In Reversal, NICE Clears Intermune's Esbriet for Reimbursement

The UK's cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has issued its final appraisal determination recommending reimbursement by the National Health Service (NHS) for Intermune's Esbriet (pirfenidone) as a treatment option for certain patients with idiopathic pulmonary fibrosis (IPF).

This marks a reversal of draft guidance issued in November 2012, when the agency recommended against reimbursement for the product due to its cost. It appears that NICE's reversal was prompted by Intermune's decision to provide the NHS with a discount for the innovative new drug.

The NICE Appraisal Committee recommended Esbriet as an option for treating IPF patients whose predicted forced vital capacity (FVC) is between 50 percent and 80 percent at the initiation of therapy, but said that treatment should be discontinued if there is evidence of disease progression (as defined by a decline in percent predicted FVC of 10 percent or more within any 12-month period).

Based on the clinical studies with the drug, Intermune expects that between 10 and 15 percent of patients could meet this definition of disease progression in a given 12-month period.

NICE further recommends the prescription of Esbriet for as long as Intermune makes the Patient Access Scheme (PAS) available. The PAS is a confidential pricing and access agreement with the UK's Department of Health. The NHS list price for Esbriet is £26,100, or about $39,350 per full year of treatment. It is estimated that around 6,800 people in the UK with idiopathic pulmonary fibrosis could be now be eligible for treatment with Esbriet.

Final guidance to the NHS in England and Wales and is expected to be published in April of 2013, and Intermune expects to begin its launch of Esbriet in England and Wales by the end of June.