Dáil debates
Thursday, 15 November 2018
Saincheisteanna Tráthúla - Topical Issue Debate
Medicinal Products Availability
4:25 pm
Alan Kelly (Tipperary, Labour)
Link to this: Individually | In context | Oireachtas source
It is very disappointing that the Minister for Health is not here to deal with this and other issues. This is a particularly important issue. I want to know why a drug, pembrolizumab, is not being made available to cancer patients who require it. The issue has received a great deal of publicity in the context of the case of Vicky Phelan, to whom I spoke before I came into the Chamber for this debate. Pembrolizumab is produced by a drug company here in Ireland - in County Carlow - and is at least two years away from being approved. It has had very significant effects on Vicky Phelan's tumours and on her cancer and has given her a much better quality of life. Like many others, Vicky Phelan has been inundated with requests from people who want to know how they can access this drug. It is not a drug that is on a clinical trial. It is off licence. It is a unique drug because it has been shown to have a significant impact on tumours in many of the cases of those affected. Two leading oncologists in this country, Professor Crown and Dr. Fennelly, have written to the Minister and the Department to ask for this drug to be trialled, or for some method to be found so that it can be provided to cancer patients. These patients need this drug.
Pembrolizumab is unique because patients can be tested in advance to determine their potential responses to it. This makes it cost-effective. The test in question, which is known as the PD-L1 test, costs approximately €2,000. In order to show that one is suitable for this drug and that it will have an impact on one's life, one must score over 55% in that test. Vicky Phelan scored up to 75% in it. Even though this drug is very expensive, it is cost-effective when compared with all the ancillary costs of other treatments, including potential hospital stays. Given that this drug has been trialled in the US, and in light of the US Food and Drug Administration's call for it to be released and approved immediately, I would like to know why a programme has not been put in place in this country to allow it to be used on a trial basis. The Government and the company could work together or some other method could be used to that end.
It is not acceptable that the 221 women affected by the CervicalCheck scandal have access to this drug, but others do not. It is morally right that the State is paying for the 221 women in question to access this drug, as a result of a Cabinet decision. While that decision is morally the right one, what distinguishes those women from people who are not in the group of 221? Why are they not entitled to access the drug in the same way? How is it legally possible for this country to say that a cohort of women who are absolutely devastated by what has happened - I know about this because I am fighting for the women in question - should have access to a drug, and have it paid for by the State, but women outside that cohort should not have the same entitlement? I do not even think that is legal. I think it is illegal. I do not think a Government decision can distinguish between two categories of people in this way. We need to have a plan in place to ensure there is equity in access to this drug for those who need it. We need to put a plan in place quickly because time is not on the side of many of these people. This point also applies to forms of cancer other than cervical cancer and to drugs other than pembrolizumab.
I encourage the Minister of State, Deputy Catherine Byrne, to go back to the Department. I am very disappointed that the Minister is not here. I have raised this issue with him directly. He knew I was probably going to bring it up soon. We need an answer to this. I am speaking with the support of Vicky Phelan and others who have raised the need to get wider access to this drug in a fair and compassionate way.
Catherine Byrne (Dublin South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source
I apologise for the inability of the Minister for Health to be here for this debate. Deputy Kelly could have withdrawn his Topical Issue if he had wished. I have been asked to respond to him on behalf of the Minister. I will read the reply that has been furnished to me. If the Deputy is not happy with it, I am sure some other arrangements can be made.
I thank him for raising this issue. The Minister appreciates that cancer diagnoses place enormous stress on patients and their families. Sadly, very few people in Ireland have been untouched by cancer. Access to potentially beneficial medicines for cancer treatment is an extremely important issue for people. The Oireachtas put in place a robust legal framework when it agreed the Health (Pricing and Supply of Medical Goods) Act 2013, which gives the HSE full statutory power to assist in making decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. The 2013 Act specifies the criteria to be applied when reimbursement decisions are being made. Those criteria include the clinical and cost-effectiveness of the product, the opportunity cost and the impact on resources available to the HSE. In line with the 2013 Act, a company that would like a medicine to be reimbursed by the HSE, must first apply to have the new medicine added to the reimbursement list.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds on the advice of the National Centre for Pharmacoeconomics, which conducts health technology assessments for the HSE and makes recommendations on reimbursement to assist decisions. The National Centre for Pharmacoeconomics uses a decision framework to assess systematically whether a drug is cost-effective as a health intervention. The drug mentioned by Deputy Kelly, pembrolizumab, is reimbursed for four indications: advanced melanoma in adults, first-line treatment for non-small-cell lung cancer, advanced melanoma in adults with combination therapy, and Hodgkin's lymphoma. The HSE has commissioned health technology assessments on the use of this medicine for two other cancers. When the output of this process for each of the additional indications is available, it will be considered by the HSE under the statutory process. The HSE is also deliberating on one further indication for reimbursement. In May 2018, a Government decision put in place a package of support measures for women and families affected by issues relating to CervicalCheck. As part of this package, all out-of-pocket medical costs incurred by the women affected may be met if they are not already covered under existing public schemes or by private health insurance. This exceptional commitment includes medicines which might not be approved for reimbursement, as long as they are prescribed by the treating clinician. Therefore, pembrolizumab would be encompassed under the support package if it is prescribed by a woman’s consultant.
Alan Kelly (Tipperary, Labour)
Link to this: Individually | In context | Oireachtas source
I thank the Minister of State. Obviously, I would prefer if the Minister were here. I appreciate the presence of the Minister of State, Deputy Catherine Byrne, and I acknowledge that she is doing her best. Tomorrow, I have to go to the funeral of a young man and father of three children in Clonmel. He was trying to get on this drug, but unfortunately he never made it. May he rest in peace.
The issue is that the health technology assessment, HTA, for the drug will take two years. Too many women and men in this country will be affected by that timeline. Consultants are willing to administer the drug. The company that produces it is based in Carlow. The drug is available here and there is a test that would determine whether it would give the people affected quality of life or a chance. We cannot tell these people who want a chance that they can wait two years because of all the rules and regulations that are necessary. They do not have time. It costs €8,500 for a three week shot of this drug and €2,000 for the test to be done. People want the chance to spend the €2,000 and have the test. I beg the Minister of State.
Vicky Phelan said on the "Ray D'Arcy Show" that she had to fight tooth and nail to get on this drug and only for her persistence that would not have happened. She is alive and has quality of life. I want the Government to work with this company and the people who need this drug to give them some hope in the same way that Vicky Phelan has given so many people hope. I stress the inequity involved in paying for this drug for the women affected by the scandalous CervicalCheck issue, while having other people outside that. It is not legal to discriminate between people, notwithstanding that it is morally right to treat these women and give them as much as possible. I urge the Minister of State to give the people affected hope, consider this drug, approach the company, consider the trial and some sort of system quickly, given the impact we know this drug has had on some people's lives, particularly Vicky Phelan's.
4:35 pm
Catherine Byrne (Dublin South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source
I thank the Deputy for raising this Topical Issue matter and I apologise again that the Minister is not here. I cannot give a definite response to the Deputy. I can see his compassion for, and passion in speaking about, people who are fighting the scourge of cancer daily. There is no family in this country, including mine, that is not affected by somebody who has either passed away from cancer or is in the throes of that terrible disease. I offer sympathy on my part and that of the Minister for the young man and to his family. I do not know his name so I cannot be more specific.
Alan Kelly (Tipperary, Labour)
Link to this: Individually | In context | Oireachtas source
His name is Martin.
Catherine Byrne (Dublin South Central, Fine Gael)
Link to this: Individually | In context | Oireachtas source
I assure Deputy Kelly that I will speak to the Minister, as I always do when I leave the Chamber. I always make sure that if I cannot get the Minister who has asked me to stand in, I give an outline of the question to a member of his or her staff and request that the Minister respond more comprehensively to the Deputy in question.
Unfortunately, I am not able to say we will be able to reimburse people but I believe that for those who are struggling against this horrible disease, we have to do whatever we can, not only in this House but through medicine and compassion to work on their behalf.