Jack Chambers (Dublin West, Fianna Fail)
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472. To ask the Minister for Health his plans to provide persons with multiple sclerosis access to Sativex; his further plans to allow the costs to be reimbursed; and if he will make a statement on the matter. [37351/18]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

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.

In September 2014, the HSE received an application for the reimbursement of Sativex.

A Health Technology Assessment on Sativex was completed by the National Centre for Pharmacoeconomics (NCPE), which did not recommend reimbursement of Sativex at the submitted price.

The HSE issued the manufacturer with notice of its intention not to reimburse.

In February 2018 the HSE received a new reimbursement application from the manufacturer. A rapid review by the NCPE was completed on 3 April 2018 and a full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of Sativex compared with the current standard of care.

The full pharmacoeconomic assessment was commissioned by the HSE on 20 April 2018.