NICE flip-flops to back J&J's Imbruvica in mantle cell lymphoma

England's cost-effectiveness gatekeepers now recommend Imbruvica for MCL patients who have had just one prior line of treatment.

With just-arrived competition in mantle cell lymphoma, Johnson & Johnson’s Imbruvica has snagged reimbursement backing in an important new market.

Thursday, England’s National Institute for Health and Care Excellence (NICE) recommended the drug for NHS coverage, flip-flopping on a previous decision not to cover it. But there are conditions: Imbruvica is recommended as a treatment option only for MCL patients who have had just one prior line of therapy.

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The other condition, as is often the case with NICE, is that J&J offer up a previously agreed-upon—and confidential—discount. The med in England bears a list price of £4,599.00 for 90×140-mg capsules, or £51.10 per capsule, and £6,132.00 for 120×140-mg capsules.

“We are pleased that patients with this hard-to-treat cancer, who in the past had few treatment options beyond chemotherapy, can now finally access ibrutinib on the NHS in England and Wales,” Jennifer Lee, director of health economics, market access and reimbursement for J&J’s Janssen UK, said in a statement, adding, “Though the process has been lengthy, we have remained steadfast in our commitment to ensuring access to this innovative medicine for those with MCL.”

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The about face comes at a key time for J&J, which just inherited formidable new U.S. competition in the MCL space. In late October, AstraZeneca picked up an FDA approval for Calquence, a future blockbuster analysts think can give Imbruvica a run for its money.

Meanwhile, the Imbruvica-NICE saga stretches beyond MCL. Last year, the cost watchdog rejected the drug in chronic lymphocytic leukemia, instead inviting Janssen to make its case for inclusion in the Cancer Drugs Fund. And last October, it shot down Imbruvica in Waldenstrom's macroglobulinaemia, too. It ultimately changed its mind on those decisions, too, agreeing to cover the drug in both indications.