The Pharmaceutical Journal
Vol 268 No 7202 p827-832
15 June 2002

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Cancer specialists seek review of NICE decision on colorectal cancer drugs

Cancer care specialists have called on the Government to undertake an urgent review of the National Institute for Clinical Excellence's decision on the use of irinotecan (Campto) and oxaliplatin (Eloxatin) for patients with advanced colorectal cancer. NICE published its guidance on the use of irinotecan, oxaliplatin and ralititrexed (Tomudex) in March this year (PJ, 16 March, p351).

In a letter published in the Daily Telegraph last week, 28 cancer care specialists say that, on the basis of high quality clinical trials, NICE's decision to limit the use of irinotecan and oxaliplatin "will condemn National Health Service patients with this cancer to inferior treatment and reduced life expectancy. It is a major retrograde step." They comment that, in their view, the NICE evaluation on the use of these drugs is "an exceedingly disappointing judgement, which appears to have misinterpreted the available evidence".

In response, NICE says that its guidance does not deny access to these drugs for patients with advanced diseases and that it is clear about where the evidence supports the use of these treatments and about their limitations. Ms Anne-Toni Rodgers, communications director, NICE, said: "Rather than deny access to treatment, the guidance will increase access to oxaliplatin and irinotecan for those patients across England and Wales who will benefit from their use. The guidance will increase NHS spending on these drugs by around £41m each year."

NICE adds that where clinicians consider it appropriate to prescribe these drugs for individual patients in line with NICE guidance, NHS organisations in England and Wales are under direction to make the necessary resources available. NICE has also encouraged doctors to enrol NHS patients whom they believe would benefit from either oxaliplatin or irinotecan as a first-line treatment in an ongoing trial that the Medical Research Council has established. Results from this trial are expected to be reported in 2004.

However, in an article published in the British Journal of Cancer this week (2002;86:1667), Dr Mark Saunders and Dr Juan Valle, Christie Hospital, Manchester say that the NICE guidance is at odds with the oncologic drug advisory committee of the Food and Drug Administration, which approved the use of the combination of irinotecan with 5-fluorouracil and folinic acid (5HT/FA) in the United States, as well as with much of Europe, where either oxaliplatin or irinotecan are regularly used in combination with 5FU/FA in this group of patients. They comment that by the time NICE reviews its guidance in 2005, "the use of [oxaliplatin and irinotecan] in North America and Europe will have become established and we will trail even further behind in the treatment of advanced colorectal cancer."

Mrs Jola Gore-Booth, chief executive officer, Colon Cancer Concern, said: "CCC fully supports the authors of this paper in their efforts to raise awareness of colorectal cancer and to encourage NICE to reconsider its ruling on the availability of advanced colorectal cancer treatments in the UK."

Tim Root, NHS London region, pharmacy specialist, clinical governance and technical services, told The Journal that the NICE recommendations on irinotecan and oxaliplatin are a "cause for disappointment and frustration among NHS oncology professionals". He added: "Whether or not cost is a major factor in their decision remains an issue. If it is really not an issue, it is even more important to understand how NICE's evaluation of the evidence has reached a conclusion fundamentally different from that of its counterparts in the health care systems of the US and the rest of Europe. This should be urgently reviewed."

Copies of the full guidance are available on the NICE website (www.nice.org.uk).