NICE draft guidance rejects Roche's Tecentriq for bladder cancer

The National Institute for Health and Care Excellence issued draft guidance Wednesday recommending against NHS reimbursement of Roche's Tecentriq (atezolizumab) for treating locally advanced or metastatic urothelial carcinoma in adults after prior platinum-containing chemotherapy. However, the agency asked the company to submit a proposal for inclusion of the PD-L1 inhibitor in the Cancer Drugs Fund (CDF). 

Carole Longson, director of the Centre for Health Technology Evaluation at NICE, said "I hope Roche will work with us to submit a CDF proposal. Funding through the CDF means it could be offered to patients who cannot undergo chemotherapy while we collect more evidence." 

In particular, NICE noted that despite clinical data backing the efficacy of Tecentriq, the treatment has not been directly compared with other therapies. The regulator stated that while the therapy met its criteria for being considered a life-prolonging drug, the lack of data examining the drug relative to competing treatments makes the benefit uncertain. 

Further, NICE said that Tecentriq could be cost-effective for patients with untreated disease who are not suitable for cisplatin but cautioned that additional evidence is needed. The regulator added that the ongoing IMvigor 130 trial could resolve some uncertainty, as the study directly compares Tecentriq with other treatments. 

Commenting on the news, Roche general manager Richard Erwin remarked "we are delighted that we have been invited to submit atezolizumab to the Cancer Drugs Fund to potentially allow advanced bladder cancer patients in the UK, for whom standard chemotherapy is unsuitable, to access our immunotherapy atezolizumab," adding that the therapy "has the potential to be the first immunotherapy approved for bladder cancer in England."

Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for the use of Tecentriq in adults with locally advanced or metastatic urothelial carcinoma who were either previously treated with platinum-based chemotherapy or deemed unsuitable for cisplatin-based chemotherapy, as well as for the treatment of certain adults with locally advanced or metastatic non-small cell lung cancer.