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NICE gives final go-ahead to Roche's Gazyvaro

This article was originally published in Scrip

Executive Summary

In its new final appraisal determination, the UK's health technology agency NICE has recommended the routine use on the NHS of Roche's Gazyvaro (obinutuzumab). Specifically, the Rituxan (rituximab) follow-on product has been recommended for use in combination with chlorambucil chemotherapy for the treatment of previously-untreated adult patients with chronic lymphocytic leukemia (CLL) and co-existing medical conditions who are unsuitable for full-dose fludarabine-based therapy, and only if bendamustine-based therapy is also not suitable. This follows a reversal in December of a previous preliminary guidance that rejected the product because of "uncertainties in the company's submission". The U-turn was based on revised cost-effectiveness analyses submitted by Roche and a patient access scheme. Roche will also provide the product to the NHS at a reduced price. It is estimated that around 22% of intermediate and high risk CLL patients cannot receive fludarabine therapy and receive a regimen combining bendamustine and Rituxan in the first line, meaning that the decision is unlikely to have a huge impact, but it will nonetheless boost sales of the product in advance of the arrival of Rituxan biosimilars in early 2017.

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