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.