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

I thank the Senators for raising this important issue. As Senators will know, I cannot comment on individual cases and I make no decisions on individual patients. There are no patients' charts on my desk so my remarks relate to the issue at hand and not any individual patient. The HSE has statutory responsibility for the decisions on pricing and reimbursement of medicinal products under the community drugs scheme 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 to reimbursing any medicine, including clinical need, effectiveness, costs 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 in St. James's Hospital. 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. It is 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, a sort of trial, 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 evidence would emerge which would assist with the future decision on making this drug.
The HSE received an application for the inclusion of eculizumab 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. I have that evaluation from October 2013. In it it concludes that there is evidence that the medicine is a treatment for adults and patients with paroxysmal nocturnal haemoglobinuriam, that it reduces transfusion requirements and there is weaker evidence that it reduces the risk of thrombosis, renal failure and mortality. Furthermore, evidence of clinical benefit in the treatment of patients with PNH is limited to patients with a history of transfusions. It also concluded that the total cost per patient per year of €437,247 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 the therapy. Consequently, the National Centre for Pharmacoeconomics was unable to recommend reimbursement of the product under the community drugs scheme.
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. I am informed that engagement with the company has now been concluded and the HSE 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. Nonetheless, the door is notclosed to a new medicine and it remains open to the company to come back with new evidence, a new price, or both.
I want to assure the House that the HSE and 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, our entire body of patients in the country and the taxpayer require that we only reimburse the most effective medicines and only do so at a fair price.