2 The technology

Description of the technology

Pirfenidone (Esbriet, Roche) is an oral immunosuppressant with anti-inflammatory and antifibrotic effects.

Marketing authorisation

Pirfenidone has a marketing authorisation in the UK for treating mild to moderate idiopathic pulmonary fibrosis in adults.

Adverse reactions

The summary of product characteristics states that the very common adverse reactions (affecting 1 in 10 or more people) associated with using pirfenidone are nausea, rash, diarrhoea, fatigue, dyspepsia, anorexia, headache and photosensitivity reactions. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

The recommended dosage of pirfenidone is three 267‑mg capsules 3 times daily (that is, a total of 2,403 mg per day).

Price

The list price of pirfenidone is £501.92 for 63 capsules (excluding VAT; British national formulary online, accessed May 2016). This equates to a daily cost of £71.70. The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of pirfenidone, with the discount applied at the point of purchase or invoice. The level of discount is commercial in confidence. The Department of Health considered that the patient access scheme does not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)