100^th NICE technology appraisal guidance offers new hope for people with colon cancer

The National Institute for Health and Clinical Excellence (NICE) has today published its 100^th technology appraisal guidance. The guidance to the NHS in England and Wales on the use of capecitabine and oxaliplatin for the adjuvant treatment of patients with stage III (Dukes’ C)* colon cancer following surgery for the condition, recommends that the drugs should be considered as options for the adjuvant treatment of patients as follows:

            • capecitabine as monotherapy

            • oxaliplatin in combination with 5-fluorouracil and folinic acid.

The guidance recommends that the choice of adjuvant treatment should be made jointly by the patient and their doctor. The patient should be informed about the differences between the medicines available and the potential contraindications and side effects so that she or he can be fully involved in the decision.

Andrew Dillon, Chief Executive, said: “The NHS cares for millions of patients each year with a wide range of potentially life threatening conditions - heart disease, diabetes, respiratory disease, serious injuries – and all these patients should have access to the best treatments. Resources are limited, so NICE weighs up what the evidence tells us about treatments to make sure that taxpayers’ money is spent on those that will have the most benefit for patients. It is right that this is done with careful thought and consideration.

“The guidance we have issued today, in common with the 99 that have preceded it, was developed following a rigorous assessment of the available evidence through a transparent and inclusive process that is held up as an example of excellence worldwide. Since our inception in April 1999 we have issued 59 pieces of appraisal guidance on cancer, more than for any other disease area. This guidance, which benefits many thousands of patients each year, covers drugs for a wide range of cancers, including breast, ovarian, lung and bowel; standards on how services for blood, urological and skin cancers, to name a few, should be delivered; and guidelines for GPs on referring people with suspected cancer to specialist services to ensure rapid diagnosis and treatment.”

He continued: “ Colon cancer is one of the most common cancers, affecting around 30,000 people each year. This appraisal is another example of NICE working to ensure that new treatments that are clinically and cost effective are made available to patients across the NHS. Today’s guidance sits alongside existing NICE guidance on the use of drugs to treat this condition and improves the options available to people with cancer. These drugs are not a cure but they can improve quality of life and increase progression free survival, and as such they are an important addition to the treatment options available to people with this cancer.”

*A method of staging how far the cancer has spread. Stage III (or Dukes’s C) refers to people whose colon cancer has spread to between 1 and 4 nearby lymph nodes but has not spread to any other part of the body.

For more information call Phil Ranson on 0207 067 5904 or 07786 390068

About NICE

1.       The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

2.       NICE produces guidance in three areas of health:

• public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS
• clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3.       Its predecessor, the National Institute for Clinical Excellence (also known as NICE), was set up as part of the Government's commitment to delivering a modern and dependable NHS to help health professionals in the National Health Service give their patients the best possible healthcare within the resources available.

4.       In April 2005, the functions of another NHS organisation, the Health Development Agency (HDA), were transferred to NICE. Now called the National Institute for Health and Clinical Excellence, NICE’s new role was set out in the 2004 White Paper ‘Choosing health: making healthier choices easier’. In it the government set out key principles for helping people make healthier and more informed choices about their health.

5.       At the time of its establishment critics mused that NICE had been set up to ration on behalf of the NHS. NICE has always been clear that its job is to inform the NHS about whether a drug works well enough to justify its cost by considering in full the evidence of both clinical and cost effectiveness and that its guidance would in fact promote the faster uptake and more equitable access to effective treatments (put an end to postcode prescribing) – that is put a rationale into the use of resources.

100 technology appraisals

6.       The Institute published its first full technology appraisal guidance – on the removal of wisdom teeth, in April 2000.

7.       Since then, the Institute has published, on average, 14 technology appraisals each year, covering new drugs and treatments across all the major disease areas.

8.       The Institute has produced appraisals ranging from the artificial joints used in hip replacement surgery; surgical treatment for hernias; drugs for a variety of cancers; treatments for smoking cessation; drugs and surgery for obesity; drugs to treat bipolar disorder and many more.

9.       The 100 technology appraisal guidance include 195 different drugs, 113 medical devices, 1 health promotion, 17 diagnostic and 56 clinical procedures – for 79 different conditions. It is estimated that the recommendations in the guidance have the potential to impact on the lives of 27,855,062 patients.

10.   The majority of NICE recommendation have suggested partial or full use of technologies, specifically 29 technologies have been recommended for routine use (all of their licensed indications), 63 for selective use (groups have been identified where the technologies are most effective) and 8 for use in research settings only.

11.   As NICE predicted the appraisal process has developed over the past 7 years:

• in line with NICE’s original intentions all consultation takes place in the public domain – consultation documents are published on the NICE web site alongside full details of the appraisal and who’s involved
• Meetings are now held with all stakeholder groups
• Consultations on the assessment report
• The addition of non-appellant commentators such as the British
• National Formulary
• Addition of NHS Primary Care Trusts ( England ) and Local Health Groups ( Wales ) as Consultees with Appeal rights.
• Appeals now held in public

12.   In response to concerns from stakeholders NICE developed a rapid process for assessing drugs. The Single Technology Appraisal (STA) process will be used initially to produce faster guidance on life-saving drugs which have already been licensed and on new medicines close to when they first become available. The new process will enable single new drugs, and existing drugs with new indications to be rapidly assessed.

Transparency of decision-making * [See the item by the Parliamentary Information Commissioner entitled "NICE secrecy is questioned..." at the end of this section]

13.   From the moment a topic is referred to NICE, information is published on the NICE website. The website contains:

• information on the appraisal and appeal processes
• details of the independent Appraisal Committee, including the minutes of the Committee meetings
• details of the staff at NICE working on appraisals
• information on the topics we are looking at, including the stakeholders who are involved, and the forward work plan (dates of meetings, planned issue dates, etc)
• the scope (question being answered) for each technology under appraisal
• the research protocol and details of the independent group conducting the research
• the Appraisal Committee’s initial thoughts (Appraisal Consultation Document), on which those visiting the site can provide feedback
• the independent Assessment Report
• the Appraisal Committee’s final recommendations (Final Appraisal Document), at the same time as it is sent to stakeholders for appeal
• full details of the outcome of appeals should they be held
• the final guidance to the NHS and a public version of the guidance

NICE’s decisions in practice

14.   Although NICE guidance does not override the responsibility of healthcare professionals to make appropriate decisions on the circumstances of individual patients, they are expected to take the guidance fully into account when exercising their clinical judgement.

15.   From January 2002 onwards, the NHS in England and Wales has been required to provide funding for treatments and drugs recommended by the NICE technology appraisal process. This does not mean that treatment will be forced on a patient; it means that provided that the healthcare professional and patient feel that it is the right treatment for the individual, then the local NHS organisation is responsible for making funds available.

Appraisal guidance issued to date