NICE - The National Institute of Health and Clinical Excellence
| Background | NICE and Sarcoma | NICE and GIST |
NICE is the body responsible for authorising new treatments for use in the NHS. It has been set up to be independent of government ministers, although ministers currently decide what investigations it should do. It looks at the clinical evidence (from practice research and clinical trials) and the economic impact of new technologies and techniques before arriving at its recommendations.
Its recommendations are binding on the NHS in England and Wales. Some of them take time to implement, particularly if it involves the re-structuring of service provision. The NHS in Scotland works differently. The Scottish Intercollegiate Guidelines Network (SIGN) produces practice guidelines for doctors and decisions on paying for new drugs are taken by the Scottish Medicines Consortium.
The NICE process is consultative and can become very extended, especially where new treatments are costly and there is debate about efficacy. The economic assessment is always made from the viewpoint of the NHS and there are complex academic methods which try and put a value on improved patient quality of life. Patient groups such as Sarcoma UK are invited to contribute evidence and there are patients on many NICE consultative groups.
NICE decisions about cancer drugs have become more contentious as the costs of treatment have risen and the effuicacy of the drugs has improved. NICE was forced into developing a fast-track process in 2006, bringing it appraisal process into line with licensing timetables in 2007, and making special allowance for 'end-of-life' situations in 2008. During 2009 it has evolved as a price control agency, generally refusing approval to costly new cancer treatments until the manufacturer has agreed a "patient access scheme" (price reductions) with the Department of Health.
Even so, the process is still lengthy thus putting Primary Care Trusts (which actually fund treatment) in the position of needing to make individual decisions about funding the treatment of individual patients, even when they have little or no expertise for doing so. This is the postcode lottery.
Sadly there is plenty of evidence that PCTs in this position are bad decision-makers, operating flawed processes and displaying discriminatory behaviour with regard to rarer cancers.
In 2004/5 a NICE Guidelines Development Group (which included three sarcoma patients) developed 'Improving Outcomes for People with Sarcoma'. This is guidance to the NHS about the structures necessary to deliver a high quality service to patients. The recommendations of this group were published in March 2006 and call for some quite substantial changes, notably reducing the numbers of places where sarcoma can be treated and concentrating specialist expertise. The recommendations are due to be implemented by the NHS in England and Wales, starting in 2007 and with completion in autumn 2011.
Download the public summary of the recommendations, the full recommendations, and the full manual produced by NICE. Other documents are also available on the NICE website.
Yondelis (trabectedin) has also been reviewed by NICE for its licensed indication - as second-line chemotherapy for advanced or metastatic soft tissue sarcoma after both doxorubicin and ifosfamide have failed. Approval was given in late 2009 to take effect from spring 2010.
Mifamurtide (Mepact from Takeda) is a treatment for osteosarcoma. Taken alongside the adjuvant chemotherapy which osteosarcoma patients receive following surgery, it has been shown to significantly increase long-term survival. It is being reviewed by NICE in early 2010.
Sarcoma UK and GIST Support UK worked together representing patient interest on the NICE Technology Appraisal of imatinib for the Treatment of Advanced and Metastatic GIST during 2004 and the appraisal of sunitinib in 2009.
The full documentation of these appraisals is available.
Glivec (imatinib) (2004) Sutent (sunitinib) (2009)
More recent research findings mean that we are now extremely unhappy about the implications for patients of the imatinib guidance. Fortunately a number of Primary Care Trusts (PCTs) have been prepared to review the latest evidence and patients have also benefited from a compassionate scheme from Novartis.
NICE has recognised that the guidance for use of imatinib (Glivec) is overdue for review and that will take place in 2010.
Imatinib has also been licensed for adjuvant use with patients who have had a confirmed complete ressection of their GIST tumour. The evidence shows that the time to relapse is lengthened although there are unanswered questions about the long-term benefit that might come from this treatment. NICE is reviewing the adjuvant use of inatinib in a separate appraisal in early 2010.
Page reviewed December 2009