NICE turns down Tecentriq in bladder cancer but suggests Roche try again for some patients

England's drug cost watchdog has rejected Tecentriq in initial guidance but invited Roche to take a second shot at an approval to treat some patients.

Roche and England’s drug cost watchdog NICE are again in an arm-wrestling match, this time over the use of Roche’s cancer drug Tecentriq for metastatic urothelial cancer.

NICE has rejected the drug for routine use for this form of cancer in the bladder or ureter for patients who have had chemo but has invited the Swiss drugmaker to apply to the cancer drug fund (CDF), presumably with a deeper discount for the National Health Service, for use in a smaller population.

In draft guidance today, NICE said reviewers deemed Tecentriq too pricey for use on patients who had already received chemotherapy. It also is leaning against approving it for use in patients who are untreated but for whom chemo is not recommended, but with this caveat.

“However, they found atezolizumab has the potential to be cost effective for patients whose cancer has not yet been treated and who cannot have cisplatin-based chemotherapy (such as people who have kidney problems).”

NICE said more evidence would be needed to confirm that possibility and invited to Roche to make its case to the CDF for use of its immuno-oncology drug in this patient group.

“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. This will be a positive step for a lot of people,” Carole Longson, director of the Centre for Health Technology Evaluation at NICE said in a statement.  

Roche's Richard Erwin, general manager of Roche Products Limited (U.K.), said in an emailed statement today that the company would work to change NICE’s mind about using Tecentriq for patients as a first-line treatment but was pleased to get the invite for possible coverage of those unable to get chemo.  

"We are delighted that we have been invited to submit atezolizumab to the Cancer Drugs Fund (CDF) to potentially allow advanced bladder cancer patients in the U.K., for whom standard chemotherapy is unsuitable, to access our immunotherapy atezolizumab. Atezolizumab 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,” Erwin said.

The company pointed out that those patients make up to half of all patients with bladder cancer. 

The initial guidance said Tecentriq met NICE’s criteria to be considered a life-extending treatment at the end of life, and is likely to prolong life for three months beyond the 24 average life expectancy for this group, but that further study is needed. NICE noted this is still just draft guidance and invited comments which will re reconsidered in a meeting at the end of August.

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Results from a recently completed phase 3 of trial of the drug in second-line bladder cancer, however, raised troubling questions in this regard. The drug failed to extend life in patients with urothelial cancer whose disease progressed during or after chemo, potentially putting at risk its conditional FDA approval. The bladder cancer indication, Tecentriq’s first, accounts for about 70% of the med’s current sales, analysts say.

NICE noted that Roche’s ongoing phase 3 IMvigor130 trial might address some of the uncertainties.

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Roche and NICE and the CDF have had a rocky relationship in the past. When the CDF, which has since been taken over by NICE, booted Roche’s Kadcyla and 15 other drugs off the coverage list to cut costs, Roche CEO Severin Schwan was so exasperated that he called the decision “stupid” and “completely arbitrary.”

But more recently the two sides seemed to have repaired their break. A Roche exec even had good things to say about NICE last week after they negotiated a deal in which Roche’s cancer drug Gazyvaro would be covered through the cancer drug fund for patients an estimated 600 patients with relapsed refractory follicular lymphoma.  

Roche U.K. general manager Richard Erwin, in a statement, called the decision “encouraging in terms of the flexibility of the new NICE and Cancer Drugs Fund system, where collecting the right data across a realistic time frame, in this case four years, is the key to demonstrating the value of Gazyvaro in the long-term.”