Patrick O'Donovan
Question:263. Deputy Patrick O'Donovan asked the Minister for Health when approval for funding will be given for the drug Eculizumab; and if he will make a statement on the matter. [23248/13]
View answerWednesday, 15 May 2013
Questions (263)
Written answers
The drug mentioned by the Deputy is extremely expensive, costing over €350,000 per patient per year. Treatment is lifelong. In 2010, in the absence of sufficient information to make a decision regarding long term funding, the HSE entered into an agreement with the manufacturer and St James’ Hospital, Dublin, whereby it provided a fund of almost €10m (inclusive of VAT) for the years 2010 to 2012. This level of funding was seen as sufficient to treat 10 patients, the expected number of patients to be identified for treatment over that time period. The agreement provided that continued funding of Eculizumab would be contingent on the results of a HSE commissioned evaluation of the clinical and economic information associated with the use of this drug. In this context, it was understood that the manufacturer was working with clinical experts internationally to develop the evidence to support continued funding of this very expensive drug.
The HSE has honoured the terms of the 2010 agreement. The agreement has now lapsed and a formal re-assessment process has been triggered as was agreed in 2010. Pending consideration of the outcome of the assessment, the HSE is continuing to fund the treatment of the original 10 patients identified by St James’s Hospital. The HSE has released funding of €848,000 (plus 23% VAT) to fund treatment for these patients in the first four months of 2013.
The HSE is progressing with the formal re-assessment agreed in 2010 so as to ensure that funding decisions are made in the full knowledge of all the benefits and costs of this drug. The HSE understands that the manufacturer is working on a dossier setting out additional evidence in support of this drug and the HSE awaits its submission. The National Centre for Pharmacoeconomics has been requested to examine that dossier on behalf of the HSE once it is submitted. Future funding decisions will be made when the assessment report is available.