U.K. cost gatekeeper gives thumbs-up to Gilead's Zydelig for CLL

Gilead Sciences ($GILD) has been working hard to build momentum for its cancer fighter Zydelig (idelalisib), racking up approvals for the drug in the U.S. and Europe. Fortunately for the company, a pricing setback in Germany didn't signal disaster elsewhere; after some initial skepticism--and a discount offer from Gilead--the U.K.'s cost watchdog gave its thumbs-up to the drug for chronic lymphocytic leukemia (CLL).

The National Institute for Health and Care Excellence (NICE) in final draft guidance recommended Zydelig in combination with Roche's ($RHHBY) Rituxan. The green light covers the combo for previously untreated adults with CLL who have a specific genetic mutation, and patients whose cancer came back less than two years after treatment.

NICE earlier this year asked the company for more information about Zydelig's cost-effectiveness, and Gilead responded with new stats and a discount to the drug's £37,922-per-year ($57,717) price tag. The cost watchdog is staying mum on the exact size of the discount, but says it is "delighted" that Gilead followed its recommendations, NICE director Carole Longson said in a statement.

"For people whose cancer has returned less than two years after their last treatment, their options are currently limited. With this new positive recommendation, the NHS will have another clinically effective option for treating adults with chronic lymphocytic leukemia," Longson said.

Meanwhile, Gilead is doing everything it can to set Zydelig apart from its competition--and pricing plays heavily into that plan. The company priced the drug in the U.S. slightly slower than its head-to-head competitor, Johnson & Johnson's ($JNJ) Imbruvica, at $7,200 for the former compared with $8,200 for the latter.

And a recent string of approvals could move Gilead closer to achieving blockbuster sales for the med, which some analysts expect to rake in $1.2 billion by 2020. Others predict even faster growth, with $1.5 billion in sales by 2017.

Zydelig was approved by the FDA in 2014 to treat relapsed CLL and two types of non-Hodgkin's lymphoma. But regulators slapped the drug with a black box warning to highlight serious risks including potentially fatal liver problems. Imbruvica's label does not carry the same warning. EU authorities last year also signed off on Zydelig to treat adults with CLL who have a specific genetic mutation and who've had at least one prior therapy, as well as patients with follicular lymphoma who have not responded to two previous treatments.

But in January Gilead faced a setback for Zydelig in Germany, as the country's notoriously strict price watchdog, IQWiG, found that the drug has no added benefits for patients with CLL compared to other therapies on the market.

- read the NICE statement

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