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.