FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

NICE Denies Expanded Use of Roche’s Esbriet

June 19, 2017
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The U.K.’s National Institute for Health and Care continued to refuse endorsing expanded use of Roche’s Esbriet (pirfenidone) beyond patients with moderate forms of the fatal lung scarring disease idiopathic pulmonary fibrosis.

Following an appeal from Roche on a previous decision, NICE sent out a second final appraisal determination in which it specified that Esbriet will only be funded by the NHS if the person has a forced vital capacity between 50 percent and 80 percent predicted, and Roche provides the drug with the discount agreed in the patient access scheme.

NICE said Esbreit was not a cost-effective use of NHS resources for the population specified in the marketing authorization because the potential incremental cost-effectiveness ratio was between $28,700 and $32,300 per quality-adjusted life-year gained, compared to best supportive care.

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