Cost regulators for the NHS in England and Wales have turned down Janssen's Imbruvica for treating some people with Waldenstrom's macroglobulinaemia (WM) - a rare type of slow growing non-Hodgkin's lymphoma.
The National Institute for Health and Care Excellence has published draft guidelines rejecting the drug's use in those who have had at least one prior therapy, or as first-line treatment when chemo-immunotherapy is unsuitable.
The Committee noted that there was no cost-effectiveness evidence submitted for part of the patient population - those whom chemo-immunotherapy is considered unsuitable, and that there were uncertainties in the evidence presented for other subsets.
It did acknowledge the unmet need for treating patients with WM, but said that "taking into account the insufficient evidence, and the ICERs presented by the company which were substantially above normal ranges considered value for money," the committee could not recommend the drug as a cost-effective use of NHS resources.
NICE also considers it was unlikely that further data collection will lead to a more favourable cost-effectiveness estimate for the drug, and so did not recommend its inclusion in the Cancer Drugs Fund.
Imbruvica (ibrutinib) is available at the list price of £4,599 for 90×140-mg capsules and £6,132 for 120×140-mg capsules (excluding VAT), but the company has agreed a confidential discount with the Department of Health, under which it provides the drug at a confidential discount.