Regulatory Focus™ > News Articles > UK's NICE Opposes Reimbursing Drug for Idiopathic Pulmonary Fibrosis

UK's NICE Opposes Reimbursing Drug for Idiopathic Pulmonary Fibrosis

Posted 30 November 2012 | By Louise Zornoza

UK's cost containment agency, the National Institute of Health and Clinical Excellence (NICE), is requesting comments on its draft guidance that does not recommend the use by the National Health Service (NHS) of InterMune's pirfenidone for mild-to-moderate idiopathic pulmonary fibrosis because NICE does not believe the drug would be cost-effective.

The drug is approved in the UK for the treatment of mild-to-moderate idiopathic pulmonary fibrosis in adults based on clinical trials that support its efficacy for that indication.  However, NICE claims the clinical trials that won the drug regulatory marketing approval were "short in duration," raising questions about the drug's long-term benefits.  That uncertainty led to the negative cost-benefit conclusion for reimbursement purposes.

Idiopathic pulmonary fibrosis is a progressive disease associated with scarring of the lungs, making breathing difficult. Each year around 4000 adults in the UK are diagnosed with idiopathic pulmonary fibrosis. The draft guidance recommends that any adults who are taking the drug should have the option to continue on the treatment until they and their doctors consider it appropriate to stop.

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