NICE invites Roche to submit Tecentriq for CDF

In draft guidelines the Institute rejected the drug outright for treating locally advanced or metastatic urothelial carcinoma in adults after prior platinum-containing chemotherapy.

NICE also said it is minded not to recommend Tecentriq (atezolizumab) as an option for untreated locally advanced or metastatic urothelial carcinoma in adults for whom cisplatin-based chemotherapy is unsuitable, because while the drug appears to be an effective treatment the results "are very uncertain".

The NICE committee maintains that stronger evidence is needed to show the drug is both clinically and cost effective in this setting and, as such, has 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.

If the CDF application is successful, it would mean that patients - who currently have few treatment options - can have access to the drug more data is gathered.

"I hope Roche will work with us to submit a CDF proposal," noted Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE. "Funding through the CDF means [Tecentriq] could be offered to patients who cannot undergo chemotherapy while we collect more evidence. This will be a positive step for a lot of people."

Urothelial cancer occurs in the bladder or the ureter, with around 10,000 people diagnosed with the disease every year. Currently, only around 15 percent of patients in whom the disease has metastasised are expected to survive for more than five years.

As an immunotherapy, atezolizumab works in a different way to standard chemotherapy and produces an average overall survival of 15.9 months in such advanced patients.

"There have been no major breakthroughs in treatment for a generation. Atezolizumab is a major advance in the treatment of this difficult disease and it offers new hope of long term durable remission for subsets of patients," noted Professor Thomas Powles, clinical professor of genitourinary oncology at Barts Cancer Institute in London.

Roche says it is "delighted" to have been asked to summit Tecentriq to the CDF. The drug "has the potential to be the first immunotherapy approved for bladder cancer in England, and one of few significant treatment advances in bladder cancer in over 30 years," said Richard Erwin, general manager of Roche Products (UK).

The drug was accepted onto the UK’s Early Access to Medicines Scheme for patients with bladder cancer earlier this year.