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Roche wins UK watchdog's nod for lymphoma drug after initial snub

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Roche wins UK watchdog's nod for lymphoma drug after initial snub

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By John Miller

ZURICH (Reuters) – Britain’s healthcare watchdog (NICE) recommended Roche’s <ROG.S> medicine Gazyvaro for previously untreated advanced follicular lymphoma patients after initially rejecting the Swiss drugmaker’s medicine last year as too expensive.

NICE recommended Gazyvaro, also called Gazyva, for use by the National Health Service (NHS) with chemotherapy in patients with higher risk of relapse. The company must provide the drug at a discount, NICE wrote.

The decision will affect about 1,200 people annually, Roche said on Friday. About 1,900 people are diagnosed with follicular lymphona a year in Britain.

Gayzvaro is a more-expensive follow-on to Rituxan, Roche’s best-selling, $7 billion(5.02 billion pounds)-per-year medicine that has lost patent protection in Europe and is seeing sales quickly eroded by rivals’ cheaper copies.

Last year, NICE opted not to recommend Gazyvaro’s broad use in first-line lymphoma, citing, among other things, “concern about the assumptions used in the company’s cost-effectiveness modelling”.

To win NICE’s change of heart, Roche revamped its analysis including by focussing on higher-risk lymphoma patients. In a statement, the Basel company called the recommendation “a positive example of how solutions can be reached when all parties show flexibility.”

A NICE committee that reviewed the drug did object to Roche’s characterisation of Gazyvaro, whose generic name is obinutuzumab, as an “innovative medicine.”

“Obinutuzumab is not innovative,” the panel wrote.

Roche has been steadily seeking expanded approval for Gazyvaro since it was originally approved in 2013 for other blood cancer indications.

The U.S. Food and Drug Administration last year expanded approvals for Gazyva to include previously untreated follicular lymphoma.

(Reporting by John Miller; Editing by Mark Potter)

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