The HSE has statutory responsibility for decisions on medicine pricing and reimbursement in the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Before deciding whether to reimburse a medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available.
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). The NCPE conducts health technology assessments (HTAs) of medicinal products for the HSE, and makes recommendations on reimbursement to assist the HSE in its decision-making process. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.
The NCPE is currently conducting an HTA on Osimertinib (Tagrisso). When completed, a report will be sent to the HSE for consideration.
The HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to add the medicine to the reimbursement list, agree to reimburse it as a hospital medicine or refuse to reimburse it.
The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments can be ongoing multi-million euro investments. Successful price negotiations also allow for more products to be approved within the finite budget available.
