The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal devices under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. I understand the manufacturer has not yet made a completed application to the HSE for reimbursement of the device under the Community Drugs Schemes. A health technology assessment may then be required to assess its clinical benefits and cost-effectiveness.
The HSE are due to meet the manufacturer shortly.