BOWEL CANCER UK

  Bowel Cancer UK is a leading charity dedicated to raising awareness of bowel cancer, improving the quality of life of those affected by the disease and, ultimately, reducing deaths from the second most common cause of cancer death in the UK, affecting men and women equally.

  Bowel Cancer UK commemorates its 20th anniversary this year: 20 years in which we have sought to represent and help those affected by bowel cancer—patients and those who care for them—including in helping them to gain access to the treatments, care and services that are right for them.

EXECUTIVE SUMMARY

  As you will see, we have responded to each of the areas of particular interest that the Committee has drawn attention to, as set out in your press notice number 11. We have also added points that we believe will be of use to the Select Committee in its Inquiry. All our responses are based upon our considerable experience of working with NICE and taking part in their appraisals of bowel cancer treatments over the last seven years.

1.   Why NICE's decisions are increasingly being challenged

  NICE's decisions are increasingly being challenged—including, where appropriate, by ourselves—because their guidance is often negative and flies in the face of the medical evidence supporting the efficacy of the treatments they are appraising. NICE is also being challenged more because their decisions seem to be based solely on grounds of cost not efficacy. This is not only wrong; it also goes against why they were set up in the first place, in their own words: "NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health."

2.   Whether public confidence in the Institute is waning and if so why

  Public confidence in NICE is waning for the above reasons and because NICE is increasingly seen as not being "an independent organisation" but an agent of government, whose sole purpose is to restrict NHS spending on treatments, rather than, as should be the case, make these treatments available to the patients who need them and could benefit from them.

3.   NICE's evaluation process, and whether any particular groups are disadvantaged by the process

  Speaking from the perspective of bowel cancer patients and carers, I can definitely say that they have been disadvantaged by the NICE process. The recent revolution in new treatments for the disease—after 50 years of only one treatment being available—has not benefited patients on the NHS. Bowel cancer treatments that are routinely made available to patients in Europe, the United States and in the private setting are being denied to patients in the UK as a result of negative NICE guidance. It is no surprise, therefore, that we lag far behind other countries in terms of how long our patients survive with the disease.

  As we've said previously, in response to a specific negative NICE verdict, it is ironic that the UK is at the forefront in developing these treatments and yet at the very back of the queue when it comes to patients gaining access to them. It is also worth noting that even though NICE guidance is just that—"guidance" and not law—PCTs treat it as law and usually refuse to go against it.

4.   The speed of publishing guidance

  While NICE guidance has speeded up in recent years, following pressure from voluntary groups and others, this is, in effect, academic when, as in the case of bowel cancer, their guidance is often negative.

5.   The appeal system

  I will refer to a summary of the comments of lawyer Peter Telford on this point, who has been working pro-bono with Bowel Cancer UK on patients' behalf in seeking to help them gain access to treatments. Peter says the following:

NICE's current system of decision making and review offers no opportunity for relevant and current material and facts to be considered in any appeal.

The NICE appeal system is, in fact, not an appeal system at all. It is a review of the material that was available to NICE at the date of the original decision only. A proper appeal would involve a reconsideration of the facts on the basis of the best available evidence at that time.

The present NICE appeal system is based on the model of a judicial review and the only legal avenue of appeal from the final decision of the appeal panel is itself by way of judicial review. Judicial review, by its very nature, prevents new evidence being submitted. The evidence is limited to that which was before the original body.

Even if one were to successfully argue before a judicial review that the evidence before the appeal panel should have been taken into account, it would still not enable the judicial review body to come to its own conclusions on those facts. It could only refer the matter back for a fresh decision.

The danger of a "never ending" system of decision making is met by the wording of the rule that would apply when an appeal body reconsidering the matter looks at what evidence to take into account. This wording would be similar to that used in appeals in other legal fields, such as immigration (not asylum) or housing, where "the appeal body may take into account evidence of material facts which appertained as at the date of decision". These bodies continue to function and do not suffer from a "never ending" process due to admitting evidence.

While the rule of admissibility is a discretionary one and not an absolute right to new evidence, the person seeking to place it before the appeal body has the onus of establishing it as relevant and material. As is the present position, the appeal body would take legal advice on whether it should be admitted.

The appeal process is limited to an essentially "due process" review, which means that the merits of the decision are not reviewed. This artificial limit is not necessary. It also means that when coupled to excessive delay in the process, the decision can become out of step with the reality of rapid technological advances.

The fact that the appeal panel members are experts is somewhat wasted when they are forced to do little more than observe that the original panel went through the right process and—having made proper assumptions on the then available evidence—came to a decision by a logical and reasonable process.

In some areas, such as housing where there are alternatives to public housing, such a process may not lead to ultimate unfairness and injustice. In cancer care and oncology, where changes and improvements to drugs, technology and methodology are ever present, such a process can lead to nonsensical conclusions that are out of step with the, by then, available facts.

6.   An example of how the NICE Appeal system fails bowel cancer patients (also provided by Peter Telford, who was Counsel pro bono for Bowel Cancer UK and Cancer Backup at the hearing of the below appeal in November 2006)

—    Treatments: Bevacizumab (Avastin) and Cetuximab (Erbitux), both biological agents for the treatment of advanced colorectal cancer.

—    NICE announces intention to review guidance in April 2005.

—    Evidence closed by August 2005.

—    Internal (Sheffield based) panel organises evidence and reports to NICE by February 2006.

—    Submissions end April 2006 (including comprehensive submission by Bowel Cancer UK).

—    Draft guidance issued August 2006 (negative on both). Non reviewable before May 2009.

—    Appeal heard for Cetuximab only November 2006 (no new evidence allowed).

—    NICE appeal committee reject appeal (end January 2007).

—    NICE appeal committee observes that they were unable to take account of new material evidence and would like NICE (not themselves but the original committee) to reconsider earlier than May 2009. However, no power in the appeal committee to order NICE (original) to review earlier as they were not informed of the merits of the decision.

—    Final guidance issued end January 2007 (negative on both).

—    Therefore a total of 21 months elapsed with no possibility of any new evidence for nearly 18 months.

—    Of course, the decision depended in part on clinical trials which were not fully complete. During those 18 months some of those trials and new trials were completed.

—    New evidence could mean that drugs originally advised negatively might be advised positively or at least neutrally.

7.   Comparison with the work of the Scottish Intercollegiate Guidelines Network (SIGN) (and the SMC)

  While in the past SIGN—and the Scottish Medicines Consortium (SMC), which are between them the Scottish equivalent of NICE—have shown some independence from NICE, in recent times they appear to increasingly follow NICE's example, which, as most NICE bowel cancer related decisions are negative, again has a detrimental effect on bowel cancer patients.

8.   The implementation of NICE guidance, both technology appraisals and clinical guidelines (which guidance is acted on, which is not and the reasons for this)

  Even when NICE approves treatments—such as oral chemotherapy and combination chemotherapy—implementation of their guidance is often patchy. There appears to be no incentive for PCTs to implement NICE guidance or monitor how guidance is implemented, beyond seeking to avoid the negative publicity that ourselves and other organisations might generate in the media and elsewhere.

9.   The "lowest common denominator" effect

  One of the saddest, and frankly shabbiest, aspects of NICE decisions is the way they appear to presume that if they approve a drug for use, clinicians are going to dish it out it to their patients like sweets from a candy store. NICE seem to ignore the fact that clinicians have the best interests of their patients at heart, which means that if a treatment isn't working, they will stop giving it to them.

10.   NICE—Creating a two tier system

  As you'd expect, when bowel cancer patients—and those who care for them—are told they could benefit from a treatment but can't get it on the NHS, often because of negative NICE guidance, they will move heaven and earth to pay for it privately, making financial and other sacrifices to do so if they are able to. This creates a two tier system that totally goes against what the NHS stands for and what NICE was created for. Consequently, the system and NICE's role within it needs to change.

  Bowel Cancer UK warmly welcomes this Review and is grateful for the opportunity to contribute to it.

Ian Beaumont

Bowel Cancer UK

21 March 2007