NICE snubs J&J's Imbruvica, this time in Waldenstrom's macroglobulinaemia

Things aren’t getting any easier for Johnson & Johnson as it works to get standout cancer med Imbruvica covered on England’s National Health Service.

The National Institute of Health and Care Excellence (NICE) has shot down the drug as a treatment for Waldenstrom's macroglobulinaemia--a rare form of non-Hodgkin's lymphoma--in patients who have received at least one prior therapy or those for whom chemo-immunotherapy is unsuitable.

The reason? Cost. There’s no cost-effectiveness evidence for the group that can't receive chemo-immunotherapy, it pointed out. And there are “uncertainties in the evidence” presented for other patient subsets. That's after J&J agreed to a confidential discount with the Department of Health on the product, whose list price sits at £4,599 for 90×140-mg capsules.

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.

"Taking into account the insufficient evidence, and the ICERs presented by the company which were substantially above normal ranges considered value for money," NICE can’t recommend Imbruvica as a cost-effective use of NHS resources, it said.

And the way the body sees it, collecting more data won’t solve J&J’s problem. It's "unlikely that further data collection would lead to a more favourable cost-effectiveness estimate for ibrutinib," it said, concluding that "ibrutinib for treating Waldenstrom’s macroglobulinaemia does not have the plausible potential to be cost effective in routine commissioning"--and so it’s leaving it off the Cancer Drugs Fund, a special fund meant to cover access to drugs NICE has rejected, too.

It’s not the first time J&J has butted heads with NICE over Imbruvica. Earlier this year, the cost watchdogs turned it away for a chronic lymphocytic leukemia treatment in patients with certain genetic changes who weren’t a good match for chemo. It followed up by inviting J&J to make its case for inclusion on the CDF--a move the New Jersey pharma giant wasn’t exactly thrilled with.

“Once again, the UK lags well behind other European countries that have already opted to fund or reimburse the medicine for a patient population who have very few treatment options,” its Janssen unit said in a statement.

J&J, of course, isn’t the only drugmaker who have recently struggled with NICE--especially now that the gatekeeper has taken the reins of the CDF, re-evaluating all the meds it covers and giving some the boot. So far this year, it’s already recommended kicking off therapies including Takeda's Adcetris and Bayer's Nexavar in draft guidance.

- see NICE's guidance (PDF)

Special Reports: Top 20 orphan drugs by 2018 - Ibrutinib | The 25 most influential people in biopharma today - 2013 - Carole Longson - NICE

Related Articles:
With Adcetris rejection, Takeda feels the sting of NICE's CDF takeover
NICE knocks Bayer's Nexavar as CDF review continues
NICE invites angry J&J to make a Cancer Drugs Fund case for Imbruvica
U.K. cost watchdogs snub key J&J med Imbruvica on first go-around
Look out, drugmakers: NICE is taking the reins of England's Cancer Drugs Fund
J&J, AbbVie's Imbruvica breaks into larger CLL market with first-line FDA nod
J&J, AbbVie's Imbruvica builds on case for first-line CLL use at ASH
Just where does AbbVie expect to find $7B in Imbruvica sales?