The National Institute for Health and Care Excellence is recommending Roche’s Tecentriq for use within the Cancer Drugs Fund to treat advanced urothelial cancer in certain circumstances.

In final draft guidelines, Tecentriq (atezolizumab) is being backed for use in patients whose urothelial cancer has not yet been treated and who cannot have cisplatin-based chemotherapy.

Initially, the Institute’s appraisal committee ruled that the drug was not a cost effective option for people who had already had chemotherapy, but that there was potential for the drug to be both clinically and cost effective for those who had not been treated.

Stronger evidence was needed to show the drug is both clinically and cost effective in this setting and, it said, and so invited Roche to submit a CDF proposal that should demonstrate plausible potential for cost effectiveness, detail how data collection will address the key clinical uncertainties, and state the likelihood that additional research will reduce uncertainty enough to support positive guidance in the future, amongst other points.

The proposal subsequently put forward by Roche laid out plans to address these uncertainties, in particular how Tecentriq compares to other standard treatments and whether the clinical benefit is enough to balance its cost, allowing its recommendation for use via the CDF, as per the conditions agreed in the confidential managed access agreement.

“I am pleased Roche has worked with us and NHS England to address the uncertainties raised by the committee. To have atezolizumab as an option for people who cannot undergo other treatment for their urothelial cancer is a positive thing,” noted Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE.

Bladder cancer affects around 10,000 people in the UK each year and when advanced, is linked with poor outcomes, with just 15 percent of patients surviving more than five years.

Tecentriq blocks PD-L1 – an important ligand found on the surface of cancer cells that camouflage them from detection and destruction by the immune system, and demonstrated a median overall survival of 15.9 months in the IMvigor210 trial.

“We welcome the news that patients will now be able to access atezolizumab via the Cancer Drugs Fund,” said Richard Erwin, General Manager, Roche UK.

“This demonstrates the importance of working collaboratively and flexibly with NICE and NHS England. Looking ahead, it is important that long-term access is achieved and we will be working with NICE to submit further evidence via our ongoing clinical trial programme, which will hopefully see atezolizumab transition into traditional NHS access routes as soon as possible.”

The drug was approved by European regulators for previously-treated locally advanced or metastatic non-small cell cancer (NSCLC) and metastatic urothelial carcinoma (mUC) last month.