|NICE CEO Sir Andrew Dillon|
U.K.'s National Institute for Health and Care Excellence (NICE) has delivered a blow to Johnson & Johnson's ($JNJ) Zytiga (abiraterone) in final draft guidance recommending against the prostate cancer pill as a treatment for prostate cancer before chemotherapy. And nobody seems very happy about it--including NICE itself.
According to the British cost watchdog, though data show Zytiga can delay prostate cancer progression and put off the need for chemo, it's not clear how much the therapy actually extends life. NICE's chief exec, Sir Andrew Dillon, pinned the body's decision on J&J, claiming the company's own economic model showed that Zytiga didn't offer enough benefit to justify its price.
"We know how important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend abiraterone for use in this way," he said in a statement.
That doesn't mean J&J's Janssen unit didn't offer up a so-called patient access scheme--a price break on the drug that manufacturers often need to throw in to get their products past the cost-effectiveness gatekeeper. On the contrary, Janssen said it did come to NICE with a reduced cost for the med, adding that it's "extremely disappointed" and plans to appeal the decision, PharmaTimes reports.
The decision, "if it stands, will leave thousands of men in England in the advanced stages of prostate cancer with no option but to accept chemotherapy," Peter Barnes, Janssen's medical director, told PT. He pointed out that patients will eventually be able to receive Zytiga on England's National Health System anyway, as NICE backs it for use after docetaxel-containing chemotherapy
NICE's stance has also stirred up ire among non-profits and patient advocacy groups, the Times reports. Owen Sharp, CEO of charity Prostate Cancer UK, called the stand-off between NICE and Janssen a "fiasco" and urged both sides to get back to the negotiating table.
Others have criticized NICE's methods for determining whether a drug should be covered. Paul Workman, interim helmsman at the Institute of Cancer Research, called its process "plainly illogical."
"It is an unintended, and quite bizarre, consequence of the current rules for appraisals that patients have to wait until their life expectancy drops before they can access beneficial drugs on the NHS," he said, as quoted by PharmaTimes.
This is not the first tie-up between Janssen in NICE over Zytiga; back in February of 2012, NICE originally snubbed the drug in draft guidance before the drugmaker threw in a cost cut. Since then, the next-gen med has gone on to take the market by storm, racking up $1.7 billion in global 2013 sales to crack the list of top 10 best-selling cancer meds.
- read NICE's release
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