Robert Troy (Longford-Westmeath, Fianna Fail)
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727. To ask the Minister for Health the reason Versatis plasters and patches are not covered by the medical card. [15290/18]

Martin Heydon (Kildare South, Fine Gael)
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741. To ask the Minister for Health the status of the work within his Department to address the concerns of users of the Versatis patches; and if he will make a statement on the matter. [15339/18]

Michael McGrath (Cork South Central, Fianna Fail)
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942. To ask the Minister for Health the steps he is taking with the HSE to ensure that persons who need Versatis patches are receiving them; and if he will make a statement on the matter. [16260/18]

Seán Fleming (Laois, Fianna Fail)
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979. To ask the Minister for Health the status of the withdrawal of the Versatis patch for persons with chronic pain; the number of persons who have been approved for this patch since the beginning of 2018; the number of persons who no longer have approval for the patch; and if he will make a statement on the matter. [16442/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 727, 741, 942, 979 and 994 together.

Medicines play a vital role in improving the health of Irish patients. Securing access to existing and new and innovative medicines is a key objective of the health service. However, the challenge is to do this in a safe and sustainable manner. Treatment must be appropriate and proportionate and clinical decision-making, such as prescribing, should be based on both patient needs and sound medical evidence.

Lidocaine 5% medicated plasters are licensed for the localised relief of post-shingles pain in adults. This is the only licensed use for the patch in Ireland. It has been reimbursed in the community drugs schemes since 2010.

Clinical concern arose when, from 2012 on, usage increased significantly, to the point where, in Ireland, more plasters were being used in than the entire UK National Health Service. In such situations, it is important and appropriate for clinicians to review usage and, in 2016, the HSE Medicines Management Programme (MMP) reviewed the use of the plasters. The review estimated that only 5-10% of prescribing was for the licensed indication.

Following the clinical review, the HSE introduced a new reimbursement approval system for the patches from September 2017, to support appropriate use and patient care. Under these arrangements, the patient's GP or consultant must apply to the MMP for reimbursement approval on behalf of the patient. In the case of a negative reimbursement decision, the treating clinician can appeal the decision. Once a patient is approved for reimbursement support, irrespective of the indication, there will be no expiry on the duration of treatment. This also applies to applications already approved by the MMP.

As of 29 March 2018, there have been 5,747 online applications from clinicians requesting the reimbursement of Versatis. Of these applications, 1,205 patients (over 21%) have been approved. Of 672 online appeals, over 71% of patients have been approved for reimbursement. The MMP has sought further information on another 41 appeals. Accordingly, since 1 September 2017, 1,681 patients have been approved for reimbursement of lidocaine plasters, based on the clinical case made by their GP or consultant.

It is clear that this new process supports appropriate use and prescribing and both post-shingles patients and other appropriate cases can continue to be treated with lidocaine plasters.

The HSE notified prescribers and pharmacies of the introduction of the new system in August 2017. This advice was re-issued recently, and information for patients and practitioners is on the HSE Medicines Management Programme website at www.hse.ie/yourmedicines.

This reimbursement decision is a matter for the HSE. However, I fully support the objectives of the HSE Medicines Management Programme.