John Curran (Dublin Mid West, Fianna Fail)
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203. To ask the Minister for Health if there is an appeals process in place for medical card holders who were previously receiving lidocaine patches but are now being refused these patches; if so, the details of the appeals process; and if he will make a statement on the matter. [7779/18]

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 – was approximately €1.8 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 has been reimbursed in the community drugs schemes since 2010. The projected budget impact on introduction was low due to the specific licensed indication but total expenditure trebled between 2012 and 2016, from €9.4 million to over €30 million, mainly from off-licence use for pain not associated with shingles.

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 other types of pain. The National Centre for Pharmacoeconomics estimated that, in Ireland, only 5-10% of prescribing of this product has been 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 its appropriate use, ensuring that PHN patients continue to receive this treatment. The HSE estimates that this protocol will reduce annual 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. No action was required by GPs and the patient’s pharmacy was notified of his or her approval status.

However, since 1 December 2017, non-shingles patients no longer receive this item under the community drugs schemes. In August 2017 the HSE advised GPs of the changes and of treatment alternatives.

It is possible for non-shingles patients to be approved for the patch through the community drug schemes. The patient's GP should apply to the Medicines Management Programme through the online system, and the MMP will review the application and inform the GP of its decision.

I am advised that the MMP has received over 4,500 applications from GPs, of which some 10% have been approved. For many of the conditions applied for, prescribing of the patch was inappropriate, for example for conditions such as deep venous thrombosis, angina, gout and endometriosis.

Where a GP’s application is rejected, it may be appealed. Of some 200 appeals to date, the HSE advises that over 50% have been accepted on clinical grounds.

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.