U.K. watchdogs turned up their noses at Halaven once again, despite a new discount. The National Institute for Health and Clinical Excellence said Eisai's breast cancer treatment still didn't meet the requirements for cost-effectiveness, partly because of troublesome side effects.
The side effects with Halaven--also known as eribulin--included fatigue, hair loss, nausea, anemia and peripheral neuropathy, NICE said. "Although the evidence ... indicated that eribulin may help some patients live for a little longer, it also caused more undesirable side effects that other treatments already available," agency chief Andrew Dillon said in a statement, adding that the drug's "effects on health-related quality of life had not been adequately assessed."
If the side effects had been outweighed by a more impressive survival benefit, Halaven might have fared differently. NICE said the breast cancer treatment could extend life by 2.7 months compared with other treatments. As PMLive points out, the agency usually looks for at least three months.
And then there was the cost: Eisai did offer a price cut off its usual £313 per vial ($500). But even with the discount--which Eisai kept confidential--NICE figured Halaven's cost-per-quality-adjusted life year at more than £68,600, or about $109,000.
Eisai said it was dismayed at NICE's decision. Halaven is the first single drug to show a significant survival benefit in women who'd already been treated repeatedly with other breast-cancer drugs. "At this point NICE is not giving enough support to women with advanced breast cancer," Eisai's Nick Burgin told PMLive. "We hope that NICE [will] grant a rapid re-review as new data is constantly emerging."
Eisai is hardly alone in its dismay. Several cancer drugs have fallen to NICE's analysis, including Johnson & Johnson's ($JNJ) Zytiga for prostate cancer. Bristol-Myers Squibb's ($BMY) breakthrough new melanoma drug Yervoy got a preliminary rejection in October, but the company since said it would offer a discount in hopes of changing NICE's mind.
- read the PMLive coverage