AstraZeneca’s lung cancer drug Iressa has suffered a setback in the UK after the National Institute for Health said it was minded not to recommend the drug for use on the National Health Service.

The NHS cost watchdog for England and Wales has published the preliminary recommendations of its Appraisal Committee that reject the use of Iressa (gefitinib) to treat patients with metastatic non-small-cell lung cancer.

According to NICE, the decision was made because the Committee was unable to properly evaluate whether Iressa would offer the NHS value for money, because it did not have sufficient data from AstraZeneca to assess its likely incremental cost compared with standard platinum combination therapy or with Eli Lilly’s Alimta (pemetrexed) and cisplatin.

Therefore, it has recommended that the Institute request further data from AstraZeneca to better clarify the clinical and cost effectiveness of Iressa, particularly regarding progression-free survival, and stressed that this information should be made available for the next Appraisal Committee meeting to help make a more informed recommendation.

Iressa’s journey to date has not been a smooth one. The drug, once considered a potential blockbuster, took a massive blow on clinical findings published in 2004, which showed that at the end of one year, just 27% of patients taking Iressa were still alive compared to 21% of those given a placebo.

Nevertheless, regulators in Europe gave the drug the all clear in July last year for adults with locally advanced NSCLC with activating mutations of epidermal growth factor receptor-tyrosine kinase (EGFR-TK), marking a significant turnaround in its fortunes.

But now it seems the tide could be turning again, unless the Anglo-Swedish drugmaker can provide enough evidence to persuade the Institute that Iressa is indeed both clinically and cost effective.