Eisai, which was hoping the drug cost regulator in England would approve its cancer drug Halaven to treat breast cancer patients whose cancer persists after a single round of chemo, had its hopes dashed Monday when authorities said no.
Halaven last year was approved for use by the National Health Service to treat breast cancer patients after two rounds of chemo, but the Japanese company was hoping improve its sales by winning approval for earlier use. In draft guidance, the National Institute for Health and Care Excellence said that while Halaven met its criteria to be considered an end-of-life treatment, there was uncertainty about its survival data. Given its cost, that doubt made it an inappropriate choice, NICE said.
According to the draft guidance, Halaven added an average of 4.6 months to the survival of patients compared with chemo alone. But Eisai’s drug didn’t increase the time during which the tumor doesn’t grow. That left reviewers in doubt about whether improved survival was attributable to the drug or to the treatments that followed use of Halaven. Given that its cost ranges from from £36,244 to £82,743 ($48,141 to $110,000) per quality-adjusted year, the math didn’t add up for the regulator.
Of course, Eisai can come back and offer discounts that might win the NICE over. That is what Pfizer and Novartis recently did for their cancer drugs, Ibrance and Kisqali to win approval for routine use in breast cancer by the NHS.
Earlier this month, after both companies agreed to confidential discounts, NICE approved their drugs for people with HR-positive, HER2-negative forms of the disease, despite uncertainties about how long they can actually prolong patients’ lives. NICE noted that both drugs have shown that they can stall cancer growth by an average of 10 months and both came to the market with a U.K. list price of £2,950 per cycle before the discounts.