Robert Troy (Longford-Westmeath, Fianna Fail) | Oireachtas source

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.

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