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EDITORIALS: Jonathan Waxman, Laura Kenny, and Sarah Ngan New treatments for kidney cancer BMJ 2008; 336: 681-682 [Full text]

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Cancer Networks can help to access new renal cancer drugs prior to NICE guidance

Linda Garvican, Nigel Marchbank, Andrew Webb   (10 April 2008)

Cancer Networks can help to access new renal cancer drugs prior to NICE guidance 10 April 2008
Linda Garvican, Public Health Director Sussex Cancer Network, Brighton, BN1 6QZ, Nigel Marchbank, Andrew Webb Send response to journal: Re: Cancer Networks can help to access new renal cancer drugs prior to NICE guidance	We agree with Waxman et al [1] that there has been an unacceptable delay in issuing of National Institute for Health and Clinical Excellence [NICE] guidance on the new renal cell cancer drugs, but this does not necessarily mean that patients cannot have access to them. In Sussex Cancer Network we have developed an agreed position which means that suitable patients have been funded via PCT exception panels for the last few months, and more than 20 patients have benefitted to date. We reviewed the evidence for the four new drugs compared with our previous treatments. We recognised that interferon is not very effective and is unsuitable for many of our patients. If sunitinib does indeed give a median increase in progression free survival of 6 months over interferon [2], it would appear that it will fall below the cost effectiveness threshold usually accepted by NICE, and will therefore be approved in due course. The trial also reported significantly better quality of life than interferon. Sorafenib is significantly more expensive. The progression- free survival benefit was not as good when compared with placebo controls but had been used later in the disease pathway following interferon, when patients had more advanced disease [3]. The different trial designs make it difficult to compare their effectiveness, but sunitinib does appear to be both more clinically effective and cheaper than sorafenib. There is little difference in either cost or total survival benefit between using sunitinib first line, and using it after trying interferon, but there is likely to be a considerable difference in quality of life for the patient whilst on interferon. In Sussex we prioritise oral formulations which are at least as good as IV preparations because they are preferred by patients but also do not require additional pharmacy manufacturing or chemotherapy chair and nursing time, both of which have reached capacity in our network. Both bevacizumab [4] and temsirolimus [5] appear to have a weaker evidence base, and on our estimations are less likely to be approved by NICE. We have taken the advice of both the London Cancer New Drugs Group and the Scottish Medicines Consortium into account but went a step further. We therefore proposed that suitable Sussex Cancer Network patients should be offered sunitinib first-line, and use of interferon be discontinued. This approach was agreed by both the Chemotherapy Group and the Urological Tumours Site Specific Group before presenting to the Sussex Cancer Commissioning Group. Our criteria for funding sunitinib are as follows: • Histologically-proven advanced or metastatic renal cell carcinoma • First-line post-nephrectomy or inoperable due to metastases or bilateral disease • Good performance status, WHO 0-1 • No history of congestive heart failure or uncontrolled hypertension • Monitoring by CT and review at 3 monthly intervals We have agreed that sunitinib and sorafenib should not be used sequentially, but if a patient rapidly develops toxicity a prompt exchange to the other medication will be permitted. The system can only improve when NICE appraisals are published around the time of licensing. The Single Technology Appraisal process was meant to address this but has proved subject to Ministerial delays in defining the work programme, lack of cost effectiveness data from industry, and protracted appeals. The Institute is now putting in place a more streamlined process, following the recommendation in the Cancer Reform Strategy [6] that all new cancer drugs and significant new indications should be appraised by default. However there is a considerable backlog of new cancer drugs in the work programme, so in the meantime we would urge colleagues to work with their Cancer Networks to develop local guidelines for effective new drugs. PCTs already know that they must not use lack of NICE guidance as a reason to reject an application to fund a new drug, but commissioners need guidance on which to prioritise and which are likely to be approved in due course, and Cancer Networks should be able to provide this advice. Linda Garvican, PhD, FFPH, Public Health Director Nigel Marchbank MRCP, FRCR, Medical Director, Andrew Webb, MD, FRCP, former Chair of Chemotherapy Group, Sussex Cancer Network, Brighton BN1 6QZ 1. Waxman J, Kenny L, Ngan S. New treatments for kidney cancer BMJ 2008; 336: 681-2. 2. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356:115-24. 3. Escudier B, Eisen T, Stadler WM. Sorafenib in advanced clear-cell renal -cell carcinoma. N Engl J Med 2007;356:125-34 4. Yang JC, Haworth L, Sherry RM, Hwu P, Schwartzentruber DJ, Topalian SL, et al. A randomised trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med 2003;349:427-34. 5. Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271-81. 6. Department of Health. Cancer Reform Strategy. December 2007. Competing interests: LG has been funded by Pfizer to provide a training session on NHS changes.