Billy Kelleher (Cork North Central, Fianna Fail)
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404. To ask the Minister for Health the position regarding the HSE's consideration of the NCPE report on Translarna; and if he will make a statement on the matter. [29451/16]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products 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 to the HSE.

Decisions on whether to reimburse medicines 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 the health technology assessment of pharmaceutical products for the HSE, and can make recommendations on reimbursement to assist the HSE in its decision-making process.

The NCPE completed a health technology assessment of ataluren (brand name Translarna) in April and did not recommend reimbursement. I have asked the HSE to reply directly to the Deputy regarding the latest position on this drug.

Michael Harty (Clare, Independent)
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405. To ask the Minister for Health the reason the drug Macushield is no longer on the list of drugs and appliances under the hardship scheme; and if he will make a statement on the matter. [29455/16]

Simon Harris (Wicklow, Fine Gael)
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The HSE has advised that Macushield products have never been made available to all persons with medical card eligibility; however, Macushield and similar products were historically available to medical card holders in many areas under Discretionary Hardship Arrangements.

In developing a national framework for the administration of Discretionary Hardship Arrangements, the HSE's Medicines Management Programme (MMP) was asked to review the available therapeutic evidence for supporting reimbursement of Macushield and similar products. The MMP report supported the view of the National Centre for Pharmacoeconomics that the evidence for dietary carotenoids for the prevention of age-related macular degeneration (AMD) is inconclusive, and the MMP therefore does not recommend that products containing these preparations be reimbursed under any community drug scheme.

In light of the MMP's published report, the HSE decided to cease reimbursement support for these products. The MMP report is available at: .