Leo Varadkar (Dublin West, Fine Gael)
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I thank the House for giving me the opportunity to discuss this important issue. It is important to state the decisions on which medicines are licensed for use in Ireland and reimbursed by the taxpayer are not political or ministerial. They are made on objective, scientific and economic grounds by the national drugs committee of the Health Service Executive, HSE, on the advice of the National Centre for Pharmacoeconomics.

The HSE has statutory responsibility for decisions on the 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. It received an application for the inclusion of fampridine, which is marketed as Fampyra in the general medical services, GMS, and community drug schemes. It is indicated for the improvement of walking in adult patients with multiple sclerosis with a walking disability. The application was considered in line with the procedures and timescales agreed by the Department of Health 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 conducted a pharmacoeconomic evaluation of fampridine and concluded that, as the manufacturer was unable to demonstrate sufficient effectiveness and a fair price for fampridine, it was unable to recommend reimbursement for the product. I will lay this document before the Oireachtas Library today to allow Senators consider it in full. On foot of this decision, the HSE decided that it was not in a position to add the drug to the list of reimbursable Items supplied under the GMS and other community drug schemes. The HSE's decision is in line with that in other European countries that have also decided not to provide the drug under their public health systems. It is open to the manufacturer, at any time, to submit a new application to the HSE with new evidence that demonstrates the effectiveness of the drug by offering a reduced price or both.

A revised application was received by the HSE on 25 July. The HSE's corporate pharmaceutical unit has since been engaging with the company. These engagements have been completed and the HSE is now considering the outcome. Fampridine will be assessed, with a range of other applications, for reimbursement of medicines for multiple sclerosis and other diseases. I assure the House that the HSE and I fully understand the concerns of patients about the availability of this drug. While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for any price a drug company demands, I hope it is appreciated that the better interests of millions of taxpayers and thousands of patients require that we only reimburse the most effective medicines and only at a fair price.

I will also this afternoon place in the Oireachtas Library the relevant document of the commissioning board of the British National Health Service, NHS. This document has nothing to do with me, my Department or anything in this country - it is an NHS policy statement from April 2013 based on the London New Drugs Group analysis. That group states that "in clinical trials, a statistically significant improvement in walking time was achieved in fewer than half of patients taking fampridine. The clinical significance of this improvement, of 0.3 to 0.8 seconds to walk 25 feet compared with placebo, is questionable". In layman's terms, the drug did not work for more than half of the patients and the other half were enabled to walk 25 feet 0.3 to 0.8 seconds more quickly than they would have had they taken a sugar tablet or a placebo. The group goes on to state it considers the overall clinical benefit of the medicine to be marginal - it supports a recommendation to not routinely fund fampridine. It is not a miracle drug. The group further states fampridine is not a cost-effective use of NHS resources. Senators will know that this is an expensive drug and I will be placing this view of the NHS in the Oireachtas Library this afternoon.

I also have a Dutch study of December 2012 by the medicinal products reimbursement committee which reaches a similar conclusion. The Netherlands has one of the best funded health services in the world. The study highlights the most frequent adverse effects of the drug, including urinary tract infections, insomnia, anxiety, dizziness, headaches, balance disorders, paraesthesia, tremors, dyspnoea, pharyngolaryngeal pain, gastrointestinal disorders, back pain and asthenia. The study states fampridine has a narrow therapeutic window and a relatively small increase in exposure can lead to a large increase in central nervous system, CNS, side effects such as convulsions. It can even have a negative effect on walking. It also states fampridine cannot be administered to patients with epilepsy and that there is a lack of data on its effects on elderly patients and those with cardiovascular disorders. It concludes that fampridine has a lower therapeutic value than exercise or physical therapy in improving the walking ability of patients with multiple sclerosis. The medicine is deemed to be less effective than physical therapy. The study states there is no proven place for fampridine in therapy. I put this study before the House today.

I am not making the decision, but I want to make it clear that, no matter what decision is made, the door is never closed to new medicines. Even if a drug is refused several times, a manufacturer can always come back with new evidence that demonstrates its effectiveness, a reduced price or both. The possibilities of cost and risk sharing arrangements are open too. In such circumstances the HSE would only reimburse the drug for the small number of people for whom it worked, not those for whom it did not.

The HSE national drugs committee has the difficult job of protecting patients from the false claims and health promises of some drug companies, clinicians and advocacy groups. The committee must also protect the taxpayer in order that resources can be used to best effect for the vast majority of patients. Everyone in this House, including me, as Minister, has a duty to support the HSE national drugs committee in its difficult and important work.

Darragh O'Brien (Fianna Fail)
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I thank the Minister for attending the House. He outlined the studies from the National Health Service in the UK, from the Netherlands and from other countries that claim that Fampyra does not have a positive effect on the symptoms of MS. While I am not a medical doctor, I have testimonies to the contrary from 15 women. The Multiple Sclerosis Society of Ireland, MS Ireland, informed me that up to one third of those suffering with MS have found mobility improvements after taking this drug. Yesterday, I had an e-mail from a lady who since July has paid €279 a month for the drug, €2,115 in total, to enable her stay on in work.

We can argue the toss about whether the HSE or the National Centre for Pharmacoeconomics believes that this drug works or does not work. In his letter to me on 19 February, the Minister stated that while he appreciated that some might take the view that the taxpayer should reimburse every licensed medicine for whatever price the drug companies demand, he hoped I would appreciate that the better interests of the health services require that we reimburse only the most effective medicines and only at a fair price. I completely agree with him on this. I never once in my correspondence to the HSE or the Department of Health, or in contributions here on the matter, stated that we should have open season, approving every drug at whatever the cost. However, Fampyra comes to €279 a month. The evidence that I have, for what it is worth, and the testimonies from MS sufferers who have used it is that they are extremely distressed by the position on the availability of this drug on the general medical services scheme.

Since 25 July, the HSE has been in possession of a revised submission from Biogen, the drug’s manufacturers. It is now nearly December. Whenever we ask the HSE when a decision will be made on this matter, no timeline is given. If the HSE firmly believes that Fampyra is not a useful drug, then it should make the decision to that effect and inform us that is the case. However, I argue against such a decision and urge the HSE to get off its hands - it has had the revised proposal from the drug’s manufacturer since 25 July - to make a decision. We are not talking about a whole hill of beans either, as the cost of the drug comes to €279 a month, and this will cover 15 MS sufferers who reckon the drug works for them.

The only way I am able to get a proper answer on this is by having the Minister in the House to address the matter. The ladies in contact with me, as well as MS Ireland, have not got that type of response from the HSE, however. MS Ireland, I can assure the Minister, is not advocating on behalf of any drug company to make money off the back of the taxpayer. It wants it for its members who believe and have shown that this drug has immense benefits and has improved their mobility, enabling them to be independent. I have spoken to MS sufferers who are back to work because of taking this drug. Others who cannot access this drug are no longer in work, unfortunately.

After these short statements today, I hope the HSE at the highest level will examine this matter and make a decision quickly on it rather than stringing people along.

Colm Burke (Fine Gael)
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I thank the Minister for Health, Deputy Leo Varadkar, for giving a comprehensive reply to this matter. Like Senator Darragh O’Brien, I have been in contact with many MS sufferers for whom the drug was successful. In one case I know, the pharmacy is providing the drug at cost to the MS sufferer. When I raised this matter on the Adjournment on 17 June, I was advised that a new application would be submitted, which happened on 25 July. I agree with the Minister that care has to be taken on the cost of pharmaceuticals, when one considers that in 2000 the health services paid €570 million for medicines but by 2010 this had gone up to €2 billion, a significant increase. Accordingly, we can no longer write blank cheques, which appears to have been the case in the ten years to which I just referred. We need to get value for money.

From my research into this matter, the drug works for some MS sufferers but not for others. There is also an issue around its cost-effectiveness. It is important that a decision is made on this soon, because the drug accommodates people and makes their lives better. For an MS sufferer, it is a condition for life. We must introduce any measure we can for those patients. We must do all possible to come to an arrangement to ensure that the availability of this drug is economically viable.

I have an Adjournment matter this evening on the approval of another drug on the GMS scheme. In this case, an application was submitted by the manufacturer to the HSE in April. My understanding is that a decision should be made in four months but, again, none has been made. In the case of Fampyra, every effort should be made to reach an agreement that will be economically viable for the HSE while providing benefits to those for whom this drug is suitable.

John Crown (Independent)
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The Minister is very familiar with the whole concept of health economics. I do not believe for one second that medicine can be practised in an economic vacuum. I understand that every decision made about a patient has an opportunity cost for another patient who may benefit from a treatment which is denied them because the money was spent on the first patient. It is a question of prioritising and common sense.

On the efficacy of the drug in question, there seems to be a suggestion that because a majority of patients do not benefit from it, it does not work. That would be an extraordinarily high bar to set for any treatment for heart disease, stroke, diabetes, high blood pressure or cancer. In all of these conditions, there is an improvement in outcome when a treatment is given. It may not apply to every patient; it may apply incrementally to some more than it does to others.

The data published by the European Medicines Agency, EMA, the independent agency which is the European equivalent of the US Food and Drug Administration, showed that in two large randomised trials, the percentage of patients who benefitted from Fampyra rose from 8% in the control group to 45% in the treatment group and, in the second study, from 9% to 43%. In oncology, we would be cracking open the champagne if we saw differences that large. I suppose we all look for small victories in our different areas.

For a variety of reasons, the drug has been generally available to MS sufferers. That availability is now compromised and the State is not picking up the tab. We know some benefit from it while others do not. Can I suggest that we do something novel and mould-breaking with this matter, something which is being looked at in other areas, particularly in cancer treatment, namely adaptive reimbursement? This involves essentially those who have benefited from the drug getting the €3,000 per annum for it. I do not want the Minister to take this personally but, several years ago, we had a debate in a different context where it was pointed out that the salary of the public relations adviser for the then Minister for Health would have paid for the drug for 50 patients for a year.

When it comes to prioritising spending on health care, some items are analysed on the basis of cost per year of lives saved, cost per quality-adjusted life year, incremental cost-effectiveness ratio and so forth. This is the argot used routinely in health economics. It is awfully easy to apply it selectively to drugs and not to other matters in the care of patients.

Should we not apply the same criteria to whether a public relations department is necessary, whether a management consultant is required or how many of the 11% extra grade 8 officials who were appointed between last year and this year are justified? How many years of life are saved from appointing those extra folk? Their jobs are probably very necessary and I am sure they work hard, but these are the same types of criteria. There should be an even playing field across the different areas of health spending for this.

With regard to quoting British figures, one of my patients, who shall remain nameless, tweeted today to announce it was his seventh cancer-versary. It is the seventh year since he was diagnosed with an incurable kidney cancer. This man has been kept alive for the last seven years through a variety of treatments, not one of which is available in the United Kingdom's National Health Service. We should not necessarily lower the bar so low as to look at how the British approve drugs for different common diseases. They are the worst in the world. It is widely recognised. The Karolinska study carried out several years ago showed that they have the worst outcomes, certainly in cancer, and these were closely correlated with poor access to cancer drugs. If one speaks to nephrologists, cardiologists, blood pressure experts or experts in any area, they will say that, in general, once one accesses the system into diagnosis, British outcomes tend to be not that great, especially if high tech interventions or medications are necessary.

In the case of this drug, it is not a humane decision to deny it to people who are already benefitting from it. I am not saying the Minister is inhumane, but the decision to take it from people who have had the drug is inhumane. Second, it is bad medicine. It is something that works in a group of people who have had the ultimate biological test. They took it and some got better and some got worse. Those who got better should continue to have access to it. Also, it is bad economics. People who are more immobile and more dependent are people who will cost more money in the long term.

Finally, I did rounds in St. Vincent's University Hospital this morning and I had to visit the emergency department. The Minister should know that all 35 of the bays or cubicles were occupied. There were 40 additional patients in the unit. There was a total of 75 people in the emergency department today, 40 of whom were not in designated places but in various corridors. It was an appalling scene.

Marie Moloney (Labour)
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I thank the Minister for coming to the House for this debate. This subject has been raised several times in the Seanad on the Order of Business. In particular, Senator Darragh O'Brien has been calling for a debate on this issue for a long time and I am glad the Minister is here to discuss it. The Minister says he does not have any input into the matter but, as Minister for Health, I am sure he has some influence somewhere along the line.

I and other Members have received e-mails and letters from people who say this drug works for them. Of course, we will not hear from the people for whom it does not work. If it is not working for them, they will not write to us. The people who are writing to us are the people for whom the drug is working. They are testament to the fact that the drug is working. The Minister referred to a report on all the side effects the drug could cause. I urge the Minister to get a packet of Panadol or any simple drug, because any drug carries a list of side effects. The makers warn people that they can suffer side effects, regardless of what drug they take. Obviously, there will be a list of side effects with Fampyra.

I travelled to Spain with my husband and he forgot his blood pressure tablets. He went to a chemist in Spain and did not need a prescription. He got them over the counter. He got a year's supply of the tablet for the price of one month's supply of the tablet in Ireland. The pricing of medication in this country is outrageous.

Martin Conway (Fine Gael)
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Hear, hear.

Marie Moloney (Labour)
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We should negotiate with the drugs companies to reduce the price of drugs and make them available to people. If the drug works for just under 50% of the people, as the Minister said, that is a huge percentage. It should be available.

Are we back to the position where the cheque book is ruling the health board? The person who can afford this drug will have the chance to walk and be mobile. People who are stricken with MS cannot get on an airplane and fly to Spain or elsewhere to get their drugs at a cheap price. They are grounded here because they are immobile. If this drug helps them in any way, we should support and help them.

Last week, I tabled an Adjournment matter in the House. The Minister was not available but he provided a reply. The matter did not relate to a drug but to an appliance to administer a drug, the i-port Advance, for children with diabetes. It is a simple cannula that goes into the body. It reduces the number of injections from 120 per month to ten a month. That is a huge reduction in the number of injections for children. The injection takes place but it goes through the cannula and does not pierce the skin. The piercings are reduced, not the injections. The reply I received is the same as what the Minister told us today, that it is being considered under the Health (Pricing and Supply of Medical Goods) Act 2013. I appreciate that, but perhaps as Minister he might have some influence or input with regard to negotiating the price of the drug to reduce it to an affordable price for the State and the people.

Gerard Craughwell (Independent)
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One of the phrases in the Minister's speech is telling. He referred to "incorporating new evidence which demonstrates the cost-effectiveness of the drug, by offering a reduced price or both". When one hears that, it becomes clear that the issue is price. Many eminent speakers in the House have referred to the fact that this drug facilitates some degree of recovery in people.

The Minister also mentioned the walking time for 25 feet. I doubt that we are expecting people with MS to run marathons, but if we can get them on their feet it is surely a benefit. The number of people in the country who will benefit from this drug is approximately 1,000. That is a cost to the Exchequer of approximately €4 million, which is not massive. My colleague referred to side effects. I am on Lipitor and there are side effects to that. I am also on aspirin, which has side effects. That did not stop a doctor prescribing them for me.

I ask the Minister to consider approaching the drug company. The trial period is very short. Within two weeks it is established whether the drug will be of benefit to a patient. Perhaps the Minister would engage with the drug company on a cost sharing methodology that might be used so that only those people who will benefit from the drug will be funded on it.

Finally, with regard to health economics, if we can improve people's walking we can prevent situations where people find themselves in accident and emergency departments as a result of a fall. There is a reduction in the demand for wheelchairs, wheelchair access vehicles and so forth. There is also a reduction in the need for carers. When the pricing for this drug is being considered, is that built into the economic model on which that depends?

I will conclude as other speakers wish to contribute.

Denis O'Donovan (Fianna Fail)
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Technically, it was to be just the groups' spokespersons but I will allow two minutes each to Senators Conway and Daly.

Martin Conway (Fine Gael)
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I raised this in an Adjournment matter a number of weeks ago and the response from the Minister then was the same as his speech today. Senator Darragh O'Brien has been campaigning on this issue for a long time because he has been contacted by people for whom this drug has worked. I was contacted by a lady who lives in Dublin who has received enormous relief from this drug. All we can do is rely on the testimonials of the people who contact us. If there are people for whom the drug does not work, that is fine. I am sure there are many drugs on the list that do not work for people depending on their conditions, circumstances, levels of illness and so forth. I believe there is an overwhelming case here.

Of course, it is appropriate that the Minister cannot get involved in the micromanagement of what drugs are and are not accepted. There is a process in place. However, the Minister can express his wish that this would be fast-tracked and examined as a matter of urgency, and perhaps report back to the House. Certainly it is not the Minister's responsibility to make a decision, nor should it be, but he can influence the process, if one can put it that way.

Mark Daly (Fianna Fail)
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I welcome the Minister and thank my colleague, Senator Darragh O'Brien, for campaigning on this issue in recent months. We have the expertise of Senator John Crown who has said no drug works in all circumstances. We have all received testimony on individual cases. The drug, fampridine, was approved on 23 July and patients were able to access it under the general medical card scheme. However, two days later it was put on trial by the HSE and in November, despite people being told they would be able to use it for six months, a particular lady was told she would no longer be allowed to receive it from her pharmacist. The pharmacist was informed not to dispense it to her and she cannot afford to pay for it. That is both a bad process and unfair. The circumstances of the lady in question had improved vastly because of the drug and her mobility had improved. As she can no longer receive it, she is confined to bed. This is a case in which the HSE promised the drug would be available for six months, but it then took it away. Perhaps the Minister might examine the case.

Denis O'Donovan (Fianna Fail)
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I call Senator Feargal Quinn to make a brief contribution as the Minister is due to respond.

Feargal Quinn (Independent)
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I am sorry I was not present to hear his statement.

Denis O'Donovan (Fianna Fail)
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He is under pressure. It was almost 1.05 p.m. when he commenced his contribution. It was only spokespersons who were meant to speak, but I will allow the Senator to make a brief contribution.

Feargal Quinn (Independent)
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I will leave it up to the Chair to decide.

Leo Varadkar (Dublin West, Fine Gael)
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I have two debates to take in the other House in five minutes.

Feargal Quinn (Independent)
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The Minister may have dealt with this query already, but some pharmacists believe the Government's move to reduce the price means that there will be a shortage of supplies. I do not know whether that will be the case.

My other point is that in Greece and one or two other countries when they ran short of money they were not able to buy the right medications because the big pharmaceutical companies decided to do something different - to sell to somebody who could pay the higher price.

What is the Government doing to address the issue of illegible prescriptions written by doctors?

Denis O'Donovan (Fianna Fail)
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They are broader issues. I invite the Minister to respond to the debate.

Leo Varadkar (Dublin West, Fine Gael)
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I accept that other issues were raised, but given that we are already over time and that there will be two further debates in the Dáil shortly, I will confine my remarks to the particular issue, on which I thank Senators for having a rational debate. Sometimes when these issues are debated in the media, the debates are not rational. I am glad that the debate in this House has been.

To respond to the remarks made by Senator Gerard P. Craughwell, this is not just about price, as we reimburse much more expensive medicines all the time; it is also about effectiveness.

I agree with the remarks made by Senator Marie Moloney who is absolutely right in that all medicines have side effects. In deciding which medicines are to be reimbursed one needs to take into account the side effects profile because real harm is caused by medicines all the time. In fact, probably more people die in hospitals every year as a result of medication errors and inappropriate medications than, say, as a result of MRSA. Therefore, the side effects profile needs to be taken into account. It is not the case that all drugs do not have side effects; of course they do.

Senator Marie Moloney also said we needed to negotiate harder with the drug companies and she is absolutely right. That is why the most effective approach by this Chamber is to exert pressure on the manufacturers to put pressure on the industry to reduce its prices, rather than always pressuring the taxpayer to pay more. I hope Senators will take this into account.

On Senator John Crown's remarks, I am sorry if I was not clear. The reason the NHS and the London New Drugs Group - this has nothing to do with Ireland - decided not to reimburse the drug was that it worked for less than half of patients, and even for those for whom it did work, the average improvement in walking was 0.3 to 0.8 of a second, only slightly better than the rate for a placebo. That many drugs do not work for all patients is not new, but for those whom it did work, the average improvement was minimal. That is not to say there may not be a smaller sub-group who have responded and for whom the drug may work very well. That is a possibility, although the evidence does not yet support it.

I note what was said about PR advisers and take the Senator's point. We should apply the same rules to all Government spending. If I was to be mischievous, I might suggest we apply the same argument to the Seanad. As somebody who actively supported its abolition, the cost of maintaining this Chamber would be better spent on the health service, but we have had that debate. Certainly, if this Chamber wants to talk about rational spending, I will happily-----

John Crown (Independent)
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On a point of information, the money would not be spent on health services; it would be spent elsewhere in the bureaucracy of government.

Denis O'Donovan (Fianna Fail)
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I ask Members not to be mischievous.

Leo Varadkar (Dublin West, Fine Gael)
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I do not think we can justify irrational spending on health services. That applies across the board, including to us.

On Senator Darragh O'Brien's comments, I appreciate that people are awaiting decisions since 25 July from the HSE national drugs committee. I have not yet been advised of the decision and, as Members are aware, I do not have a role in making it. However, I reiterate that whatever the decision is, the door is never closed.

Gerard Craughwell (Independent)
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Extend the scheme until the decision is made.

Leo Varadkar (Dublin West, Fine Gael)
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It is always open to the manufacturer to submit new evidence, a new reduced price, or both, or, as Senator John Crown has suggested, there is always the possibility of a cost-sharing arrangement whereby the HSE would only reimburse the cost of medicine for those in whom it was proved to work. These are all options, but we need to start to put pressure on the industry to come up with and agree to such arrangements, rather than always putting pressure on the taxpayer to pay more and more.

Darragh O'Brien (Fianna Fail)
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We need a decision from the HSE.

Denis O'Donovan (Fianna Fail)
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I thank the Minister, whose time is up.

Terry Brennan (Fine Gael)
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I propose the suspension of the Seanad for 15 minutes. The Minister has been delayed in the Dáil.