Written answers

Wednesday, 26 October 2016

Department of Health

Medicinal Products Availability

Photo of Clare DalyClare Daly (Dublin Fingal, Independent)
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118. To ask the Minister for Health the reason a drug (details supplied) is not available to multiple sclerosis sufferers here, despite clinical trials showing its effectiveness in reducing symptoms and improving quality of life for persons with MS. [32157/16]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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On 11 July 2014, the Misuse of Drugs Regulations 1988 were amended to allow for certain cannabis-based medicinal products to be used in Ireland. The Health Products Regulatory Authority subsequently granted a marketing authorisation for the cannabis-based medicinal product Sativex to be marketed in this State. It was then open to the holder of that authorisation to make the product available for prescribing in Ireland.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the GMS and community drug schemes, under the Health (Pricing and Supply of Medical Goods) Act 2013. 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 (NCPE).

The HSE has received an application for the inclusion of Sativex on the High Tech Scheme. However, an NCPE health technology assessment report on Sativex did not recommend reimbursement at the submitted price. The NCPE report is an important input to assist the HSE in its decision-making process and informs engagement between the HSE and the supplier.

Sativex is not currently reimbursed; the HSE is awaiting further engagement from the supplier.


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