Tuesday, 27 February 2018

Questions (438)

Charlie McConalogue


438. Deputy Charlie McConalogue asked the Minister for Health the status of the provision of a drug (details supplied) for persons here; and if he will make a statement on the matter. [9569/18]

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Written answers (Question to Health)

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.

On 9 February 2018 the HSE received a new reimbursement application from the manufacturer. A rapid review by the NCPE was commissioned on 12 February 2018 and this application will be assessed in line with the 2013 Act.