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pirfenidone (EsbrietĀ®)

Advice

following a resubmission:

pirfenidone (Esbriet®) is accepted for restricted use within NHS Scotland.

Indication under review: In adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).

SMC restriction:  For use in patient with a predicted forced vital capacity (FVC) less than or equal to 80%.

Pirfenidone reduced the decline in lung function parameters associated with IPF compared to placebo in a pooled analysis of two similarly designed phase lll studies.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pirfenidone. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.
 

Drug Details

Drug Name: pirfenidone (EsbrietĀ®)
SMC Drug ID: 835/13
Manufacturer: Intermune UK Ltd
Indication: In adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
BNF Category:
Submission Type: Resubmission
Status: Restricted
Date Advice Published: 12 August 2013

Extra Notes

In January 2013, SMC reviewed pirfenidone (Esbriet) for the treatment of mild to moderate idiopathic pulmonary fibrosis in adults. The SMC Advice was withheld, in-confidence, pending confirmation of product availability. The company subsequently made a resubmission and this was reviewed by SMC in July 2013. Advice for the original submission was not issued as the product was made commercially available in May 2013 and close to the date of issue of the SMC advice for the resubmission. Therefore the advice for the resubmission only is published on the SMC website.

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