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.

RELATED: NICE invites angry J&J to make a Cancer Drugs Fund case for Imbruvica

Sponsored by Lubrizol Life Science

[Webinar] Cannabinoid Formulation - from Farm to Pharma

Wednesday, June 24, 2020 | 12pm ET / 9am PT

A handful of cannabinoid-based pharmaceutical products are on the market today, and an ever-growing number are in the global development pipeline. This webinar will explore key considerations in developing cannabinoid-based pharmaceutical products, including an overview of global pharmaceutical cannabinoid usage today, common challenges formulating with CBD and other cannabinoids, and more.

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.”

RELATED: ASH: J&J, AbbVie tout long-term Imbruvica data in the face of a new AstraZeneca threat

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.

Suggested Articles

Sanofi's Sarclisa is coming full-force at Johnson & Johnson blockbuster Darzalex in the multiple myeloma field—now backed by new data.

The antidepressant Zoloft and its generics are in short supply as the COVID-19 pandemic has caused higher demand and manufacturing interruptions.

WuXi AppTec has appointed Celgene CAR-T program veteran David Chang to lead its cell and gene therapy CDMO, WuXi Advanced Therapies.