Wednesday, 19 June 2013

Questions (221)

Dara Calleary


221. Deputy Dara Calleary asked the Minister for Health if he will reconsider the decision not to allow patients with Idiopathic pulmonary fibrosis access to the drug pirfenidone; his views on whether it is unfair to disallow access to the drug on a purely economic basis; and if he will make a statement on the matter. [29590/13]

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Written answers (Question to Health)

The HSE has received an application for the inclusion of pirfenidone in the GMS and community drugs schemes. The application is being considered in line with the procedures and timescales agreed last year by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association (IPHA) for the assessment of new medicines. In accordance with these procedures, the National Centre for Pharmacoeconomics (NCPE) conducted a pharmacoeconomic evaluation of pirfenidone and concluded that, at the submitted price, pirfenidone is not cost-effective for the treatment of patients with mild to moderate idiopathic pulmonary fibrosis. The report is available on the NCPE's website ( The NCPE report is an important input to assist decision making and informs further discussions between the HSE and the manufacturer of the drug.

The HSE has had negotiations with Intermune (the manufacturer of pirfenidone) in relation to the pricing of pirfenidone and is examining an offer made by Intermune. The offer will be assessed in the context of the procedures for the assessment of new medicines as per the 2012 agreement between IPHA, the HSE and the Department of Health.

The HSE is carefully considering all the issues which arise in relation to the proposed benefits and costs of this medicine and expects to reach a decision in the near future.