| 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
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.
