Top-up fees - Health Committee Contents


Examination of Witnesses(Questions 260-279)

PROFESSOR MIKE RICHARDS CBE, DR FELICITY HARVEY, MS UNA O'BRIEN AND PROFESSOR SIR MICHAEL RAWLINS

12 FEBRUARY 2009

  Q260  Dr Naysmith: Somebody has to take account of it.

  Professor Sir Michael Rawlins: Parliament has specifically said in our statutory instruments that we are not to take into account the budgetary impact. One of the dangers of course is towards the end of the financial year, having a discussion about something that really is rather expensive and fairly cost ineffective but it is March, there are £10 million left, let us stop the argument, say yes and go ahead. I have worked with committees for 30 or 40 years now and I know how they behave and if there is an easy way out they will use it.

  Q261  Dr Naysmith: We have had a lot of experience of committees here too and we know how they work. PCTs work in a similar sort of way; come about January they are stopping things they were funding or they are funding things they would not otherwise fund.

  Professor Sir Michael Rawlins: I think the real problem is that one year it might be £100 million and another year it might be £200 million. It is very difficult to work it out that way.

  Dr Harvey: I think the point that Sir Michael makes is very apt. If there was an issue about affordability would NICE actually take a slightly different view from the view it takes now? Our view is that in terms of negotiation, in terms or pricing et cetera, those issues are for government. However, in terms of actually having a view on clinical and cost effectiveness and now, as we have in the PPRS, value, we think it is very important that they have that role, that they do not have a role in negotiation et cetera which properly sits with us. The other issue is that NICE will look at technology appraisals as just one part of their business and, as you know, the NICE work now is extraordinary broad over technology appraisals, over clinical guidelines, interventional procedures and indeed now they are taking on quality standards for the NHS. There certainly is no intention at the moment that we would change the legislative base to give them affordability as well.

  Q262  Chairman: Looking at this debate we have just had for the last few minutes, you have obviously looked at comparable systems in terms of access to medicines throughout the world. One of the comparable health services I have come across from personal experience is New Zealand in terms of what happens there and how it is funded overall. They have a Crown entity system which decides where the priorities are and subsidises medicines for the general population. I do not know whether that is in all areas of medical care. Its remit is prioritising which medicines are publicly subsided which they believe is crucial to ensuring that the best health outcomes are obtained from medicines and those outcomes provided the best value for money. I hear what you say about having £10 million and it is heading towards the end of March but that is an accountant's view of society. If you could take the £10 million into next April it does not mean that you have to take a decision. Have you looked at these types of comparable systems?

  Professor Sir Michael Rawlins: Yes, and we have a lot of links with the Australian system. They invited me over there last year to celebrate their 60th anniversary. They have a similar sort of process to our technology appraisals but they do not do anything else. They do not do devices, they do not do diagnostics and they do not do guidelines. It is a very circumscribed field but they do very similar things and they usually come up with very similar conclusions, although not always because pricing is different.

  Q263  Chairman: Have you looked at New Zealand?

  Professor Richards: Not in detail but I have been to New Zealand to talk about Cancer Matters in the past and the conclusion I came to from talking to both parliamentarians and clinicians in New Zealand is that their regime is rather a lot stricter in terms of availability of drugs than ours is. That was certainly true two or three years ago when I was last there. In the course of my review I have talked to people from Canada, from Italy, from Australia. We engaged through the London School of Hygiene and Tropical Medicine and commissioned a report on what the approaches were in different countries. One of the recommendations I made in my report was that that work should be taken further forward looking in more detail at international comparisons and we will be taking that forward this year.

  Q264  Charlotte Atkins: Should there be a different threshold for end of life care or should it be the same as any other threshold?

  Professor Sir Michael Rawlins: We use the same threshold. For those treatments that fall into the category we take account of the weighting of the QALY and the appraisal committees have been doing this since the beginning of January. They have made two positive decisions relating to end of life treatment. We make sure that the quality of life weighting they are prepared to accept brings it broadly within the normal threshold range.

  Q265  Charlotte Atkins: So it is not at a much higher level.

  Professor Sir Michael Rawlins: No. Under some circumstances one might want to double the QALY.

  Q266  Charlotte Atkins: That is because we are only talking about a few weeks or months of life.

  Professor Sir Michael Rawlins: Exactly, yes.

  Q267  Charlotte Atkins: The other issue which this Committee has looked at, as you will know from our 2008 report into NICE, is the whole issue of disinvesting from interventions where they are not effective or cost effective. That was a recommendation we made in 2008; what progress have you made in terms of making sure that that happens?

  Professor Sir Michael Rawlins: You may recall our response to you when you made that recommendation. We have actually got a pretty formidable disinvestment programme but it is not labelled as such. Much of the disinvestment opportunities actually arise from our clinical guidelines, not from the technology appraisals. There are not actually in the British National Formulary useless drugs; I would be ashamed if there were because I was Chairman of the Committee on Safety of Medicines for six years. There are some rather old fashioned drugs which people do not use very much now.

  Q268  Charlotte Atkins: There are plenty of old fashioned GPs and doctors are there not? When you have old fashioned doctors you may well have old fashioned prescriptions.

  Professor Sir Michael Rawlins: Yes, and there will be people using methyldopa for the last 30 years who will be very cross if we take it away because it is effective but has associated side effects for many people. It is really in the clinical guidelines where the opportunities for disinvestment occur. It is not usually so much a question of stopping doing things altogether, it is refocusing and making sure that children with sore throats only get antibiotics under some special circumstances and not as a routine. These are the rather more subtle things. In 2007 we counted there were over 150 disinvestment opportunities from the guidelines and we keep on recycling these to remind people. So we do have disinvestment. We have not forgotten it but it is a bit like the problem with the bed occupancy in the oncology units, that sort of subtlety.

  Q269  Charlotte Atkins: You have not been successful in getting doctors on side. If you take something like generic prescribing, for instance, attempts to get doctors to move in that direction have not been particularly fast.

  Professor Sir Michael Rawlins: I beg your pardon, we have the highest rates of generic prescribing in Europe.

  Q270  Charlotte Atkins: There is still a wide variation between doctors.

  Professor Sir Michael Rawlins: Actually there is very little variation. One reason why there is not much variation is the repeat prescribing systems that are computerised which all do it under the generic names so even if the doctor cannot remember the generic names and can only remember the brand name it actually comes out as a generic. We have very, very high rates of generic prescribing in Britain.

  Q271  Charlotte Atkins: I am pleased to hear that.

  Dr Harvey: There is about 83% of generic prescribing on prescriptions dispensed in the community in England. Even if there is no generic because it is actually a branded product that has not come of patent, nonetheless the prescriptions are written in the generic form for 83% of prescriptions and it is the highest in Europe.

  Q272  Jim Dowd: Before I go onto the substance of my question, Professor Richards, you mentioned New Zealand and the drugs regime there. When we were in Australia a few years go it was drawn to our attention that they allow direct to patient advertising by the drug companies in New Zealand. I wondered if you knew anything about that and felt that it was a good or a not so good scheme.

  Professor Richards: I do not personally support direct to patient advertising. I think that is one of the things that a clinician meeting with a patient can explain what he or she thinks is in the patient's best interests and explain all the pros and cons of different treatments. I personally think that is the right way forward. I do not know about that particular aspect of what might be happening in New Zealand. All I can say is that when I was in New Zealand the very clear impression I was given was that on cancer drugs they were more restrictive than we were.

  Professor Sir Michael Rawlins: There is a lot of direct to consumer advertising in the United States of America. It makes for very boring television to keep on seeing different drugs for erectile dysfunction which seem to be the predominant adverts on American television whenever I watch it.

  Q273  Jim Dowd: I want to move onto risk sharing schemes. The experience in Sheffield has been described variously but I think the kindest euphemism one can use is "unfortunate". That was the study over the MS drug glatiramer. Is there any future for risk sharing schemes and, if so, what framework should they be conducted under?

  Dr Harvey: I think you may be referring to the MS risk sharing scheme which was started back in 2002. There are four drugs involved and that is between government and the manufacturers of those four drugs. That study is continuing.

  Q274  Jim Dowd: Sheffield is not going ahead with the second stage of it, is it?

  Dr Harvey: It is actually being taken forward through Parexel so actually the study will continue. It continues for 10 years; the first set of data has been analysed and is about to be submitted for publication. There are fixed points throughout the 10 years where the data will be locked, there will be an analysis and it will be published. The first of those will be published fairly shortly. In terms of the risk schemes going forward, we have referred to them within the PPRS scheme as patient access schemes. They are not likely to be in the same way as the outcome guarantee scheme. The sorts of things we are likely to see are responder schemes, discount schemes et cetera of the sort we saw before the PPRS was agreed for Lucentis and Velcade but those are the sorts of schemes we are likely to see in the future as patient access schemes, so slightly different.

  Q275  Jim Dowd: Professor Nicholl, who was leading the scheme in Sheffield, told this Committee that they pulled out because they felt that the structures were weak and it was not going to provide the science they hoped it would. Have you discussed these reservations with them to decide whether they are valid and what actions you need to take to address them?

  Dr Harvey: When we re-tendered for this second part of the scheme they in fact did not put in for that tender and therefore we are now working with Parexel as well as the neurologists, the MS Society, MS Trust et cetera and we have a scientific advisory committee that is chaired by Professor Richard Lilford and I think it is the scientific advisory committee that recommends to the funders, trying to ensure that the scientific validity of the study as it moves forward, is as good as it possibly can be. I think we are confident that it is robust. We have a cohort of about 5000 patients who are being studied over the course of this 10 year scheme and there is a collection of data from their outcomes being collected. Clearly the first of the publications from that will be submitted for publication imminently. It will depend on how long the peer review journal takes before it is actually published but it will then come out into the public domain.

  Q276  Jim Dowd: What about the previous view of this Committee that risk sharing should operate under a system whereby the burden of proof will be on the drug companies to demonstrate that a drug provides adequate benefits?

  Dr Harvey: I think that is really more in the sort of risk sharing/patient access schemes that we are moving towards as part of PPRS which are less likely to be of the outcome guarantee scheme. In the case of Velcade, for example, if there is something that is measurable in terms of a responder scheme but, if not, it might be a simple discount scheme as a way of getting access to patients for innovative drugs that could actually have benefits for them. I think the important thing about patient access schemes is that they need to go through an appraisal by NICE in terms of the clinical and cost effectiveness of the scheme and the drug, so it is not just the drug but the drug in the context of the scheme. I think that is going to be very important moving forward.

  Q277  Chairman: To what extent does the debate about top-ups obscure the real issue that the NHS has failed to get cheaper drugs available more quickly?

  Professor Sir Michael Rawlins: In the sense that we have been too slow at producing guidance I have held my hands up to this Committee before and we have put in train measures to try to make sure that does not happen again. If you like, that is my failure.

  Professor Richards: I think all the measures that are being taken through the next stage of the review, through the Cancer Reform Strategy to make sure that NICE guidance and the technology appraisals are done in a more timely fashion is extremely welcome. As I said earlier, we are beginning to see the benefit of that in cancer anyway. That particular problem of there being long delays is likely to become a thing of the past quite soon.

  Q278  Chairman: Professor Rawlins, you have had some sharp comments to make in relation to how you feel the system works in terms of the pharmaceutical industry and what we pay. I am not going to ask you to repeat them here today but the real issue is around whether the National Health Service could use its bargaining power with the industry more effectively by becoming a price maker as opposed to a price taker?

  Professor Sir Michael Rawlins: The difficulty is that the National Health Service is actually only a very small market; we are roughly about 3% of the world market. People think that because the National Health Service is a monopoly buyer it can be a price maker but it is not, it is a 3% market; it does not have the clout to be able to do that. Many companies have told me privately that sometimes they would rather take the business out of the UK because of the danger that if they sold it at half price in the UK the rest of the world would want half price too. We have to have arrangements that meet their aspirations and our aspirations. The PPRS I think is as good an arrangement as there is in the world.

  Q279  Chairman: Do you agree with that, Professor Richards?

  Professor Richards: I do, yes. This issue of it being only 3% of the world market keeps coming up and the pharmaceutical industry can decide just not to play ball in that way.



 
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