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NICE rejects Imbruvica for non-Hodgkin’s lymphoma

Draft guidance cites insufficient cost-effectiveness evidence for J&J’s drug

NICE has once again rejected Johnson & Johnson's Imbruvica (ibrutinib) for use on the NHS in England and Wales, this time for the treatment of patients with a rare form of lymphoma.

In draft guidance the UK watchdog cited a lack of cost-effectiveness evidence submitted for patients where chemo-immunotherapy is considered unsuitable, and is therefore not minded to recommend the drug.

Imbruvica is used to treat Waldenstrom's macroglobulinaemia - a rare type of slow-growing non-Hodgkin's lymphoma - in people who have had at least one prior therapy or as a first-line treatment instead of chemotherapy.

NICE said in a statement that it acknowledged the unmet need for treating these patients, but could not back the drug on the level of data provided despite cost ratios presented by Johnson & Johnson, which were "substantially above normal ranges considered value for money".

NICE previously decided not to recommend Imbruvica for the treatment of chronic lymphocytic leukaemia (CLL) on the NHS due to "numerous uncertainties in the evidence base and economic modeling" of the drug.

Shortly after this draft guidance was issued, a wider license for Johnson & Johnson's drug as a first-line CLL treatment was approved by both the FDA and the European Commission, and is currently recommended in 48 countries worldwide.

Commenting on the decision at the time, Mark Hicken, managing director of J&J's Janssen unit, said: "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.

"This is a worrying sign for people living in England and is, unfortunately, likely to much more common under the new CDF process."

Article by
Rebecca Clifford

14th October 2016

From: Regulatory



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