Wednesday, 24 September 2014
Topical Issue Debate
Medicinal Products Supply
I thank the Ceann Comhairle's Office for affording me the opportunity to raise this extremely important topic. I ask the Minister for Health to intervene to ensure that the HSE puts in place an early access programme for patients with hepatitis C to a new direct acting antiviral drug. We all know that these patients were infected with hepatitis C through no fault of their own. Their infection came about as a result of negligence on the part of the State.
A couple visited me at my constituency office before the summer recess with a harrowing tale. My constituent, Mrs. Kennedy, who does not mind being named in the House, was infected with hepatitis C 15 years ago. At that time, the then Minister for Health, Deputy Michael Noonan, assured her and approximately 1,000 other patients who were accidentally infected that they would receive the best possible care and treatment. Mrs. Kennedy is now dying from cirrhosis as are around 200 other patients. There is a legal issue here as the court judgment stated that if the condition of patients deteriorated and they developed cirrhosis, their cases could be reopened. However, these people do not have the time to go to court. The Kennedy family examined the possibility of purchasing the new drug privately abroad but to no avail. The cost of purchasing the drug here is close to €50,000.
A consultant from St. Vincent's University Hospital has told me that the drug Sovaldi offers my constituent and many other patients a 90% chance of survival. It has been approved in almost all other European countries but Ireland is lagging behind. The consultant wrote to me informing me that Mrs. Kennedy attends the hepatology clinic at St. Vincent's University Hospital in Dublin and that she was infected with hepatitis C following a contaminated blood transfusion many years ago. She has established liver cirrhosis and has developed a complication called ascites. Without viral eradication, according to the consultant, Mrs. Kennedy's prognosis is poor, with an annual risk of further decompensation or death of approximately 20% per year. Viral eradication could dramatically alter this prognosis and is potentially life-saving. He stated that the current standard method of care, which includes the drug Interferon, would be deleterious to Mrs. Kennedy, given the advanced stage of her liver disease. The consultant maintained that exciting developments in the field of hepatitis C virus biology have led to the development of new direct acting antiviral, DAA, drugs. These agents provide, for the first time, an effective curative therapy for patients with advanced cirrhosis.
The consultant went on to explain that the first DAA drug with potential in these patients has recently been licensed in Europe. The Scottish Medicines Consortium completed its assessment of Sofosbuvir and approved it for use in Scotland. Recently, an early access programme using Sofosbuvir and Daclatasvir in combination has been approved by the NHS in the UK to treat a cohort of 500 patients whose condition is similar to that of Mrs. Kennedy. They are in the advanced stages of the disease and are likely to develop serious complications while awaiting National Institute for Health Care and Excellence, NICE, approval for more widespread use. Early access programmes have been developed and are under way in several other European countries and are providing life-saving therapy to the most critically ill patients. The consultant also informed me that a funded early access programme for DDA drugs in Ireland would have an enormous impact on Mrs. Kennedy and similar patients, with expected cure rates of greater than 90% and a risk reduction rate for complications from cirrhosis and death of in excess of 80%.
Does the Minister of State agree that these high-risk patients need an early access programme now? Such a programme could be initiated through the Irish Hepatitis C Outcomes Research Network, ICORN at the National Centre for Pharmacoeconomics. If something does not happen in the next few months, these patients will die.
I thank Deputy Tory for raising the issue of hepatitis C which is not just topical, but also a significant public health problem with its associated burden on individuals, families, health services, communities and society. We all know the origins of the difficulties for many hepatitis C patients in Ireland, although the people to whom Deputy Troy refers are not the only sufferers in the country. We are talking about a specific cohort of people in this instance but there are other hepatitis C sufferers in Ireland.
The development of new and innovative medicines for the treatment of hepatitis C is an opportunity to alleviate the burden for patients, their families and society as a whole. There are a number of new direct acting antiviral, DAA, therapies licensed in Europe for the treatment of hepatitis C. It is expected that several other therapies will be licensed in the coming months. However, these products have a significant cost. One of these new treatment regimens includes Sofosbuvir or Sovaldi which has been the subject of recent attention. The HSE received an application in February 2014 for the inclusion of Sofosbuvir in the GMS and community drugs schemes. The application is being considered in line with procedures and time scales agreed by the Department and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines. I am sure that Deputy Troy would agree that we must ensure the safety of patients in Ireland.
In accordance with these procedures, the National Centre for Pharmacoeconomics initiated a pharmacoeconomic evaluation of this new product in June 2014. The health technology assessment report on Sofosbuvir is expected in mid-October. This evaluation will provide detailed information on the potential budget impact of the medicine. It will also assess whether the products are cost effective at the price quoted by the manufacturer, and I am sure the Deputy will accept the importance of that point. This evaluation provides valuable information to enable the HSE to take a decision on the funding of this new medicine and ensuring that it is clinically appropriate, fair, consistent and sustainable.
With the advent of these new treatment regimens which are better tolerated by patients, it is necessary to consider how to optimise access to these treatments in a managed way over the coming years. In that regard, my Department is chairing an expert advisory group to advise the Minister for Health on the optimal management and treatment strategy for patients with hepatitis C. This group will advise on the development of a public health plan that will focus on the treatment and management of people with hepatitis C which will lead to reduction in prevalence in the population and a reduction in infection and spread of hepatitis C. Decisions around the feasibility of a HSE early access programme to these drugs will be considered in this context.
I hope this information is of some help to the Deputy. We are all very conscious of the urgent need as outlined by him.
I thank the Minister of State for the response but she has not answered my fundamental question, namely, whether the Department of Health will instruct the HSE to initiate an early access programme. Quite frankly, we do not have time for feasibility studies. The Minister of State made reference to significant costs but these people were infected as a result of negligence on the part of the State. What cost do we put on a person's life? That is the fundamental question. We do not have time to wait. Other countries did not wait. This drug is being used in England, Scotland and other countries across Europe.
The Minister of State also made reference to the expert advisory group - the setting up of which I welcome - which will look at the long-term roll-out of treatment for these patients. However, those same patients feel that they do not have any input into that process. They are also very concerned that they also have no input into the decision-making process regarding an early access programme. That is the issue we are discussing here today. We are talking about a specific cohort of patients who urgently need an early access programme.
These patients have been identified. The Minister of State is worried about costs. That group, ICORN, has identified the patients most in need of this treatment and it is willing to identify the patients who should avail of the early access programme so that we can keep control of the costs.
We need to act now to ensure that my constituent and in the region of 200 others do not die. We simply do not have to time to wait. If we do not act now, people will die prematurely.
I am not certain Deputy Troy heard fully all of my reply. I stated that the health technology assessment report is expected in mid-October. We are almost at the end of September and it is just another month away. It is important, and I am not dismissing for one minute the urgency of all of this.
We are also taking a serious look at clinicians who would have to identify who within the 200 to 300 - it would not be only 200 - would have significant clinical need. We all are conscious of that. Equally, for our own sake - because there have been issues with medications, although I am not saying that in this case it is so - it is important that within our own domain we have clinical governance over what we use in this country. I have always been a strong advocate of that. We cannot merely accept what others say.
In terms of cost, which is an issue, it is a terrible pity that we do not have some kind of collaboration within the European Union on such drugs. If there were and if one decided to use it, the bigger the market the better the deal and, therefore, the better the service one would be able to get for those who need such extremely expensive but innovative and exciting drugs. We must accept that medication is changing constantly.
It will be mid-October when we will have this report back to us and a decision will be made then. That is not too long to wait. If we were talking about June next year, I would be agreeing with Deputy Troy.