After NICE setback, Roche strikes deal for Gazyvaro coverage in U.K.

Roche and the U.K. government agreed to a coverage arrangement for blood cancer med Gazyvaro.

After sparring with England’s cost gatekeepers on several occasions, Roche has sealed a deal to provide Gazyvaro to U.K. patients through the revamped Cancer Drugs Fund. Under the arrangement, it’s estimated 600 relapsed refractory follicular lymphoma patients will have access to the blood cancer drug each year.

To be given in combo with chemotherapy and after treatment with Roche’s Rituxan, Gazyvaro will be available for up to four years as authorities gather more data on its long-term cost effectiveness. The Cancer Drugs Fund is a second-line program for drugs that don’t make it past an initial review at NICE.

The deal is contingent on a confidential discount, according to a final appraisal document.

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In a statement, Roche U.K. general manager Richard Erwin said the decision is “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.”

“We have worked tirelessly with NICE to ensure that those patients who need Gazyvaro can receive it and we are delighted with this outcome,” Erwin added.

Roche has had somewhat of a contentious past with NICE as budget problems have forced the cost regulator to get tough on approving innovative new meds. The Swiss drugmaker has been among the pharma companies to criticize the regulator’s review methodology, and last summer the company critiqued an overhaul of the beleaguered Cancer Drugs Fund.

RELATED: Roche cancer-fighter Perjeta finally wins thumbs up from NICE

Last year, NICE and NHS England took over the CDF in response to budget overruns at the fund that created coverage concerns for dozens of expensive cancer drugs. Erwin said the process "could mean that thousands more cancer patients are denied medicines their doctors believe could be effective in their treatment."

Before the overhaul, also due to cost issues, CDF stopped covering 16 medications, including Roche breast cancer treatment Kadcyla. At the time, Roche CEO Severin Schwan called the decision “stupid” and “completely arbitrary.”

NICE held up another of the drugmaker’s breast cancer drugs, Perjeta, for years before ultimately recommending the med for routine coverage in November.

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