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Medicinal Products Licensing

Dáil Éireann Debate, Tuesday - 25 March 2014

Tuesday, 25 March 2014

Questions (1112)

Pearse Doherty

Question:

1112. Deputy Pearse Doherty asked the Minister for Health if he will provide an update on the Health Service Executive's assessment of the drug Nalmefeme, or Selincro; and if he will make a statement on the matter. [13628/14]

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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) is currently conducting a pharmacoeconomic evaluation of Nalmefeme (Selincro) 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.

The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable. It would not be appropriate to comment any further at this time as the decision making process is ongoing.

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