Posted by Michael Wonder on 19 Sep 2016
NICE says no to expanding scope of Roche’s IPF drug
19 September 2016 - Patients in England and Wales with the lung scarring disease idiopathic pulmonary fibrosis will have to wait until their disease has worsened before getting routine NHS access to Roche's Esbriet.
NICE has published a Final Appraisal Determination rejecting the use of Esbriet (pirfenidone) for the treatment of early IPF, which Roche says leaves patients with no treatment option to slow the progression of their disease until lung function has been lost.
In 2013, the Institute recommended Esbriet for patients with moderate disease based on positive Phase II and Phase III data. Findings from the Phase III ASCEND trial - which included more patients with the early form of the disease - showed that, after one year of treatment with drug, the risk of death from IPF nearly halved, with a 48 percent relative reduction in mortality at 52 weeks compared to placebo.
