Janssen's Imbruvica runs into trouble with NICE in mantle cell lymphoma

Janssen may have to apply to the Cancer Drugs Fund to reimburse its Imbruvica in relapsed or refractory mantle cell lymphoma, after NICE rejected it in first draft guidance.

Imbruvica (ibrutinib) is currently available in this use on the old Cancer Drugs Fund, but is one of a backlog of drugs NICE is reassessing - and could otherwise lose all reimbursement.

In the mantle cell lymphoma guidance, NICE said it would like further data investigating the overall-survival-benefit of Imbruvica in this indication.

A NICE appraisal committee was also concerned about the uncertainty associated with an indirect comparison with chemotherapy plus rituximab – one of the more commonly used treatments at this stage of the disease.

There is no currently accepted standard of care for relapsed or refractory mantle cell lymphoma and patients are treated from several chemotherapy options, sometimes combined with rituximab.

Because of the uncertainties, Imbruvica exceeds the £30,000 upper cost-effectiveness threshold, and is too expensive even after extra leeway given for end-of-life treatments.

In its guidance, NICE said it would consider a proposal for inclusion in the CDF that would allow funding for around two years.

This would allow for collection of further data to address NICE’s concerns. But a similar process involving Bristol-Myers Squibb’s Opdivo (nivolumab) in second line lung cancer took around a year.

Representatives of Janssen have already expressed concerns about availability of cancer drugs in the UK.

Jennifer Lee, director of health economics, market access and reimbursement and advocacy at Janssen has been an outspoken critic of access to cancer drugs in the UK.

When NICE rejected Janssen’s Darzalex in third line multiple myeloma earlier this year, Lee called for reforms from NICE, which has particular issues when drugs are approved based on data from mid-stage trials in order to fast-track them to market.

And at a recent round table organised by pharmaphorum and Wilmington Healthcare, Lee said the NHS is seen as slow to adopt new technologies, warning that the UK has a reputation for being a difficult market for new launches.

In separate final draft guidance, NICE also said Imbruvica will be reimbursed by the CDF in Waldenstrom’s macroglobulinaemia.

The company made an offer to provide Imbruvica at a cost-effective price so the committee could recommend the drug as an option within the CDF in final guidance.