Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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123. To ask the Minister for Health if the drug Sativex is authorised here for sale; if so, if it is available by prescription; the number of persons prescribed same here; and if he will make a statement on the matter. [15743/19]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. As Minister for Health I have no role in this statutory process. 

I am informed by the HSE that a new application for the reimbursement of Delta-9-tetrahydrocannabinol/Cannabidiol, THC/CBD (Sativex) was received in February 2018.

A rapid review by the National Centre for Pharmacoeconomics (NCPE) was completed on 3 April 2018 and a full pharmacoeconomic assessment was recommended to assess the clinical and cost effectiveness of this medicine compared with the current standard of care.

The HSE commissioned a full pharmacoeconomic assessment on 20 April 2018 and requested that the manufacturer submit the required dossier to enable the application to be assessed.  

The NCPE engaged in a pre-submission consultation with the applicant company in September 2018.

The NCPE has not received a dossier from the applicant company to date. The submission of a dossier by the applicant company is the next required step to complete this assessment process.