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Medicinal Products Availability

Dáil Éireann Debate, Tuesday - 24 April 2018

Tuesday, 24 April 2018

Questions (332, 333, 334)

Eugene Murphy

Question:

332. Deputy Eugene Murphy asked the Minister for Health if Versatis patches will be reinstated and made available to persons with medical cards; and if he will make a statement on the matter. [17394/18]

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Eugene Murphy

Question:

333. Deputy Eugene Murphy asked the Minister for Health the list of ailments that can be treated with Versatis medicated patches on the medical card scheme; and if he will make a statement on the matter. [17395/18]

View answer

Eugene Murphy

Question:

334. Deputy Eugene Murphy asked the Minister for Health if there is an investigation into the possible extension of the ailments that Versatis medicated patches can treat; and if he will make a statement on the matter. [17396/18]

View answer

Written answers

I propose to take Questions Nos. 332 to 334, inclusive, 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.

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