Seán Kyne (Galway West, Fine Gael)
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41. To ask the Minister for Health the position regarding a medical device, Medtronic’s i-port advance injection device, and the primary care reimbursement scheme; if the substantially less invasive nature of the device and the easier method of treatment for young persons with diabetes has been taken into account regarding its introduction; and if he will make a statement on the matter. [20763/15]

Kathleen Lynch (Cork North Central, Labour)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. They are not political or ministerial decisions.

The HSE received an application for the inclusion of the product, i-port Advance™, to be added to the List of Reimbursable Items in the GMS and community drugs schemes. The application was considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines.

An Expert Group, chaired by the Clinical Lead of the HSE Diabetes Programme, was convened by the HSE to (i) assess the clinical evidence to support the use of the product, (ii) consider whether the product is appropriate for reimbursement status under Schemes and (iii) assist in the determination of the ‘value’ that the innovation presents. The Group also considered the quality of life dimension from using the product.

The Expert Group did not find that the product was either clinically effective or cost effective, and therefore did not recommend that the product should be reimbursed. The Director of Primary Care accepted the recommendation of the Expert Group and the company was informed of the HSE's decision on the 20 April 2015.