Question to the Minister for Health (Dr. Leo Varadkar, TD)
To ask the Minister for Health if he will provide an update on the assessment process concerning Sativex; when it is anticipated that the process will be complete and a decision made on the availability of the medicine; and if he will make a statement on the matter. – Jerry Buttimer
For WRITTEN ANSWER Wednesday, 1 April 2015.
On the 18 of July 2014 the Health Products Regulatory Authority granted a marketing authorisation for cannabis based medicinal product Sativex® to be marketed in Ireland. The remaining timeframe for making the product available for prescribing in Ireland is the responsibility of the holder of the product authorisation, GW Pharmaceuticals PLC and their European partner Almirall.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the GMS and community drug schemes in accordance with the provisions of 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. They are not political or ministerial decisions.
The HSE received an application for inclusion of Sativex® under the Community Drugs Schemes High Tech Arrangements in early September 2014. Sativex® is indicated for the relief of symptoms of spasticity for people with multiple sclerosis where other conservative treatments have failed to provide adequate benefits.
A Health Technology Assessment on Sativex® has been completed by the National Centre for Pharmaceoeconomics which did not recommend reimbursement of Sativex® at the submitted price.
The Report by the National Centre for Pharmaceoeconomics is an important input to assist the HSE in its decision making process and informs further discussions between the HSE and the supplier. No further comment can be provided at this time as the assessment process is on-going.