Leo Varadkar (Dublin West, Fine Gael) | Oireachtas source

I thank the Deputy for raising this important issue. 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. These include 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 and on the advice of the experts in the National Centre for Pharmacoeconomics. They are not political or ministerial decisions, nor should they be.

This drug eculizumab or Soliris, to give it its brand name, 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 ten patients with this drug. The interim agreement was put in place with the expectation that further evidence would emerge which would assist the future decision-making on this drug.

The HSE received an application for the inclusion of Soliris in the general medical services, GMS, and community drugs schemes. In accordance with agreed procedures, the National Centre for Pharmacoeconomics conducted a pharmacoeconomic evaluation of eculizumab. The report of the centre in October 2013 concluded that the total cost per patient per year for this drug is €437,247 and would have a cumulative gross budget impact over five years estimated at €33 million. In addition, the manufacturer did not include an economic model as part of its 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.

The HSE has been engaging with the company 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 available resources. The engagement with the company has now resumed and I hope that a positive outcome can be achieved to the benefit of all patients who avail of our health services and all the taxpayers who pay for them.

I want to assure the House that the HSE and I fully understand the concerns of patients regarding the availability of this medicine 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.

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