Gerry Adams (Louth, Sinn Fein)
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158. To ask the Minister for Health if persons in County Louth can access versatis lidocaine 5% medicated plaster under GMS services; and if he will make a statement on the matter. [40027/17]

Gerry Adams (Louth, Sinn Fein)
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159. To ask the Minister for Health if the HSE has implemented changes to the reimbursement of versatis lidocaine 5% medicated plaster; the date on which these changes commenced; and the way in which this now affects persons that previously had access to this drug via GMS services [40028/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 158 and 159 together.

Medicines play a vital role in improving the overall health of Irish patients. Securing access to existing and new and innovative medicines, is a key objective of the Irish health service. However, the challenge is to deliver this objective in an affordable and sustainable manner. The medicines bill for the community drugs schemes – primarily the GMS, Long Term Illness, Drugs Payment as well as the High Tech Arrangement – including fees and ingredient costs, is forecast at just over €1.7 billion in 2017. To ensure that patients receive the highest quality care, it is essential that these resources invested in medicines are used efficiently and effectively. This requires an integrated approach to secure best value for money for all treatments, to deliver greater efficiencies across the supply chain and also to promote the use of the most cost-effective treatments.

In 2013, the HSE established the Medicines Management Programme (MMP). It is headed by the (NMIC) and the (NCPE) in collaboration with the (HSE-PCRS) and provides sustained national leadership relating to issues such as the quality of the medicines management process, access to medicines and overall expenditure on medicines.

The Medicines Management Programme has undertaken a number of initiatives aimed at enhancing evidence-based and cost-effective prescribing nationally and the review of Versatis is an example of this.

Versatis 5% medicated plaster is licensed for the symptomatic relief of neuropathic pain associated with previous herpes zoster (shingles) infection, known as post-herpetic neuralgia (PHN), in adults.

Following a review by the MMP of the evidence available to support the use of Versatis, the HSE has introduced a new system for the reimbursement of Versatis from 1 September 2017. This process will support the appropriate use of this medication while ensuring those with an indication of post-herpetic neuralgia (PHN) continue to have access to this treatment.

The product has been reimbursed under the community drugs schemes in Ireland since 2010. Initially, the projected budget impact was low due to the specific licensed indication. However, total expenditure has increased significantly, from €9.4 million in 2012 to over €30 million in 2016, due primarily to off-license use i.e. prescribing Versatis as a general treatment for pain not associated with shingles. Currently, there are over 25,000 patients in receipt of this item. The MMP prescribing and cost guidance report highlighted that the clinical evidence to support the use of Versatis 5% medicated plaster for PHN is limited due to lack of comparative data and its value is uncertain for all other types of pain.

The NCPE estimated that, in Ireland, between 5-10% of the prescribing of this product is for the licensed indication of PHN.

All patients who currently receive antivirals for shingles, or patients who are prescribed antivirals for the treatment of shingles by their GP in the future, will automatically be approved for Versatis for a period of three months. No action is required by the GP in this instance and the patient’s pharmacy will be notified in real time of the patient’s approval status.

All patients who are currently initiated on Versatis have been identified and automatically registered on the HSE-PCRS system for a period of three months and will continue to receive the treatment from their pharmacy until 30 November 2017.

From 1 December 2017, non-shingles patients will no longer be dispensed Versatis under the community drugs schemes. The HSE has produced patient information leaflets and advised GPs on treatment alternatives.

In exceptional circumstances, the product may be dispensed for unlicensed indications. In such circumstance, the GP will be required to make an application for reimbursement for unlicensed indications for new and existing patients through the online system.

Where the application is under exceptional circumstances, the application will be reviewed by the MMP before a decision is made and communicated to the GP.

Full details of the review of Versatis are available on the HSE website at

.

As this is a matter for the HSE, I have no role in this decision in relation to individual treatments. However, I fully support the objectives of the HSE Medicines Management Programme.