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Medical Goods Regulation

Dáil Éireann Debate, Tuesday - 1 April 2014

Tuesday, 1 April 2014

Questions (566)

Pearse Doherty

Question:

566. Deputy Pearse Doherty asked the Minister for Health the date the pharmacoeconomic evaluation of Nalmefeme Selincro began and when it is likely to conclude and if there are any particular reasons this evaluation might be more complicated than usual; and if he will make a statement on the matter. [15203/14]

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Written answers

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drugs schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE received an application for the inclusion of Nalmefeme (Selincro) in the GMS and community drugs schemes. The application is being considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association (IPHA) for the assessment of new medicines.

In accordance with these procedures, the National Centre for Pharmacoeconomics (NCPE) commenced a pharmacoeconomic evaluation of Nalmefeme (Selincro) on 21 October 2013, which will provide detailed information on the potential budget impact of the medicine. It also assesses whether the medicine is cost effective at the price quoted by the company in question. The NCPE report is an important input to assist the HSE in its decision making process.

No further comment is possible at this time while the NCPE assessment process is ongoing.

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