HEDS is part of the School of Health and Related Research (ScHARR) at the University of Sheffield. We undertake research, teaching, training and consultancy on all aspects of health related decision science, with a particular emphasis on health economics, HTA and evidence synthesis.

Monday, 19 March 2012

More evidence required for rivaroxaban

NICE has given a ‘minded no’ to the use of rivaroxaban (Xarelto, Bayer) for the treatment of deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults. Such a recommendation is given when a clear decision can not be made due to resolvable uncertainties within the manufacturer’s submission.  The Evidence Rview Group were ScHARR-TAG, with Sue Harnan, Rachid Rafia, Edith Poku, John Stevens, Matt Stevenson and Ruth Wong doing the work.

The key issue within this appraisal appears to be an alarming change in results when a different patient populations are used.  The ACD notes that within the manufacturer’s submission “rivaroxaban dominated treatment with enoxaparin and a vitamin K antagonist in the manufacturer’s deterministic analysis, that is, rivaroxaban was less costly and more effective across all three treatment durations (3, 6 and 12 months).”  However,  “the Committee noted that the ERG presented an additional analysis in which estimates of relative treatment effects were based on the subgroup analysis by intended treatment duration rather than the whole trial population. This analysis showed that rivaroxaban remained dominant over LMWH and a vitamin K antagonist for the 6 and 12 month treatment durations, but the 3 month treatment duration was associated with an ICER of £11,800 saved per QALY lost (that is rivaroxaban was less effective and less costly than LMWH and a vitamin K antagonist).”

It is also worth noting that this is the third minded no in the last couple of months (to our knowledge), with the others being botox in chronic migraine and erlotinib for the first-line treatment of locally advanced or metastatic EFGR mutation-positive non-small-cell lung cancer (NSCLC).  Why is it that manufacturers are unable to provide the necessary evidence for a decision – poor clinical research, poor MTCs or poor cost-effectiveness modeling?