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Oral evidence: Cancer Drugs Fund, HC 583

Oral evidence, 30 November 2015.

Chair

Thank you very much for your patience. We had an interesting first panel, which you may have picked up on. I am delighted to welcome Professor Peter Clark, who is chair of the Cancer Drugs Fund for NHS England and a consultant oncologist at the Clatterbridge Cancer Centre NHS Foundation Trust in Merseyside—I hope I have got that right, Professor.

Professor Peter Clark

Very good. Thank you very much.

Chair

Welcome back to Simon Stevens, one of our frequent fliers. He is chief executive of the NHS.

Simon Stevens

My weekly visit.

Chair

He is fresh from Radio 4’s “Any Questions?”. We then have Will Cavendish. You are fast becoming a frequent flier, Mr Cavendish—I think this is your second appearance before us this term. You are the director general of innovation, growth and technology at the Department of Health. We also have Sir Andrew Dillon, who is the chief executive of the National Institute for Health and Care Excellence, also known as NICE. I will hand straight over to Stewart Jackson, who is leading our questioning today.

Mr Jackson

Good afternoon, gentlemen. May I begin by asking you a general question about our performance compared with international partners? What comes specifically out of the Report is that hitherto we have lagged behind in the use of new cancer drugs, well below the international average. Why do you think that has been? What evidence is there that we are addressing that issue? Even more generally, why are we still lagging in respect of cancer recovery rates, compared with other countries, particularly in Europe?

Professor Peter Clark

Thank you for the question. In terms of drugs, there are two key issues about why we are seen to lag behind other countries in Europe. First, we have a very different health technology assessment programme, run by Sir Andrew here, which I have no doubt is the most rigorous of all assessments of the key question that affects cancer drugs: how clinically effective the drug is versus how much extra life and quality of life the extra cost brings. NICE stands on its own, in my view, in the rigour of that process. The consequence for cancer drugs, of course, which generally, until recently anyway, have relatively modest efficacy but are increasingly highly priced, is that they become, or are seen to be, the casualty of that health technology assessment process. So we have NICE, which is very rigorous and few other countries in Europe have such a body, but therefore there are more negative NICE recommendations on cancer drugs, which is why we are seen to spend less on those cancer drugs. The other key issue, as you heard from Harpal, is that the problem that bedevils cancer in the UK is late presentation. Late presentation patients are generally less fit; many cancer drugs often require you to be quite fit in order to have them and benefit from them. In terms of the balance between benefit and the side effects of treatment, less fit patients have greater side effects and the balance becomes more finely tuned in patients who present late. Those are the two key reasons why we are seen to lag behind European spend on cancer drugs.

Mr Jackson

Is that a result of poor diagnosis in the primary care sector?

Professor Peter Clark

As you have heard from Harpal, it is a multitude of factors. One of the biggest ones, in my personal view, is that patients in England are conservative; they go to their GP late. Yes, there are problems with bottlenecks in diagnostics, as Harpal said, so patients may go along the patient pathway more slowly than we would like, but the biggest problem is getting the patient to the general practitioner in the first place, with a set of symptoms that are recognised and merit rapid referral.

Mr Jackson

Does anyone else have any opinions on this?

Will Cavendish

It is obviously true that there has been an issue historically; that is well known. I think that has been changing in the last period. Partly in preparation for this session, I was looking again at the spending on cancer drugs in the past four to five years, and overall, if you take the spend on cancer drugs in primary and secondary care, it has gone up from about £1 billion five years ago to £1.5 billion now, so that is a 50% cash increase in five years. The latest credible international study, the RAND study, which looked at the performance of England and the UK in different drug areas, generally showed that there has been some catching up in the last three or four years in different areas, including cancer. So looking at drugs that have been licensed in the last zero to five years, the UK is now doing better than it was five years ago—it is not at the top, but it is not at the bottom. So all the things that Professor Clark said are obviously true, but there has been a reasonable uptick in the last few years—

Chair

Has it gone up from 11th to seventh? I think I read that somewhere.

Will Cavendish

I think that that is the overall figure. I cannot remember the exact cancer ranking—

Simon Stevens

Figure 6 in the NAO’s excellent—as always—Report illustrates the point that we were up from 46% of the average of 13 countries to the 92nd percentile, and that was in 2013. Since 2013, in the following year, there was a 27% increase in the number of patients being funded on the Cancer Drugs Fund anyway, so we might have seen further advances since then.

Mr Jackson

It would be churlish not to concede that quite a lot of it has been quite positive. Having said that, you have spent £968 million and treated 74,000 patients, which is great, but again, data collection bedevils the NHS. Data collection, particularly a lack of outcomes focus, is very poor, according to the Report. Assertions were made when the Committee reported in March 2015 that that issue would be taken seriously. Notwithstanding the fact that NHS England has done better in levelling the playing field, the figure on page 27 that I referred to before shows that 93% of patients had no outcome summary in the CDF. When are we going to take data collection and robust methodology seriously to find out whether there is efficacy in this very significant public expenditure?

Professor Peter Clark

I share your frustration about the lack of many outcomes in the NHS, about cancer outcomes and in particular chemotherapy outcomes. Before I give my answer, I would like to say that we do take seriously the Public Accounts Committee’s recommendations, and in particular the three that you aimed at the CDF outcome data collection process in March 2015. Whenever you look at unselected real-life data about a particular drug in a particular place in a cancer pathway for a particular cancer, the data has to be robust. There has to be a large number of patients and the requisite duration of follow-up, and it has to reflect, in my mind, not just the fancy academic centres that may have more time to collect the data; you want to know what happens to the NHS, so that is in little centres and big centres.

Chair

Which one of you is responsible for making sure that data is collected? Is it you, Professor Clark?

Professor Peter Clark

It is shared between NHS England and Public Health England. I hope my reply will allow that question to be answered. When we publish, it has to be robust data, because we know it is going to be challenged, whether that is by patients, patient groups, clinicians or of course the pharmaceutical industry. The current Cancer Drugs Fund came under the umbrella of NHS England in April 2013. NHS England and Public Health England were brand new organisations, and it took time for them to establish themselves and then start working together. The first thing the chemotherapy clinical reference group for NHS England did once it was established in the summer of 2013 was to ask exactly that question: can we mandate the collection of chemotherapy data outcomes in the chemotherapy contract? The great power of having NHS England have one chemotherapy contract is that you hit all 147 providers of chemotherapy in England. Alas, we were not able to do that until April 2014, as you know. Since April 2014, the returns to the SACT office in Oxford have greatly improved, but as you identified, problems remain. Since your Report in March 2015, non-compliant trusts have been subject to leverage by the specialist commissioning hubs in terms of their contracts, so that they can be penalised for the lack of data submission, and non-compliant trusts were also subject to data quality improvement plans. To give you a sense of the scale of what SACT has to deal with, in calendar year 2015, 165,000 different patients will have chemotherapy in England. They have an average of five cycles of treatment, so that is 850,000 cycles of treatment that will each create at least 10 data items. So you are talking about 8 million data items. In our keenness to follow your strong recommendation in March 2015, NHS England and Public Health England looked very closely at whether, in the 165,000 patients, SACT could identify the CDF patients easily. For various reasons, they could not. After we sorted out the patient confidentiality issues, as the NAO Report describes, NHS England and Public Health England were able in July 2015to sign the data-sharing agreement, which enabled all the CDF patients to be identified, such that SACT now has 63,000 CDF patients on its database. In terms of the mandatory dataset—

Chair

Professor Clark, I am sorry to cut you off—

Mr Jackson

It is quite dense—

Chair

It has taken five years to get to this point.

Professor Peter Clark

It has.

Chair

That is a bit too long.

Mr Jackson

Can I ask you to park that? It is very dense, but it is valuable, so would you be so good as to provide a note for us so that we can have a look at that?

Professor Peter Clark

Sure. The bottom line is that data outcome submission by trusts and analysis by SACT have improved greatly, such that in the next two to three months Public Health England expect to publish outcomes for some CDF drugs, just as they expect to start publishing outcomes for the non-CDF drugs, too. So, has it been frustrating? Yes. Has it taken too long? Yes. But we are getting to the position where those outcome data will be published for scrutiny by you and everyone else.

Mr Jackson

Thank you for that.

Caroline Flint

You have explained what you are doing now. What discussion was there at the time the Cancer Drugs Fund was being established about what evidence would be collected? This was a new fund and there were huge public expectations about what it would deliver, so what discussions were there to try to work through some of the problems that you have done five years later?

Professor Peter Clark

There were discussions, because at this time the guidance for the CDF was run by the Department of Health, although the implementation was in 10 different strategic health authorities, so they ended up with 10 different cancer drugs funds with 10 different ways of assessing which drugs should be in the fund and 10 different ways of potentially collecting that data.

Caroline Flint

So perhaps I can ask Mr Cavendish, because it is a Department of Health issue: given the huge expectations for the fund, why did the Department of Health not knock the heads of the SHAs together to ensure that there was some sort of common collection of data?

Will Cavendish

Back in 2011, the DH issued guidance to the SHAs about data collection for the Cancer Drugs Fund and that guidance recommended that it cover the eight key pieces of data that are also contained in the systemic anti-cancer therapy database—the SACT database. The issue, though, was that it was not mandatory; it was guidance.

Caroline Flint

Why?

Will Cavendish

At the time, there were a lot of complaints about burdensome cascades from the centre—trusts being inundated with mandatory requests from the centre—so, at that time, the fashion was more for guidance rather than mandation. That clearly led to the situation where there was not consistent data being collected across all 10 areas.

Caroline Flint

In the last session, Deb Lancaster, who I understand was involved in some of the discussion around setting up the fund, said that she was verbally assured by SHAs that data would be collected because this is also helpful to the drug companies both in terms of whether their drugs are working and in terms of outcomes having an impact on price. You are saying that because of a worry about over-bureaucracy in regard to setting up the fund, you backed off from making sure that data collection would happen.

Will Cavendish

That was the reason why it was guidance rather than mandatory—

Caroline Flint

So it was about being worried about being burdensome on the SHAs, not about making sure—

Will Cavendish

Not the SHAs, but the trusts who collect the data. That was the issue at the time. But you have to remember also that these problems laid across cancer drugs across the piece, as Professor Clark was just saying; it is not just about the CDF. Another issue—

Chair

The CDF has taken a lot of taxpayers’ money.

Caroline Flint

The whole point about the CDF is that it was set up because it was felt there were some issues with NICE—I am sure we will come to this—about how people get access to certain drugs. It is an area that is incredibly charged and emotive in many different ways for very good reasons, so you can understand why we are asking the question about why, for a particular fund to meet a particular gap that existed in the health service, you would not from the outset try to have some more effective measures of outcomes, at least in this area.

Will Cavendish

Indeed. My point was just that the data collection on the CDF was not adequate, but the data collection across all cancer drugs has also not been adequate, as Professor Clark was just saying. That is why we had to address it—

Chair

We will come back to this point.

Mr Jackson

I have to make an observation. Mr Stevens reminds us at every opportunity when he goes on the media about the forward planning in the NHS and the need both to invest properly and to save, because of the demographic changes. There is a significant amount of money just for chemotherapy across the whole NHS, and we probably do not know what that is costing and what impact it is having in terms of outcomes. Without flogging a dead horse about the data, can I ask Mr Stevens and Mr Cavendish, is there not a causal link between not really knowing how effective the spending is being and figure 13, which shows a very significant overrun of costs? In 2014-15, we were looking at about a 50% overrun cost to budget—budget being £280 million, costs £416 million. Allowing for the fact that this was just before the general election—we make funny decisions just before a general election and try not to be too controversial—surely the two are linked. If you do not know whether the drugs fund is successful and is making the biggest impact for taxpayer pounds, you are obviously going to have cost overruns.

Simon Stevens

I don’t think that is the principal reason why there are cost overruns. Professor Clark can describe the drivers around patient volume and pricing inside the original CDF mechanism, but I do think you are right in pointing to the fact that as currently structured, this is not a sustainable vehicle for properly evaluating how potentially important new drugs work in practice. That is precisely why, as you know, we are now at public consultation on a mechanism that I think will be much better. Part of that will be a mandatory data generation to answer these clinical questions about whether the drugs benefit patients or not. If lessons are learned, the new CDF, if that is what we do following consultation, will deal with the issue. Peter, do you want to say a little more to Mr Jackson about the actual drivers of the overspend?

Professor Peter Clark

You will probably tell me to hurry up too, so please do.

Mr Jackson

The Chair will, I am sure.

Professor Peter Clark

The first thing that happened was in April 2013. We had inherited a north-south divide in terms of access to the Cancer Drugs Fund: application rates were twice as high in the south as in the north. The moment we had a single national system for saying these are the drugs that are available, we abolished that straight away. Did it bring the south down? No, it brought everyone else up. It immediately caused a big rise in the number of applications. Add that to the fact that some good, exciting drugs, which are given for longer and have ever-higher prices, came out at a time when, because of those things, NICE was saying no to many of them. This produced a big pressure on the Cancer Drugs Fund, with increasing numbers, increasing durations of treatments and increasing costs—hence the overspend.

Mr Jackson

Can I just jump in there, because it comes back to Ms Flint’s interesting question about the genesis of the fund in 2010? To play devil’s advocate, would it not have been better to have said: there are discrepancies and not a level playing field across the country; let’s just take those oncologists who are top of their field and are commissioning cancer drugs well and roll that best practice across the whole country, for fewer pounds than creating a cancer drugs fund, where effectively 36% of the £968 million has been for drugs that are either “too expensive” or have not had their efficacy tested? Couldn’t you have looked at that option in 2010?

Professor Peter Clark

First, may I correct you? Every single cancer drug that has gone into the Cancer Drugs Fund has an evidence base that has been robust enough for that very group of clinical experts that you have just described to say the evidence for this drug is good enough for it to come into the Cancer Drugs Fund. I do not want anyone to go away thinking that they were drugs of no proven efficacy. Every single drug that went into the fund has had an evidence base.

Mr Jackson

The point I am making, which comes out in the report, is that because you have proximity to teaching hospitals, and you have more experience and expertise among some clinical staff, there is inevitably going to be a discrepancy in the prescription of those drugs. That is the issue and surely the reason that the Cancer Drugs Fund came into existence: to get rid of those postcode lotteries.

Professor Peter Clark

The biggest reasons why the Cancer Drugs Fund came into existence were, first, the public disquiet about the drugs that NICE had deemed were clinically effective but not cost-effective and then, for the rare cancer drugs, NICE at that time, as you have heard, could not appraise everything. There were worthwhile cancer drugs that we knew were clinically effective but we did not know whether they were cost-effective because they had never gone to NICE. Also, there is a small but important group of off-label use, particularly for the rare cancers, where a drug is not licensed for a certain condition but you know that there is a strong enough evidence base to use it for a rare condition. They were, I think, the three main reasons why the Cancer Drugs Fund came into being.

Mr Jackson

Sir Andrew, may I ask—[Interruption.] Finish pouring your gin.

Chair

For the record, it is water, just in case anyone reads the transcript and gets the wrong impression about Sir Andrew’s habits.

Simon Stevens

Judge by the quality of his answers.

Mr Jackson

An earlier witness intimated that the timeliness of research might be impacted by the efficiency of NICE, in terms of processing applications for prescription drugs in respect of the Cancer Drugs Fund. There was some debate earlier about whether NICE was fit for purpose in its present form. How do you respond to that criticism?

Sir Andrew Dillon

There have been criticisms and questions about whether NICE is fit for purpose for all the 17 years that we have been going. It is not an observation that I make lightly—those challenges matter. Every three years we have gone through pretty rigorous reviews of our methods for looking at drugs and other technologies, to test if there is a better way of doing it and whether the approach that we take is consistent with the ambition that the NHS has for getting access to drugs, including cancer drugs, and all the other treatments that we look at. It is a perfectly reasonable challenge. If there are ways in which we can do better in understanding the incremental benefit that new drugs bring, whether they are for cancer or any other disease or condition, and better ways to assess value for money of those treatments, we would be happy to engage in a discussion about it. For all the years that we have been going, however, nobody has yet come up with a fundamentally better approach, particularly for assessing value for money, than the one that we use. The critical point about value for money is not the tool or techniques that you use to establish it, it is what you do with the information. It is not NICE that decides what the reasonable opportunity cost is for the NHS is in acquiring a new treatment. In other words, the point at which the health gain that something new brings in starts to displace more health than we are already buying with existing resources is something for the NHS and the Government, with their stewardship responsibility for the system. What we do is to operationalise that decision. We say that if that is the ambition and the expression of the opportunity cost, here are the mechanism and methods that enable you to convert that into a decision on a case-by-case basis. We can change our approach to establish new value for money but we have to change it only on the basis that it moves to a more accurate approach, with greater consistency with what the NHS itself wants to offer.

Chair

We will touch on the future in a moment but I am aware that Richard Bacon unfortunately has to leave early, so I will bring him in briefly now on the point he wanted to raise then I will come back to Stewart Jackson.

Mr Bacon

Thank you, Chair. I have met Professor Sir Iain Chalmers and Professor Paul Glasziou, who are epidemiologists who have been working on The Lancet studies on research waste and, in particular, on improving value and reducing waste in medical research. I wanted to ask, Mr Stevens, if you are aware of The Lancet’s work?

Simon Stevens

Yes.

Mr Bacon

You are. They say on the front page of their website, www.researchwaste.net, that, “It has been estimated that 85% of research is wasted, usually because it asks the wrong questions, is badly designed, not published or poorly reported”. I do not want to ask you about the 85% specifically, but do you recognise there is an issue here?

Simon Stevens

Yes. I think all medical researchers do. Not just The Lancet but the BMJ and the major US journals have also been pushing towards mandatory registration and disclosure of trials, so that we don’t get repeated trials or trials that have been funded that are not likely to answer relevant questions. There is a big worldwide movement on the part of research funders and the medical journals that publish the data to deal with that question.

Mr Bacon

Mr Cavendish, this may be for you, since you are the director general for innovation. What work is the Department of Health doing in this space?

Will Cavendish

On improving clinical trials and transparency in outcomes?

Mr Bacon

No. Specifically on the waste in research; on “improving value and reducing waste” in the words of The Lancet.

Will Cavendish

I will not pretend to opine on things that I do not know much about so I will go back and ask that question.

Mr Bacon

If you could write to us, that would be great.

Chair

Sir Andrew wants to come in.

Mr Bacon

Sir Andrew, if you want to answer my previous question from the last time you appeared, which was whether Tamiflu was more efficacious than Lemsip, which you refused to answer, I would welcome an answer even now. If not, you don’t have to.

Chair

We are not getting into that. Sir Andrew wants to come in on the point you have just raised.

Sir Andrew Dillon

Perhaps we could go to the bar to talk about that later. The point I want to make about research is that there is a big issue with research that is not sufficiently targeted to address the key questions that health systems need to answer. One of the things we have done is to offer a scientific advice service to drug companies and other technology developers. That has been going for about four years. That allows companies to come and talk to us about the nature of the studies that they ought to be conducting and the kind of economic evaluation that they need to do, in order to provide NICE advisory committees with the information they need in order to make a judgment. This is not a back-door way to get a “yes” from NICE, but it is a means for companies to ensure that they do not come to a NICE appraisal committee that says, “Look, if only you had done this kind of research we could have come to a clear conclusion.” The companies would rather it said, “We can come to a clear conclusion because you have given us the data we need.” That is proving to be a very popular service with companies and we are in the process of extending it.

Chair

Is it working yet? Are you getting better research?

Sir Andrew Dillon

Yes, it is.

Mr Bacon

Professor Clark, did you want to add anything? The first example that Professor Chalmers and Professor Glasziou quote is actually from a medical researcher who had the condition of myeloma, which is a cancer. They quote him: “Research results should be easily accessible to people who need to make decisions about their own health…Why was I forced to make my decision knowing the information was somewhere but not available?”

Professor Peter Clark

I sympathise greatly with that view. We have already talked about the key questions that affect the relevant patient pathway in NHS practice. That is fundamental to what NICE needs I want to pick up on the wretched state of journals not wanting to publish negative results, because negative results are just as important as positive results. They are not as glossy and they do not hit the headlines. I chair several international trial data monitoring committees and it is a source of great frustration that you know that there are data there, and that a trial has finished accruing and might be quite similar to the one that you are looking at, but you are not able to find anything out, the assumption being, of course, that it was negative.

Chair

This is an issue we may return to when we look at some of these issues in the new year. That is part of the reason for Mr Bacon’s line of questioning.

Mr Jackson

Mr Stevens, we have talked about the cost overrun. There was some disquiet in the Report at the lack of remedial action on that until March 2015, well into the life of the fund. Maybe you would want to reflect on that. I want to ask about a wider issue, which is the role of the drug companies, the pharmaceutical organisations.

Simon Stevens

Could I just say, Mr Jackson, on the remedial action, that December 2014 is when we first did the delist, and that was obviously preceded by action? When it became clear during the course of the financial year 2014-15 that the fund was headed for a substantial overrun, then the first delist process began. We obviously had a consultation to go through, an appeals process, and the opportunity for companies to lower their prices, so it was March of the following year, as you say, that the impact of it was felt, but it was early on in 2014 that action was taken.

Mr Jackson

I concede that. Thank you for clarifying. In terms of the drug companies, we had an interesting discussion earlier for those of us who enjoy economics—or not—about the fact that we do not have perfect competition or perfect knowledge, we do not have access to information in the market, and we possibly have an oligopoly. Is the review of the Cancer Drugs Fund going to take into account all these factors? It seems to me not a coincidence that where the drug companies were effectively threatened with being removed from the list—the fund—they miraculously came forward with discounts. What is NHS England going to do about the whole asymmetry between purchasers and providers of these cancer drugs?

Simon Stevens

Your analysis is right, and that is what the proposal that we are consulting on for the evolved version—the next version—of the Cancer Drugs Fund is trying to rectify. Just to summarise, although I am sure everybody knows the proposal, effectively NICE will give a preliminary review of all cancer drugs, and then on the basis of the information available at the time of marketing authorisation, provided that that has been supplied by the manufacturers, we will be able to say, “Yes this looks to be a strong product at a price that works, and therefore you are into routine commissioning”; or, “No, this is so way off the mark on either front that nothing in the way of new data is likely to change our mind,”; or—this important third category, which we think will be where quite a number of these new drugs will end up—“This could turn out to be promising if priced appropriately, so here is up to 24 months’ worth of real-world usage under these data-collecting conditions, and on the strength of that we will make a final determination.” What that does is to put some of the pricing discipline back into the system, in that there is a NICE assessment, provisionally and definitively, and during the period that the medicine is in the Cancer Drugs Fund, it will, in all likelihood, be reimbursed at less than the price that would eventually occur, given the number of patient months or products that are going to be funded through the CDF. So it is going to be less than if you had a definitive yes while we are all finding out, and I think that is a reasonable compromise to strike.

Mr Jackson

Obviously, the NHS is a massive organisation. How are you going to ensure that you have the co-operation of clinicians, who, on a daily basis, are doing a fantastic job dealing with a very difficult situation, as Ms Flint has said, in very sensitive areas with the patients and their families? How will you ensure that they understand these issues and these decisions that you have inevitably got to take? It seems to me that unless you get clinicians on your side, you are not going to make real progress in reforming the Cancer Drugs Fund.

Simon Stevens

Yes. I will ask Professor Clark in a moment, but my sense is that oncologists are looking for this kind of mechanism to help them generate these data so they can make smart choices; and, more generally, among the group of doctors who treat cancer patients, there is a sense that we have perhaps got a little out of balance in terms of where we put our marginal investment, with a strong thumb on the scale on the drugs. Radiotherapy and cancer surgery will also have a big impact on survival rates and cures, so we have got to have a more balanced view in the round. Peter, do you want to talk about the oncologists’ perspective?

Professor Peter Clark

The oncologists will be very keen to use these drugs because for many of them, the preliminary data is exciting, they have novel modes of action and they are targeted in terms of how they work, so this translation of understanding how cancer develops into where a drug is going to hit is now in practice. They will be very keen to contribute to what will be a very important data collection exercise. I have no doubt that oncologists will grab their opportunity in the same way as they have grabbed the opportunity for the drugs in the last couple of years in the Cancer Drugs Fund.

Mr Jackson

Can I make one final point? One of the most tragic figures that we have ever heard on this Committee is the number of people who present at A&E with advanced cancer. It is a very high figure—in the 40s, I think. If we do nothing else in the next five years or so, we have to drive that figure down, because it is an absolutely terrible tragedy that that happens.

Simon Stevens

That is completely right. Delayed diagnosis is a big part of why our cancer outcomes for some conditions are worse. There is a shimmer of good news in that in 2006, I think one in four cancers were diagnosed in A&E. That has now fallen to one in five, so 80% of people are getting proper—

Chair

When do you think we are going to meet the target for early diagnosis?

Simon Stevens

We have a particular issue around bowel cancer and lung cancer, with far too many patients getting diagnosed at stage 3 or 4.

Chair

Do you have a target date?

Simon Stevens

We are going to be implementing Harpal Kumar’s Cancer Taskforce recommendation, which has a whole series of milestones, one of which is moving to a new standard for four weeks—28 days—to definitive diagnosis, a sort of “soup to nuts” standard by 2020.

Chair

And that has a date attached to it.

Simon Stevens

No, that is redesigning the clinical pathways so that patients get that definitive diagnosis and start their treatment quickly.

Mr Jackson

Would you be so kind as to write the Committee a note on that, because that would be very helpful?

Simon Stevens

It is in the Cancer Taskforce report—in Harpal’s report.

Chair

We probably don’t need the note.

Professor Peter Clark

Can I add a clinical dimension very quickly? I quite agree that we want fewer people presenting with cancer to A&E, but in the last three years, NHS England has invested heavily in oncologists—called “acute oncologists”, who are people like me, who have big experience in cancer—who spend half their time looking at the patients who have been admitted on the acute medical and surgical takes and triaging them appropriately. What we know is that that has first, reduced the diagnostic time, and secondly, reduced bed usage, as the patients get put into the right multidisciplinary team for their management.

Chair

We are aware that there are many ways of tackling this, and one of the concerns is that the Cancer Drugs Fund is dealing perhaps more with people with late diagnosis—people with terminal cancer—and if that was resolved, we may have a slightly lower bill.

Q91Deidre Brock

I have three questions. I am not quite sure which person to address this one to, but at paragraph 2.12, it says that a member of the Association of the British Pharmaceutical Industry went off the clinical reference group for chemotherapy. Can you tell me why that was?

Professor Peter Clark

Why the ABPI member left?[1]

Deidre Brock

Yes. I think it was in late 2014.

Professor Peter Clark

It was because first, part of our partnership working was to get someone from the ABPI in in the first place. The reason why was that the change in the CDF standard operating procedure that Simon has described introduced not only an assessment of clinical benefit, which we had always had, but an assessment of median drug cost. Of course, a lot of that information about the median drug cost is confidential between the pharmaceutical company and the CDF team, because of the deals that we were making. Because a member of the ABPI worked for one of the pharmaceutical companies, he would have been privy to a lot of confidential data about the pricing of potentially competing drugs, which is why he had to step down.

Q92Deidre Brock

Some people might question why that person was there in the first place, given the potential conflict of interest.

Professor Peter Clark

We gained an awful lot from going beyond the usual triumvirate of oncologists, haematologists and oncology pharmacists. I think we gained a lot of understanding about how the pharmaceutical industry works, how it prices its products and what kind of arrangements we might be able to enter into, just as we gained from having patients and patient group representatives on the panel too.

Q93Deidre Brock

Can you tell us who that person was?

Professor Peter Clark

His name is Dr David Montgomery and he is the medical director for oncology for Pfizer.

Simon Stevens

Your point, Peter, is that at the point you actually started talking prices, they were not there any more.

Q94Deidre Brock

Secondly, you have changed the method of reporting the data on the number of patients who are supported by the fund, in terms of their geographical location. It is now reported by location and treatment hospitals, rather by where the patient lives. Can you tell us why you changed that?

Professor Peter Clark

We thought that was only fair, because the reimbursement goes back to the treating trust. It is much easier to administer because you have the four commissioning hubs operating four geographical areas clearly, and it is much easier if they look after the CDF expenditure within the confines of that geographical region, rather than the previous arrangement whereby if the patient lived in Oxford and travelled to London for treatment, the London people then had to gain approval for the CDF drug from the Oxford SHA. It streamlined the bureaucracy.

Deidre Brock

I know there were concerns about geographical variations in access to the fund; how does this enable NHS England to assess whether that is fairer? I know you were aiming to even out the bumps.

Professor Peter Clark

Again, this is one of the many things we are demanding from the SACT team in Oxford. Part of the mandatory data set is the patient’s postcode, so we can plot all 60,000 patients in relation to their postcodes and their CCGs and for example the deprivation indices of those CCGs.

Deidre Brock

From now on, that work will be undertaken? Okay.

Professor Peter Clark

It will be part of the rolling data returns that SACT will be providing for us.

Deidre Brock

Lastly, Mr Cavendish, I know that the pharmaceutical price regulation scheme limits the amount of money paid by the NHS to pharmaceutical companies and thereafter a rebate comes back—that is correct, yes?

Will Cavendish

Broadly speaking, yes.

Deidre Brock

In Scotland, I think that money is put back into the new medicines fund. What happens to that money in England?

Will Cavendish

In England, that money is handed over in total from the Department of Health to NHS England, and NHS England decides which of its priorities it wants it to fund.

Deidre Brock

Might it potentially be of interest to the Department of Health to put that money back into the fund to help fund further drugs?

Chair

Or to NHS England.

Will Cavendish

All the money that comes from the PPRS rebate, we forecast what that money is likely to be and we provide that in the NHS England allocation, in total. So that is really NHS England’s decision. I know that a deal of that money has been used in specialised commissioning, which is the national funding for specialised products, and some of that is for CCGs locally.

Chair

Perhaps Mr Stevens could answer.

Simon Stevens

The situation is as Will describes. The Department of Health takes into account the PPRS rebate.

Chair

I think Ms Brock’s point was that in Scotland it goes to the fund, but in the UK it goes back into the general pot.

Simon Stevens

It becomes part of the total allocation for the national health service.

Chair

Have you ever thought about directing it back into the fund?

Will Cavendish

There is not a top-sliced fund here in the way there is in Scotland. In Scotland, a new medicines fund was set up, as you know, that takes the element of PPRS rebate that comes to Scotland—I do not know whether it is all of it—and puts it into a new medicines fund. That is not the decision we have taken here.

David Mowat

This fund was necessary because NICE was not authorising drugs that apparently were being used in other parts of Europe and there was a problem with that, which implies that there was an issue with the NICE criteria at that time. Is that something we are going to fix, going forwards? Sir Andrew, is my assertion correct, first?

Sir Andrew Dillon

Yes. There were a number of reasons operationally why the Cancer Drugs Fund was thought to be important. At the general rate at which NICE was approving them at that time—and it has remained reasonably consistent—we were able to make positive recommendations about just over 60% of the cancer drugs we look at. That compares with just over 80% of non-cancer treatments. That is the position. There is clearly something about cancer drugs at the time we were appraising them that separated them out from other treatments.

David Mowat

That implies a methodology issue of some type in the way you were evaluating cancer drugs, particularly.

Simon Stevens

Or a pricing issue.

David Mowat

I shall come on to pricing; but yes, it could be pricing, you are right. So either methodology or pricing, because it does not fit the criteria.

Sir Andrew Dillon

On the question of a methodology issue, even before the cancer drugs fund was instituted, NICE had already been asked by the then Government to introduce a more generous assessment, or a more generous approach to assessing cost-effectiveness for cancer treatments compared with non-cancer treatments. So we were already doing that, but despite that, the fact that the additional benefits that new cancer treatments would bring relative to their cost was making it extremely difficult for NICE to significantly change the rate of—

David Mowat

Fair enough, but that raises a question, doesn’t it? Professor Cavendish described your processes as the best in the world and everything else. You have all these extremely good processes, and then along comes a new system that effectively takes things that your extremely good processes were uncomfortable with, or didn’t feel there was value in, and does them anyway. That raises the question why we made that decision—whether it was emotive or political.

Sir Andrew Dillon

It was made because it was anticipated that the new process in CDF would be a closer match with the ambition that the new Government coming in had for access to cancer treatment.

David Mowat

Yes, but a Government decision is not a clinical decision, is it? I won’t ask you whether you thought it was the right decision, but if your processes, which have been described as the best in the world for getting value for money and all the rest of it, didn’t authorise these products, and another product was superimposed on you, that raises some questions as to why we did this.

Sir Andrew Dillon

There were, clearly, at the point at which the Cancer Drugs Fund—

David Mowat

Mr Stevens made the point that it is about price as well as methodology, which it is, clearly, because if you put in the price, the whole thing changes. I am not an expert in this at all, but it seems to beg for outcome-based pricing. You have a product that costs relatively little to manufacture, but a great deal to develop. Companies are getting their money back over the process, and they have great flexibility over what they charge. Presumably, they want to get their product out there to get the volume. Is that something that your group thinks about a lot? It seems to me to be a big win-win potentially.

Sir Andrew Dillon

NICE has always been concerned to establish what outcomes will ultimately be obtained from a new treatment and to compare those outcomes with those—

David Mowat

What I was thinking more about was, if you were actually paying based on outcomes into the future, you could effectively put the risk back on the pharmaceutical companies. You could say, “We haven’t got the proof that this is there yet, but you are telling us it is. Charge us this amount, and we will pay you the extra when we’ve seen it is working.” They are happy, and you are bound to be happy, because you are getting the drugs out. It seems to be such a good solution that it is odd we are not doing this.

Sir Andrew Dillon

The new Cancer Drugs Fund provides the opportunity—in cases where there is real uncertainty about the outcomes and about the additional benefit that patients can get—to provide some space for the drug to be used for the benefit of patients in the UK for whom it is indicated, but also, in effect, to put the company on notice that we need to gather the data that will allow us to resolve the uncertainty and then make a final decision.

David Mowat

Yes, it does mean that the data has to be gathered. What the companies said, or implied, in their evidence—I do not want to put words in their mouth—was that there was a bit of reluctance within NICE to go down this route of outcome-based pricing, for whatever reason. Maybe that was because it was bureaucratic, not clear or whatever. Is that something you would acknowledge?

Sir Andrew Dillon

We certainly do not regard ourselves as bureaucratic. The point of the process we put in place is to identify for patients what the additional benefit is going to be. Ultimately, we can work only on the basis of the information that companies give us. Companies already have the opportunity to say to us—

David Mowat

No, you could work on the basis of the eventual outcomes, with a pricing model that is based on that. That would give the companies more if things are done well and less if they aren’t.

Simon Stevens

That was the theory, as I understand it, when the Cancer Drugs Fund was originally set up: there would be a short-term thing while this new method of value-based pricing rippled out across all the medical drugs bought by the national health service. It turned out in practice to be completely undoable—utterly unworkable. You can do it for some individual classes of drugs, and for some particular products, but the idea that we can use this as a basis for buying billions of pounds of different medicines is just not there. So if we proceed following consultation—just for the record, we will obviously have to analyse very carefully the range of consultation responses we get, so no decisions have yet been taken about what we will do with the future of the Cancer Drugs Fund—and if a variant or a version of the proposal on the table that we are out consulting on is what we go ahead with, then, exactly you as have described, that is a method for setting a price at the end of the process, based on the outcomes data that have been achieved.

David Mowat

But the evidence you have just given me, very strongly, is that when the pharmaceuticals companies told us that they thought we could do more in that regard—

Simon Stevens

We probably can do more, but we can’t do the whole thing. There was, I think, a rather over-ambitious expectation back in 2010 or 2011—I was not here, but that is my reading of it—that somehow this would be ubiquitous.

David Mowat

There is a lot of concern about opaque pricing and different prices being paid in different countries. The drugs companies do not tell you what the figure is because it is commercially sensitive. I suppose one way around that would be for you to go and ask the French, the Spanish or the Americans what they are paying. I don’t think that is illegal and you could get around the market issue that way. Do you do that?

Professor Peter Clark

Asking is not illegal, but they will be bound by the same confidentiality clauses as we are, so they will not be able to answer the question.

David Mowat

So when you buy the drugs, you sign a confidentiality clause?

Will Cavendish

Yes. The direct answer to your question is yes, we ask that regularly. Many of the drugs are provided in things like patient schemes, which are confidential, so we are bound by that confidentiality just as other countries are, but where we can get transparency on the prices being charged in different markets, we certainly go for that. Can I come back to your point about outcome-based pricing? Not only is there a proposal in relation to the Cancer Drugs Fund for a managed access fund as was just being described, but equally, in the broader accelerated access review, for which the interim report came out a few weeks ago, there is a very significant focus on new models of decision making, including new models of pricing, which could be used for cancer and other drugs more broadly. The wider answer to your question is yes, this issue of innovation coming through and flexible pricing arrangements is very much part of our thinking and we have a very serious programme of work under way to see whether we can move to those kinds of models.

Sir Andrew Dillon

Specifically on the point about outcomes, there is already a mechanism in place for companies to offer their drugs and for the effective price that the NHS pays to be a function of what patients actually get in terms of improvements to their condition. In about 40% of the cancer appraisals that we do, companies put those proposals forward. So it is not the case that NICE is not interested in outcomes or outcome-based pricing. We are using the mechanisms that we have in place already to enable companies to put schemes forward that effectively set their price against the real benefits that patients get, with real-world experience.

Chair

A few quick-fire points from me. Mr Stevens, one of the main points of the fund was to tackle rare cancers, but a very high percentage of the money goes on routine cancers, if I can say such a thing about cancer. You know what I mean—mainstream chemotherapy. Do you think the fund has failed on rare cancers, and how sure are you that the new process being proposed will make a difference?

Simon Stevens

No, I don’t. I think 70% or thereabouts of the indications supported by the Cancer Drugs Fund are for rarer cancers, but I will obviously be interested in what Professor Clark has to say.

Professor Peter Clark

I do not think that there should be any difference between a patient who has a rare cancer and one who has a common cancer, and that is one of the achievements of the Cancer Drugs Fund. Provided that the evidence base is there, patients have been granted access whether it is a common cancer or a rare cancer.

Chair

The point is that with the more common ones, you are more likely to eventually get agreement from NICE, because there is volume take-up.

Simon Stevens

Sure, but not in the new CDF. In the new CDF, they will get fair dibs, just like every other one.

Professor Peter Clark

Exactly, but the whole thing about the Cancer Drugs Fund was that it opened the door to those drugs that had not been appraised by NICE and it opened the door to those cancers that had a relatively small evidence base—very rare cancers. It had a mechanism for dealing with those, too.

Chair

Can I again ask Simon Stevens how much the fund has cost so far in 2015-16—this financial year?

Simon Stevens

I think we are anticipating that the year-end position—I would have to pull out the month 9 or 10 position, but the year-end position is going to be in the zone of £400 million to £430 million, with a central forecast of £410 million. However, as a result of the second delisting we have done, we think we are closer to the run rate budget position of about £340 million, going into 2016-17.

Chair

You talk about delisting. Professor Clark, you were making decisions about that delisting. How did you make the clinical decision about which drugs to delist?

Professor Peter Clark

We had a system that looked at the clinical benefit. We had a scoring system for that and a scoring system for the amount that the drug cost per patient. Drugs that were delisted either were below the threshold in terms of clinical benefit, so it did not really matter what the cost was, and there were other drugs that had greater benefit, but their cost brought their overall score to below the threshold. Those are the drugs that you have heard about, where some manufacturers chose to reduce the cost to bring their drug above the threshold.

Chair

That brings me back to the question I asked the previous witnesses. They managed to reduce the costs when the pressure was on. Do you think it shows a failure of the NHS in negotiating the cost in the first place that manufacturers were quite quickly able to reduce the cost when there was a threat of drugs being delisted from the Cancer Drugs Fund?

Simon Stevens

I think in the early days of the Cancer Drugs Fund, there was not enough of a mechanism in there to drive a value and pricing conversation with the manufacturers. That has changed in the past 12 months or so.

Chair

The past 12 months or so?

Simon Stevens

Since 2014-15 and 2015-16. Going into the evolved version of the CDF, if that is what we do, we will have a really good mechanism for doing that.

Chair

Do you think there are lessons for the Department about that kind of negotiation? We often touch in this Committee on negotiation with the commercial sector across Departments. Do you think the Department of Health is falling down on the job?

Will Cavendish

No. As Simon says, the budget pressures really started emerging in 2014-15. You talked about quickly getting on top of it. It is a very sensitive area, and it has taken a lot of effort and time to develop the clinical protocols, methodologies and consultations. Even now, as Simon was saying, the fund is a little bit out of balance, but I do not think we were slow on that; it was just difficult and careful work that needed doing.

Chair

We heard a bit from our previous witness from Cancer Research UK about there being an increasing number of stratified or targeted drugs in future, focusing on the patient’s reception of the drug rather than the drug just being blanketly supplied. Is that something the new proposals will really tackle, and will it save money for the taxpayer as a result?

Professor Peter Clark

I am sure they will tackle exactly that, because that is where the big exciting arena is for these new cancer drugs. For example, you can have a drug developed for lung cancer that may only be applicable to 5% of lung cancer patients, but all the cancer research is now finding the same target in a whole range of other cancers. One of the things the consultation makes clear is our need to sort out off-label use, because it is quite possible that that drug may have a licence indication in lung cancer while also offering a very valuable tool for a range of other cancers. That is why off-label use, which has been sorted out by the present Cancer Drugs Fund—those lessons need to be swept up into the future.

Simon Stevens

To be slightly controversial, I would also say there is a growing issue with the pricing of new cancer drugs that every industrialised country is on the receiving end of. If previously you had a single medicine that treated, say, 100,000 patients, and now you have 10 separate medicines that treat 10,000 patients each, it is not going to be possible for healthcare systems to say, “Just because you’re treating 10,000 patients, we can pay three or five times more than we would have done,” because 10,000 patients times 10 is the same 100,000 people. That issue is showing up in the United States, which, let’s face it, has the world’s highest prices. It is certainly showing up across Europe as well. The win-win here with the life sciences and pharmaceutical industry has to be to help them take costs out of drug discovery, so that mechanisms like the accelerated access review and so on can enable them to—

Chair

We look forward to the outcome of your review, because that will be interesting.

Simon Stevens

It is not going to absolve us of difficult choices.

Caroline Flint

On data collection, all of you have talked about being led by the evidence. Professor Clark, you talked about the delisting of certain drugs, looking at the cost and the clinical evidence there. It still seems to me we are trying to solve some issues here without the reference point of the data that is important to make those decisions. Mr Stevens, as my colleague said, only 7% of records had an outcome summary in 2014-15. What can you do in that particular area to ensure that professionals—I presume they are the ones who have to ensure the data is on people’s records, so that we can look at it—improve on that? When do you think we will see an improvement?

Simon Stevens

That is what Professor Clark covered quite extensively earlier, in response to Mr Jackson.

Caroline Flint

I am not sure we got the answer.

Simon Stevens

I think you got quite a long answer.

Caroline Flint

I do not think we got an answer about the priority of this improvement. I heard in evidence that oncologists and others are really concerned about evidence, but it looks like only 7% of them actually fill in the forms that are necessary for us to pool the information and to see about clinical effectiveness.

Professor Peter Clark

I think you need to be very careful about what the outcome summary means. In particular, it is a measure of the toxicities of treatment, which has always been one of the most difficult things for any NHS system to collect. Does that mean that it is a whole absence of data—of knowing how long the patient was under treatment for? No. Does that mean that we do not know how long the patient lived? The answer is no. So we know the key things, but there were some issues in that outcome summary which, as I said, are a challenge to the NHS, but would not stop me from knowing how long patients were on that treatment and how long they lived.

Caroline Flint

I completely understand the complexity of all this. We have had a huge row in the last year where the public were very concerned about access to their patient records, which could then be used as an evidence base for looking at treatments and interventions. Surely, part of getting the public on our side about this—and I think it is a good idea to have access to this information—is to make sure that the professionals are confident about what they are asking for and what they are doing. You cannot argue for patients to open up their record if, on the one hand, you are saying that, and on the other, professionals are saying, “It is not really that good anyway, because it doesn’t cover this, that or the other.”

Laura Brackwell

You said, “on the date of death”, and I am looking at the data we have got on that. According to the data, only 18% of records in 2014-15 had the date of death. Am I misreading that?

Professor Peter Clark

No, that is data submitted by the trust. It may only be less than 100% because patients are still on treatment, but the date of death is got from a different dataset.

Chair

I think you have picked up the Committee’s concerns about data. The Comptroller and Auditor General has some questions.

Sir Amyas Morse

You very eloquently explained the quality of data fields you need to able to make pricing decisions based on outcomes. Even if people start doing it properly, how many years will it take before you have a reliable dataset? It is not going to happen immediately the first time people fill it out, so how long will it be before you have a reliable data matrix that you can look at and say, “This is how we should price these drugs”? How many years will that take, starting from now?

Professor Peter Clark

In terms of all the patients having chemotherapy in the CDF, I think that is imminent.

Sir Amyas Morse

Can you help me with “imminent”?

Chair

In the civil service, imminent might mean several years.

Professor Peter Clark

Because of the mandatory stipulation in the contract in April 2014 and the contract levers that NHS England is now vigorously working to improve those data returns, I think that 2015-16 will see a dramatic rise in improvement in those data returns, such that in the next financial year, 2016-17, we will have data systems that I am confident will not only be delivering data about non-CDF patients—the 165,000—but CDF patients and, of course, new CDF patients too.

Sir Amyas Morse

So you think it will be possible to price by 2016-17, based on outcomes?

Professor Peter Clark

Data will be submitted by 2016-17, but it will take that data time to mature.

Sir Amyas Morse

How much longer will it take to mature?

Chair

When will it be useful?

Simon Stevens

Let me be clear about what we are and are not pricing. For cancer drugs in routine commissioning, we have a reimbursement mechanism and a PPRS. There are no proposals to change that. For drugs in the new CDF, we will have data because, as a condition of entering the conditional funnel through CDF, they have to produce the data to the satisfaction of NICE, such that they can then make an outcomes-based pricing decision on the back of it. How long that takes will depend on the individual drugs or indications. The expectation is that it will take up to 24 months to generate those data for the new products that are put into CDF.

Sir Amyas Morse

So it will be about 3 or 4 years.

Simon Stevens

No, I don’t think that is right.

Sir Amyas Morse

You start pulling it up, and then it is 24 months—

Sir Andrew Dillon

As the new Cancer Drugs Fund comes into operation from next April, there will be a cohort of drugs in the scheme at that point, together with new ones coming in. All those drugs will be subjected to the data collection exercise that Peter has talked about, so we are collecting data immediately. In the process, as you have read, after a maximum of two years—it could be earlier—NICE will take another look at all the available data. That might be clinical trials that are conducted somewhere else in the world, clinical studies conducted in this country, and the SACT data. All that data will be brought together. The SACT data itself is not the difference between being able to progress towards outcomes-based pricing; it is a helpful addition. It will start being applied to and collected from next April.

Caroline Flint

In terms of what Mr Stevens has just said about what will happen now about data collecting going forward, was it a mistake that this was not thought through at the outset of the Cancer Drugs Fund?

Simon Stevens

I think the Cancer Drugs Fund was designed at the time to deal with a problem, which in some ways it has dealt with, with over 80,000 people having been successfully treated. But it is clearly not—

Caroline Flint

And a lot of public money.

Simon Stevens

Quite a lot of money, but we do not think this is the optimal evolution of the mechanism. It filled the gap, pending a proposition—

Caroline Flint

If you had your time again?

Chair

Just answer Ms Flint’s question.

Simon Stevens

I wasn’t there at the time.

Caroline Flint

Well no, but with all your experience of the health service, if you had been there at the outset, is data collection for evidence of effectiveness in pricing something that you would wish to have seen?

Simon Stevens

Clearly.

Caroline Flint

Right. May I ask one more thing? When is bowel cancer screening going to be rolled out across England?

Simon Stevens

We will be responding to the Cancer Taskforce report. One of the recommendations it makes is on the various modalities that we should be adopting, based on the national screening committee, as you know from your previous—

Caroline Flint

It is available in some areas, but not in others?

Simon Stevens

Sure: so we have to roll out a programme. In the case of bowel cancer, we have the original faecal occult blood test, which is offered every two years, and the new bowel scope screening programme for 55-year-olds, which is being rolled out. The bowel scope screening has been rolled out to 76% of centres and we are on track to open all centres in England by the end of next year. More than 50,000 55-year-olds have been screened so far.

Caroline Flint

A relative of mine went to their GP in south Yorkshire and was told that it was not available in their area because they are not being paid for it.

Simon Stevens

They might be one of the 24% of centres that has yet to open, but that should be open, according to this briefing, by the end of 2016.

Chair

That is quite a long time to wait. I have one last question, Mr Stevens. We touched earlier on the target between GP referral and decision to treat. The target is 95% by 2020. Are you confident that you are going to meet that target?

Simon Stevens

We certainly want to meet it, and we have a lot of work to do in order to meet it, because, among other things, we have to expand endoscopy capacity. There has been a big increase in the number of people being referred, including, as Ms Flint has just said, for bowel cancer. We want more of that. We need a big training programme for more nurse endoscopists. We have another 200 to 300 in the pipeline, but unless we expand the endoscopy capacity we will not meet that 28-day target.

Chair

In Denmark people swallow a camera pill, which seems to make things very effective. I don’t know the cost of that. Are you confident you are going to meet the target? You say there is a lot to be done. It is a target for a reason.

Simon Stevens

Exactly, it is a clinically-grounded target that we are committed to.

Chair

Are you on track now?

Simon Stevens

It is a few months since the taskforce published its report. We need to mobilise in order to do so.

Chair

We will come back to you on that one. Mr Stevens, you said in a muted way that lessons can be learned from the Cancer Drugs Fund, right at the beginning of this inquiry. I think we would say quite expensive lessons can be learned. The overall message seems to be that sorting this out has taken five years—well, it is not even sorted out yet—from when the Cancer Drugs Fund was set out. It begs the overall question of how long it takes the NHS to reform something. It seems to take three or four years before the problem is recognised and acknowledged. We expect as a minimum with the new proposals—you will read our Report when we finally decide what to put in it—that clear objectives need to be set from the beginning and necessary data. We have heard a lot of the Committee’s concerns about that. The budget needs to be managed much better and the drug company negotiations need to be more effective. Do you agree with any of that?

Simon Stevens

Some, but not all. From the get-go, five years back, there was a problem that needed to be solved. When the thing was first set up, in its first year of operation it dealt with 3,000 patients, and 12,000 patients the year after. In 2012-13 it was 15,000 patients, and then 20,000 patients. It has been a victim of its own success, in that sense. There were more patients coming through, more expenditure and, as a result, a need to drive a different mechanism to use the money wisely. I think it would be a rewriting of history to suggest that there was a budgetary problem in the early stages of the fund; I do not think that there was. In fact, there was an underspend, which was deployed on boosting radiotherapy equipment, because it was not receiving sufficient applications for the budget to be fully deployed.

Chair

Perhaps the problem was not dealt with quickly enough when it arose, but we can touch on that, I am sure, in our Report. Thank you very much, all four of you, for your time. Our uncorrected transcript will be on the website in two or three days’ time, and our Report will be published at some point in 2016—hopefully in the first couple of months. Oral evidence: Cancer Drugs Fund, HC 583 15 [1] Professor Clark should have said “left the CDF panel”. Deidre Brock had said that the ABPI member left the clinical reference group for chemotherapy. To clarify: the ABPI member was on, and therefore left, the CDF panel, not the CRG itself.