Niamh Smyth (Cavan-Monaghan, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

147. To ask the Minister for Health his plans to introduce a drug (details supplied) to the Irish market; if there is a timeframe for same; if not, the reason; and if he will make a statement on the matter. [30115/16]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I understand that officials in my Department have clarified with the Deputy's office that the drug in question is Vimizim.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Prior to 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 pharmaceutical products for the HSE, and can make recommendations on reimbursement to assist the HSE in its decision-making process.

At the request of the HSE, the NCPE is currently conducting an assessment of Vimizim for the treatment of mucopolysaccharidosis, type IVa (also known as Morquio A syndrome) in patients of all ages. Once this assessment is completed, a summary report will be published on the NCPE website. The HSE will then consider the NCPE assessment as part of its decision-making process when considering the drug for reimbursement.

As the NCPE's assessment of Vimizim is ongoing, it is not possible to provide further details at this time.