Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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165. To ask the Minister for Health if the Health Service Executive will fund the drug soliris, eculizumab, for the treatment of paroxysmal nocturnal haemoglobinuria; and if he will make a statement on the matter. [2995/15]

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.

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 decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. They are not political or ministerial decisions.

This drug Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Haemoglobinuria or PNH. It is considered to be one of the most expensive drugs in the world.

I understand that in 2010 the HSE entered into an interim Access with Evidence Development Agreement between the company Alexion Pharma and St James's Hospital to treat 10 patients with this drug. The interim agreement was put in place with the expectation that future evidence would emerge which would assist with the future decision making on this drug.

The HSE received an application for the inclusion of Eculizumab in the GMS and community drugs scheme. In accordance with agreed procedures the National Centre for Pharmacoeconomics conducted a pharmacoeconomic evaluation of Eculizumab.

The National Centre for Pharmacoeconomics published an evaluation of the medicine in October 2013 which found that the manufacturer failed to demonstrate the cost-effectiveness of this drug and reimbursement would have an estimated cumulative gross budget impact for the HSE of €33 million over 5 years. Consequently the National Centre for Pharmacoeconomics was unable to recommend reimbursement of the product under the community drugs scheme.

Notwithstanding the pharmacoeconomic evaluation of this drug, in recognition of the burden of illness experienced by those with PNH, the HSE has been engaging with the manufacturer, Alexion Pharma, for some time in seeking to arrive at a price that would assist it in its desire to fund this medicine for as many patients as possible within the resources available.

The price being offered at present would involve the medicine in question costing €420,000 per annum for each additional patient treated, with treatment continuing over a person's lifetime in most cases.

The HSE's engagement with the company has now been concluded. The Executive is considering the outcome of that engagement and I expect that the HSE will shortly make its determination. 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 that every effort is being made to achieve a satisfactory outcome. 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, the better interests of the health service require that we reimburse only the most effective medicines and only at a fair price.