Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE, through its Senior Leadership Team, has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices. There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed. The HSE commissions evaluations (Rapid Reviews / HTA) of new medicines, and new uses of existing medicines, from the National Centre for Pharmacoeconomics (NCPE) as part of that formal process.
During the assessment process, the NCPE also collects patient submissions for use by the HSE in the pricing and reimbursement decision process. The NCPE maintains a database of patient representative organisations and actively seeks submissions from these organisations when a relevant medicine is being assessed. Training is also offered to assist these organisations in the development of their submissions. These submissions are shared with the HSE Drugs Group to inform their deliberations.
The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. Pharmacoeconomic reports are reviewed by the HSE Drugs Group along with the outputs of commercial negotiations, and any patient group submissions received. The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Leadership Team.
The decision-making authority in the HSE is the HSE Senior Leadership Team. The HSE Senior Leadership Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013.