Official Report 303KB pdf
I thank members of the public and the witnesses giving evidence to this important inquiry for their patience and welcome everyone to the seventh meeting this year of the Public Petitions Committee.
I think that we would both like to make a few opening remarks.
It might be helpful if I give a little bit of background about Cancer Research UK's view of and role in all of this. First of all, however, I offer my condolences to Mr Gray's family and friends, for whom we feel very keenly.
I thank the witnesses for their helpful introductions.
Professor Johnson, you said that in general the appraisal system is effective. That has probably come through in most of the written evidence that we received in response to our questions about the relative roles of bodies who are involved in the system. Can the appraisal process and relationships between bodies be improved?
The appraisal process is probably as good as it can be if it is to serve the different constituencies and ensure that appraisals are objective and authoritative. As I said, there appears to be some opacity around the implementation of judgments and appraisals. In particular, area drug and therapeutics committees, which are responsible for implementing guidance, appear to vary in their approach. I have no way of knowing to what extent that is the case, but a case can be made for a good deal more transparency in the process, because patients who try to negotiate their way through the system often find that arriving at where decisions are made is a rather opaque and Byzantine process.
I agree that there should be more transparency, probably at local area drug and therapeutics committee level. Everything is on the web for people to see, but perhaps we do not know everything that goes on between advice being given to health boards and decisions being taken at area committee level, which is probably where inequalities in the system emerge.
I appreciate that. Given that there is acceptance that the SMC does a good job of assessing drugs early and letting health boards know about them, is there any need for area drug and therapeutics committees, which are another layer between the SMC and the patient? You say that the process is not transparent enough. Does it need to be changed?
Without knowing the detail of the different bodies' responsibilities, I would say that there is probably a good case to be made for a uniform national system of implementation. If such bodies are to exist locally, it would be extremely helpful for a standard approach to be taken. I understand that the SMC's rulings are not statutory, but it would be helpful for the Government in Scotland to take a view about the uniform implementation of such guidance.
Do you think that the SMC's rulings should be statutory, in the same way as NICE's rulings are statutory south of the border?
The approach south of the border has been helpful.
Why are the SMC's rulings not statutory?
I cannot answer that question.
When you speak to colleagues about how policy is arrived at and so on, do you get the sense that we have not adopted the statutory approach because we are trying to recognise the principle of responsibilities being devolved to different levels? Is that the history behind our process?
I honestly cannot say why the non-statutory route was taken when the system was set up.
The SMC's rulings are set out as guidance, and a health board does not need to follow that guidance if it does not want to pay for the treatment. I do not think that the local committees add much; the SMC does a good job on the whole. When the SMC gives advice, I do not see why the decisions should be made by another layer, because that means that the process takes longer and health boards might not take the advice. Either it is good advice or it is not. If it is good advice, why would a health board not take it? Does it come down to the funds available to each health board? We end up with a postcode lottery, which means that a patient in the north might not get medication that a patient in the south gets, and vice versa.
I have read so many documents that my memory might be failing, but am I right in thinking that the area committees are represented on the SMC?
Someone who is appearing before the committee later can probably answer that question, but I think that people can sit on both.
As part of the cancer reform strategy, the cancer team in England will undertake a recurrent audit of the implementation of guidance from NICE, which is the statutory body. My understanding is that such an audit has not yet happened in Scotland. It may be worth having a systematic review of the level of implementation of the guidance that has come out. There is evidence of heterogeneity, but we do not know the underlying reasons for that. There may be something to be said for systematically reviewing implementation.
On localised decision making, I read in the committee papers about managed clinical networks, which seem to be yet another area of, I presume, clinical decision making. Can either of you throw any light on whether MCNs make things more consistent?
The organisation and funding of health care is continuously evolving. There has been a series of initiatives, and MCNs provide another means to streamline, if you like, the process of cost control and provision of care.
Am I right in thinking that a managed clinical network operates within a health board area, rather than across health boards? That is my point.
Generally speaking, yes.
Throughout this process, I have been interested in the idea of exceptional prescribing circumstances. I have to be careful about what I say because I am not a doctor and do not really know what they do—I guess that I will never find out—but on what basis is a doctor able to say in principle that a patient really should have product X when the rest of the world says that that would not be appropriate? How can an individual doctor build up a sufficient body of knowledge about that product to want to prescribe it when the rest of the world says that it is not a good idea? I am certainly not being critical of anybody; I simply wonder whether you can throw any light on how that happens and how we might accommodate it.
In Mike Gray's instance, it was a last resort. It depends on when patients are diagnosed, because many do not know that they have the symptoms of cancer. It is important that they go along to their general practitioner and get all the tests done to diagnose what their problem is but, sometimes, they go for some considerable time with rather vague symptoms and do not really know what is wrong. Therefore, we end up with patients arriving to see a consultant at different stages. As it is the doctor's duty to do the best by the patient and pull out all the stops, they might prescribe a drug that they would not use in the normal course of events. A doctor might think about what else they can give a patient who is not lying in their death bed but walking about and trying to keep going to work. Given their knowledge, an oncologist should be able to say that a certain drug is the only way forward and should therefore be able to ask for special circumstances to apply. No two patients are alike.
Cancer medicine's reliance on evidence is probably better than that of almost any other field of medicine: our evidence bases are put together very carefully and more trials are conducted in cancer medicine than in just about any other area. We are comfortable with our evidence base, but the difficulty is always to extrapolate from the general to the particular, because there will always be unusual cases and cancers that behave in a way that does not fit the norm.
I know that we are here because of Mike Gray's case. He was a brave man indeed and I am grateful that he got us here, but I do not want to get lost in his case. If I understand you aright, you are suggesting that it is perfectly reasonable for a clinician to examine the total body of evidence that the SMC might have seen, form his or her own judgment that, in the particular case of the patient whom he or she is treating, the evidence says that a certain drug might work and decide on the basis of that evidence to prescribe it.
Yes. I would not advocate unfettered autonomy, because that would risk creating a system that was difficult to manage. On the other hand, you could ask why we train doctors at vast public expense over a long time if we are simply going to tell them to follow a recipe. The exercise of individual judgment has to enter into the process, albeit within a clearly confined and constrained system.
That is encouraging. Thank you.
I return to a point that I made a moment ago. Exceptional cases are often dealt with in a closed process and little information comes out about the basis on which decisions were made. As a general principle, it would be helpful for such proceedings to be as transparent, open and iterative as possible between the patient, their clinician and the body that makes the decision. That is the point that we were making in our submission.
Fine. To extend that to the particular case that led to the committee's inquiry, I presume that you expect specialists to be able to argue for exceptional prescribing entirely on their own authority and based on their professional judgment. They would not need any back-up from the patient to make that happen.
I think that it is probably a combination of the two. The clinician draws principally on the body of evidence that is available and the particular circumstances of the patient, but I agree that, to a large extent, it is up to the clinician to make the case.
Why would it be fair for a patient to have to be involved in the process, given that the vast majority of us do not know what the words mean and could not spell them?
We would not encourage a patient to become involved if they were unwilling. I do not know the circumstances of the particular case that you mentioned, but my experience of similar cases is that, often, the patient wishes to engage with the process. A large part of the problem of incurable illnesses and serious malignancies is that so little of what happens to the individual is within their grasp or their control. Many of the systems that we have set up seem almost deliberately to move the locus of control away from the sufferer. The greater their sense that they have an input to what happens to them, the more comfortable they feel. The process is often heavily driven by the patient themselves.
I think that you would find that many patients do not want to be involved. If the system was a good one, they might not have to go through the torture of being involved in it. If we think beyond cancer treatment to other areas in the national health service, there is a tendency for patients to feel that they are coincidental to the running of the system. Professor Johnson alluded to that. Although doctors are taught to involve the patient, they come up and examine patients and speak to them without introducing themselves. Patients sometimes lose their personality and their control.
You said that certain drugs are sometimes used when all else fails. Is the patient given a proper chance of successful treatment if drugs are being used when there is almost no hope of anything really working? Is it fair to the patient that, because of the cost, the drug is not used until there is almost no chance of it being successful? Given that drugs are approved for use on the basis of a cost benefit analysis, I guess that the question is: what are the benefits and the cost? Who makes that decision? An individual would consider a cost benefit analysis to be important to them and would pay a lot of money for a short-term benefit. It all seems to come down to that.
Patients will take absolutely anything. They have said to me that, even if a treatment is experimental and has not been proved, they would take it if it gave them a chance of a few more weeks and months. However, on the whole, people get the right treatment for the right cancers. It is only as they go through their treatment that we see how they respond to it. As I understand it, not everybody responds in the same way to similar treatments. When you are running out of successful treatments, you will try those that have just been licensed or are sitting on the sidelines—although they might not be the first choice for that cancer, they might help with the symptoms. You are trying not to cure the cancer but to deal with the symptoms. That is what I meant.
The petitioner and his family expressed concerns about self-funding. Cancer Research UK's response said that a wider debate needs to be opened up on a co-funding model. Will you expand on that? If I have picked it up correctly, the concern is that, because the individual had to pay for treatment, he could not get the other support and care that he would have expected from the health service.
At the moment, national health service patients can obtain free treatment under the framework about which we have talked. If treatments are approved, they receive them free, but treatments that do not meet the cost benefit criteria that are laid out are not provided.
I would certainly like a system whereby patients did not have to pay out of their own pockets. Private care has co-existed with the NHS for many years, since the inception of the health service. More and more people go for private health care and mix it with NHS care. They do not understand why, when they have cancer, they are suddenly up against a brick wall and have to pay for the drug and the NHS care. I do not see why there could not be central funding, in particular cases, for named patients that apply for it. That might be a way round the problem.
I have the Health Department's letter of 5 February 2007, which essentially gives guidance on co-payment. To me, there are discrepancies. The first bullet point in the letter says that
I agree that the subject is extremely confused and confusing. The question of private treatment is, perhaps, separate. It is clear that we should not mix private and NHS care within one episode because, for example, it is extremely difficult to understand how clinical responsibility could be maintained in such circumstances.
When I first read the letter, I reread it and reread it. I thought that, if I was in that situation, I would not know what to do. The English is dreadful, and there are questions about its legality. It leaves people unsure about what they are supposed to do.
I return to your previous comment about the cost of rarely prescribed drugs. Simple economics suggests that if the drugs were prescribed more often, their price would come down. Then again, simple economics says that their price would come down only if there were a substantial change in their volume. I wonder whether the volume of a drug's sales in the UK would significantly affect its price internationally. If, say, instead of being prescribed in 1 in 1,000 cases a drug was prescribed in 1 in 100 cases, would that make any difference to the price or would there merely be a tenfold increase in the cost?
I am not sure that that would have much impact internationally, although quite a few parts of the world base their pharmaceutical pricing on what is determined in the UK.
I cannot help wondering whether a drug's price should be based on a fixed return, whereby it would not matter how many pills were made because the cost would be entirely fixed. One could get a quantity to use in any way that one liked for a fixed cost per year. That would perhaps be pushing the boat out a bit too far.
There are different varieties of pricing, of which value-based pricing is one. The other possibility for mitigating the cost of expensive new medicines is the so-called cost-sharing arrangement that has been used for some new medicines, whereby the pharmaceutical industry provides the new treatment either free or at a discounted rate for a certain period in order to determine whether there is a benefit in an individual patient. If there is a demonstrable benefit to that patient, the national health service might be expected subsequently to pick up the cost. Different pricing models are available, but until now we have been rather rigid in our thinking about how we set prices.
We have had a fairly extensive series of questions. I will try to provide a wash-up of the core issues.
I want a considerably shortened process. In Mike Gray's case, it took weeks for the clinician to ask for permission to prescribe. We forget that if we are not actually involved in the process. Patients do not have an awful lot of time. All of us are born to die, but a person who is diagnosed with cancer knows fine well that the clock is ticking and does not have time to wait for somebody to make a decision about their treatment. The doctors may debate the merits but, for the patient, we must make the process simpler and speedier. I would like the committee to take that up with the Cabinet Secretary for Health and Wellbeing and perhaps get the Health and Sport Committee to review the process and whether there really is a need to have area drug committees.
I agree. I hope to see a more streamlined and transparent process for implementation of the guidance. Different models of pharmaceutical pricing and, possibly, a more liberal regime to allow people to help themselves in such circumstances would also be positive steps forward.
I thank you both for your contributions this afternoon. They have been extremely helpful in developing our awareness of the issues.
Meeting suspended.
On resuming—
I welcome our second panel of witnesses. They have seen the format, so I hope that this will not be too intimidating for them—some experienced faces are looking at me, so I do not expect that to be the case. Dr Ken Paterson is the chairman of the Scottish medicines consortium and Dr Andrew Walker is its health economic assessor. Dr Kohli is the medical advisor of NHS Quality Improvement Scotland and Andrew Dillon is chief executive of probably the best-named organisation in Scotland, if not the UK: the National Institute for Health and Clinical Excellence, which is sometimes known as NICE.
It would make sense just to go to questions.
Okay. You have heard what has been said so far.
I will pick up—as I did before—on the various bodies' roles and functions. The written evidence suggests that they work fine. Is there any need for improvement to the system? Is there anything that would streamline it more? Is there a need for the area drug and therapeutics committees? How would you envisage any reform of the present system?
I guess that I should answer that first, wearing my SMC hat. We do not believe that there is any need for significant reform of the current structures. We believe that each of the organisations that are involved—the SMC, the area drug and therapeutics committees, NHS QIS—and our interaction with NICE are clearly defined. We each have particular roles and responsibilities and the SMC would not wish its responsibilities to be expanded beyond their current levels because doing what we do is enough work for us.
I would echo what Dr Paterson has said. The word "Byzantine" was used earlier. Perhaps to the outsider—someone who is not in the system—our structures and processes look complex, but those of us in the system are very sure that each organisation knows its remit and what it has to do. We have very good working relationships across the different organisations. We have mechanisms for communicating with each other: if issues arise, we deal with them.
Should the English route be followed and SMC advice put in statute?
Technically, the SMC does not exist. It is an informal coming together of area drug and therapeutic committees. Making our informal organisation produce statutory advice would be going some distance.
From earlier contributions, I appreciate the need for consistency, and the contribution that your organisations make.
Given that I am not an oncologist, I feel slightly unable to answer the question in detail. Later this afternoon, the committee will take evidence from expert oncologists. They will give members a better idea. Our advice prevails in Scotland, but it is up to local clinicians how to treat patients.
The SMC, NHS QIS and NICE provide advice to health boards and organisations. Each organisation states that health care professionals need to take account of the circumstances of their patients. Each organisation also recognises the advice that we provide to the health service. However, individual health professionals, together with their patients and the patients' carers, continue to have issues to consider.
When I read the papers of the written evidence to the committee, I was struck by how little good evidence the committee was presented with. There was a lot of opinion but very little data. You will gather that one of the deficiencies in the health service at the moment is a lack of good quality data on hospital prescribing. There is a real gap and that has been the case for years. I wish to correct one point. You have figures, for instance in the written evidence from the Association of the British Pharmaceutical Industry (Scotland), but they are sales figures based on cancer networks that cut across health boards. We know about the figures on an aggregated level—we know how much of a particular medicine was used in the west of Scotland—but we cannot get down to health board level. I am not sure that there is evidence for heterogeneity in prescribing, although I could not prove that homogeneity exists either. There is a real lack of data.
Can you provide me with any data?
No. I suppose the data exists in individual hospitals, or individual clinicians know what they prescribe for patients, but we do not have—and never have had—a national system that collects the data centrally and which would allow us to say how many patients are getting one drug and how many patients are getting another drug. Earlier witnesses were asked what they would like to change in five years. I would pick our having a national system that would enable us to flick a switch and produce tables and charts to show you how many patients were or were not getting a drug in each area.
In fairness, the cancer networks are further down the route of having that data than almost any other part of secondary care in the NHS in Scotland. They may be able to give you rather more data than those in some other areas of care.
That is helpful. Would you even hazard a guess as to whether we are within reasonable striking distance of being able to gather information that would allow the likes of Dr Walker and others to carry out a more systemic analysis, or are we a substantial distance away from it?
That question is probably better directed to the witnesses who come after us, as they are closer to the grass roots and will know better than us. I would not hazard a guess about any NHS information technology system.
A process is under way to try to procure an electronic prescribing system for Scotland. We are at the point of trying to see whether we can get a system. If we can, it will have to be bought and installed, which will take a minimum of five years.
That is why we all love the NHS so much. Getting the data is one issue and how the data are gathered is another. I concede the point that because of national strategies, more progress is being made on cancer data. It would be helpful to get some pointers in the right direction. We will inquire of the subsequent witnesses in that respect. A number of questions have probably cropped up in the meantime.
I accept Dr Paterson's point that just because the SMC approves a drug and enables it to be used does not necessarily mean that the drug should be used. He referred to local circumstances. Can Dr Paterson give an example of why a drug that the SMC has approved for use should not be used?
The obvious example I can think of is outside the area of cancer. We approved the seventh drug in a class called triptans for the treatment of migraine. It was yet another drug in the therapeutic class and six other drugs were already on the market. It was the same price—to be honest it was slightly cheaper than and not quite as good as some of the others—and we said that it was an acceptable drug for use in Scotland. It has sold virtually nil since then. That is probably as it should be, because there are six other drugs on the market that are of equivalent benefit and equivalent price. The last drug to arrive in the marketplace is always going to struggle. There are many other examples of that within therapeutic areas. Such drugs tend not to have widespread uptake because by the time we get to the third, fourth or fifth drug—what are known as "me too" drugs—the therapeutic area is mature and well established.
I listened with interest to your comments about the lack of data, and the opinions—I note what you said about them being only opinions—in the written submissions. I noted with interest that Dr Kohli said that he felt that the system actually worked well. I do not mean to put any of you gentlemen on the spot, but I am interested to hear whether you can convince us that the postcode lottery does not apply in Scotland.
No one else seems to be rising to the challenge.
Given the lack of data and all those on-going evaluations, can you give examples or more specific evidence of why the system is, in your view, working well?
We have now carried out more than 400 assessments and we have put out more than 400 pieces of advice. As part of our primary care review, we found that when we have recommended drugs for usage, there has been usage—although there are exceptions. When we have said that drugs are not recommended for use in the NHS in Scotland, there has been a very low level of usage, although not zero usage, because an individual patient's circumstances might mean that a particular SMC decision does not apply in that case. In general terms, the outcome of the evaluation so far is that SMC advice seems in large measure to be followed.
The processes and the structures that are in place allow for that consistency of advice to be given to the health service in Scotland. The issue of data has been noted, and increasingly in future we will have access to such data. In all the organisations—NHS QIS and SMC—the feedback on the consistency of the advice provided and the understanding of the different forms of advice is positive.
In the field of cancer, from what we hear from colleagues down south, we believe that where we have assessed a cancer drug and have recommended its use, the uptake here has been more rapid than it has been in the NHS in England, because of positive SMC advice. Obviously, that is good, because we are not just about preventing non-cost-effective treatments from being used; we are about ensuring that cost-effective treatments are used and are available to patients in Scotland.
There is also an issue around what you mean by talking about a postcode lottery. At the end of the previous century—the previous millennium—we were still talking about a situation in which Glasgow could say yes to a medicine and Edinburgh could say no. The choice was that stark. Patients living 50 miles apart with the same condition would or would not get the treatment.
In a sense, the case that we are talking about took that journey. The patient perhaps sensed that it was a yes/no decision and moved into a discussion with the health board to make it decide yes, but was concerned about how they came to be in that situation and was faced with the lack of data and clear information that you have talked about.
I agree. The situation has changed because there is now one consistent source of advice in Scotland. Now, the question is whether there are any exceptional cases in which one might step away from centralised advice in a particular set of circumstances, rather than whether two health boards are looking at the same evidence and coming to fundamentally different conclusions.
What is the relationship between the roles of SMC and NICE and the advice and guidance that they each give?
The relationship is very constructive. NICE does what Scotland wants it to do. If there is a need in Scotland that is not immediately covered by the SMC's work or by other activities sponsored by NHS QIS, NICE guidance, where it exists, is available for use.
That is a helpful contribution.
I want to ask about criteria for approval. I can easily understand the criterion of benefit versus side effects. I also understand that clinicians may build an exceptional case on that basis. They might say that a particular patient is in generally good health and could withstand the impact of any side effects, or they could point to the lesser side effects of some drugs. I can understand how exceptional cases could be made.
I totally understand what you are saying. You are talking about the difference between the patient perspective and the population perspective. Groups such as NICE and the SMC will always come to such issues from the population perspective, and they will talk about the typical patient and their quality of life. There is an immediate issue there, in that the exceptional case will always be seen from the point of view of the individual patient and their particular circumstance. We never have that luxury. We might be dealing with a drug that could affect, say, 400 or 4,000 patients. We cannot conceivably take every single case into consideration.
We would be grateful if you could provide a written submission on that—we do not want you to go on for too long.
Sure.
Perhaps you could make your written submission a wee bit shorter than the explanation that you have just given.
Okay; I will try.
My second point goes back to the lack of data. Surely the role of the SMC is to evaluate the situation following approval or non-approval of a drug. If such data were available, they would be extremely important in informing decisions about whether to update advice and guidance. For example, if people were using drugs that had not been approved, they could feed back data that would add to the available information and would enable you to update your advice. Data could also be provided on drugs that had been approved, but which were not being used because they were not that great. Would that not be a benefit?
It could be a benefit, but it would involve a huge amount of work. We put through seven or eight new drugs a month, which is a daunting undertaking. If we began to revisit previous decisions by pulling together and reanalysing data, we would create a huge amount of work for ourselves. There are other agencies within the information services division that are beginning to collect such data. I do not believe that the SMC, as it is presently constituted, has the resource to monitor decisions that it made a year or two ago or to gather its own evidence on them. That would require a huge investment, as it goes well beyond the scope of the data collection that we talked about earlier.
I want to come back to the use of QALYs. As a representative of NHS Quality Improvement Scotland on the SMC, I know that we are kept right by the health economists on some of the heavy-duty health economics. I think that Andrew Walker emphasised that point. The QALY should be seen in the context of the other information that is before the SMC. As a mere public health physician, I would be worried if any assessment considered only the cost per QALY, but it does not; all the other information is taken into account. The QALY is not a technical answer but is a tool that helps us to assess and evaluate. In this case, it helps us to evaluate cancer drugs.
Have there been instances of SMC guidance being superseded by or changed following a NICE appraisal?
Andrew Walker is our data guru, so I shall let him answer. He will know the number.
Our data guru is actually behind me in the public gallery—my research assistant, Corinne. However, I think that there have been five instances in which an initial SMC no has been overturned by a subsequent NICE yes. As Andrew Dillon has already said, NICE guidance supersedes SMC guidance only when NICE has done one of the slightly longer, multiple technology appraisal processes. Some of the guidance that NICE is producing now, based on single technology appraisal processes, does not supersede what we do at SMC.
So that is five out of a total of about 400, did you say?
The total for cases that we and NICE have considered is not 400; it would be five out of about 90 or 100, I think.
No, it is 55.
I am sorry; it is 55.
I want to return to the issue of price. So far, price has been spoken about as if somehow it were handed down on tablets of stone. Perhaps you feel that it is.
You are now taking me well outside my area of expertise and are asking me to change sides, over to the pharmaceutical industry.
I recognise that I am asking you to change sides, in a sense, which is, perhaps, not fair, but am I right in thinking that an awful lot of the cost effectiveness of what you are doing is entirely dependent on people who have nothing to do with you sorting out the cost and price models of the drugs and what the NHS is prepared to pay for them? Their decisions could make a huge difference to the decisions that you come to without you changing your clinical assessment.
Perhaps. The worry about a value-based pricing approach is that companies will all set the price at £30,000, and that you might end up paying more for some drugs than you might have paid otherwise, because it is recognised that you are willing to pay that much. However, I suspect that the knowledge that the drug will be subject to an assessment process by the SMC is factored into the pricing of some drugs and results in the price of some drugs being lower than the companies would like them to be because they realise that, otherwise, it is unlikely that the £30,000 threshold will be met. Of course, it is possible that some companies might realise that they can get away with charging a bit more and still come in under the threshold. The difficulty is that the NHS has no involvement in that process at all.
Thank you. I think we know where to point the guns.
A number of you talked about the progress that is being made nationally on cancer. The petition dealt specifically with cancer, but is there any evidence that other illnesses have less resources? If someone was in a similar situation to Mike Gray, but suffered from a different illness, would they be able to secure the same sort of intervention from the SMC and others?
Absolutely. The SMC is not about cancer, cardiac disease, respiratory disease or mental illness; we are about getting the right drugs to the right patients. Therefore, we have exactly the same assessment process and criteria for drugs for any illness. As Andrew Walker said, part of the difficulty that we have is that, often, we find ourselves comparing apples and oranges—and, sometimes, things that are much more differentiated than two sorts of fruit. However, our aim is to make the same sort of decisions, regardless of what the therapeutic area is. In other words, we should try to get the maximum benefit for the NHS's drug expenditure without being influenced by the sort of illness that someone is suffering from. People suffer symptoms of and have their lives shortened by all sorts of illness, and we should be trying to deal with the issues, irrespective of the underlying diagnosis.
I asked this question of our previous panel, so I will ask it of you as well. What changes need to occur over the next four or five years for the situation to become better or more effective?
I hope that in four or five years' time the SMC is doing exactly what it is doing at the moment, unless we move to a value-based pricing structure, which would then automatically ensure that every drug was cost effective, because the price would be set in way that would ensure that it was possible to prove its cost effectiveness.
The point about data has been made. I would also want to keep the organisations and bodies that are involved in the area under constant review, so that if any streamlining is necessary, we can argue for that. We will keep a watchful eye on that.
If I were in the patient's position, I would want consistency. No matter how good or bad I thought that the decision was, I would not want to feel that the health board area that I lived in was what mattered. Speed and transparency are fine, but I would like consistency on top of that, so that I would know that the same factors were being considered.
I hope that, in five years' time, science has advanced sufficiently so that the new treatments that we are looking at will generate sufficiently substantial additional benefits for patients over current treatments that we do not have to have these arguments at all, and that any evaluation of the additional benefit that a new treatment brings is so significant that, based on a reasonable price being charged to the health system, it makes sense to use it.
I think that we have asked the questions that we wanted to ask, so I thank the members of the panel for their participation.
Meeting suspended.
On resuming—
I welcome our final panel of witnesses this afternoon. With us are Dr Marianne Nicholson, who is a consultant in clinical oncology with NHS Grampian; Dr Roelf Dijkhuizen, who is the medical director of NHS Grampian; Professor Alan Rodger, who is medical director of the Beatson oncology centre; Scott Bryson, who is a specialist in pharmaceutical public health with NHS Greater Glasgow and Clyde; Dr Frances Elliot, who is the medical director of NHS Fife; and Ewan Morrison, who is lead pharmacist at the south east Scotland cancer network.
I will be consistent and ask for your opinions on area drug and therapeutics committees. We probably accept that the system works between the SMC, NICE and NHS QIS. What are your opinions on the need for those local committees and their work? Coupled with that, are the cancer networks throughout Scotland working? It was suggested at a recent meeting of the Parliament's cross-party group on cancer that a review of the networks is required because they are not working consistently—they are not all working well.
Some discussion has taken place already about the role of the local committees. Advice comes down from the SMC to local boards. When the SMC has approved a medicine, whether it goes on the formulary—the local board's record—automatically depends on the nature of the medicine. It also depends a little bit on the points that we have already heard about, for example there might be many similar drugs on the market at the same or a lower price, it might not be considered responsible to use the drug, or the drug might not be as good as other drugs. Under those circumstances, a local committee can decide not to put a drug on the local board's formulary.
At the sharp end, I sat with the SMC in its early days and I now accept its decisions. There have been situations in which a drug for cancer has been accepted by the SMC and the local drug and therapeutics committee has asked me whether I need the drug and want it to be added to the armamentarium. My main oncological interest is lung cancer, and on at least one occasion, because of my personal experience of a drug and its side effects, and the fact that there was an active alternative with which I was more familiar and happier, I decided not to request that our local drug and therapeutics committee add the drug to the armamentarium. That saved the committee from going through the machinations of implementing the SMC's advice. That is how individual clinicians' decisions can play a role.
I strongly support the SMC, but I also strongly support the current ADTC system, particularly because of my experience in NHS Greater Glasgow and Clyde. As far as I am aware, over the past four years, four cancer drugs have been approved by the SMC—not all of them chemotherapy drugs—that our ADTC, on the advice of the clinicians who treat cancer, has agreed not to add to the formulary. Two of those drugs deal with chemotherapy-induced vomiting, but we already have access to much cheaper and very effective drugs to reduce chemotherapy-induced vomiting. However, we allow the use of drugs that are not on the formulary through the exceptional case process, which, since its introduction four years ago, has proved to be very smooth and quick. The fact is that patients are not disadvantaged. A very small number of them with particular chemotherapy regimes might benefit from such drugs, and we can build that into protocols if required.
I chair NHS Fife's ADTC which, I should point out, has a number of other functions apart from receiving recommendations from the SMC. In the south east Scotland cancer network area, which my colleague Ewan Morrison can say more about, NHS Fife is not involved in any of the SMC decisions on cancer drugs. Such matters are dealt with by NHS Lothian on behalf of the network boards to ensure that any cross-border delays that might affect not only Fife but Dumfries and Galloway—which also plays into the cancer network—are avoided. The ADTC's other functions relate in particular to primary care prescribing. For example, we monitor clinician compliance with the board area formulary.
We strongly support the SMC and welcome the specialist input from the regional networks.
I want to add to what Frances Elliot said and possibly answer part of Nanette Milne's question about the cancer networks. There are four health boards in the south east Scotland cancer network. The advice from the SMC comes to NHS Lothian—the largest health board with a cancer centre—and is then adopted by the four constituent boards. The advice is adopted quickly so that there is a consistent approach across the four health boards, which is particularly useful for clinicians. The process involves considering not just the cost of drugs but the local service costs to cancer centres, such as pharmacy, medical, nursing and pathology costs. We do not just rubber stamp the SMC's guidance; we add our local advice to it and then push it out to units for use at the sharp end.
Are the cancer networks working effectively across Scotland or are there regional variations that should be looked into?
As you probably know, the networks are often tumour dependent. For example, for rare tumours, such as hepatobiliary cancer, there is a national network rather than a regional network. The north of Scotland network deals with lung cancer and cancer research.
I think that the networks work quite well. I read the minutes of the cross-party group on cancer and noted that the clinicians from Dundee had raised questions about the networks. The north of Scotland network has a particular problem, because it has three cancer centres within it that must function as a unit. There have been difficulties in the past, but the situation is improving. I am the chair of the Scottish radiotherapy advisory group, which has been proactive in trying to help parts of the northern network's radiotherapy service. For instance, Inverness has only one machine, and it is quite old. What would happen if it stopped working? Using the good offices of the network up there, the radiotherapy community in Scotland as a whole has drawn up a process to deal with that crisis should it arise. A similar process has been drafted for the brachytherapy facilities on the east coast. That works.
The networks look at outcomes and how drugs are working. How is that information fed back to the SMC to be disseminated to other networks?
It is not.
Would that not be a good idea, so that other networks could benefit from the information?
That is outwith the SMC's current remit. The SMC is tasked with considering new drugs or new indications for drugs and judging their acceptability for the NHS in Scotland. If there is an information gap that needs to be closed in terms of the penetration of drugs to patients, it would mean a new and separate remit for the SMC or for a different organisation entirely.
I would like to move on to exceptional prescribing. I am conscious that exceptional prescribing has brought us here today, but I do not want to get too close to any particular case. Are exceptional prescribing systems now effective, speedy, and transparent? To what extent are they public?
In our submission is a copy of the NHS Fife request form. The system is fairly speedy. The forms come to every ADTC meeting where a clinician feels that they have a case to bring. Occasionally, if the request is very urgent, we will circulate it to ADTC members between committee meetings so that we get a rapid response. We do not deal with cancer drugs locally; as I said, they are dealt with at regional level. In light of our experience of using the request form, we plan to modify it.
I will address the SCAN perspective on exceptional circumstances. Exceptional circumstances are handled through the Edinburgh cancer centre medicines management committee, which meets every two weeks. Proposals can come from any part of the network—from Dumfries and Galloway right up to Fife. If something is needed very quickly, the chairman can put it through, which helps with the speed of the process.
You will have received the NHS Grampian procedure with our written submission. Our policies are transparent in principle; minutes and policies are on the website. It is optional, rather than compulsory, for patients to attend hearings. In NHS Grampian, the clinician who requests exemption from the SMC's decision because of exceptional circumstances presents the clinical data that support the request, but the patient or their representatives are invited to attend.
I am concerned about speed. I come from an industrial background, as you may have appreciated. During my industrial career, if I had to make a decision in a hurry, my relationship with my boss enabled me to get his approval to do what I wanted to do, and it was done within hours. It was more to do with communication than the substance of the decision. Fundamentally, it was about whether he trusted my judgment.
It is certainly incumbent on the organisation to limit, as far as possible, the amount of time that is involved, but the organisation must have a process to involve various people, including clinicians, in making judgments. That is part of the transparency that we have discussed. We are talking about providing equity of access to cancer treatments for patients in Scotland. If we leave such judgments purely to individuals, we have no guarantee whatsoever that there is equity of access to treatments. We need some kind of transparent process to confirm the assessment.
Is it wholly unreasonable to suggest that two days is different from two weeks, and that two days would be better?
Two days would be better, but getting the data together for consideration at the meeting tends to take more than two days.
I understand.
I would like to reassure the committee. I support my colleagues' comments about getting the balance right, but, at the risk of becoming anecdotal, I will describe a recent, very difficult case in Glasgow that was outwith the field of cancer. A small child was seriously ill with a rare disease and was treated with an orphan medicine. We were able to put the review case together and deal with it within 48 hours. If the circumstances dictate, NHS boards can be responsive. Different boards have different systems, but we all adopt the same principles. On this occasion, it worked in the patient's interest.
When I took up my post in Glasgow about five years ago, I could see no formal process in the Beatson. I felt that being phoned in the corridor by someone asking for a particular drug for patient X was not the best process. We therefore developed a process, which has continued to be developed and is now the regional process. I do not take decisions on the entire region—different processes exist across the region—but we use basically the same form.
The Edinburgh cancer centre medicines management committee is a committee of clinicians' peers. Although individual clinicians make decisions about exceptional circumstances, a committee of their peers decides whether those decisions are reasonable. After that committee has met, the process is the same as that which Alan Rodger described for emergency situations, and there is instantaneous feedback to the clinicians by both phone and electronic means. As Alan Rodger said, the timescale is very short.
I am reassured by your comments. Maybe one of the issues is a lack of understanding in the media about appropriate timescales. That is not something that I choose to judge, but if we can improve the public's expectations and understanding it might help the whole process.
However, in a life-threatening situation in which a decision must be made in 30 minutes or a few hours, such a process cannot be followed. There will always be decisions that have to be made on the spot, responsibility for which goes up the medical line management structure. We have to make such decisions occasionally, as we cannot get people together and get data on the table in a matter of hours. When it is clinically indicated, decisions are often made on the basis of thin evidence and short communications between clinicians and their senior managers.
It is always much easier and faster to say yes than it is to say no. That is why it is essential to have the documentation and the core quorate group to make the decision, which can take time to arrange.
I am trying to clarify in my mind what I have heard this afternoon. I understand what you have said about the work of the SMC, the regional groups and the boards. By the time you have finished your consideration of a drug and it comes down to clinicians' choice from the drugs that are available, cost effectiveness is no longer an issue because it has been dealt with at a higher level, but in exceptional circumstances there could be drugs the cost effectiveness of which has not been fully tested. Is that correct?
Yes.
Yes.
When you have a committee meeting under exceptional circumstances, would cost be a consideration, despite the recommendation of a clinician who is used to making decisions without having to consider costs?
That is a very good question. At that point, if a clinician makes a submission as an exceptional circumstance, they will be convinced that it is more likely that the patient will gain benefit. The clinician will appreciate the fact that there is a cost implication but, because we are advocates for our patients, if we believe that there are extenuating circumstances—whether or not they are identified from a particular feature of the patient's tumour on the biopsy—we will want to make that case strongly while acknowledging that the drug is likely to fail the cost-effectiveness evaluation.
Cost does not usually come into our consideration. In first-round applications for non-formulary, non-licensed drugs, I see the cost of the drug on the form less than 10 per cent of the time. Clinicians usually do not bother to ask the pharmacists, although they are encouraged to do so. The decision is driven not by the cost of the drug, but by the clinical judgment in a particular patient's situation.
Do you agree with the comment that the availability of data right across the board and the speed of decisions could be improved? I totally accept your reasons for spending longer on certain decisions, but you can take some quite swift decisions where it is sensible to do so.
I will certainly add my weight to the emerging consensus about the importance of data. Indeed, the current deficit has been recognised at the highest level, and NHS National Services Scotland information services division is working on the hospital medicines utilisation database, the initial focus of which will be cancer and antimicrobial medicines. I expect genuine progress to be made on this issue within this calendar year. That can only be to the advantage of the NHS, the specialist networks and individual patients.
I would welcome the ability to produce better data. For a start, it would allow us to avoid using data from the Association of the British Pharmaceutical Industry, which simply delves into what it has sold and tries to illustrate through demographics that one area is underutilising its products.
At the moment, we use very broad information, but we want micro-level information that tells us, for example, which cancer niche prescribers are using the drugs for and lets us follow the process to see whether we are getting the full effect of the drug for the money that we are spending. It would be good if we were able to support the NHS in that manner.
Can pressure from the pharmaceutical industry and, indeed, from your own system result in cancer drugs being wasted? Has anyone, for instance, suddenly become keen on a drug, which might have led to overbuying?
We do everything possible to save money. For instance, if possible, we run clinics that are purely for Herceptin, which means that if part, but not all, of a vial is used, the rest can be put into the next syringe for the next patient. That can be done with drugs that must be made up on the spot rather than bought in syringes, which is sometimes another way of saving money. However, that approach means that it may not be possible to deliver Herceptin in every local chemist shop, as some people think it is dead easy to do. We have saved an enormous amount of money by centralising some of our Herceptin clinics in Glasgow. We have also ensured that we have many clinics outside Glasgow. To start with, all the other health boards with which we work, apart from one, had difficulty delivering Herceptin, because they needed extra staff, but we now deliver it in each of those health boards, at least in one centre and sometimes in two. We try to save money.
Robin Harper is right, but I want to go beneath his question and talk about the relationship with pharmaceutical companies. In oncology, we do a lot of clinical trials because we generate an evidence base. Many of the trials are sponsored by pharmaceutical companies, so that we have access to new drugs, but I remain convinced that those companies do not have enough influence on individual clinicians to alter what they would normally do—we still have our patients' interests at the heart of what we do.
I want to move on to top-up payments, or public and private payments. One issue that was behind petition PE1108 was that, when the drug concerned was not available on the NHS, the whole treatment became private. Is that not wrong? When we dug down into the figures, we realised that the cost of the drug was small compared with the cost of the full treatment. Surely a person could receive most of their treatment free and pay for the drug that is not funded, rather than for the whole treatment. That could make a big difference to the number of people who are able access such drugs.
I was fairly closely involved in the case to which you refer. I agree that the situation is uncomfortable. Ironically, it is evident that cost did not drive the issues, because the drug was not all that expensive. We would appreciate more clarity on mixing private and NHS treatment. We have tried to obtain clarity on that, but we are not getting it. We are left having to judge, case by case, whether the mix of private and public funding should apply. One particular problem is that we often cannot hand a patient over to the private sector because in many centres the private sector is not big enough to take them. NHS Grampian would want to keep everything under one hat for that purpose because it is not practically possible to make the separation in the way the health department letter suggests—we have difficulty with it because it places us in the uncomfortable position of having to make judgments on a case-by-case basis.
As Nanette Milne said to a different panel, we have all seen the Health Department letter that states that there is no legal status for withholding NHS funding for one part of a treatment, but it also states that you should not be able to access co-funding. That is confusing. Do you envisage any problems with co-funding? I suppose that an obvious one is that co-funding can still produce inequality because some people might not be able to afford the drug, far less the rest of the treatment. Can the panel see ways of getting round such problems?
Many matters will need to be thought through in detail, particularly where responsibility for the delivery of the various aspects of treatment lies. The question is who, in the end, is responsible for the treatment. Clarity on that point is needed. The governance aspect is important.
The situation is a moral, ethical and logistical nightmare and minefield. For example, it is possible to argue that the health service should provide the antibiotics for someone who is getting private treatment for, say, having their bunions removed, because they would get the antibiotics anyway. That is the silly side of the coin. Petition PE1108 is about a drug that is not particularly expensive, as has been said, but drugs that are not on the formulary because the SMC has said that they should not be used in NHS Scotland can be horrendously expensive—we are talking not about a few hundred pounds but about several thousand pounds. The question is what type of treatments we should consider.
That is fairly candid. Are there any examples of people co-funding elsewhere in Europe? Does it work?
I do not know of any examples in Europe. In Australia, they have a peculiar mixed health-care system where the federal Government underpins private care and the state Governments pay for public care. There is a fair bit of moving back and forward between the two. The average Australian spends 800 Australian dollars, which is about £400, each year on health care, through private insurance or prescription charges—their charges even for subsidised drugs are slightly higher. There is a rather mixed economy. We are about to see changes in England, where people are being paid not by results but by what they do in cancer, such as delivering x-ray treatments and chemotherapy. Of course, there is then more pressure to utilise the private sector. It will be interesting to see what happens there, as we have heard from the representatives of CR UK.
I have frequently talked to patients who are facing their mortality and are therefore desperate for something to be done. They ask me whether it would be different if they were paying for treatment. I can tell them hand on heart that it would make no difference at all if they were paying, because no treatment is guaranteed to work and no treatment would not have side effects. I would therefore say that the clinical judgment is that it is better to go for quality of life without any specific anti-cancer treatment than to pull something from the cupboard so that I can feel like a god in a white coat.
In Michael Gray's case, it appears to me that the clinician said that there would be a benefit in using the drug. A clinician might say that there would be a benefit in using a drug, but the health board might not fund it. It does not always seem to come down to the clinician's decision about what is in the best interests of their patient—others seem to be making the decisions. The process does not appear to be open and transparent. If it is your life and you cannot understand why someone is withholding the treatment, that makes a bad situation much worse.
I played with the idea of bringing the clinician who was involved in this patient pathway to the committee to answer your question, but I understood that the issues are wider and that we did not want to talk only about Michael Gray's case. The clinician is aware of the funding situation and that he and his peers are involved in the SMC decision-making process. The SMC's turning the drug down was not a controversial issue with the clinician who treated the patient. The clinician was completely aware of and in agreement with the SMC decision. The clinician was also of the opinion that no exceptional circumstances allowed the patient's case to be brought to the board. That has never come out in discussion afterwards, but that was the situation.
You are saying that if the clinician had said, "This is the best treatment for my patient," the health board would have approved it.
If the clinician had said that the patient's circumstances were different from those in the SMC decision-making process, we would have started the exceptional treatment process and tried to keep it to one or two weeks, but the clinician did not hold that opinion.
We come back to somebody funding treatment privately to prove the case for it—to prove the benefit and that they are an exception—because that is the only way they can do it in some circumstances.
That is the dilemma that has arisen from the situation.
Much of what you have said is in the written evidence and the letters between you and the committee, so that has been confirmed, in a sense. The issue is difficult and sensitive. Our inquiry was precipitated by a particular case, your role in which has been contested gently today, that might highlight a general issue.
There is a guideline that boards need to have an exceptional circumstances route in place but, as far as I am aware, there is no diktat on how exceptional circumstances boards should be configured—on who should be members of such a board or the timescale in which it should come to its decisions—so we put our own system together by going through the literature and seeing how other health care systems had handled similar situations. That is how we configured ours in NHS Grampian, but perhaps other witnesses have further information on how they constituted their boards to consider exceptional treatment requests.
I support the observation that there is no national directive. I understand the background to the question. Thinking about the logistics of it and the scale of variation across individual NHS boards from NHS Greater Glasgow and Clyde, which serves the needs of a quarter of the population, through to some of the island boards, I wonder whether a one-size-fits-all approach would be appropriate for exceptional circumstances. Reflecting on earlier comments about the need for individual boards to show responsiveness and act promptly in exceptional circumstances, I do not see immediately how a single structure could suit every eventuality.
That is certainly the case within SCAN as well. The purpose of our committee is to support the SCAN network. It provides expertise and a speedy turnaround of the advice for that group. I am not aware of any documentation or legislation that covers who is on it, but it provides a peer-reviewed group that examines the clinician's submission.
I have a broad question for the clinicians on the panel. Will they say something about their experience over the years of patients having, for whatever reason, opted to fund their medicine privately? Is it rare? Is it exceptional? Is it becoming more common? Has the patient opted to do it or have they felt compelled to do it?
I have been a consultant in Aberdeen for 14 years. It is the oil capital of Europe and we have many people who are privately insured. When they come to me to ask whether they can go private, I usually tell them that they will have the same treatment from the same clinician in the same team without any inordinate delays in accessing it and that the only benefit to them of going private may be that we will try to get them a single room if they come in for chemotherapy, but it is not guaranteed, and that the hospital will be refunded for the cost of their drugs. Most of them then decide to stick with the NHS.
There is really no private practice in the Beatson. There are private hospitals that deliver chemotherapy and consultations, but the people who use those services are insured and want to make use of their insurance. They will see a particular consultant. Only a very small number of people do private practice. It is possible for someone to be treated for breast cancer, for example, in the private sector but not by one of the breast team at the Beatson. The same applies to other diseases. There is quite a small amount of private practice.
Members have no other questions. We have gone over the core areas that we needed to address.