Versatis Medicated Plasters: Statements

Spokespersons have eight minutes and can share time.

I thank the Leader and Members for the opportunity to address this important issue on behalf of the Minister, Deputy Harris, who is unable to be here, and I look forward to hearing the Senators’ contributions. People are rightly concerned about this issue, and I am conscious of the impact which a change in reimbursement arrangements has had on individual patients.

As Minister of State at the Department of Health, I have tried in everything that I do to put the interests of patients first. Of course I can empathise with people who are experiencing all sorts of pain, whether post-shingles or otherwise, and who are of the belief that lidocaine plasters offer the best course of treatment. That is why the Minister, Deputy Harris, has worked with the HSE over the last couple of weeks to seek to make the new arrangements as compassionate as possible, all the time accepting that clinical evidence and patient safety must be the first consideration. In that context, I will outline the background to the decision by the HSE's medicines management programme to change the arrangements that had applied. I will also outline the process that is now in place to enable patients to seek continued access to the lidocaine plasters.

Lidocaine plasters are licensed for localised post-shingles pain in adults. This is the only licensed use in Ireland. The plasters have been reimbursed through the community drugs schemes since 2010. When the plasters were first introduced the budget impact was low because of the specific indication for which they are licensed. It was a cause of clinical concern when, from 2012 on, usage increased significantly, to the point where we were using more plasters than the entire UK National Health Service, which serves ten times our population. When a treatment is intended for a small group of patients and evidence suggests that it is being used for many times that number, it is important and appropriate for clinicians to review its use. That is what happened in 2016 when the HSE medicines management programme reviewed the use of the plasters. The review estimated that only 5% to 10% of prescribing had been for the licensed indication.

Following the clinical review, and to ensure the most appropriate patient care, the HSE introduced a new reimbursement approval system from 1 September 2017. This was a clinical decision made by the HSE in the interest of appropriate prescribing and patient safety, which should always outweigh all other considerations.

The introduction of the new approval system was flagged in August 2017 when details of the proposed changes were circulated by the HSE to prescribers and pharmacies. This gave practitioners time to inform patients about the changes and, where appropriate, to change treatment or seek continued treatment. This advice has been re-issued in the last week, and information for patients and practitioners is on the HSE medicines management programme website page.

Under these new arrangements, all patients who were receiving lidocaine plasters for the licensed indication, shingles, were automatically approved on the HSE system. All these patients continue to receive the treatment under the community schemes. Patients who had been prescribed lidocaine plasters for other indications were given a three month grace period. They would continue to receive the lidocaine plasters up to the end of November but were required to be registered by their GP for continued reimbursement approval after 1 December. In other words, from 1 December 2017, non-shingles patients no longer automatically qualified for the lidocaine plasters. The system put in place enabled their GPs to apply, using a dedicated online system, for continued use. If an application is refused, the GP may appeal, making a clinical case for the patient.

The HSE advises that the turnaround time for applications is three working days and for appeals, it is five days. I want to stress that non-shingles patients can still be approved for plasters through the community schemes, where their GP can make a clear clinical case. As of last Friday, approximately 1,500 post-shingles patients have been approved and the plaster is being provided to these patients in the normal manner. Another 4,784 patients were registered by their GP for use other than post-shingles pain, and 14% of these, or 670 people, have been approved. In addition, 284 online appeals have been made, including patients who were never registered and over 65% of these appeals have been approved.

This means over 2,300 patients are now approved for the plaster in the drug schemes, with more than 850, over one third, approved for use other than post-shingles pain, based on the clinical case made by their GP. It is clear this new process supports appropriate use and prescribing. Both post-shingles patients and other appropriate cases can continue to be treated with lidocaine plasters.

I call Senator Murnane O'Connor. Is time being shared?

It is. I am taking five minutes and Senator Daly is taking three minutes if that is okay?

Yes, I will let the Senator know when there is a minute remaining.

I would like to thank the Minister of State for coming to the House but I am disappointed the Minister, Deputy Harris, is not here. This is a serious issue and it is not being addressed. Since the removal of Versatis patches from the drug payment scheme some weeks ago, I, my Seanad colleagues and members of the Fianna Fáil Party have witnessed people's tears, desperation, distress and pain. The HSE introduced a new scheme for lidocaine, a 5% medicated plaster known as Versatis patches, from September 2017. That was without what I would consider fair warning. I know the Minister of State said three months' notice was given but that was given to doctors. Many people buy them under the drug payment scheme or get them on their medical cards every few months, so that certainly was not long enough.

From 1 December 2017, non-shingles patients were no longer to receive this under the drug payment scheme. Doctors and consultants were still prescribing it but the patients could no longer access it unless they had the money to pay for it. I believe this is down to money and to someone in the HSE deciding that people in England, a larger country, were not using as many patches as people here. We have people crying in chronic pain but because we are spending too much, they are being told that they cannot have it. I have a major issue with this.

According to reports I read, more than 25,000 people were affected when Versatis patches were removed from the scheme in December following a review. Some have said their health and quality of life have rapidly gone downhill since. Versatis patches cannot be purchased without a doctor or consultant prescription. Doctors are still prescribing it. However, the HSE seems to think it knows more than doctors and consultants in regard to what is good for a patient. It points out that the patches are not licensed for use for many of the ailments for which they were being prescribed. Of the roughly 200 appeals the HSE received, it said that over 50% were accepted on clinical grounds. It also said it wrote to all GPs in August 2017 advising them of the changes and of alternative treatments and it published a patient information leaflet. Many people who spoke to me did not see it. The news came as a shock and a surprise to most, if not all, the patients who were told they could no longer receive the patches under the drug payment scheme.

Doctors, patients and their families took to radio shows, social media and places they felt they would be heard. The common thread in their conversations was these patches had become a lifeline and to take them away was cruel. The Department of Health said it had been informed by the HSE that it is possible for non-shingles patients to be approved for the patch under the scheme. We were told the patient's GP should apply to the HSE medicines management programme through the online system, and the application would be reviewed. Why are they making these people apply? It is online but the doctors have to do it for the patients. It has to be appealed through the doctor, if he or she has time as we are short of doctors. However, it has to be appealed every three months, which is disgraceful.

The issue at the heart of the matter for the HSE is that the patches cost too much and there had been a rapid rise in their use over the last number of years. The cost skyrocketed. This is an issue we need to look at. A lady who came to my clinic in Carlow told me the patches for one month cost almost €300. However, in Spain, they are cheaper.

Why did the HSE let the cost skyrocket in the first place? Why were these patches allowed to be prescribed in such volume, if they were not licensed? There are too many questions and too many people in turmoil because of this. The HSE, which works for us, seems to be allowed to do whatever it likes. There is no accountability. Nobody seems to be listening to the people who are drawing the short straw in every decision. People have been prescribed something that makes them feel better without the nasty side effects of other medications.

I call on the Department of Health to begin an immediate impact study of the withdrawal of Versatis patches from the scheme and a review of same. There is an online petition, which 7,000 people have signed, because people are in a terrible amount of pain. This is not about money but about people's quality of life and people who are in chronic pain. Their quality of life has been taken away. I ask the Minister of State to meet with the HSE and to say this is unacceptable. Please change this.

I welcome the Minister of State to the House. There comes a time when the official line does not always tally with what is happening in the broader community and society. This is an occasion where we have to address an underlying problem. The withdrawal of Versatis patches has left many people with pain levels they can no longer tolerate. There is no doubt there has been a huge escalation in the prescribing of the patches and in the demands on the budget. At the same time, we have to accept many people claim this has had a major impact on their lives because of their ability to deal with pain.

Some of the longest waiting lists in the country include long waits in the area of neurological illnesses and diseases. I refer to waiting for outpatient and inpatient appointments with neurological consultants and neurosurgeons. A huge number of people need these patches to function on a daily basis because they are waiting for a long time to see consultants or to get treatment for a neurological condition. If waiting lists and waiting times were addressed, it might save the money we seem to be worried about.

However, we now have a situation where these patches have been withdrawn from the drug payment scheme and where there is a change in what they can be prescribed for. When a huge cohort of people are highlighting something on "Liveline" and in many other fora and are contacting politicians' offices, it is evident the change is having a profound impact on people’s lives. Officially the HSE said the medication, Versatis, has not been withdrawn. However, since last September, a second layer of approval has been in place for GPs who want to continue prescribe it beyond three months.

It has been estimated that up to 25,000 people were on Versatis patches. The Government has, by reducing the number of patches available by 90%, also reduced the cost by 90%. That shows the Government would rather save money than enhance people's lives. The Government has taken a vital medicine away from 90% of its users for whom it was essential on a daily basis. These people suffer chronic pain and the action taken by the Government is equivalent to shutting down an emergency department for each sufferer across the country.

We ask the Government and the Minister for Health to intervene and suspend the decision taken by the HSE. We ask the Government and the Minister to put the patient at the centre of the issue rather than on the periphery, as has been the case to date. We ask them to carry out due diligence and enable people to get their lives back together again, to live meaningful lives and to live as they had done while using the patches. The Taoiseach claims the decision is about patient safety but I believe it is a blatant cost-cutting measure. The briefing note that the HSE sent to the Oireachtas Joint Committee on Health also lists the costs involved if there is a significant increase in the number of patients using the medicine. The sudden, overnight nature of this decision was appalling and visited untold trauma on people. Dr. John Goddard, a researcher in Sheffield, has published an article in a medical journal called Pain Medicine. In his article he identified that there was a 70% effective rate for juveniles who use Versatis patches. The casual, arbitrary, sudden and overnight nature of the HSE's decision on Versatis was appalling and it was not about patient safety.

I thank the Senator for his brevity. I understand that Senators Colm Burke and Michelle Mulherin have agreed to share time.

I propose that I take five minutes and Senator Mulherin takes the remaining three minutes.

I welcome the Minister of State to the House. The withdrawal of Versatis is a very serious issue. It is important that everyone realises that the medication has not been withdrawn from the drugs refund scheme and there is now a different mechanism for dealing with same. The way this matter has been approached was probably not the correct way to do so. People had become reliant on Versatis so are concerned about suddenly being advised by their GPs that the medication was no longer available under the old mechanism.

Another issue that should be of concern is that the medication is prescribed more in Ireland than in all of the UK combined. We must consider how medication and pharmaceuticals are used in this country. Over €2.5 billion will be spent on medication or pharmaceuticals in 2018, which leads me to ask if we get value for money. Is there more suitable medication available to tackle medical complaints?

In Northern Ireland, the use of Versatis is regarded as the third line of treatment and it is clearly understood that Versatis should not be used to relieve back pain. In the UK, Versatis can only be prescribed by clinicians who specialise in pain management. In the Republic, there has been a huge growth over a short period in the usage of Versatis. Why has the Republic not adopted the same stance as Northern Ireland and the UK? Why has the usage of Versatis been allowed to develop so much in this country?

This debate draws attention to how medication is used in this country. An over-reliance on medication and over-prescription of medication has been extensively reported. We definitely need checks and balances. Do we have an adequate amount of checks and balances in this area? Recently I learned about a person who attends four consultants, that each consultant prescribed medication and the case has also been referred back to a GP. Is a GP, in that instance, equipped enough to identify contraindications?

It has been mooted that we should have one file for each patient. In the case I mentioned the four consultants and the GP have probably created one file each but there is no co-ordination of the whole system. On quite a number of occasions I have mentioned the Danish system that allocates each person a patient medication card. Such a system allows a doctor to access his or her patient's file in order to see what else has been prescribed. Likewise, when a patient attends a pharmacy the prescription will have been placed on his or her computerised file. A patient simply has to hand his or her card to the pharmacist thus allowing the pharmacist to access the prescription recorded on the computerised file.

By contrast, the health system in this country uses as many as 1,700 computer systems yet Denmark has only 25 systems. As I have said on previous occasions, a huge amount of work must be done to co-ordinate health care here. We must also ensure that we get value for money in the way we prescribe and use medication. For instance, in one part of my city of Cork, over 30% of the local population are on anti-depressants.

Those people should move away from Cork.

I am only referring to one part of that city. It seems that once anti-depressants are prescribed one must always take them. That is not what medicine is about. It is about ensuring a person's health can improve and that he or she can be weaned off medication over time. The debate has started but we must find ways to improve the health system overall.

I thank the Senator for finishing on time. I call Senator Mulherin. She has three minutes.

I thank my colleague, Senator Colm Burke, for sharing time with me. He has covered a lot of points.

It is important to note that the Minister of State has come here because it is clear that the changes to the way Versatis patches are prescribed has upset a lot of people. It is important that the people who have been caught out by the changes are given reassurance and clearly told how they will be looked after. The Minister of State has set out, in a clinical fashion, why the changes have been made. He said the decision was taken in the interest of patient well-being and health, and to ensure that the medication is properly prescribed, which is what we would all subscribe to.

Many people were surprised by the changes. In this situation one cannot adopt the view that changes have been made but one can think about the situation. If people need patches to help manage their pain they will be very quickly reminded of their pain when they either run out of the patches or have to pay for them out of their own pocket. Let us remember that many people who suffer chronic pain are not in a position to work and that is why we must provide support to them. A person who suffers chronic pain needs pain management medication or pain management of some sort. These people really suffer on a daily basis. The graphic descriptions and personal testimonies have been very moving. It is shocking to think that people must live with such pain and it is no surprise they feel desperate now that the way Versatis patches are prescribed has been changed.

The Minister of State has explained the new mechanism. A GP can make a clinical case to change the original prescription and continue to prescribe the patch for his or her patient. In such cases, to what extent will a GP be challenged? Clearly, a GP will have made a clinical decision before writing a prescription, which is where many people will feel upset and say their GPs feel they should receive the patches. When a clinical case is lodged with the HSE, to what extent are a doctor's views taken as the correct position? Each GP knows his or her own patient.

Another issue was brought to my attention by somebody who was affected by the recent changes. I know of a woman who has been approved and decreed to be one of the exceptional cases following an appeal. Unfortunately, she will have to have her prescription assessed again in three months' time. The woman has a neurological problem that will only get worse over her lifetime. It is not like she suffered an accident and will recover. Unfortunately, many people have to deal with the recent changes. It does not make sense that they must keep applying for their medication to be approved. If one has been diagnosed as having a permanent ailment that will gradually get worse, the new system must be fine tuned to achieve what the Government seeks to achieve.

We also need to protect vulnerable patients who are stuck in the middle of this impasse. We need to see there is a clear pathway whereby people who need the patches that are being prescribed by their GPs will have them.

Senator Conway-Walsh has eight minutes.

I thank the Minister of State, Deputy Jim Daly for coming to the House today. I am absolutely disappointed that the Minister for Health, Deputy Harris did not see that it was fit for him to be present because of the number of people affected by the withdrawal of Versatis. Does he not think that the 25,000 people affected were sufficient to warrant him coming to this House? I am not sure what else he is doing, and I will give him the benefit of the doubt. I thank Deputy Daly for being present.

I wish to welcome the people in the Gallery who have direct experience of this. They know what it is like as they are going through this pain. People are present from Chronic Pain Ireland, Arthritis Ireland, Fibro Ireland and all of the other organisations. They are in pain and are not making it up. They have lots of better things they could be doing today, but this is an issue that has caused physical and mental distress to thousands of low-income citizens and their families. I stress that many in pain have low incomes.

For several weeks we have been unsuccessfully trying to get answers to a number of questions. I furnished some of these questions to the Minister in advance of today's debate because I wanted the answers to be incorporated into the Minister's opening speech.

I asked whether the HSE had made any attempt to negotiate a better price with the manufacturers of Versatis before this decision was taken. I want a "yes" or "no" answer and I want details of what was done and how the price was reduced.

Was there a full and proper cost benefit analysis carried out before limiting access to Versatis? Did the HSE consider the extra costs associated with the alternative medication, the hospitalisation, the home help, the home care, the antidepressants and all the other costs related to this decision, as well as the numbers of people who would have to reduce their working hours and come out of the workplace because of the pain they would now experience?

How can we say that it is perfectly fine to prescribe Versatis for pain relief for patients who do not have shingles but who can pay for it? How can it be safe for those who can pay but not for those who cannot pay? How can it not be safe for those who have a medical card and the drugs payment scheme? I do not get the reasoning. I want somebody to clarify that point for me. How can the use of Versatis be safe for one cohort of patients and not safe for the other cohort of patients? Does the Minister of State, Deputy Daly, not trust the judgment of the GPs and the medical consultants who prescribe Versatis? Does he not think that introducing an additional layer of approval totally undermines the patient, the GP, and the consultant relationship? No indication was given to the GPs on how to take patients off this treatment safely. I saw what was given to the GPs and I thank all the GPs and consultants who have contacted us in the past several months. I saw that it purely related to cost, not to patient safety.

In terms of the appeals, it takes a medical professional at least 90 minutes to do a proper appeal and then it has to be done every three months. The GPs and consultants cannot see the numbers of people who need to be seen, never mind an additional task of form filling that takes 90 minutes for 25,000 patients. It makes no sense whatsoever. The Minister will respond with information on the numbers in the United Kingdom not using Versatis, but perhaps there is a direct correlation between the fact that there are 700,000 people waiting for treatment and for procedures in this country. The Minister needs to take that into consideration. He needs to look at the waiting list for the pain management clinics as well.

We cannot get the right figures for the pain management clinic in Galway that is nearest to my constituency. However, I can tell the Minister that patients have been waiting at least two years before being told they must wait for another 15 months to get an appointment with the clinic. These people are in chronic excruciating pain. The solution to this most distressing situation is possible and must be lasting and sustainable. That can only happen once the Government looks at the issue in a patient-centred and compassionate manner.

At the stroke of a pen, the Minister of State, Deputy Jim Daly or the Minister for Health, Deputy Harris can go back to the HSE and request it to carry out a review of the decision to restrict Versatis for low-income patients. Deputies Daly and Harris can ask them to revert to the pre-December position whereby those experiencing chronic and unbearable pain can avail of Versatis regardless of their income.

Let me put it to the Minister of State that the time spent by very expensive senior HSE personnel would be better spent examining the international research around Versatis that demonstrates its effectiveness rather than looking at appeals. That is a pure waste of these people's money.

The HSE officials need to look at this research. Research is becoming available all the time.

I thank each and every person who has picked up the telephone and put pen to paper to tell us of their personal experience, to tell us about their pain and their need to continue the only effective treatment available to them.

I acknowledge also the important role that our national broadcaster RTÉ, through "Liveline" and Joe Duffy, has played in ensuring that the voices of those suffering the most are heard. I found it very offensive when the Minister asked if we expected health policy to be based on people ringing up a radio show. That was deeply offensive to those who are suffering as a result of the decision to withdraw Versatis.

He explained that and apologised.

I am sorry Senator Norris, but it does not cut it with me to be that flippant about people who are in chronic excruciating pain. I want to leave the space there. Anybody can make a mistake, anybody can make a decision, and I know there are huge decisions to be made in the HSE and in the Department of Health but surely when new information comes to light and when the information of the thousands of people who have been contacting public representatives comes to light, the Minister could say he will review it and we revert to the decision. I am not looking to hang anybody out to dry. I am looking to protect the most vulnerable people in our society. These people do not have options. I know from talking to fibromyalgia patients that the other options are not there. It is not a case of taking another medication that is effective. These people would not be doing that if they were not in such pain. When the Minister says that the number of appeals is not significant, that is because many of these people cannot get out of bed to go to request the GP make the appeals. Many of these people do not want to burden their doctors. They know their doctors do not have the 90 minutes that is needed to do this. I can give the Minister of State dozens of personal testimonies. I ask the Minister of State to please go back and do the right thing. It is never too late to do the right thing. The right thing must be done by these patients.

I thank Senator Nash for his offer to give me time when it looked as if this debate would be over-subscribed, but apparently it will not be.

He will speak next.

This is about money. There is no doubt that it is about money. We will face many more of these problems, because as more expensive drugs become available for the treatment of cancer, pain and this that and the other, decisions will have to be made. It is extremely difficult. I do not envy the people making those decisions.

I do not like pain. I had very severe, agonising pain for one night when I had cancer. It was a most appalling experience. I cannot imagine what it must be like, it is inconceivable to me that there should be people who have chronic pain. I spoke at a Chronic Pain Ireland fundraising dinner in Galway some years ago. There was one woman present who had endured chronic pain for 17 years. I could not bear it for one night. I salute anybody in this situation who continues on. I will chose my words very carefully. I think I would just give up.

Lidocaine acts as an anaesthetic.

With regard to the manufacturing of lidocaine, did the Department shop around to get the best possible price for this product? I have been told it did not. I am not sure if that is correct, but if it is, the Department should have searched around. I have also been told that this drug is available much more cheaply in some continental countries. Is that true?

This treatment was originally designed for small cohort. In light of the fact that an unexpectedly enormous number of people take it - if 25,000 people use it when it was expected to be only used by 500 - then the manufacturers are making enormously increased profits and, therefore, should reduce the price of the drug. That is the market in operation.

Are the people in the HSE who are making the decisions to second-guess GPs and consultants medically qualified? I beg your pardon, Senator Burke, but I heard a grunt.

This has been clearly set out by the expert working in the health service who is the qualified person to deal with the supervision of medicines. That is clearly on the medical records.

I cannot allow a debate between the Senators.

I am asking-----

It is clearly set out.

It is not. Who is it to second-guess a GP or a consultant?

The Minister of State will respond at the conclusion of the debate.

When a treatment intended for a small group of patients suddenly becomes enormously widely applied, the question to ask is why all these people are using this drug. One should not second-guess the people with chronic and excruciating pain. They are the ones who know. If it miraculously works for people with chronic pain, then that is wonderful and should be welcomed. Years ago, there was a medicine used for men's hair growth which was found to be an effective cardiac treatment. People did not say it was only for old bald fellows. They said thank God that there was a medicine which addressed a situation.

There was a reference to the placebo effect and how some people taking lidocaine may think they immediately feel better. There may be a small element of that but it is pretty tiny. Will the Minister of State look at the situation again and not try to second-guess the people suffering from chronic pain? Instead, he should listen to them. I have a sheaf of letters from people which would break one's heart. These are from people unable to work or engage with their families due to chronic pain. It is a truly dreadful situation. If a plaster can alleviate that, then that is wonderful. The Department of Health needs to get the manufacturers of lidocaine to reduce the cost. If there is an exponential growth in the number of people taking it, then that is a profit to the company. The company should be asked to give some of its profits back to the people who are in pain.

It is important we debate this issue of enormous public importance and concern. I welcome to the Visitors Gallery those who are affected by the denial of the opportunity to use Versatis in the future, as well as those who represent those experiencing chronic pain as a result of several conditions. I thank them for speaking out individually and collectively to raise public awareness of this critical issue and to ensure we are debating this matter of enormous public concern.

I was hoping at this juncture that the Minister of State would respond to public concerns by reviewing the original decision made. Unfortunately, given his demeanour and the statement he made today, it appears unlikely the Government is prepared to do that. Like other colleagues in this House and the Lower House, I have been contacted in recent weeks by constituents, and in some cases by friends, who rely on this particular treatment to ease or dissipate the chronic pain they experience. It is difficult for many of us to understand the lifeline Versatis represents if we do not experience the chronic pain that thousands experience and who are reliant on this particular intervention. Rearing a family, working, enjoying social events and having what might be considered a reasonable quality of life is denied to people because they do not have the opportunity to access this particular treatment as of right. These are things most people take for granted. The reality, however, will be a difficult one for those experiencing a variety of conditions and who are being denied the opportunity to access the treatment now and into the future. Everybody accepts that, even though we might differ on the response.

From the representations I have received and from my research, it appears this decision has been made for a combination of reasons. There are concerns over the efficacy, as reported, of the treatment for conditions outside of the post-shingles, nerve pain condition, as well as concerns over cost. I fear the real reason, however, this treatment has been essentially withdrawn for everyone who has access to it is a cost control measure dressed up as an efficacy issue. I understand this particular treatment has been prescribed extensively over the past seven years for pain associated with a wide range of different conditions. I do not have any difficulty in working with the system to look under the bonnet to establish the reasons there is extensive prescribing of this particular treatment outside of the area for which it was originally licensed several years ago. One reason, which Senator Paul Daly focused on earlier, is the two to three-year long waiting list for access to pain management specialists in the public health system. There also appears to be evidence to suggest that pain specialists in Ireland have been markedly more reluctant to prescribe opiate-based treatments for pain management than their counterparts internationally. These may very well be two important factors feeding into the extensive use of Versatis.

The market costs of Versatis are in the range of between €160 and €400 per patient each month. It is also known - it is to be hoped it is known in the system too - that this particular treatment will be taken off patent next year which will inevitably lead to lower costs. In the meantime, there is little evidence of any approach being made by the HSE to the manufacturers of this drug to make the case and negotiate for a reduction around cost. I understand the cost has gone from €6 million in the first year of its availability to €36 million over seven years. This is clearly as a result of the widespread growth of the prescribing of the intervention.

Due to a decision made by experts in this field, this intervention has been denied to many people who need this treatment just to function and manage the pain they experience every day. While not wanting to personalise the issue, I am also led to believe that Professor Michael Barry, when reviewing both the cost and the efficacy of Versatis, may not have availed of the opportunity to assess and consider other important evidence-based research from the United States and Germany, which supports and backs up the arguments made by patients and patient groups in recent days.

It is important that the opportunity would now be provided to the system to review the issue of access to the drug and, in the context of any review that might take place, to ensure that the plasters would be restored to those who have relied on them. I understand that the NHS is undertaking a review of Versatis in the British system but I am led to understand that no patient there will experience a withdrawal of Versatis until those reviews are completed, the outcomes are known and the risk assessments are properly done in association and collaboration with consultants.

The opportunity should arise where this decision could be reviewed. I do not believe in pillorying anyone. I believe in persuading people. If a mistake has been made, experts and the political system should be given the space and opportunity to address it and to take on board any information that may have been overlooked or not considered when the original decision was taken because many thousands of people are now being denied the opportunity to have chronic, insidious and incessant pain managed properly. I appeal to the Minister of State to review the original decision to withdraw this particular treatment from the drugs payment scheme and the medical card scheme and, in the meantime, restore the opportunity to patients who need it to have this treatment. The review should be robust and it should engage with patient groups, individual patients and medical experts.

I thank the Senators for their contributions. I am always appreciative of the constructive, solution-led contributions that come from the House. They are more generous in this House than others. It is easy to give out, punch the air on these things and take the populist route, but I always appreciate that many Members in this House go to a lot of effort to come up with solutions and alternatives as well. I have listened to and will take on board the contributions and progressive suggestions of Members today. Of course we can do more to address the issue and we can put pressure on the HSE to see that the market value for this particular patch is as efficient as it has to be. We can examine how the entire saga has been handled because it would be preferable, as Senator Nash remarked, if the scheme is to be closed, that it would be closed to new entrants. That is basically what he was saying. We could pick up the trends earlier where prescribing has been strong.

We are where we are, however, and I am concerned about the worry and upset that I have heard from patients. I understand why people felt that they had to air their concerns and they were right to do so. I want them to know that we have been listening and I want them to receive the compassion that they deserve in seeking treatment. I am also conscious of the fact that treatment must be appropriate and proportionate and that clinical decison-making such as prescribing should be based on both patient needs and sound medical evidence. There is no getting away from the fact that this has been a clinical decision which is aimed at ensuring the most appropriate patient care. Prescribing must always be appropriate and proportionate, making sure that any treatment is the right one. Any medication used incorrectly can have adverse consequences for patients, and this is why medicines are controlled by national and international legislation.

The new reimbursement arrangements, which I outlined in my opening statement, were brought in by the HSE to address what was in its view a significant level of inappropriate use of this prescription medicine. As I stated, under the new arrangements, all patients with the licensed and approved indication remain on the plasters. At the same time, it affords all other patients the opportunity, through their GP, to make a clinical case for continued use for their specified indications. There is nothing new in these arrangements. The HSE already uses such systems for a number of other medicines. The new system follows the recommendations of the clinical experts. It uses the licensed specified indication as the baseline for reimbursement approval. Treatment is not always straightforward, however, and any system must be able to address exceptional cases. This is why the new arrangements allow doctors to make a case, through the appeals process, for non-shingles patients who they feel would benefit from this product and for whom it is, in their view, an appropriate treatment.

A responsive system should always avoid administrative difficulty. As I have mentioned, the online system allows decisions on both applications and appeals to be made within days. Of course, the GP must provide clinical information to support a decision. That is as it should be so that the treatment is used appropriately, as for any other prescribing decision. In that context, I was delighted to see in recent days statements from the Medical Council, among others, on the ongoing development of decision-making support for prescribers through information and undergraduate and continuing education. I hope that this will continue to be built upon.

I am advised by the HSE that the new arrangements are addressing exceptions where the evidence is strong. Currently, nearly two thirds of appeals for non-shingles patients have been granted on the basis of the clinical case made by the patient’s GP. We are listening. We want patients who have an identified and certified clinical need for this product to have access to it under the community drugs schemes. I am pleased to note that the HSE appeals process is taking a compassionate approach so that anyone who needs these plasters, on the basis of a clinical case made by their GP, can have access to them.

I thank the House for the invitation to address it on this important matter.

Sitting suspended at 5.25 p.m. and resumed at 5.35 p.m.