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Medicinal Products Prices

Dáil Éireann Debate, Thursday - 8 February 2018

Thursday, 8 February 2018

Questions (187)

John Brassil

Question:

187. Deputy John Brassil asked the Minister for Health the position regarding the reimbursement of Vimizim by the HSE after the recent drugs group meeting on 18 January 2018; and if he will make a statement on the matter. [6496/18]

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Written answers

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 Department of Health has been informed that, following an intensive process, the HSE decided not to reimburse Elosulfase alfa (Vimizim). The applicant was notified on 7 November 2017 of the HSE’s decision not to add Vimizim to its reimbursement list. The HSE Drugs Group, which reviewed the effectiveness of the drug, did not consider the evidence for its clinical benefit to be sufficiently strong, in the context of the proposed cost and budget impact.

The HSE advised the company that it would be open to reviewing any additional clinical evidence if same becomes available.

The HSE has confirmed that it has recently received a new application from the manufacturer which is currently under consideration.

Until such time as the process has concluded and a formal decision has been communicated to BioMarin, the application for reimbursement remains under consideration.

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