Dáil Éireann Debate, Thursday - 17 December 2015
466. Deputy Ruth Coppinger asked the Minister for Health the decisions he has made regarding the funding of Orkambi, a medicine that, according to reports, has improved the lives and conditions of cystic fibrosis sufferers; if he will ensure sufferers can access it through the Health Service Executive; and if he will make a statement on the matter. [46229/15]
View answer477. Deputy Billy Kelleher asked the Minister for Health his plans for the approval of Orkambi for the treatment of cystic fibrosis, given its recent approval by the European Medicines Agency. [46347/15]
View answerI propose to take Questions Nos. 466 and 477 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Prior to reimbursing any medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available to the HSE.
The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics (NCPE). They are not political or ministerial decisions. The NCPE conducts the health technology assessment of pharmaceutical products for the HSE, and can make recommendations on reimbursement to assist the HSE in its decision-making process.
Vertex Pharmaceuticals, the manufacturer of Orkambi™, submitted a Rapid Review application for the drug to the NCPE on 26 November 2015. The company is expected to submit a full pricing and reimbursement application to the HSE/Primary Care Reimbursement Service in the immediate future.
Once this application is received, it will be considered by the HSE in line with criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013 and using the processes outlined in national pricing framework agreements.
