| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23003 |
| Drug | Voclosporin |
| Brand | Lupkynis® |
| Indication | Voclosporin is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN). |
| Assessment Process | |
| Rapid review commissioned | 10/01/2023 |
| Rapid review completed | 10/02/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of voclosporin compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 01/03/2023 |
| Pre-submission consultation with Applicant | 23/05/2023 |
| Full submission received from Applicant | 20/09/2023 |
| Preliminary review sent to Applicant | 24/04/2024 |
| NCPE assessment re-commenced | 31/05/2024 |
| Follow-up to preliminary review sent to Applicant | 02/09/2024 |
| NCPE assessment re-commenced | 09/09/2024 |
| Factual accuracy sent to Applicant | 25/10/2024 |
| NCPE assessment re-commenced | 05/11/2024 |
| NCPE assessment completed | 05/12/2024 |
| NCPE assessment outcome | The NCPE recommends that voclosporin (Lupkynis®) 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.
