The National Institute for Health and Clinical Excellence (NICE) has launched a public consultation on its preliminary recommendation that InterMune's Esbriet (pirfenidone) is not recommended for the treatment of mild-to-moderate idiopathic pulmonary fibrosis.Each year, around 4,000 adults in the UK are diagnosed with idiopathic pulmonary fibrosis, a progressive disease associated with scarring of the lungs, making breathing difficult. Esbriet is an oral medication that has a UK marketing authorisation for the treatment of mild-to-moderate idiopathic pulmonary fibrosis in adults; it is believed to show down the decline in lung function.
However, after evaluating the evidence provided by InterMune, NICE concludes in its draft guidance that it does not recommend the drug for this use because, it says, there are uncertainties over its clinical benefits in the long term and, based on the available evidence, it would not be a cost-effective use of NHS resources.
The draft guidance recommends that any adults who are taking Esbriet should have the option to continue on the treatment until they and their doctors consider it appropriate to stop."Our committee found that pirfenidone seemed to have a modest but measurable effect on slowing the decline in lung function, but that it was uncertain whether this benefit persisted over time because the clinical trials were short in duration," said Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE.
"Also, 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," she added.
Given these uncertainties and when compared with best supportive care, the committee concluded that treatment with the drug would not represent a cost-effective treatment option for the NHS, so the draft guidance does not recommend its use for mild-to-moderate idiopathic pulmonary fibrosis, said Prof Longson. However, she added: "we encourage healthcare professionals, people with idiopathic pulmonary fibrosis and other relevant third parties to comment on our committee's provisional recommendations during this consultation so that they can contribute to the development of this guidance."