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Medicinal Products Availability

Dáil Éireann Debate, Tuesday - 11 June 2013

Tuesday, 11 June 2013

Questions (901, 902, 941)

Mary Lou McDonald

Question:

901. Deputy Mary Lou McDonald asked the Minister for Health if he will consider reversing the decision of the National Centre for Pharmaeconomics to cease providing Pirfenidone to patients with Idiopathic Pulmonary Fibrosis. [27275/13]

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Mary Lou McDonald

Question:

902. Deputy Mary Lou McDonald asked the Minister for Health the additional annual cost to the Health Service Executive budget for more frequent and longer hospital stays arising from the National Centre for Pharmaeconomics decision to cease providing Pirfenidone to patients with Idiopathic Pulmonary Fibrosis. [27276/13]

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Brendan Smith

Question:

941. Deputy Brendan Smith asked the Minister for Health if he will clarify the position regarding supply and or availability of medication (details supplied) under the various drug schemes; if such medication is available under any circumstances; the extra documentation necessary to support a case for inclusion of this medication under current schemes; if there is an appeal process; if there is an alternative approved medication; if guidance will be offered on the way this necessary medication to curtail this life threatening illness can be obtained; and if he will make a statement on the matter. [26844/13]

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Written answers

I propose to take Questions Nos. 901, 902 and 941 together.

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 (www.ncpe.ie). 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.

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