| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | - |
| 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
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.
