Micheál Martin (Cork South Central, Fianna Fail)
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178. To ask the Minister for Health if a person (details supplied) will be provided with Versatis patches. [27103/18]

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. If an application is refused, the clinician may submit an appeal, making a clear clinical case for the patient, to the MMP. Information for patients and practitioners is on the HSE MMP website at: hse.ie/yourmedicines.

The decision to introduce a new reimbursement approval process is a matter for the HSE and you will appreciate that, as Minister for Health, I cannot intervene in individual cases. However, I fully support the objectives of the HSE Medicines Management Programme.

Robert Troy (Longford-Westmeath, Fianna Fail)
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179. To ask the Minister for Health if he will engage with an organisation (details supplied) and the pharmaceutical industry to ensure new medicines are available to persons with multiple sclerosis. [27104/18]

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.   As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines. The Act specifies the criteria for decisions on the reimbursement of medicines.

In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the Community Drugs scheme, the company must first submit an application to the HSE to have the new medicine 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 either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.

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 (HTAs) 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 are often multi-million euro investments on an on-going basis. This 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 which are in place and must also recognise the fundamental pricing/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.