Simon Harris (Wicklow, Fine Gael) | Oireachtas source

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.

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