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Medicinal Products Availability

Dáil Éireann Debate, Tuesday - 7 May 2013

Tuesday, 7 May 2013

Questions (367, 369, 370, 371, 401, 402)

Maureen O'Sullivan

Question:

367. Deputy Maureen O'Sullivan asked the Minister for Health if he will consider reversing the decision made by the National Centre for Pharmaeconomics not to make available pirfenidone for patients with idiopathic pulmonary fibrosis based on economic grounds; and if he will make a statement on the matter. [21750/13]

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Regina Doherty

Question:

369. Deputy Regina Doherty asked the Minister for Health if a review is planned for the treatment of ideopathic pulmonary fibrosis with the drug pirfenidone; and if he will make a statement on the matter. [21788/13]

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Kevin Humphreys

Question:

370. Deputy Kevin Humphreys asked the Minister for Health further to Parliamentary Questions Nos. 238, 239 and 243 of 18 April 2013, the position regarding the progress of negotiations ongoing in relation to securing Pirfenidone for those diagnosed with Idiopathic Pulmonary Fibrosis; if there is a deadline in place towards finalising these discussions to enable the drug to be provided to patients; and if he will make a statement on the matter. [21938/13]

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John Deasy

Question:

371. Deputy John Deasy asked the Minister for Health if he is concerned at the decision of the Health Service Executive to refuse funding, on economic grounds, for the drug Pirfenidone, which is the only effective treatment for lung fibrosis, a rare and extremely debilitating disease; and if he will make a statement on the matter. [21990/13]

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Paschal Donohoe

Question:

401. Deputy Paschal Donohoe asked the Minister for Health if he will provide an update as to when the drug pirfenidone will be available in the Irish market for sufferers of idiopathic pulmonary fibrosis; and if he will make a statement on the matter. [21451/13]

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Charlie McConalogue

Question:

402. Deputy Charlie McConalogue asked the Minister for Health if his Department will make pirfenidone readily available for sufferers of idiopathic pulmonary fibrosis; or if his Department will consider providing funding to sufferers of IPD so they can avail of pirfenidone; and if he will make a statement on the matter. [21459/13]

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Written answers

I propose to take Questions Nos. 367, 369 to 371, inclusive, 401 and 402 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 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.

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