Delta-9-tetrahydrocannabinol/Cannabidiol, THC/CBD (Sativex®)

Assessment Status NCPE Assessment Process Complete
Drug Delta-9-tetrahydrocannabinol/Cannabidiol, THC/CBD
Brand Sativex®
Indication Indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
Assessment Process
Rapid review commissioned 05/12/2012
Rapid review completed 04/01/2013
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full pharmacoeconomic assessment commissioned by HSE 20/04/2018
Pre-submission consultation with Applicant 25/09/2018
Full submission received from Applicant 12/08/2019
Preliminary review sent to Applicant 10/02/2020
NCPE assessment re-commenced 01/12/2020
Additional follow-up to Preliminary Review sent to Applicant 19/03/2021
NCPE assessment re-commenced 04/05/2021
Factual accuracy sent to Applicant 08/06/2021
NCPE assessment re-commenced 21/06/2021
NCPE assessment completed 15/07/2021
NCPE assessment outcome The NCPE recommends that Sativex® not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations. October 2023


Pharmacoeconomic Evaluation

Commenced Completed Outcome
11/07/2014*  26/09/2014 Reimbursement Not Recommended

*Formal assessment commenced following legislative changes.

The NCPE does not recommend reimbursement of Sativex® at the submitted price.