Clare Daly
Question:749. Deputy Clare Daly asked the Minister for Health when the drug C1 esterase inhibitor Berinert will be made available by the HSE to persons with hereditary angioedema. [35981/18]
View answerFriday, 7 September 2018
Questions (749)
Written answers
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines in the community drugs schemes, under the Health (Pricing and Supply of Medical Goods) Act 2013.
For a medicine to be considered for reimbursement by the HSE, it must first have a marketing authorisation from the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA), before being assessed under the 2013 Act.
I understand that C1-esterase inhibitor (Berinert) is not licensed for use in Ireland.
Should C1-esterase inhibitor (Berinert) receive marketing authorisation, the company may make an application to the HSE for reimbursement.