Bríd Smith (Dublin South Central, People Before Profit Alliance)
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166. To ask the Minister for Health the reason Versatis 5% medicated plaster, Lidocaine, has been removed from the drugs payment scheme and the medical card (details supplied) [53386/17]

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 do this in an affordable and sustainable manner. The medicines bill for the community drugs schemes – primarily the GMS, Long Term Illness and Drugs Payment schemes and the High Tech Arrangement – is forecast at just over €1.7 billion in 2017.

To ensure patients receive the highest quality care, resources invested in medicines must be used efficiently and effectively. This requires an integrated approach to secure best value for money for all treatments, greater efficiencies in the supply chain and the use of the most cost-effective treatments.

Lidocaine 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. It was reimbursed in the community drugs schemes from 2010. The projected budget impact was low due to the specific licensed indication but total expenditure has increased significantly, from €9.4 million in 2012 to over €30 million in 2016, mainly from off-license use for pain not associated with shingles. Currently, over 25,000 patients receive this item.

An HSE Medicines Management Programme (MMP) review of this product highlighted that the clinical evidence for its use in PHN is limited due to lack of comparative data and its value is uncertain for all other types of pain. The National Centre for Pharmacoeconomics estimated that, in Ireland, between 5-10% of prescribing of this product is for the licensed indication of PHN.

Following the MMP review, the HSE introduced a new reimbursement system for the product from 1 September 2017. This process supports the appropriate use of Versatis, ensuring that PHN patients continue to receive this treatment. The HSE estimates that this protocol will reduce expenditure on this product by approximately 90%.

Under the protocol, all patients who were receiving antivirals for shingles were automatically approved for the lidocaine medicated plaster for three months. No action was required by GPs and the patient’s pharmacy was notified of his or her approval status.

These patients were identified and automatically registered on the HSE-PCRS system for three months and continued to receive the treatment from their pharmacy until 30 November 2017. However, from 1 December 2017, non-shingles patients will no longer get this item under the community drugs schemes. The HSE has produced information leaflets for patients and advised GPs on treatment alternatives.

In exceptional circumstances, the product may be approved for supply through the community schemes for unlicensed indications. GPs apply for reimbursement for unlicensed indications through the online system. The MMP reviews applications before a decision is made and communicated to the GP.

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

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