Dáil Éireann Debate, Tuesday - 14 October 2014
204. Deputy Sean Fleming asked the Minister for Health if he will provide the medication Eculizumab to the six persons who have been diagnosed with paroxysmal nocturnal haemoglobinuria (details supplied); and if he will make a statement on the matter. [39229/14]
Amharc ar fhreagraThe decisions made 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.
With regard to the drug Eculizumab, in 2010 following prolonged discussions and in the absence of sufficient information to make a long term permanent decision around this agent, the HSE entered into an access with evidence development agreement with Alexion Pharma and St James’s Hospital, Dublin whereby the HSE provided a fund (almost €10m, inclusive of VAT) for three years (2010-2012) sufficient to treat 10 patients (the expected number of patients to be identified for treatment over that time period). At the end of this period, Alexion was expected to have developed additional evidence to allow the HSE to make a long term decision in relation to the funding of this incredibly costly agent. The HSE honoured the terms of that agreement.
The agreement lapsed and a formal re-assessment process was triggered as was agreed with Alexion / St James’s in 2010. Pending consideration of the outcome of the assessment, the HSE continued the funding commitments entered into with Alexion on behalf of the original 10 patients identified by the National Centre i.e. St James’s. The HSE has released funding of €1.9m in the first 8 months of 2014 to fund treatment for the 10 existing patients.
Many countries have struggled to accept the pricing point put forward by Alexion. The medicine in question requires €355,000 per annum plus 23% VAT (multi-year commitment) to be found for each additional patient treated.
The HSE continues to try to engage with the pharmaceutical company 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 has sought to meet the company again in October but Alexion are unavailable to meet this month. 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 the Department, and the HSE, 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 the 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.
In relation to the administration of the Treatment Abroad Scheme, the Health Service Executive has been asked to examine this matter and to reply to the Deputy as soon as possible.
