U.K. cost watchdogs snub key J&J med Imbruvica on first go-around

The U.K.'s cost effectiveness gatekeepers have issued a preliminary thumbs-down to blood cancer star Imbruvica in chronic lymphocytic leukemia--and maker Janssen isn't happy about it.

Wednesday, the Johnson & Johnson ($JNJ) pharma unit said it was "extremely disappointed" with draft guidance from the National Institute of Health and Care Excellence (NICE) that did not recommend the med as a treatment for CLL patients who aren't good candidates for chemo-immunotherapy. It also slammed the body's appraisal process, which Mark Hicken, Janssen U.K.'s managing director, called "not fit-for-purpose in responding to the needs of cancer patients."

As he pointed out in a statement, Imbruvica--currently available through the country's Cancer Drugs Fund (CDF), which pays for some of the meds rejected by the watchdogs at NICE--is the most requested CLL drug on the fund, demonstrating a "huge clinical demand."

But NICE often turns down therapies on the first go-around in order to snag discounts from drugmakers, and when pharmas do offer up the so-called "patient access schemes," it's been known to change its mind. That's what happened to Roche ($RHHBY) in December, 2014 when it cut NICE a deal on $42,850 CLL med Gazyvaro; Gilead ($GILD) went down a similar path when it convinced the watchdog to back its CLL contender, Zydelig, with a price break on the $57,717 treatment last September.

Janssen is hoping it can secure an about-face, too. Imbruvica has been a key med for the company lately, with sales of former hep C standout Olysio crashing on stiff competition. Last quarter, Imbruvica's worldwide sales more than doubled, leaping to $235 million from $92 million in 2014's Q4. And its promise in CLL was one factor that spurred AbbVie ($ABBV) to last year shell out $21 billion for J&J's partner, Pharmacyclics.

On that front, Janssen said it would be "actively participating" in NICE's consultation process "to ensure a solution can be found so that eligible patients can continue to access" Imbruvica.

Meanwhile, changes are afoot at the CDF--and they'll make verdicts like NICE's "no" on Imbruvica all the more common, Hicken warned. Last week, NHS England green-lighted reforms to the fund that will give NICE the ability to make "yes," "no," or "maybe" decisions about funding cancer meds, changes that the industry says will prevent many patients from benefiting from new oncology products.

- read Janssen's release

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