Uncertainties hinder Esbriet appraisal

 NICE has failed to recommend InterMune’s Esbriet (pirfenidone) as a treatment option on the NHS for people who have idiopathic pulmonary fibrosis in draft guidance.

Questions were raised by NICE’s independent Appraisal Committee over the cost-effectiveness and the long-term clinical benefits of the treatment.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said that although the Committee is aware of Esbriet’s benefits “it was uncertain whether this benefit persisted over time because the clinical trials were short in duration.”

The recommendation is now open for consultation. Final guidance is expected in April 2013, after NICE’s committee reviews any responses on the decision in January.

Esbriet has a UK marketing authorisation for the treatment of mild-to-moderate idiopathic pulmonary fibrosis in adults. The condition is a progressive disease associated with scarring of the lung, which makes breathing difficult. There are around 4,000 adults diagnosed each year in the UK.

“It was unclear whether the drug could improve overall survival for people with the disease because of uncertainty about the correct classification of deaths in the clinical trials as being related to idiopathic pulmonary fibrosis or not, a low number of deaths in both treatment and placebo arms and short follow-up,” said Professor Longson.

“Given these uncertainties and when compared with best supportive care, our committee concluded that treatment with pirfenidone would not represent a cost-effective treatment option for the NHS.”