FEmISA—Fibroid Embolisation: Information, Support & Advice, an independent voluntary patient group to ensure women are informed about and have access to embolisation to treat symptomatic fibroids.

BACKGROUND

  As the co-ordinator for FEmISA I have taken a very active part in 2 NICE reviews—the interventional procedures review for fibroid embolisation [UAE—uterine artery embolisation] and the more recently Clinical Guideline Development on Heavy Menstrual Bleeding, originally Hysterectomy and Alternatives. I have also served as a member of patient fora for both the Oxford City PCT and Ambulance Trust. Originally a scientist [Applied Biology, specialising in Biochemistry] in medical R&D I have experience of clinical trials as a scientist, manager and more recently a patient. I am also a medical marketing professional and senior manager in the healthcare industry and Chairman of the Chartered Institute of Marketing Medical Marketing Group, which spans all sectors of healthcare from NHS to pharmaceuticals. I have a special interest in NICE and experience of the health service in other EU countries and the statistics on health outcomes.

1.   Why NICE's decisions are increasingly being challenged?

  1.1  The UK is the fourth largest economy in the world. However, despite extra spending health outcomes are much worse than our EU neighbours. We have been promised that NHS treatment is "free at the point of need", but thanks to NICE [and local PCT cost saving] it is not. Patients rightly expect that treatments available in other developed countries—EU and USA should also be available here and yet NICE often denies these life saving treatments on the NHS, especially new cancer drugs. People die from cancer much earlier in UK than the rest of Europe and this has been exacerbated by NICE not allowing many of the new cancer drugs to be used in the NHS. Some of NICE's decisions make us sound like a third world country—NICE ruling on wet macular degeneration—the drug can only be given to patients who are already blind in one eye!

  1.2  NICE needs to put more emphasis on clinical excellence and clinical outcomes, benchmarking against other developed countries ie major EU countries, USA, Australia, New Zealand and Canada. Their decisions are based on "cheap to the NHS" rather than clinical excellence and good health outcomes.

  1.3  NICE considers only the short-term cost to the NHS. This does not give a true reflection of cost effectiveness, which should include short and longer-term economic and social costs to patients and carers, social services, employers and the economy.

  1.4  If a new treatment is rejected by NICE due to cost effectiveness it is killed stone dead and will not be available to anyone on the NHS. Even if a NICE outcome supports a new relatively expensive treatment it does not necessarily become available as PCTs say they cannot afford to fund it. eg IVF.

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

  2.1  It is very questionable whether NICE is as independent as they seem. The Health Ministers decide all the topics for review. Some of NICE's decisions are politically very convenient ie with the lack of NHS dentists it was very convenient that NICE decided we only needed dental check ups every 2 years instead of every 6 months.

  2.2  NICE is being used as a scapegoat by the Government to stop the NHS providing new expensive treatments, even though they may be cost effective, cure disease and prolong life.

  2.3  NICE only counts the costs to the NHS in the short term, pays no regard to long term costs and more significantly to costs to patients—direct, social and economic and to the economy as a whole NICE puts NHS expenditure far above other considerations and there are grave doubts about their economic and financial analyses eg Alzheimer's disease

  2.4  NICE has no teeth. PCTs and clinicians can reject their recommendations on the grounds of local cost pressures.

  2.5  Extravagance and Cost of NICE's Offices—Anyone visiting NICE's plush offices in Holborn would ask why they need such expensive premises. This is not value for money.

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

3.1  Clinical Evidence

3.1.1  NICE started work with pharmaceutical products and does not really understand medical devices, clinical procedures or interventional procedures. It needs to recruit some people who do. It insists that randomised controlled trials [RCTs] are the highest level of evidence available. This is true for pharmaceuticals, however, when comparing completely different treatments, by different specialities there are too many variables. Other types of trials should be given a higher weight. This was particularly noticeable in the recent clinical guidelines for heavy menstrual bleeding, where some small obscure RCT clinical studies were given high status and the VALUE studies, DoH funded retrospective studies of 37,298 patients showing short and long-term morbidity and mortality of hysterectomy were not included. Thus the longer term costs to patients and the NHS were not included or considered. When patients are making decisions about treatments they want to know how effective the treatment is, how long it will take them to get better, possible side effects and complications, how long it will be before they return to work and feel completely better. NICE does not address these important issues.

3.1.2  In the clinical guidance on heavy menstrual bleeding all stakeholders were asked at the initial meeting to submit any non-published data, such as patient surveys etc. However, the documents asking for evidence specifically stated that non-published data would not be considered and the clinical papers we submitted—the VALUE studies and others, were also not included.

  3.2  Side Effects of Recommended Drugs and Alternative Treatments—In the Clinical Guidelines for Colon Cancer a drug 5FU—Folonic Acid is recommended as first line treatment for all. It is cheap, old, and reasonably effective. However, it is stated in the 5FU summary of product characteristics [SPC] that it can cause angina [due to coronary artery spasm] in some patients and the drug cannot be continued. NICE does not recommend an alternative drug. My mother recently had an angina attack due to 5FU. We had a huge battle to get her any alternative chemotherapy at all, as NICE had not made provision for patients suffering serious side effects from 5FU. This was extremely distressing to us all and the next patient in the same position would probably not have the knowledge to get an alternative drug. There should be greater flexibility in NICE clinical guidelines and provision for alternative therapies should the first line not be suitable.

  3.3  The Interventional Procedures Review, is very sloppy and does not do a review of the most recent clinical papers or those not written in English, which is essential for new technologies. In the review on uterine artery embolisation NICE initially cited only 9 papers for the advisory committee to review. FEmISA, in a 10 minute search on the internet, found 120 papers, many significant, that NICE had overlooked. One of the advisory committee members, a leading clinician, now conducts an independent search before reviewing NICE's evidence. The committee cannot be expected to come to a sensible decision if they do not have the clinical evidence. There is a large question mark over the competence of NICE staff.

  3.4  Technology Appraisals—Clinical Evidence—NICE deliberately does not invite leading clinicians in the field under review if they have taken part in a clinical trial on the new drug. This deprives the committee of expert evidence.

  3.5  Cost effectiveness—NICE's economic evaluations are very questionable. NICE values human life by QUALYs and restricts treatments to a cost of approx £20k, This amount is far too low. Many people pay more than this in tax each year and have certainly contributed more than this in tax. Only the short-term costs to the NHS are considered not the costs to patients and their families, whose taxes pay for the NHS, nor long-term costs to the NHS, nor social services, nor employers or the economy. A true economic evaluation would take all these into account. This leads to very distorted outcomes particularly exemplified by the ruling on drugs for Alzheimer's disease

  3.6  Patient Involvement—NICE invites patients to take part during the working day. They are unpaid and must take holiday from work to attend. NICE will not contemplate evening sessions more convenient to patients and members of the public.

3.6.1  Although registered as a patient group with NICE for uterine artery embolisation FEmISA was not invited to take part. It was only through my personal interest in NICE that I discovered this interventional procedures review was planned and insisted on taking part. I did complain to NICE about this. If registered patient groups are not informed about NICE reviews affecting them, it is unlikely that other small patients groups will be able to take part.

3.6.2  Many patient groups submitted evidence to the clinical guidelines development on heavy menstrual bleeding. These were protesting against the reduction in scope and suggesting other clinical evidence should be considered. I have little confidence that any of the patient submissions were read. The points raised were completely ignored and not addressed at all.

  3.7  Lack of Transparency of Decisions—In the clinical guideline development for heavy menstrual bleeding this was originally entitled hysterectomy and alternatives and had a much broader scope. The title and scope were reduced against patient wishes and without explanation or appeal. This change only benefited the Royal College of Obstetrics and Gynaecology and seems to be the result of secret lobbying.

3.7.1  Many patient groups volunteered to take part. One of the two patient representatives did not come from the registered stakeholders and many were upset by the appointment, as there was no explanation. The reasons were not transparent. However, I was impressed with her, her input and outcome, but there should have been a proper explanation.

  3.8  Inaccessibility of Evidence, Guidance and NICE Documents—The systematic review in the interventional procedures review of uterine artery embolisation was 110 pages. While it is important that the review is detailed and comprehensive there should be a shorter summary version for patients and busy clinicians to review more quickly.

3.8.1  In the clinical guidelines development for heavy menstrual bleeding a short summary was written, but this bore little resemblance to the full version of 400 pages. It was necessary to read the 400 page document to make sensible comments.

  3.9  Guidance for Patients—The patient booklet NICE produced for uterine artery embolisation did not give a clear explanation of what was involved. It did not compare this procedure to the safety and effectiveness of other treatments for fibroids, usually hysterectomy and it did not require gynaecologists to inform women needing treatment of this option. FEmISA brought these issues to NICE's attention at the time and offered to help rewrite it, but was rejected. Subsequently a number of women have contacted FEmISA saying they had been pressured into having an unwanted hysterectomy and were not informed about alternatives.

  3.10  Danger of New Treatments not Being Made Available to Patient in UK—The pharmaceutical industry has described NICE as the fourth hurdle to getting a new pharmaceutical product launched in UK. NICE has made it much for expensive to launch new pharmaceutical products in the UK as companies need to commission a lot of extra economic studies just for the UK. Medical device companies are in an even more difficult position as they have much lower profit margins and cannot really afford to fund extra economic studies for NICE. There is a great danger that, due to the cost of NICE, new life saving treatments may not be available to UK patients, when they are available in other EU and US countries. The UK lags greatly behind other countries in making new less invasive and less expensive treatments available, to the detriment of patients and the NHS alike. NICE tends to play a negative rather than positive role in this by making adoption of new less invasive, less expensive treatments much longer.

4.   The speed of publishing guidance?

  The past delays of 3 years or more in reviewing and publishing guidance, particularly on new chemotherapy drugs has had a serious negative impact on the health and outcomes of English patients. PCTs have used future NICE assessments as a reason for not allowing the use of new drugs and technologies. The speed of publishing is about 6 months, which is rather lengthy.

  The speed of reviewing a new expensive medical intervention is excessive

5.   The appeal system?

  I have not taken part in an appeal, but have searched the NICE web site and can find no details on how to do so.

6.   Comparison with the work of the Scottish Intercollegiate Guidelines Network (SIGN)?

  6.1  Why are drugs available in Scotland but not England? Why are the same drugs available in other EU countries but not England? This is not in the interests of NHS patients. We get worse treatments and health outcomes as a result of NICE.

  6.2  NICE should be pulling NHS treatment up to a higher level of clinical excellence, instead it is doing the opposite.

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

  7.1  NICE should be concentrating on clinical excellence and comparing UK/English health outcomes and survival rates

  7.2  If a new drug/technology review is negative from NICE it is killed stone dead for use in NHS. Patients can only obtain the benefits by paying for it themselves. If positive then PCTs and Acute Trusts can and do ignore it if it doesn't suit them, citing cost constraints.

  7.3  Whatever one thinks of the outcomes of NICE guidance it is a complete waste of time developing them if PCTs and Hospital Trusts can then ignore them. NICE guidance implementation should be mandatory as the lowest level of treatment available to patients. It should be acceptable for the local NHS to offer better treatments if they see fit.

  7.4  A recent patient report on the radio on wet macular degeneration showed a patient having to pay £500 per injection for Avastin to stop him going blind, as NICE has recommended that it should not be available on the NHS. The patient said this was ridiculous as blindness costs the NHS, social services and the economy a huge amount of money.

Ginette Camps-Walsh

FEmISA

March 2007