Watchdog set to reject four drugs for kidney cancer on the NHSBMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a1262 (Published 14 August 2008) Cite this as: BMJ 2008;337:a1262
The UK clinical watchdog has proposed rejecting four drugs for use on the NHS for advanced renal cancer, saying they are clinically effective but not good value for money.
The National Institute for Health and Clinical Excellence (NICE) issued draft guidance this week that rejects the drugs sunitinib (Sutent), bevacizumab (Avastin), sorafenib (Nexavar), and temsirolimus (Torisel). The guidance is out for consultation until 29 August, with the final guidance due in early 2009.
The recommendation, which applies in England, Wales, and Northern Ireland, has provoked an angry response from charities that claimed that NICE’s appraisal system was not appropriate for all types of drugs.
NICE’s draft guidance says that it does not recommend these drugs for advanced or metastatic renal cell carcinoma but that people who are receiving the treatments should have the option to continue with their treatment until they and their clinicians consider it appropriate to stop.
About 7000 people in the United Kingdom are diagnosed as having renal cancer every year, and about 1700 are diagnosed as having advanced kidney cancer. The four drugs have the potential to extend progression-free survival by five to six months.
A statement from NICE said that the cost of the drugs is about £24 000 (€30 600; $46 000) a year. But when quality of life was also taken into account the cost was higher. The cost per quality adjusted life year of these treatments varied from the manufacturers’ estimate of £28 500 to £90 600 per patient, and the estimate of an independent academic group of £71 500 to £171 300 per patient. That took the cost above the institute’s acceptable level, which is £20 000-£30 000.
Peter Littlejohns, NICE’s clinical and public health director, said, “The decisions NICE has to make are some of the hardest in public life.
“Although these treatments are clinically effective, regrettably, the cost to the NHS is such that they are not a cost effective use of NHS resources. If these treatments were provided on the NHS other patients would lose out on treatments that are both clinically and cost effective.”
Three of the four drugs have already been rejected north of the border by the Scottish Medicines Consortium, but in some European countries and the United States these drugs are available. The makers of temsirolimus have never applied for a review.
The charity Cancer Research UK said in a statement that it wanted to see a change in the way NICE reviews the value of drugs for rare diseases, such as for this type of renal cancer, “where clinical benefit is proven but evidence is limited.”
Peter Johnson, the charity’s chief clinician, said, “These drugs have shown a small but definite improvement in an illness where there are few alternative treatments. If this decision stands it will be very frustrating for cancer patients and their clinicians.
“This decision once again raises questions about whether NICE’s system of appraisal is appropriate for all types of drugs. It is often difficult to get unequivocal research data in rarer cancers, such as metastatic kidney cancer, which have a small patient population.”
NICE has been assessing the cost effectiveness of drugs since 1999, and has been visited by many other countries who wish to set up an equivalent body, something that has been done in France, Germany, and Canada.
A NICE spokesperson said, “We have a good reputation internationally as an arbiter of cost effectiveness, and our processes have been assessed and accredited by the World Health Organization, which thinks our system is the best technology appraisal system there is.”
Cite this as: BMJ 2008;337:a1262
The draft guidance is at www.nice.org.uk/guidance/index.jsp?action=article&o=41473.