Micheál Martin (Cork South Central, Fianna Fail)
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538. To ask the Minister for Health the reason a treatment (details supplied) has not been reimbursed here despite it being the first drug approved in all other member countries of the BeNeLuxA initiative to which Ireland is a member; when he expects reimbursement to be approved; and if he will make a statement on the matter. [37586/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions.

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 are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process.

Nusinersen (Spinraza) is for the treatment of 5q spinal muscular atrophy (SMA).

An application for the reimbursement of Nusinersen (Spinraza) is currently being processed by the HSE. No decision has been arrived at as yet as the statutory assessment process is still ongoing.

Two members of the Beneluxa Initiative (Belgium and the Netherlands) completed a joint negotiation for the reimbursement of Spinraza in July 2018. This process began before Ireland joined the collaboration and Ireland was not party to these negotiations.