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Home > Dail Eireann debate. Written Answers 794 - Medicinal products availability [42108/14].

[Oireachtas] Dail Eireann debate. Written Answers 794 - Medicinal products availability [42108/14]. (04 Nov 2014)

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794. Deputy Liam Twomey asked the Minister for Health in view of the fact that two people here die each day from alcohol dependence, the reason Selincro, nalmefene, an innovative treatment which was found to be cost effective and received a positive recommendation by the NCPE on 8 April 2014, has yet to be introduced under any HSE drug payment or reimbursement scheme for persons who are alcohol dependent.  [42108/14]

795. Deputy Liam Twomeyasked the Minister for Health in view of the Health Research Board's outlining of current treatment for alcohol here as predominately individual counselling, brief intervention and group counselling, all of which are likely to be defined as psychosocial interventions, the reason the HSE has not made an additional pharmacological treatment Selincro, nalmefene, which is evidence based, licensed by the European Medicines Agency and found to be cost effective by the NCPE, to be available to people who are alcohol dependent.  [42109/14]

796. Deputy Liam Twomeyasked the Minister for Health her views regarding the NCPE's positive recommendation of Selincro, nalmefene, on 8 April 2014, the UK's National Institute for Health and Care Excellence has recommended the use of Selincro for alcohol dependent persons in England; and if she will provide an update on the position regarding the relevant pharmaceutical company’s application to the HSE for Selincro's inclusion in the GMS and community drug scheme.  [42110/14]

Minister of State at the Department of Health (Deputy Kathleen Lynch): I propose to take Questions Nos. 794 to 796, inclusive, together.

The decisions on which medicines are reimbursed by the taxpayer, are not political or ministerial decisions. These are made on objective, scientific and economic grounds by the Health Service Executive (HSE) on the advice of the National Centre for Pharmacoeconomics (NCPE).

The Health Service Executive (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. This requires consideration of a range of statutory criteria prior to reimbursing any medicine, including clinical need, cost-effectiveness and the resources available to the HSE.

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 for the assessment of new medicines. In accordance with those procedures the NCPE conducted a pharmacoeconomic evaluation of Nalmefeme.

The Report of the NCPE was published in April 2014. It estimated that the investment required from the taxpayer to provide access to Nalmefene would be between €6.7m and €12m over the next five years. The NCPE advice to the HSE also made clear that the introduction of Nalmefene requires the availability of appropriate psychosocial supports. The availability of those supports is being considered by the Mental Health, Health and Wellbeing and Primary Care divisions of the HSE.

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 is appropriate for the HSE prior to committing scare resources to assess whether the required supports are in place and if not, the resources required to put such supports in place, to ensure the appropriate use of this medicine.

It would not be appropriate to comment any further at this time as the decision making process is ongoing.

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