Wednesday, 13 January 2016
Department of Health
Medicinal Products Availability
556. To ask the Minister for Health if he will ensure that the cystic fibrosis drug Orkambi is made available at an early date as it is life-transforming to patients who have qualified for the drug and enables them lead a reasonable quality of life (details supplied); and if he will make a statement on the matter. [46520/15]
561. To ask the Minister for Health if he has completed a cost-benefit analysis on the introduction of the drug Orkambi for patients with cystic fibrosis; and if he will make a statement on the matter. [46554/15]
596. To ask the Minister for Health if the Health Service Executive will make Orkambi available to patients with DDF508 cystic fibrosis; and if he will make a statement on the matter. [46803/15]
I propose to take Questions Nos. 546, 552, 556, 561, 583, 596, 613, 662, 665 and 693 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.
Orkambi™ is currently being considered by the HSE under the national medicines pricing and reimbursement assessment process. As the assessment process is ongoing, it is not possible to discuss potential outcomes or comment further at this time.