The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE issued a Notice of Proposal not to support reimbursement of Elosulfase alfa (Vimizim) to the manufacturer BioMarin in June 2017.
The Health (Pricing and Supply of Medical Goods) Act 2013 allows suppliers at least 28 days in which to make representations on any proposed decision.
Those representations have been received and are being considered carefully by the HSE.
Until such time as the process has concluded and a formal decision has been communicated to BioMarin, the application for reimbursement remains under consideration.