Japan’s Eisai, which is battling England’s drug cost watchdog to win approvals for its cancer drug lenvatinib, has prevailed in kidney cancer.
The National Institute for Health and Care Excellence (NICE) in an email today said that in final guidance it has recommended use of Kisplyx, marketed as Lenvima in the U.S., to treat certain patients suffering kidney cancer. It had turned the drug down in draft guidance in August.
Specifically, Kisplyxcan/Lenvima be used along with chemo in adults who have had one previous treatment with VEGF-targeted therapy and only if the patient’s Eastern Cooperative Oncology Group performance status score is 0 or 1. Also, it has to be priced as was agreed in the patient access scheme, NICE reported.
The fact that NICE often initially rejects expensive new drugs for payment by the National Health System after other markets has drawn sharp criticism from both drugmakers and patient advocacy groups. The FDA in 2015 approved Lenvima to treat thyroid cancer, and the FDA and the EU in approved it to treat renal cancer in mid-2016.
But it has been like a ping-pong game for Eisai’s lenvatinib with NICE. In 2016, regulators did not include it for coverage by the country’s revamped Cancer Drugs Fund (CDF) for treating thyroid cancer, a move that delayed reconsideration for more than a year. Executives at Eisai, which is counting on the drug to drive a financial turnaround, were incensed.
"Eisai may be forced to consider its level of investment in the UK because it is unacceptable that drugs which are manufactured in England cannot be provided to people in England, without delays of many years," Gary Hendler, Eisai EMEA head, told Reuters at the time.
When Lenvima finally came up for consideration in October, NICE gave it a thumbs-down for thyroid cancer, even though the cost overlord noted that trial data showed Lenvima extends overall survival to 42.8 months compared with 34.5 months for those patients treated with placebo. The hang-up, as is often the case, was cost. NICE determined that at about £35,000 ($47,000) per patient for a year of treatment, it exceeded its cost guidelines.
Meanwhile, Eisai continues to test Lenvima in other areas as it works to build sales for the treatment. Last summer it showed promising results in treating liver cancer, in a head-to-head noninferiority study against Bayer’s Nexavar in patients with inoperable hepatocellular carcinoma. So far, Bayer has had that lucrative market to itself.