Billy Kelleher (Cork North Central, Fianna Fail)
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I thank the Ceann Comhairle for giving us the opportunity to raise this. There comes a time when official replies do not always tally with what is happening in broader community and society. This is an occasion where we have to address an underlying problem, the fact that the withdrawal of the Versatis patch has left many people with pain thresholds they can no longer tolerate, anxiety and concerns. There is no doubt that there has been a huge escalation in the prescribing of the patch and in the demands on the budget. At the same time, we have to accept that many people claim that this has had a major impact on their lives with regard to their ability to deal with pain. Some of the longest waiting lists in the country include very long waits in the area of neurological illnesses and diseases and waiting for outpatient and inpatient appointments with neurological consultants and neurosurgeons. That was only alluded to last week in the context of parliamentary replies in this Chamber last Thursday. Huge numbers of people need this patch 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. At the same time, we now have a situation where there is withdrawal of reimbursement and a change of what it can be prescribed for. When a huge cohort of people are saying things, highlighting them on "Liveline" and in many other fora, and are contacting our offices, it reminds me of the time of the medical card debacle of 2014 when officialdom told us that there was no change of policy but at the same time it was evident that the change was having a profound impact on people's lives. Those decisions had to be reversed subsequently because they were wrong in the first instance.

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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The withdrawal of Versatis patches from the drugs payment scheme and the medical card has been a debacle. Somebody should put his or her hand up and say that he or she has got it very wrong. Those who benefit from the patches, numbering tens of thousands, are being denied this medication that gives them relief. I know the HSE has said it is based on clinical grounds but most people listening in or who have been on radio or television think it is a monetary decision. A number of people contacted our office about this, and to say they are distraught is an understatement. They are going through life with a condition that has chosen them. They have not chosen the condition of chronic pain or neuropathic pain. The patches give them some sort of relief. The decision by the HSE has put those people outside of the reach of these patches. The HSE might save money in the short term but it will cost the HSE much more money in the long term and hardship, particularly for the people benefitting. I know the Minister remarked this morning that a radio station should not make decisions. I think that is a flippant remark and I do not know if the Minister meant anything by it. I know clinicians make these decisions but I ask for the HSE to repeal this decision.

Simon Harris (Wicklow, Fine Gael)
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I thank the Deputies for raising this issue, which I recognise is causing significant concern for a number of people. I welcome the opportunity to put some facts on the record of the House and to try to provide some guidance and information into how best patients might be able to proceed with regard to this important issue. I am conscious of the impact of changes on individual patients and I would like to use this opportunity to set out the background to the decisions made by the HSE's medicines management programme and the process by which patients can apply for continued access to the patches. I am concerned that I have heard many patients worried and upset about this and it is important that they hear how they can have their case reviewed. Lidocaine 5% medicated plasters are licensed to treat neuropathic pain from previous shingles infection, or post-herpetic neuralgia, PHN, in adults. They have been reimbursed in the community drugs schemes since 2010. When the patch was first introduced, its projected budget impact was low because of the very specific licensed indication. It was clearly a clinical cause of concern when the reimbursement cost increased from €9.4 million in 2012 to over €30 million in 2016, mostly from unlicensed use of the patch. When one has clinicians in a medicines management programme seeing that a patch which was expected to be used for a small cohort of patients is now being used for a large cohort, and in many cases for indications for which it was never meant to be used, it is important and appropriate for clinicians in the HSE to review it.

In 2016, the HSE's medicines management programme reviewed the use of this product. The National Centre for Pharmacoeconomics estimated that only 5% to 10% of prescribing of the patch has been for the condition it was licensed for. In light of this clinical review, the HSE introduced a new reimbursement system for lidocaine patches from 1 September 2017, as has been done for other medication, including Entresto, a heart failure drug. This process supports its appropriate use and ensures that post-shingles patients continue to receive this treatment. I heard accusations in this House earlier which led to my response about this being a Government decision. It is not a Government decision. This was a clinical decision made within the HSE. Under this protocol, all patients who were receiving antiviral drugs for shingles were automatically registered on the HSE's primary care reimbursement service, PCRS, system. These patients continue to receive this treatment under the community schemes. However, since 1 December 2017, non-shingles patients no longer automatically - which is the important word - receive this item. The HSE advised GPs and pharmacies in August 2017 of these changes and of treatment alternatives for non-shingles patients.

I stress that it is possible for non-shingles patients to be approved for the patch through the community schemes. The patient's GP should apply to the medicines management programme through the online system. That medicines programme will review the application and inform the GP of its decision. I am not talking about some abstract thing. I am informed that, as of today, over 450 such applications from GPs have been approved. That represents 450 people whose GPs have applied, saying that their patients do not have post-shingles but have a condition and need this patch. Where a GP's application is rejected, it can be appealed. I am informed that, as of today, over 220 appeals have been granted, which represents over 61% of appeals being accepted on clinical grounds. Nearly 700 patients are receiving these patches despite that it is beyond the shingles indication. While this is a clinical decision for the HSE and its medical experts, a process is in place for appeals. I want to see that process applying the maximum compassion, which I have conveyed in the clearest possible terms to the HSE. This needs to be done in a compassionate way where, if a GP highlights to the HSE's medicines management programme that a person needs these patches, that application and appeal would be looked upon compassionately. I am encouraged to see the successful rate of appeals increasing from 50% in recent days to 61% today.

Billy Kelleher (Cork North Central, Fianna Fail)
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We had discretionary medical cards in previous times and the word "compassion" was invoked on numerous occasions. It was not a compassionate programme in the sense that it became very bureaucratic and inflexible and discretionary medical cards were effectively withdrawn in their thousands even though the Government and HSE at the time were saying that was not the case. I am concerned that we have a situation again where people depend on these patches for pain relief and will now be in a position where they simply cannot access them.

It is creating huge anxiety. "Liveline" is only a sounding board but it has been a very loud sounding board over the past week. The programme has received numerous calls from people who are very agitated, anxious and concerned. The Minister said that a compassionate programme is in place, but he will have to be more specific on how people can access the lidocaine patch for pain relief in the first instance. We need more specifics so that GPs will be able to prescribe and people will be able to get it.

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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The system is overly bureaucratic and compassion gets lost in bureaucracy. I acknowledge that there is an appeals mechanism and that appeals are dealt with on a case-by-case basis, but surely this is putting people through unnecessary suffering and bureaucracy. One in eight people suffer from chronic pain and a huge volume of opiates would be required to treat those patients. Versatis patches are less harmful to such patients in the short and long term. I listened to "Liveline" last Friday and I heard one caller say that they were real people with real evidence and real pain. That says it all. The HSE should listen to people rather than make bureaucratic decisions that will have a huge impact on them.

Simon Harris (Wicklow, Fine Gael)
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It is important that the process is not bureaucratic and that is the reason the appeals process is online and done by a general practitioner. Applications are turned around very quickly. Hundreds of people are now accessing this patch above and beyond the post-shingles indication as a result of the appeals process. Deputy Kenny is right that the process needs to be compassionate and I want to see that happen. I am encouraged by the fact that the number of successful appeals has increased from 50% in recent days to over 60% today. People can try if they wish for political reasons to liken this to previous issues in the health service but is not at all comparable. This is a clinical decision. This is about medication that, if used incorrectly or long-term, can have adverse consequences. It is important that the medical experts in the HSE have a role in this area. They are doctors too.

I hope that the answer I gave here earlier did not give anyone the wrong impression. I am very concerned about the worry and upset I have heard from patients. I want them to know that I am listening and I want them to receive the compassion and treatment they need. The point I was making is that there is an application and appeals process in place that doctors can use to gain access to these patches for patients. Almost 700 patients in this country have gained access to these patches as a result of that process. I did not mean to be dismissive of people feeling that they had no option but to call a radio programme that is rightly highlighting an issue that is concerning people, but I have always been clear that when it comes to our citizens accessing medication, I want them to be able to do that through engaging with their doctors and in this case their doctor engaging with the medicines management programme.

I am listening. I believe those patients who need these patches can and must continue to receive them through the process that has been put in place. Doctors can make a case to the medical experts on behalf of their patients. These applications are being turned around quickly and, as I said, the success rate for these applications is increasing significantly because of the compassionate approach being taken. I want to see the HSE continue to take that compassionate approach so that anyone who needs these patches on the advice of their GP should be able to receive them.