Written answers

Tuesday, 9 December 2014

Department of Health

Medicinal Products Availability

Photo of Michael LowryMichael Lowry (Tipperary North, Independent)
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318. To ask the Minister for Health further to Parliamentary Question No. 315 of 25 November 2014 if he will address the specific issues raised in respect of a person (details supplied) in County Laois; if he will specifically review the particulars of this case and intervene, rather than provide an overview of the situation nationally; if his attention has been drawn to the fact that this person will die if the required treatment is not made available as a matter of urgency either here or abroad; and if he will make a statement on the matter. [46946/14]

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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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) and often on the advice of the National Centre for Pharmacoeconomics.

The HSE received an application for the inclusion of Eculizumab in the community drugs schemes. The application was considered in line with the procedures and timescales agreed in 2012 by my Department and the HSE with the Irish Pharmaceutical Healthcare Association.

In accordance with these procedures, the NCPE conducted a pharmacoeconomic evaluation of Eculizumab and concluded that, at a total cost per patient per year of €437,247 and a cumulative gross budget impact over 5 years estimated at €33 million, the therapy did not represent value for money for the treatment of patients in the Irish healthcare setting. In addition, the manufacturer did not include an economic model as part of their submission and failed to demonstrate the cost-effectiveness of this therapy. Consequently, the NCPE was unable to recommend reimbursement of the product under the community drug schemes. The report is available on the NCPE's website.

In relation to the Treatment Abroad Scheme I understand that the individual in question has appealed the decision by the HSE. As this is currently going through the appeals process it would not be appropriate to provide further comment at this time.

With regard to the 10 people that currently have access to this drug an interim agreement was put in place to fund these patients. This was to allow the pharmaceutical company, Alexion Pharma to have developed additional evidence to enable the HSE to make a long-term decision in relation to the funding of this incredibly costly agent.

Many countries have struggled to accept the pricing point put forward by Alexion. The HSE has been engaging with Alexion for some time to arrive at a pricing point that would assist it in its efforts to fund this medicine for as many patients as possible. The HSE met the company again in November and is currently considering the outcome of that engagement. It is worth noting that the current Irish list price of €4,557.50 per vial substantially exceeds the list price in the UK (£3,150 sterling).

I would like to assure the Deputy that I fully understand the concerns of patients regarding the availability of this drug. While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever price the drug company demands, I hope the Deputy will appreciate that the better interests of the health service require that we reimburse only the most effective medicines and only at a fair price.


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