The National Institute for Health and Care Excellence, the U.K.'s advisory body on drugs and treatments, rejected Roche Holding AG's urothelial cancer drug Tecentriq for distribution under the National Health Service.

In a draft guidance, NICE's appraisal committee said the most likely estimates of cost effectiveness for the drug are uncertain due to limited clinical evidence, and the cost of the drug is higher than what NICE normally considers acceptable for end-of-life treatments.

The committee added that the drug is not cost-effective for patients who had received chemotherapy but has the potential to be cost-effective for untreated patients and those who cannot have cisplatin-based chemotherapy.

Tecentriq's list price is £3,807.69 for a 1200 milligrams vial. The drugmaker has not yet confirmed the price with the Department of Health.

The drug has been studied in a trial but has not been directly compared with other treatments. The panel said that the drug appears to be an effective treatment but the results are very uncertain.

In the phase 2 trial, untreated patients and for whom cisplatin was unsuitable, the objective response rate was 22.7% at 15 months, while it was 15.8% at 20 months for patients has received chemotherapy. Median overall survival was 15.9 months for previously untreated patients and 7.9 months for patients who had chemotherapy.

The drug met the regulator's criteria to be considered a life-extending treatment at the end of life, but the lack of evidence comparing it with other treatments means that this is uncertain, NICE stated.

NICE said stronger evidence is needed to show the drug is both clinically and cost effective. The advisory body also urged the company to submit a Cancer Drugs Fund proposal for the drug. The CDF is an alternative source of funding and helps patients receive cancer drugs not routinely paid for by the NHS.

The European Medicines Agency's Committee for Medicinal Products for Human Use recently recommended the approval of Tecentriq for treating locally advanced or metastatic urothelial carcinoma and of non-small cell lung cancer.

In May, the drug failed to meet its primary endpoint of overall survival when compared to chemotherapy in a phase 3 trial.

The closing date for comments on NICE's decision is Aug. 23, with a second appraisal committee meeting Aug. 30.