Zelboraf vemurafenib regulatory update

The U.K.'s NICE said it needs additional information before it can recommend the use of Zelboraf vemurafenib from Roche to treat patients with unresectable locally advanced or metastatic melanoma who are BRAF V600-mutation positive. NICE is asking for clarification on the assumptions made in a new economic model that Roche submitted after the committee's June recommendation against Zelboraf. The new model includes adjusted survival estimates for patients who switched from the comparator, dacarbazine, to other treatments, which NICE had said made comparison with Zelboraf difficult. The new model resulted in an incremental cost-effectiveness ratio (ICER) of £52,327 ($81,635) per quality-adjusted life-year (QALY) gained, slightly lower than the original model's estimate of £56,400 ($87,989).

Despite the new model, NICE reiterated that the most plausible ICER for Zelboraf is "highly uncertain" and could be significantly higher than £50,000 ($78,005) per QALY gained even with an undisclosed discount under a patient access scheme. NICE did say that Zelboraf meets the criteria for being a life-extending, end-of-life treatment. However, £50,000 is usually the highest cost per QALY of a recommended drug under that criteria. Comments are due Sept. 3, with final guidance expected in October (see BioCentury, June 18). ...