The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. The Minister for Health has no role in relation to reimbursement decisions.In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the new medicine added to the reimbursement list. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority. Epidyolex received a marketing authorisation valid throughout the EU on 19th September 2019 (Agency Product Number EMEA/H/C/004675). It is a medicine used in addition to clobazam to treat patients from the age of two years who have Lennox-Gastaut syndrome or Dravet syndrome.
I am advised by the HSE that it has not received a formal application for pricing and reimbursement to date for the drug Epidyolex (Epidiolex in USA). If an application for reimbursement is received, it will be processed in line with the Health (Pricing and Supply of Medical Goods) Act 2013.