Primary care trusts are able to appoint committees of the trust, but there is no requirement for a special exception committee, an exceptional circumstance committee or other committee to approve treatments. There is no national guidance on the functions and operation of any such committee.[Official Report, 11 July 2007; Vol. 462, c. 1566W.]
So, no messing there. As has been said, little is known about the operation of exceptional case processes. Committees do not publish details of their process, their membership and the outcomes of their meetings. However, data about the usage of the rarer, often higher-cost treatments would be invaluable to NHS planners and could be useful to NICE when such treatments eventually become part of its appraisal and review process.
I have been the chair of the all-party group on cancer for 10 yearsindeed, we will celebrate our 10 year anniversary in a few weeks time on the Terrace. We are
very proud of the process that the Government have carried through under cancer plan one, the reform strategy and so on. We have seen real movement on the treatment of cancer right across the country: money has been put in, structures have been set up and people are living longer, which is a great tribute to the Government and to what they have done since 1997.
The all-party group is, however, concerned that applications from patients and clinicians are not always fully assessed case by case. In some cases, people are discouraged from proceeding, while some PCTs predetermine the outcome of cases. According to anecdotal evidence from Bayer Schering Pharma, clinicians have told members of its sales force that their PCTs tell them not to bother applying for certain drugs under exceptional case processes.
Dr. John Pugh (Southport) (LD): I am listening carefully to the hon. Gentleman. He mentioned resolving such issues case by case, but he also said that he wanted more uniformity. Is there not a paradox here? I understand that people want uniformity of procedure, but is there not a real difficulty about trying to deal with exceptional cases in a wholly uniform way?
Dr. Gibson: Yes, there will always be difficultiesnot least the availability of funding. Provision will differ in different parts of the country, and a certain tumour might, for example, be more prevalent in one part of the country than another. Although there is a process for assessing cases, we must bear in mind how helpful the treatment would be for the individual concerned. To take another example, Herceptin was not the best thing for everybody with early-stage breast cancer. People had to have a particular genetic factorHER2before the drug became active, although it was hard in the climate that evolved at the time to stand opposite a patient and say, This is not going to affect you. However, the day is coming when personalised medicine will allow us to say that a certain drug will work with A, but not with B, although it might work with C. That is happening more and more, and we should encourage it to bring a certain rationality to the use of drugs. However, such knowledge must be plugged into the system before we can make decisions in Dorset, Norfolk or wherever.
Many people use Macmillan Cancer Supports helplines to seek information about the exceptional funding processes operated by PCTs. Such processes can be lengthy, arduous and difficult for patients, and the problem is often perpetuated by the lack of information and support. An attempt has been made in the reform strategy to keep the process to 31 days, although that is still a long time. My instinct is that information and treatment should be made available much more quickly, and that should happen right across the country. That would be a real advance, and it would be extremely popular with the public.
I know that fellow MPs receive correspondence from constituents on this issue, because they often give it to me. In conjunction with groups such as Macmillan and Cancerbackup, which have now merged, of course, I use that information for other individuals. Exceptional case studies and processing are an important part of the PCT process, as PCTs resources are finite, and treatment
decisions must be made. The system could, however, be more equitable and transparent, and patients and clinicians should expect to receive the same decision wherever they live.
I do not want to go into lots of different cases, and I will mention just a couple. One woman, whom I will not name, was being treated for bowel cancer by Enfield PCT, and details of her case were sent to me for a view. She had had six years of treatment, involving chemotherapy and radiotherapy, but her condition was advancing. Her oncologist advised her that the next line of treatment would be a substance called Erbitux. The PCT does not routinely fund the drug, but the oncologist was allowed to appeal to the trust. That would have taken four to six weeks, so the woman, who was concerned that it would take such a long time, contacted the trust. She was told that funding decisions were taken at a monthly meeting on the seventh of the month. Eventually, her appeal was turned down. She was told that the extra life that the treatment might provide was not worth the money. She will apply again. As hon. Members can see, that takes us into the private sector, where there is the money and all the resources. The Library has sent me details of many such cases, which have featured in the newspapers over the years.
In another case, from a constituency next to mine in Norfolk, a patient sought Sutent from the PCT to treat kidney cancer. The drug is going through the NICE process, and there is no final guidance yet. Reissued health service circular 1999/176 states:
It is not acceptable to cite a lack of NICE guidance as a reason for not providing a treatment,
which is fine. According to the press coverage of the case, Norfolk PCT said that the treatment is not cost-effective and that it cannot prescribe it. However, PCTs have a duty in such cases to consider not only cost-effectiveness, but clinical effectiveness. The individual concerned is using £3,000 a month from a nest egg to pay for his treatmentthat is the level of commitment that individuals need to make.
Mr. Peter Bone (Wellingborough) (Con): The hon. Gentleman is making a powerful and important speech. Has he come across cases in which somebody has said, Okay, you wont provide this on the NHS. Ill pay cash for the drug, but where the NHS has said, If you do that, we wont carry on with NHS cancer treatment? That seems wholly unfair.
Dr. Gibson: Yes, there are such cases. Somebody will offer to use the co-payments systems, under which the individual will pay something and the NHS will pay something. That is not allowed under the current system, and the NHS cannot work on that basisit must operate at the level that the PCT has decided.
I mentioned Erbitux and I want to say a little more about it. In Kent, co-payments are refused, and it is not possible to give Erbitux for bowel cancer. At Maidstone hospital, however, the PCT allows co-payments and Erbitux, so there are differences within counties, and the position is not always clear. The patient in Kent has been happy to talk to me about his case, but I have said enough to illustrate what happens.
I have a whole list of places to illustrate the differences that I have described. Surrey, Sussex and Bromley are not good for allowing exceptionality. In North Yorkshire
and Dagenham, there is a 50:50 success rate, but only if people threaten, or actually undertake, a judicial review. In Cumbria and north Lancashire, there is some mixed funding, and treatment is carried out on a case-by-case basis. In the Birmingham area, there is little exceptionality. In Manchester, however, there is nearly 100 per cent. success. That is the extent of the variability. That information comes from lawyers who have taken up the cases.
So what is the solution? We must make sure that we provide the best treatment available under the NHS. In relation to drugs, there isnever mind about NICE approvalthe exceptionality process. For the system to continue to operate in the national health service, there must be national guidance outlining the obligations of PCTs. A framework should be set up to help committee members decide what should be considered an exception. For the patients with whom I have been in contact, one of the hardest things is that there is no way of knowing whether their case will be heard, let alone whether they will finally get the treatment they require. The additional stress and uncertainty is detrimental to the health and quality of life of patients with cancer.
A recent report on NICE by the Select Committee on HealthI am pleased to see a member of the Committee, the hon. Member for Wellingborough (Mr. Bone), present for the debatemade several recommendations on tackling postcode lotteries, including the need to assess all medicines at launch and to involve PCTs in developing guidance. However, in my opinion the recommendations fall somewhat short of what is required, as they would still leave a discrepancy between PCTs in the matter of exceptional cases. That was not clear in the report.
Patients should have all the information that they want, at the appropriate time, to make informed decisions about their treatment. The lack of transparency and the postcode lottery affecting exceptional funding are not acceptable. PCTs are autonomous in the way they spend their limited resources, and must provide the best health care for the community they serve. Patients should be informed about how resources are distributed within the local PCT, and arrangements for exceptional funding should no longer be shrouded in mysteryto use a phrase from a judges deliberationsfrom the general public.
Macmillan is in the process of surveying all PCTs in England by way of a freedom of information request, to discover how many have a formal exceptional funding process, what the processes are, details about the decision-making panel, how much it is used, patient criteria, whether information on the process is published, and so on. That information will be used to inform PCTs of how their processes compare with those of other PCTs.
Other organisations in the cancer community are doing the same thingfinding out how different PCTs operate. Some hon. Members will have been involved with the screening procedures that Cancer Research UK is examining to see whether different PCTs have different ways of carrying out screening for particular cancers. The current mood is that in addition to what was outlined by the Select Committee, an attempt should be made to do something about the differences between PCTs in certain fields. Those concerned will of course share their findings with MPs when the information is obtained.
I call on the Government to provide direction to PCTs and to support them in operating equitable and accessible exceptional case processes. That should include
guidance on how exceptional cases should be dealt with, what criteria exceptional case committees should use to decide whether a case should be approved, who should sit on the committees and what patients should be able to expect, regardless of where they live. I want all PCTs to publish their exceptional case processes on their websites and through the local office of the patient advice and liaison service set up by the Government. The information should be freely available. PCTs should ensure that patient information about the exceptional case process is made widely available, in different formats and languages. I am continually astonished that in Norfolk 108 different languages are used, and I found that the PCT used only oneEnglish. Suddenly Portuguese, Lithuanian and other tongues must be fed into the process, so that everyone gets the appropriate treatment, even within a county. It is a more complex matter than just trying to equalise what happens county by county. PCTs should provide all members of exceptional case committees with training in considering the relevant situation. They should collect data on how many cases are heard, the numbers approved or refused, and the therapy to which the decisions relate. That data should be considered by NICE when it gets round to appraising or reviewing its guidance.
The issue is an extremely important one in dealing with a facet of the work in question. Drugs are a major part of the treatment of patients in the national health service, and there will be more cancer drugs coming on to the market. It is estimated that in the next two years there will be 12 new drugs for different cancers. We should be proud that our scientists and medics are coming forward with new treatmentsnew cures, evenprolonging life and the quality of life. Politicians should ensure that if those treatments are available, they are available to everyone, wherever they live in this country.
Dr. Richard Taylor (Wyre Forest) (Ind): It is a privilege to follow my hon. Friend the Member for Norwich, North (Dr. Gibson)I can call him my hon. Friend because sitting in the middle I can have Friends on both sides. I pay tribute to him for his work as chairman of the all-party group on cancer. For 10 years he has been indefatigable in working for cancer patients.
I shall try to illustrate my remarks from my local experience in Worcestershire, where we have what is called a complex case panel. I have had several battles with it over the years. The first related to anti-tumour necrosis factor drugs for rheumatoid arthritis, several years ago when Worcestershire had three PCTs and postcode rationing was even more ridiculous, in that one of those small PCTs would not fund anti-TNFs and the other two would. A huge advantage resulted from the merging of PCTs into larger areas, from that point of view. Since the merger I have had battles over biventricular pacemakers, cochlear implants and drugs for wet macular degenerationall before NICE has made a ruling.
There is a tremendous difficulty, even with technology appraisals, which are mandatory, because they may override local clinical priorities. I remember that during the first inquiry into NICE by the Health Committee, several years ago, we received objections from St. Thomass, over the water; the hospital representatives could not equate the demands from the technology appraisal for
implantable defibrillators with their much greater desire for more nurses in accident and emergency. There is a tremendous conundrum: local priorities against national uniformity. I do not pretend to have an answer to that, but we must think about it.
My most recent, continuing, failing battle with the complex case panel is over the drug called sunitinib, which the hon. Member for Norwich, North mentioned under its proprietary name, Sutent. Sunitinib is for renal cell cancer, and amazingly has been approved as a first-line treatment for renal cell carcinoma in the north of England. On 23 July 2007, the north of England cancer drug approval unit, taking the cost into account, approved the drug not for second-line but for first-line treatment of patients with renal cell carcinoma, and listed such evidence as improved progression-free survival and improved survival in patients who had failed on, or could not tolerate, current therapy. That was enough for the north of England patients, and for medical oncologists in Birmingham. One with whom I have had dealings in connection with two patients in my area wrote, in reply to an inquiry from me about the current position in the west midlands:
I have worked with most PCTs in the West Midlands and Worcestershire regions and in many cases the PCTs have funded treatment with this drug. I am aware that Worcestershire PCT is funding treatment with Sunitinib in at least two cases.
To ask the Secretary of State for Health which primary care trusts in England provide funding for Sunitinib for patients with renal cancer who have failed to respond to all other treatments.
I do not really blame the Department of Health, but this is one of the many matters on which it does not hold information. However, the Minister who responded said, because we all know that NICE is appraising the drug:
In the meantime, it is for local PCTs to decide whether to make Sunitinib available to patients. In doing so, they need to take into account the available evidence. It is not acceptable for national health service organisations to refuse to fund a treatment simply because it has not been appraised by NICE.[Official Report, 19 November 2007; Vol. 467, c. 599W.]
On 22 November, Mr. Nicholson, the chief executive of the NHS, came before the Health Committee. That was just when we had heard the revelations that the NHS had gone out of deficit and into the most magnificent surplus. When we asked him about the surplus, he said quite clearly that the Department of Health was not telling PCTs not to spend their money on measures to undo postcode rationing. He said:
What I can say is that the kind of decisions that you have described can now be taken wholly on clinical grounds, not on the basis of whether we have the resource.
I went back to the PCT, because in the meantime my two constituents who need the drug had failed in their appearances before the complex case panel and their appeals. Worcestershire PCTs reply quoted the PCTs area prescribing committee. In his letter to me, the chief executive said:
Sunitinib is not routinely used or funded for patients in Worcestershire with metastatic renal cell carcinoma.
1. There should be no funding of these agents until further evidence is available to support use. It is expected that this should be in the form of mortality data.
2. No cases are likely to be exceptional in nature, and in view of the current available treatment it would not be equitable to consider any case as exceptional in the future. All cases considered as such to date merely represent the natural progression of the disease and response to existing treatment options. It is not appropriate to consider any further requests in line with previous requests considered.
I trust that this reassures you that the prime decision for not funding this treatment is the lack of sufficient clinical evidence with which to support use; and that the way in which this drug was considered for use is consistent with the mechanism by which all new drugs are introduced into clinical practice in Worcestershire, i.e. through the Area Prescribing Committee.
I was further confused by a letter from the chief executive of the West Midlands strategic health authority; I was trying to apply a little pressure higher up. I cannot resist reading this paragraph, which she herself admitted she did not understand:
I understand from the Cancer Network that an improvement in progression free survival alone is not accepted as reason for approval of a drug and, in this situation, if a drug is on the NICE agenda then the Network would await a decision from NICE, as the survival of patients is not compromised. They add that an improvement in progression free survival is not evidence that a drug changes the natural history of the disease; progression may be delayed but there may be accelerated repopulation of the tumour after the drug stops being effective. As a clinician, I assume this statement is more readily understandable to you than to the lay person.
Is there an answer? Ideally, NICE should make its appraisals, which are mandatory, much quicker. We shall debate that here in about a weeks time. That would be the ideal, as we all know that NICE goes into incredible detail to find out the facts. Another answer would beplease do not think that I am asking for more money for the health servicefor more of the money in the health service to be made available so that more of the new, expensive drugs can be afforded and NICE can use its quality-adjusted life years to let a few more drugs through. I am seeking not more money but more efficient use.