| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Obinutuzumab |
| Brand | Gazyvaro® |
| Indication | In combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma. |
| Assessment Process | |
| Rapid review commissioned | 08/08/2017 |
| Rapid review completed | 13/09/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 25/09/2017 |
| Pre-submission consultation with Applicant | 10/10/2017 |
| Full submission received from Applicant | 21/11/2017 |
| Preliminary review sent to Applicant | 26/02/2018 |
| NCPE assessment re-commenced | 08/03/2018 |
| Factual accuracy sent to Applicant | 27/03/2018 |
| NCPE assessment re-commenced | 13/04/2018 |
| NCPE assessment completed | 03/05/2018 |
| NCPE assessment outcome | The NCPE recommends that obinutuzumab (Gazyvaro®) in combination with chemotherapy followed by obinutuzumab maintenance therapy for this indication should 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; May 2019
