Helen McEntee (Meath East, Fine Gael)
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I thank the Ceann Comhairle for accepting this issue and I thank the Minister for coming into the Chamber to take it.

I acknowledge the presence of Mr. John Duggan, his wife, Aileen, and his brother, Stephen, who are in the Gallery. John is a suffer of paroxysmal nocturnal haemoglobinuria, PNH, the disorder that I am about to outline. I want to acknowledge they are here and that they have gone through a lot to get here.

PNH is an extremely sensitive and tough issue. I feel helpless in this respect as I do not have a medical background and while I am doing my job as a Deputy, we are talking about a life-threatening illness and a young man's life. PNH is an extremely rare and debilitating blood disorder. It is essentially characterised by the breakdown of red blood cells. Mr. John Duggan who is from Bellewstown in County Meath was diagnosed with this rare blood disorder in 2010. Since his diagnosis he, his wife, Aileen, and their family have probably been terrified every day and every night that John will have a blood clot, kidney failure, a heart attack or God knows what else. He is currently receiving blood transfusions every six weeks. I do not know how he does it but he has managed and continues to manage to work since his diagnosis in 2010. That is no way for somebody to live, especially when a treatment is available, has been diagnosed and is known to his doctors and himself.

The drug to which I am referring is Soliris. It is one of the most expensive drugs in the world. It costs more than €400,000 a year. While I acknowledge that is great deal of money, we are talking about a man's life. I could perhaps acknowledge what has happened in this respect if we were talking about 400 or 500 people, but I am taking about two people, John being one of them. The Minister might clarify if there are many more people who are in need of this drug.

I understand that in 2008 the HSE entered into an interim agreement with Alexion Pharmaceuticals, the company that makes this drug, and St. James's Hospital to treat four people and after two years they decided to continue this treatment but also to include a further six people. At present ten people who are sufferers of PNH are availing of the drug, yet there are two people who are sufferers who cannot avail of it. That is extremely unfair and unethical.

There are three components involved. One is the Minister's Department and the HSE, which essentially work together. Another is the National Centre for Pharmacoeconomics, NCP, which essentially decides what drugs are or are not accepted. Another is Alexion Pharmaceuticals, the company that makes this drug. The Minister made his view on this known last week and I thank him for his comments in the Seanad, and I understand the job he has to do. The NCP has made its views well known by the fact that it will not accept Soliris into the community drugs schemes because it says it is too expensive. Alexion Pharmaceuticals has made its views very clear by the fact that up to now it has not been willing to engage and to lower the price of the drug, which seems to be the main problem. We need these three components to come and work together to find a solution now, not in six or ten months time. For the company and the HSE, an issue that might continue for weeks might not seem to be a long time, but for John and his wife this is a lifetime. I am aware that in the last two days Alexion Pharmaceuticals has re-engaged with the HSE and other relevant bodies. That is good but while they are talking about it and I am talking about this issue now, John and Aileen will still go home tonight not knowing exactly what is happening or whether he will be able to avail of this drug.

I urge the Minister to help further facilitate these meetings and to try to find a solution, however it may be found, because we are talking about a young man's life.

Leo Varadkar (Dublin West, Fine Gael)
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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.

Helen McEntee (Meath East, Fine Gael)
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I thank the Minister for his response, but I must stress that two people are involved. While I understand that we need to consider a cost-benefit analysis and the cost to the taxpayer, this does not involve a large number of people. The two people concerned, out of a possible 12, are not involved in a pilot scheme. I am aware that the company met HSE officials and other bodies this week and is engaging in talks, but we know from a number of different people that talks have been ongoing for years. This is something which should have been resolved a long time ago. I ask the Minister to facilitate these meetings and to find a solution.

I have brought this matter to the attention of the chairman of the Committee on Health and Children, Deputy Jerry Buttimer, who met John and his wife Aileen last week. He has promised to monitor the situation and if progress is not made it would possibly consider bringing the relevant bodies before the committee. We hope it does not get to that stage. I urge all bodies to come together to find a solution to this now, rather than after a number of weeks or months have passed.

Leo Varadkar (Dublin West, Fine Gael)
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I appreciate that the Deputy has referred to two people, and that is the perspective from which she is coming. It is fair to say that the HSE national drug committee has to take a slightly different perspective, and has to have regard to the tens of thousands of other patients also in need of services and the millions of taxpayers who fund them. In that context, a medicine which costs nearly €1 million for two people would be enough to provide a primary care service for an small town, which could improve the health of, and maybe even save the lives of, tens of people. As the Deputy knows, €1 million would hire two consultants and five midwives who, through their work on a daily basis, could improve and save thousands of lives. That is the reality of healthcare funding and it is true for very wealthy countries as well as those under financial pressure. Resources are limited and have to be used in the best interests of as many people as possible.