Written answers

Tuesday, 11 July 2017

Department of Health

Medicinal Products Reimbursement

Photo of Niamh SmythNiamh Smyth (Cavan-Monaghan, Fianna Fail)
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431. To ask the Minister for Health if he will review a matter (details supplied); and if he will make a statement on the matter. [32501/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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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.

In reaching a reimbursement decision, the HSE examines all the evidence which may be relevant in its view, including information submitted by the applicant. It will also take into account expert opinions and recommendations which it may have sought, for example from the National Centre for Pharmacoeconomics (NCPE). In addition, the HSE will have regard to the criteria set out in the 2013 Act, including the cost effectiveness of the item and the resources available.

The NCPE completed a health technology assessment of ataluren (Translarna) in April 2016 and did not recommend reimbursement.

The HSE considered all information related to ataluren (Translarna) and did not support its reimbursement.

The company was informed of this decision and, under the 2013 Health Act, was entitled to make written representations to the HSE within 28 days of the decision having been made. The notice period for applicant representations recently ended and the HSE is now considering the representations received from the applicant.

A final decision can only be made after the representations have been carefully considered.

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