Joan Collins (Dublin South Central, Independent)
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312. To ask the Minister for Health the reason versatis 5% medicated plaster has been taken off the medical card since 1 September 2017, (details supplied); if his attention has been drawn to the fact that persons will be forced into the day ward system as a result of same; and the pressure and estimated costs on hospitals. [42578/17]

Simon Harris (Wicklow, Fine Gael)
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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 deliver this objective in an affordable and sustainable manner. The medicines bill for the community drugs schemes – primarily the GMS, Long Term Illness and Drugs Payment, as well as the High Tech Arrangement, is forecast at just over €1.7 billion in 2017.

To ensure patients receive the highest quality care, it is essential that the resources invested in medicines are used efficiently and effectively. This requires an integrated approach to secure best value for money for all treatments, greater efficiencies across the supply chain and also 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 on issues such as medicines management, access to medicines and the cost effective provision of medicines in Ireland. The MMP has undertaken a number of initiatives to improve 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 an MMP review of the evidence available for the use of Versatis, the HSE introduced a new system for reimbursement of Versatis from 1 September 2017. This process will support the appropriate use of Versatis, ensuring that PHN patients continue to have receive this treatment. The HSE estimates that this protocol will reduce expenditure on this product by approximately 90%.

Versatis has been reimbursed in the community drugs schemes 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 to off-license use as a general treatment for pain not associated with shingles. Currently, over 25,000 patients are in receipt of this item. The MMP report highlighted that the clinical evidence for Versatis in PHN is limited due to lack of comparative data and its value is uncertain for all other types of pain. The NCPE estimates 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 shingles in the future, will automatically be approved for Versatis for three months. No action is required by GPs and the patient’s pharmacy will be notified of his or her approval status.

All patients who currently use Versatis have been identified and automatically registered on the HSE-PCRS system for three months and will continue to receive the treatment from their pharmacy until 30 November 2017. However, 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. GPs will make an application for reimbursement for unlicensed indications for new and existing patients through the online system. Applications 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

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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.