| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Fremanezumab |
| Brand | Ajovy® |
| Indication | For prophylaxis of migraine in adults who have at least four migraine days per month. |
| Assessment Process | |
| Rapid review commissioned | 12/03/2019 |
| Rapid review completed | 17/04/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of fremanezumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013. |
| Full pharmacoeconomic assessment commissioned by HSE | 01/05/2019 |
| Pre-submission consultation with Applicant | 11/06/2019 |
| Full submission received from Applicant | 26/09/2019 |
| Preliminary review sent to Applicant | 06/12/2019 |
| NCPE assessment re-commenced | 10/01/2020 |
| Follow-up to preliminary review sent to Applicant | 30/01/2020 |
| NCPE assessment re-commenced | 12/05/2020 |
| Factual accuracy sent to Applicant | 24/07/2020 |
| NCPE assessment re-commenced | 31/07/2020 |
| NCPE assessment completed | 07/09/2020 |
| NCPE assessment outcome | Chronic migraine: The NCPE recommends that fremanezumab (Ajovy®), for the prophylaxis of migraine in adult patients with chronic migraine who have failed three or more migraine-preventive treatments, be considered for reimbursement. * Episodic migraine: The NCPE recommends that fremanezumab (Ajovy®), for the prophylaxis of migraine in adult patients with episodic migraine who have failed three or more migraine-preventive treatments, be considered for reimbursement if 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 2021