot comprehend how blindness would affect my life. I suspect that that applies to many of us. If we look at QALYs, do you believe there is any treatment that the visually impaired get on the National Health Service that could be or should be foregone so people can get comprehensive treatment for wet AMD? You said that it was a tough decision. This morning there was a bit of an academic discussion about a drug that prolonged life for a month. It is the easiest thing in the world for us to turn round and say we do not believe x thousands of pounds for another month is worth it, but we are not the patient, or the patient is not sitting in front of us. Do you think there is anything that the RNIB may be prepared to forego in terms of the treatment for the visually impaired under the NHS so that we have this comprehensive treatment?

  Mr Winyard: Sadly, the level of provision particularly with low vision aids and support is poor and patchy, so there is not a big pot of money sitting there. This is another area where we campaign hard to try to get access to treatment in the 21st century. If one loses one's sight maybe one gets a white cane, a magnifier if one still has some useful sight, perhaps a liquid level indicator and that is it. The whole of the government community equipment programme is moving away from the provision of services. Ideally, what people should get in many cases is a CCTV which is enormously helpful in terms of access to information. At the moment, sadly if one loses one's sight the support one gets is very limited. In some places one must even buy the white cane. It comes as an incredible shock to the public that that is the case. The data that has emerged today from the Healthcare Commission suggests that maybe one quarter of trusts are not managing their finances very well, so there are other areas and procedures that in the end may be less important.

  Q630  Chairman: Dr Hasan, do you think there are any areas in which your company should disinvest?

  Dr Hasan: If you ask what proportion of the total NHS budget is represented by pharmaceutical products it is relatively small; it is about 11%. One asks about the other 89%. We always hear that QALYs are such a great measure because you can assess different types of technologies and interventions. We heard this morning about the cost per QALY of an exceptional case committee. Surely, we should be assessing the cost-effectiveness of that other 89%. What about building that new hospital wing or putting in place a new clinic? What is the cost-effectiveness relative to another intervention? We welcome that type of work. Let us have a broader debate. It is very easy to target pharmaceuticals because they are relatively transparent. Let us also assess the cost-effectiveness of some of these infrastructure investments.

  Q631  Chairman: We are individuals and all react differently. There are bathroom cabinets up and down the land which contain hundreds of millions of pounds worth of pharmaceuticals that are never used.

  Dr Hasan: Absolutely.

  Q632  Chairman: You would be happy if we disinvested in that. It might cost your company some income if that was done.

  Dr Hasan: If you said to me, "Here is one of your products where the data is weak. We think we should disinvest", I would ask to see the data. Over the past 12 to 18 months there has been a drive for NICE to provide guidance in terms of areas of disinvestment and there will be products or types of interventions where the evidence is not strong enough.

  Q633  Chairman: What about tighter prescribing? I do not refer to your company. I have been in this place for a long time. I remember that in the 1980s when there was a central drive to restrict what drugs could be given to individuals a lot of noise was made by the pharmaceutical companies. They said that that was the wrong thing to do, and yet some drugs are prescribed which do not work in particular patients. Do you think that is an area that we should look at?

  Dr Hasan: I think that is a question you should ask the BMA. A lot of physicians feel that they should have autonomy to choose the right drug for their patients.

  Q634  Chairman: But that is a different issue, is it not? Some pharmaceutical companies may have better knowledge of what works in what individuals.

  Dr Hasan: One area that is generating greater interest is the almost personalised approach to medicine. There may be interventions that do not work for the broader population, or maybe not as effectively, but everybody is interested in whether there are sub-populations of patients in whom we can see greater effect and consequently a greater degree of cost-effectiveness. That is the way medicine is going.

  Q635  Chairman: I am tempted to ask you whether or not you would be prepared to look at this treatment on the basis that it will be paid for where it is successful.

  Dr Hasan: The clinical trials show that over 90% of patients experience an improvement or maintenance in vision, so the drug is pretty effective.

  Q636  Chairman: Would you want a system like that employed by the Scottish Medicines Consortium?

  Dr Hasan: SMC and NICE were set up with slightly different remits and they serve slightly different healthcare systems in terms of the direction of travel. I believe that they have positive attributes and some weaknesses. In Scotland one has speed of guidance, which is a clear benefit. What we see now is that Lucentis is widely available in Scotland and patients are not being denied access to it, but there is less scope for consultation under that process. We welcome a debate as to how to improve the NICE process, and we believe there is opportunity in terms of transparency and collaboration. There are some methodological issues. There is also a question of driving implementation. We would encourage the Healthcare Commission to take very seriously the fact that PCTs may not be implementing NICE guidance.

  Q637  Chairman: Has your company ever done any comparable studies and published them?

  Dr Hasan: We look at how our products perform both with SMC and NICE. As you have heard this morning, there is a remarkable amount of consistency in terms of decision-making.

  Q638  Chairman: If you have anything further that you can share with us we shall be interested in looking at it.

  Dr Hasan: I will be happy to do so.

  Mr Winyard: From our perspective, the two NICE appraisals in which we have been involved have been phenomenally slow, whereas in the case of the SMC we put in our evidence and three months later a positive result came out, which is great. It is very important that there is scope for some comment on draft proposals. The NICE process is wretchedly slow. If you ask about it, as I asked Andrew Dillon in Bournemouth, you do not get any clear answers. You are told that it is all to do with NICE being much more consultative and involving, but as consultees we are given a month to respond to the ACD. There is no flexibility for us. If we want to appeal we are given 15 days. There are periods of seven or eight months in the appraisal process when nothing appears to happen. It does not take seven or eight months to do a bit of economic analysis. There just is not the sense of urgency that needs to be injected into the system.

  Chairman: Thank you for coming along. No doubt you will be looking at our deliberations with interest over the next few months before we publish our report on NICE and how it operates.






 
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