NICE rejects Janssen leukaemia drug Imbruvica

The National Institute for Health and Clinical Excellence (NICE) has preliminally rejected Janssen’s leukaemia therapy Imbruvica.

Draft guidelines published by NICE rejecting its use on the grounds of cost could mean that NHS patients in England and Wales suffering from chronic lymphocytic leukaemia (CLL) will be denied access to the drug which has been hailed a potential future blockbuster by industry experts. 48 other countries, including 27 European countries, have opted to fund or reimburse the medicine.

NICE said that uncertainties in the Janssen’s submission leave it in doubt over whether Imbruvica (ibrutinib) is a cost-effective use of NHS resources in this setting. Imbruvica is currently available through the Cancer Drugs Fund in England for use in adult patients with relapsed or refractory CLL.

The firm had offered Imbruvica to the Department of Health at a discounted rate to its list price of £55,954.50 (excluding VAT) for a year’s course.

Janssen said it was “extremely disappointed” with NICE’s stance. Mark Hicken, Janssen UK’s managing director, added that the decision was “yet another example of how the current NICE appraisal process is not fit-for-purpose in responding to the needs of cancer patients and the healthcare professionals who treat them”.

The firm said it would challenge the recommendation.