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Medicinal Products Supply

Dáil Éireann Debate, Tuesday - 14 May 2013

Tuesday, 14 May 2013

Questions (89, 134, 606, 640, 659, 660, 664, 670, 671, 672)

Joan Collins

Question:

89. Deputy Joan Collins asked the Minister for Health if he will ensure that the drug Pirfenidone will be made available for patients with Idiopathic Pulmonary Fibrosis despite the cost of this drug; and if he will make a statement on the matter. [22622/13]

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Catherine Murphy

Question:

134. Deputy Catherine Murphy asked the Minister for Health if he will outline the manner in which the National Centre for Pharmacoeconomics decides on the merits of making new drugs available for public patients in the State; if there are specific guidelines in place to ensure that public health concerns are taken fully into account and the decision is not purely an economic one; if he has any direct input into any stage of the decision making process; and if he will make a statement on the matter. [22458/13]

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Michelle Mulherin

Question:

606. Deputy Michelle Mulherin asked the Minister for Health if he will reverse the decision on funding for pirfenidone, the only drug to date to be effective in the treatment of idiopathic pulmonary fibrosis; and if he will make a statement on the matter. [22307/13]

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Catherine Murphy

Question:

640. Deputy Catherine Murphy asked the Minister for Health if, in view of the decision taken by the National Centre for Pharmacoeconomics not to fund Pirfenidone for patients with Idiopathic Pulmonary Fibrosis based on economic grounds, he will consider overturning that decision in view of the fact that the drug has significant benefits and its absence results in significant suffering for patients with the condition; and if he will make a statement on the matter. [22475/13]

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Pearse Doherty

Question:

659. Deputy Pearse Doherty asked the Minister for Health if he will consider including Pirfenidone on the drug payment scheme for sufferers of lung fibrosis; if he will confirm that is the only drug available to treat patients with idiopathic lung fibrosis; and when the Health Service Executive will conclude its negotiations with the manufacturer [22656/13]

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Michael McNamara

Question:

660. Deputy Michael McNamara asked the Minister for Health if he will reconsider his decision on the drug Pirfenidone a new drug for the treatment of lung fibrosis; and if he will make a statement on the matter. [22657/13]

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Gerry Adams

Question:

664. Deputy Gerry Adams asked the Minister for Health if his attention has been drawn to the benefits of the drug Pirfenidone; the reason the NCPE has announced that pirfenidone will not be made available for patients with IPF based on economic grounds; and if he will make a statement on the matter. [22727/13]

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Aengus Ó Snodaigh

Question:

670. Deputy Aengus Ó Snodaigh asked the Minister for Health if he will provide details of the recent pharmacoeconomics evaluation of Pirfenidone conducted by the National Centre for Pharmacoeconomics; and if he will make a statement on the matter. [22754/13]

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Aengus Ó Snodaigh

Question:

671. Deputy Aengus Ó Snodaigh asked the Minister for Health the annual cost of treating a patient with Pirfenidone when they are suffering with idiopathic pulmonary fibrosis; the number of persons who suffer from this condition within this jurisdiction; the method by which the National Centre for Pharmacoeconomics assess if a treatment is cost effective; and if he will make a statement on the matter. [22755/13]

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Aengus Ó Snodaigh

Question:

672. Deputy Aengus Ó Snodaigh asked the Minister for Health if he will provide an update in the Health Service Executive negotiations with the manufacturers of Pirfenidione, Esbriet; and the date on which these negotiations will conclude [22756/13]

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Written answers

I propose to take Questions Nos. 89, 134, 606, 640, 659, 660, 664 and 670 to 673, inclusive, 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 is currently in negotiations with the manufacturers of pirfenidone and therefore it would not be appropriate to comment further while these negotiations are ongoing.

The HSE assessment process is intended to arrive at a decision on the funding of pirfenidone that is clinically appropriate, fair, consistent and sustainable. The HSE understands that patients and clinicians are very anxious that a decision be made as soon as possible.

The following information was provided under Standing Order 40A

In reply to Question No. 671, specifically "the number of persons who suffer from this condition within this jurisdiction", it is not known how many patients suffer from idiopathic pulmonary fibrosis in Ireland.

The Orphanet report in 2011 estimated the prevalence of idiopathic pulmonary fibrosis in Europe to be 1.67/10,000 which, if applied to the Irish population, would mean that there are approximately 766 people with idiopathic pulmonary fibrosis in Ireland.

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