The National Institute for Health and Clinical Excellence has denied patients with kidney cancer access to Roche’s Avastin (bevacizumab), Bayer’s Nexavar (sorafenib) and Wyeth’s Torisel (temsirolimus) on the National Health Service.

The Institute has published a Final Appraisal Determination rejecting the use of Avastin, Nexavar and Torisel for first-line use and Pfizer’s Sutent (sunitinib) and Nexavar as second-line agents for renal cell carcinoma on the NHS in England and Wales, as it considers them too expensive.

Sutent was approved for as a first-line therapy for kidney cancer earlier this year, after NICE concluded that it offered a cost-effective use of NHS resources, but its rejection of the other three drugs has sparked anger from charities and patient groups.

A blog on the Cancer Research UK described the decision not to recommend Nexavar as a second-line agent as “particularly disappointing”, as there are no standard treatment options for patients who fail to respond to initial therapy.

And in the case of Avastin, CR UK says it is concerned that the Institute’s rejection seems to contradict its own recommendations for end-of-life care.

According to the charity’s chief executive, Harpal Kumar, the decision is “bizarre and out with the spirit of the government’s end of life guidance set out last autumn”, because NICE is basically saying that, because the drug can be used for other common cancers, the end of life criteria can’t be used in the advanced kidney cancer setting.

“However, NICE has not given approval for use in other cancers in the UK,” and so he decision “sends out confusing signals about what NICE is trying to achieve”, Kumar stressed. Consequently CR UK has called for clarification from the Institute over its end of life guidance, both in this case and generally.

Drugmaker Wyeth has also criticised the decision, claiming that the move to oust Torisel “discriminates against a small group of patients with the poorest prognosis” as it bars them from a treatment indicated exclusively for them.

Furthermore, it says the appraisal of Torisel is “in direct conflict with the Department of Health's topic selection criteria 2006”, which says drugs for very small patient populations will be not assessed by NICE. In fact Torisel, which is considered an “ultra orphan” drug with only around 390 patients in England and Wales eligible for treatment, appeared to be put through the standard appraisal procedures by the Institute, which inevitably would not find Torisel to be ‘cost-effective’ for use in UK patients, the drugmaker said.

Wyeth argues that under the current framework, drugs for very rare conditions are “extremely unlikely to be recommended by NICE”. This will continue to foster an environment of postcode prescribing, it stressed, as decisions on who has access to such therapies will be made locally in a “haphazard fashion dependent on the priorities, views and financial position of varying local Primary Care Trusts”.

Disparity in cancer care
“The recommendation made by NICE accentuates the disparity in cancer care between the UK and other advanced countries, where Torisel and other kidney cancer drugs are accessible and routinely used,” commented Vignesh Rajah, Medical Director, Wyeth UK.

"If adopted, NICE's decision not to recommend the only drug that has been proven to extend life in these gravely ill patients may deprive many of them of extra months of life at improved quality when compared to immune treatment,” he said, and added that it is “especially disappointing” as the drug is “widely available to patients throughout the European Union.”

The drug manufacturers now have until May 12 to lodge an appeal.