Brendan Griffin (Kerry South, Fine Gael)
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I thank the Minister of State, Deputy White, for coming to the House to respond to this matter. I first became aware of this problem on Facebook, when a constituent tagged me on a post uploaded by a young Galway woman in relation to the circumstances facing her family, particularly her mother who suffers from MS. Rather than try to describe the situation I propose to read into the record the post uploaded onto Facebook by the young woman, which I believe will illustrate the situation far better than I can. It reads:

I don't normally make statuses like this on FB but our government needs to see and hear what effect the decisions they make have on families, from the families themselves! My name is Caitriona I'm a 24 year old student nurse, from Galway originally but I'm studying in Sligo. As you know, nursing is a profession that involves providing high quality care and treatment for the sick and promoting health for all. And as a nurse the situation my family is facing at the moment has greatly affected me because our country won't provide my mother with the treatment she needs. We recently received the news that my mum, who has Multiple Sclerosis, will no longer receive her medication (Fampyra) on the Long Term illness Scheme. Meaning that she will now be forced to pay 500 euro a month if she wants to have the only tablets that have treated the symptoms of her MS in particular her walking ability and fatigue. My mum retired early because of the illness, and her loss of mobility and loss of power in her arms and hands, she uses a collator to walk, and has a hand controlled adapted car as her legs have severely reduced power, she has foot drop and has had two falls, one of which took me and my brother ages to get her off the ground and resulted in a fractured shoulder. Watching the effects that her condition has on her has been awful, hell actually and without her medication things will progress sooner. It will be impossible for her to afford these on the pension that has already been cut and making ends meet at the moment is already difficult. She currently has a six weeks supply left and if I have to write to every TD in this country for the next 6 weeks I will, because she needs this medication as much as anyone with a terminal illness needs theirs! This issue is not only affecting her but others around the country and it needs to be brought to your attention, and I cant emphasise this enough! It took me hours to write this because I couldn't get the words out, but because of the fear of what the future has for her, I did!! Please like and share this status in the hope that someone hears my voice and yours in support of my mums treatment.

In a recent article in The Irish Independent a man said that the drugs allow him to continue to do a job he loves, pay taxes and not need any home care. He has been on the medication for three years and in one instance when he could not get the drug for two weeks he went from using one stick to needing two sticks to walk. The article states:

If I forget to take one of the tablets I am very unsteady and can barely walk. It gives me the strength to lift my feet up steps and basically get around the house and get in and out of work. In the evening when I have a double dose in my system I can even climb a flight of stairs.

I have gone on to secondary progressive multiple sclerosis and there is no cure. All I can do is hope that it will not get bad quickly.

Alex White (Dublin South, Labour)
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I thank the Deputy for raising this issue. I wish to clarify that Fampridine, Fampyra, was never available to multiple sclerosis patients under the long-term illness scheme. However, I understand that the manufacturer of Fampyra supplied the drug free of charge to some patients who were prescribed it by their clinician. The manufacturer has recently decided to stop supplying the drug free of charge and, as a consequence, these patients are now faced with financing the drug themselves if they wish to continue with this drug treatment.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE received an application for the inclusion of Fampridine in the GMS and community drugs schemes. The application was considered in line with the procedures and timescales agreed by my Department and the HSE with the Irish Pharmaceutical Healthcare Association, IPHA, for the assessment of new medicines.

In accordance with these procedures, the National Centre for Pharmacoeconomics, NCPE, conducted a pharmacoeconomic evaluation of Fampridine and concluded that, as the manufacturer was unable to demonstrate its cost-effectiveness in the Irish health care setting, it was unable to recommend the reimbursement of the product. The report is available on the NCPE's website.

The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable. In these circumstances, the HSE has not approved the reimbursement of Fampridine under the community drug schemes, including the long-term illness scheme.

I understand that studies are ongoing to assess the wider impact of Fampridine on both walking and quality of life for persons diagnosed with multiple sclerosis. The account the Deputy read out demonstrates a very real human situation. The description of the very real circumstances faced by the individual concerned was very eloquent. The studies to assess the wider impact of the medicine in question are ongoing. The results of these studies will contribute to the evidence base demonstrating the clinical effectiveness of Fampridine that can be used to support future applications for its inclusion on the lists of reimbursable items supplied under the community drugs scheme. In this context, it is open to the manufacturer, at any time, to submit a new application to the HSE for the inclusion of Fampridine on the community drug schemes.

I understand the manufacturer has indicated to the HSE that it intends to submit a revised application for Fampridine. The HSE will then re-consider the application in line with the agreed procedures and timescales for the assessment of new medicines.

Brendan Griffin (Kerry South, Fine Gael)
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I thank the Minister of State for his response. I welcome the indication from the company that it is trying to submit a new application to the HSE. However, time is of the essence as the end of June is not very far away. My concern, which I am sure is shared by the Minister of State, relates to the individuals whose supply is running out. The lady in Galway, to whom I spoke last Friday and whose testimony was quite similar to that of the man from Wexford, stated she was without her drugs for a very short period when she realised the consequences. She did not feel the drug was making very much difference in her life until she went without it, at which time she regressed very quickly. When she went back on the drug, she was able to do things she was not able to do when off it.

Can the Department take a proactive approach to this and engage immediately with the drug company to try to find a resolution to this matter? One particular chain of pharmacies is offering the drug mark-up free but it is still beyond the affordability of many. We must bear in mind also that people in the circumstances described have considerable expenses in addition to that of the drug. Providing the drug at an affordable rate or free of charge would be of some help, although it would not fix everything financially.

Would it be unprecedented for the Minister of State to engage directly with the company given that there is a specific problem for the people to whom I have referred? Can something be done more quickly than normal given the human cost associated with the people in question not being able to have their drugs?

Alex White (Dublin South, Labour)
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Although I believe it would probably not be appropriate for a Minister to engage directly with the company, I understand and accept very much the force of what the Deputy states in respect of the case in question. The only way the process can be triggered is for the manufacturer to submit a new application. I do not believe that has happened yet but I understand it is to happen. I will certainly give any undertaking I can to the Deputy and the House. As I said, the HSE will reconsider the application. It has to go through particular procedures in regard to balancing the efficacy of the drug against the cost. That process must be engaged in on behalf of the State. It is often very difficult when somebody is in a very particular human situation and in need of the support of a particular medicine or drug to address the opposite side of the case, that is, the fact that the drug must be assessed for efficacy and that this must be balanced against the cost. The drug in question is the subject of some comment — I do not know whether I should describe it as controversy — in the United Kingdom owing to an assessment by the National Institute for Care and Excellence, NICE, the equivalent of our assessment organisation. This is a live issue. It may be of some comfort to the Deputy to know that I will do everything in my power to ensure that once the process is triggered by an application, it will be expedited by the HSE so the matter will be addressed and dealt with as quickly as possible.