Britains National Institute for Clinical Excellence (NICE) is being hailed as a potential solution to perceived problems of care rationing, poor medical practice, and the absence of a sensible mechanism to introduce new drugs under the nations health care system.
The chair, Sir Michael Rawlins, M.D., a clinical pharmacologist, said NICE will issue treatment guidelines he hopes will supersede those that, he says, are "bewildering in number, uncertain in content, difficult to access, and very often totally indigestible." NICE, established by the government to evaluate new technologies and issue guidelines, intends to prevent long delays in bringing innovative therapy to the National Health Service. Cancer therapy is a high priority.
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NICE is expected to publish recommendations for NHS use of taxanes, including paclitaxel in ovarian and breast cancer and docetaxel in breast cancer, in spring 2000. But CancerBACUPs report asks if it is really necessary for NICE to evaluate paclitaxel in the wake of a series of investigations by government-funded and independent bodies. These included the Joint Council for Clinical Oncology, the NHS Centre for Reviews and Dissemination, and the National Cancer Guidelines Steering Group. They all recommended that platinum/paclitaxel treatment should be provided as a first line treatment for most women with ovarian cancer.
Conclusions Based on Science
Their conclusions were based on published, internationally accepted randomized controlled trials. One of the co-authors of the CancerBACUP report, health policy analyst David Taylor, of the University of London, said: "The available data indicate that such treatment offers on average a year or more of additional life compared to the next best form of care, at an NHS cost per year gained of between £6,000 and £7,000 [approximately $9,500 and $11,000 U.S.]. This is well within established health service affordability thresholds."
A survey in late 1999 by the University of London School of Pharmacys Unit for Health Services Development showed that more than 80% of health authorities felt that the NICE review would not affect their local policy in treating ovarian cancer. The main reason for this was that the evidence base in favor of platinum/paclitaxel was already so robust.
"The question remains as to why NICE did not simply endorse the existing national guidelines on gynecological cancers and issue an appropriate recommendation immediately," Taylor said.
A spokeswoman for NICE said: "The appraisal we are undertaking is for both ovarian and breast cancer. The fact that the Institute is appraising a therapy does not preclude its use by health authorities."
But CancerBACUP claims that some health authorities have taken the NICE review to be "evidence" that there is uncertainty as to whether or not platinum/paclitaxel is the best first line therapy for most women with ovarian cancer.
The irony is that NICE was developed to end what Alan Milburn, the British health secretary, called a "lottery of care." This is better known as "postcode prescribing" literally prescribing by ZIP code. For example, an ovarian cancer patient living within any one of the 118 health authorities in England and Wales may receive first-line platinum/paclitaxel therapy, while another patient in a neighboring authority may be denied it on grounds of cost. As Rawlins said: "Such differentials have appalled health professionals."
The key question is perhaps not so much related to the acceptance of best practice in ovarian cancer, but the extent to which NICE will improve treatment for breast cancerwhere success rates are far better. A number of new agents, including the taxanes, have substantial new cost implications for the NHS, and specialists fear that health authorities may decide to wait for a NICE appraisal before introducing innovative therapy.
Concern is not restricted to breast cancer, but extends across all cancer therapies. Tim Allen-Mersh, M.D., of the Chelsea and Westminster Hospital, London, and consulting surgeon to Colon Cancer Concern, fears that NICE may be unable to keep pace with innovation.
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This theme was explored in the October Journal of the Royal Society of Medicine by Simon Ellis, M.D., of Keele University and the North Staffordshire Royal Infirmary, Stoke-on-Trent. He said: "NICE does not have sufficient capacity to deal with new chemical compounds coming to the market, never mind extensions of use, or surgical procedures. So hospital and regional therapeutic committees will continue with their inadequate appraisals of new drugs and perpetuate the inequalities of access.
"Like most government initiatives, NICE looks under-resourced and over-ambitious. The result is likely to be substantial delays before treatments are considered the antithesis to stated aim."
Rawlins insists that NICE intends to encourage innovation while ensuring that the NHS makes the best use of available resources. This is a difficult balance to strike in a country that devoted less than 7% of its gross domestic product to health care in 1997 (compared with 14% in the United States; about 10% in Germany, France, and Sweden; and 8.5% in the Netherlands).
But Allen-Mersh is optimistic that if anyone can make NICE work, it is Rawlins, who is widely respected by the medical profession, civil servants, and the pharmaceutical industry. The hope, says Allen-Mersh, is that NICE will "introduce some logic into rationing."
At CancerBACUP, chief executive Jean Mossman is not convinced NICE will work. "Official guidelines and recommendations must be updated and implemented quickly to avoid delays in access to innovative treatments," Mossman said. "The difficulties NHS patients have experienced in getting paclitaxel, or in provision of advanced radiotherapy for lung cancer, typify the problems that may otherwise occur in future."
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