Brendan Griffin (Kerry South, Fine Gael)
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451. To ask the Minister for Health to set out his views on a matter (details supplied) regarding medication; and if he will make a statement on the matter. [2720/15]

Kathleen Lynch (Cork North Central, Labour)
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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 decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the Health Service Executive on the advice of the National Centre for Pharmacoeconomics. They are not political or ministerial decisions.

The HSE received an application for the inclusion of Eculizumab in the GMS and community drugs schemes. Eculizumab or Soliris® to give it its brand name is indicated for the treatment of patients with paroxysmal nocturnal haemoglobinuria or PNH.

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 National Centre for Pharmacoeconomics conducted a pharmacoeconomic evaluation of Eculizumab.

The Report of the National Centre for Pharmacoeconomics was published in October 2013. It concluded that at a total cost per patient per year of €437,247 and a cumulative gross budget impact over 5 years estimated at €33million, 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 National Centre for Pharmacoeconomics was unable to recommend reimbursement of the product under the community drugs schemes.

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 price put forward by the pharmaceutical company. The HSE has been engaging with Alexion Pharma for some time to arrive at a price that would assist it in its desire to fund this medicine for as many patients as possible, within agreed resources. The HSE's engagement with the company has now been concluded and the Executive is considering the outcome of that engagement. It is regrettable that to date the company has not been able to provide this drug at a more sustainable price to the HSE to reflect the clinical evidence.

I would like to assure the Deputy that I fully understand the concerns of patients regarding the availability of this drug and every effort is being made to achieve a satisfactory outcome to this issue. 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 it is appreciated that the better interests of the health service require that we only reimburse the most effective medicines and only at a fair price.