Pat Breen (Clare, Fine Gael)
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321. To ask the Minister for Health his plans to review the system for reimbursement of lidocaine 5% medicated plasters and make them available on the community drug scheme; and if he will make a statement on the matter. [19936/18]

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 health service objective. 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 localised relief of post-shingles pain in adults. This is the patch's only licensed use 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 more plasters were being used in Ireland than in 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.

From September 2017, following the clinical review, the HSE introduced a new reimbursement approval system for the patches, to support appropriate use and patient care. Under these arrangements, the patient's GP or consultant applies to the MMP for reimbursement approval on behalf of the patient. In the case of a negative decision, the treating clinician can appeal the decision. Once a patient is approved for reimbursement support, irrespective of the indication, there is no expiry on the duration of treatment. This also applies to applications already approved by the MMP.

As of 1 May 2018, there have been 6,250 online applications from clinicians requesting the reimbursement lidocaine patches. Of these applications, 1,451 patients (over 23%) have been approved. Of 807 online appeals, over 70% of patients have been approved for reimbursement. The MMP has sought further information on another 71 appeals. Accordingly, since 1 September 2017, 2,019 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.

Seán Haughey (Dublin Bay North, Fianna Fail)
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322. To ask the Minister for Health if he will engage with an organisation (details supplied) and the pharmaceutical industry to ensure that new medicines are made available to persons with MS; and if he will make a statement on the matter. [19939/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act sets out criteria for decisions on reimbursement. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines.

In line with the 2013 Act, if a company would like a medicine to be reimbursed through the community drug schemes, it must submit an application to the HSE to have the new item added to the Reimbursement List.

As outlined in the IPHA agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to add the medicine to the reimbursement list, agree to reimburse it as a hospital medicine or refuse to reimburse it.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

The NCPE conducts health technology assessments for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments can be ongoing multi-million euro investments. Pricing issues can lead to a protracted deliberation process.

I am keen to engage with industry and to explore ways in which new medicines might be more easily introduced in Ireland. However, any innovative approaches that may be tabled must be compatible with the statutory provisions in place and must also recognise pricing and funding issues in the context of finite Exchequer resources.

I have indicated willingness to meet with MS Ireland and my office is in contact with the organisation to arrange a mutually convenient date.