Friday, 6 September 2019

Questions (835)

Gino Kenny


835. Deputy Gino Kenny asked the Minister for Health if his attention has been drawn to the difficulties regarding accessing the drug Sativex here even when prescribed by a consultant neurologist; the status and prescription protocol in relation to the drug; the changes planned in the prescription of and access to the drug in the aftermath of the introduction of the medicinal cannabis access programme; and if he will make a statement on the matter. [34939/19]

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Written answers (Question to Health)

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, 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.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

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.

A rapid review by the NCPE was completed on 3 April 2018 for Sativex and a full pharmacoeconomic assessment was recommended to assess the clinical and cost effectiveness of Sativex compared with the current standard of care.

A full pharmacoeconomic assessment was commissioned by the HSE on 20 April 2018. The NCPE had a pre submission consultation with the applicant in September 2018. However, the NCPE was unable to continue with the HTA assessment at this time due to the dossier not being submitted by the applicant. The NCPE received the required submission from the manufacturer on 12 August 2019.

I am advised that this assessment is currently in process.