Paddy Burke (Fine Gael)
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I welcome the Minister, Deputy Varadkar, to the House. The next motion is Senator Thomas Byrne's and I understand he is sharing time with Senator Whelan.

Thomas Byrne (Fianna Fail)
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I thank the Minister for coming to the Seanad and wish him the best. I will speak about a young man, John Duggan-----

Paddy Burke (Fine Gael)
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I ask the Senator to refrain from naming people on the record of the House.

Thomas Byrne (Fianna Fail)
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The gentleman himself is here today, in the first seat beside the door in the front row of the Visitors' Gallery. He is a young man from Bellewstown in County Meath and I believe he deserves the chance of a normal life and, indeed, the chance of life. John was diagnosed with paroxysmal nocturnal haemoglobinuria, PHN, in 2010. It is an extremely rare blood disorder which is characterised by the breakdown of red blood cells, as I am sure the Minister will know only too well being a doctor himself. I understand about a third of patients with PHN die within five years. In John's case, PHN is resulting in him having blood transfusions every six weeks or so, he is lethargic and he greatly fears blood clots. He describes his prognosis in his own words:

I am getting worse and worse. There is every chance I will have a heart attack or kidney failure. A blood clot is definitely coming and this is not a time for messing around.

This strikes me as fundamentally wrong, unethical and unfair. How can this State arbitrarily decide that Mr. Duggan is different from those already being given the medicine by the State? How are these decisions made?

May I quote from Mr. Duggan's GP, Dr. Oliver Lynn?

Paddy Burke (Fine Gael)
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I ask you to refrain from putting the names of people on the record of the House because they are not here to defend themselves.

Thomas Byrne (Fianna Fail)
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His name is already on the public record. He said that he would urge the HSE to consider providing to this young man the correct treatment before he reaches catastrophic thrombosis, which would be catastrophic. I will not name his consultant haematologists but will quote them. His consultant said that given the overwhelming evidence that eculizumab is the only effective therapy for PHN, and given that the HSE already funds eculizumab therapy for ten patients, they believe there is a very strong moral and ethical argument that the HSE should agree to fund eculizumab.

I ask the Minister, his officials, the relevant body and the HSE to please reconsider the decision. Please give this man, and the other person of whom I know affected by this, the chance of life. Please do not tell him and his wife, Aileen, that there is no hope for them.

John Whelan (Labour)
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I am particularly heartened to see the Minister, Deputy Varadkar. I am grateful to him for taking these questions from myself and Senator Byrne. It is not unfair to say the Minister is regarded as one of the most forthright, upstanding and decent politicians of all time. His reputation and credibility precede him. I am not saying that, in any way, as a charm offensive but I know he is a straight-talker who will do anything that can, and should, be done. In that regard, we appeal for fairness, natural justice and basic equity of medical provision for the handful of people in the country who have been diagnosed with the rare blood disorder PNH, including Ms Mary Gorman from Ballinakill in my neighbourhood.

Paddy Burke (Fine Gael)
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I have already explained this to Senator Byrne and I ask you to refrain from naming people on the record of the House.

John Whelan (Labour)
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I respect that but Ms Gorman has travelled here today from County Laois to be with us. She has gone public on this as a result of suffering in silence for the past two years in what has turned out to be a vain hope that the HSE would address her medication and her treatment, as recommended by her consultant team and haematology team from St. James's Hospital whose reputation is second-to-none in the world, as is the work it is carrying out there. It does not lightly prescribe and recommend this treatment, which first became available to ten patients in this country, as Senator Byrne said, as far back as 2010. It is proving to be technically excellent and it is a life-saving intervention. There is no other way to put it. It is beyond me how we can continue to stand over making fish of one and flesh of another. There is no equity to it.

Notwithstanding that, the moral bankruptcy of the exorbitant fees the pharmaceutical company which manufactures Soliris charges, the State has to intervene and make the best possible treatment available to Ms Mary Gorman and the handful of people who have this rare condition. We appeal to the Minister. One word from him to the HSE could resolve this and we appeal for that.

Leo Varadkar (Dublin West, Fine Gael)
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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.

Paddy Burke (Fine Gael)
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A brief question, Senator Byrne.

Thomas Byrne (Fianna Fail)
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I would make a brief comment. There are significant differences between what the Minister read out and his script. He completely changed the meaning of one sentence and read out additional information. I am not complaining to the Minister but if one only had the script-----

Leo Varadkar (Dublin West, Fine Gael)
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I think it may state "now" but it should be "not".

Thomas Byrne (Fianna Fail)
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Yes. The Minister also read out another paragraph which put a bit more meat on the bones.

I appreciate the Minister does not deal with individual cases but there are so few of these cases that they must come under consideration. If the Minister is looking for evidence of a history of transfusions in a case, that is certainly the position in the case of the person I spoke about earlier. The Minister stated that the HSE is considering the outcome of that engagement. Does that mean that people should be awaiting a decision or has a decision been made? That is my follow-up question. I appeal to the Minister is the nicest possible way because I do not want to be political, critical or anything like that on an issue like this that affects people's lives. I ask him to please look at this. There is a fundamental unfairness here in that ten people have this drug. I do not know the terms of the agreement with the company for those ten people but they have the drug. They have the chance of life. I ask the Minister to please give it to the other people who badly need it.

John Whelan (Labour)
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I thank the Minister for his reply. I was glad to hear him say that the door is not closed. However, time is of the essence. The conduct of the pharmaceutical company is despicable in this regard. I urge the Minister to use his good offices to ask the HSE to engage with urgency on this and come to a positive conclusion with urgency. People's lives are at risk here and we must help them if we can at all.

Leo Varadkar (Dublin West, Fine Gael)
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The HSE national drugs committee and the HSE as a body corporate is always open to pharmaceutical companies to make new applications or revise applications. Members may be interested to know that Alexion as a company has a revenue of €1.15 billion, had profits of €253 million and equity of €2.4 billion. The chief executive officer of the company is paid €12 million a year. In Belgium in 2013, politicians of Government and Opposition alike alleged that the company was guilty of moral blackmail when it was discovered byDe Standaard, a newspaper in that country, that Alexion had hired a PR company to help a nine-year old child who was denied the drug by the Belgian authorities.

The parents of the boy believed that they were being helped by a patients' organisation and were not told that a PR company was behind it. That is the kind of thing we are dealing with in these cases.

Thomas Byrne (Fianna Fail)
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There is no PR company in this case. None whatsoever.

Leo Varadkar (Dublin West, Fine Gael)
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There may not be, but there was in Belgium.

Thomas Byrne (Fianna Fail)
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There is not.

Leo Varadkar (Dublin West, Fine Gael)
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I do not suggest that there is in this case. This is a company that is very aggressive in the way it prices its medicines. The door is never closed to a new medicine. The company can present new evidence, a better price, or both. I call on the Seanad to stand behind the taxpayer in the interests of patients as a whole and support the HSE national drugs committee in its efforts to ensure a fair price for this medicine. Even though I have no direct role in this matter at all, and do not make decisions under legislation, I am of course happy to discuss the matter in the Seanad today, and there will be a similar question in the Dáil tomorrow. However, I suggest to Senators that the Joint Committee on Health and Children might call in representatives of Alexion in order to help in a way that might be most effective by putting pressure on the company to do right by Irish taxpayers and patients.