The UK’s drug cost-effectiveness watchdog has put back further guidance on four kidney cancer drugs which were not recommended for use on the National Health Service in a preliminary decision in August.

NICE says it has held its second meeting to discuss the appraisal of Roche's Avastin (bevacizumab), Bayer's Nexavar (sorafenib), Pfizer's Sutent (sunitinib) and Wyeth's Torisel (temsirolimus) for the treatment of advanced and/or metastatic renal cell carcinoma. However, new data for a subgroup of patients was received from Pfizer concerning the benefits of Sutent, so the institute has commissioned “further critical review of the evidence base”.

Carole Longson, Director Centre for Health Technology Evaluation at NICE, said that “in accordance with our published process, we must consult on the new evidence and the results of the critical review” before convening a final meeting of the Appraisal Committee, on January 14. She spoke of her disappointment that the appraisal will need to be extended, but “it is important that the basis on which the Appraisal Committee will make its recommendations is made available…before it does so”.

The announcement in August of the preliminary rejection caused uproar. NICE acknowledged that the four drugs have the potential to extend progression-free survival by five–six months, but at a cost of £20,000-£35,000 per patient per year. If they were provided on the NHS, other patients would lose out on treatments that are both clinically and cost effective, it said.

Responding to the latest turn of events, Wyeth said it “welcomes the fact that NICE is considering new evidence and will again be consulting with key stakeholders over these drugs”. The firm had previously expressed its concern to NICE that if its normal appraisal criteria were used to evaluate temsirolimus, “then inevitably it would not find Torisel to be ‘cost-effective’ for use in UK patients”.

Of the four treatments under review, Torisel is the only one indicated for a very rare (or ‘ultra-orphan’) condition, with only around 390 patients in England and Wales eligible for treatment. The total additional cost of treating patients with Torisel would be £8.6 million per annum, “which needs to be seen in context with the annual NHS budget for England of over £100 billion per year”, Wyeth claims.

The company added that a rejection of Torisel “would be yet another example of the disturbing disparity between treatments available in Europe and the UK, especially as the cost of Torisel in the UK is amongst the lowest in Europe”. It would also set “a worrying precedent for patient access to another 30 or so drugs for rare cancers anticipated by 2010”, Wyeth concluded.