| Assessment Status | Assessment Process Complete |
| HTA ID | 20034 |
| Drug | Nintedanib |
| Brand | Ofev® |
| Indication | For the treatment of other progressive, chronic fibrosing interstitial lung diseases (PF-ILD) in adults. |
| Assessment Process | |
| Rapid review commissioned | 17/07/2020 |
| Rapid review completed | 28/08/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nintedanib compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 01/09/2020 |
| Pre-submission consultation with Applicant | 05/10/2020 |
| Full submission received from Applicant | 10/11/2020 |
| Preliminary review sent to Applicant | 16/03/2021 |
| NCPE assessment re-commenced | 15/04/2021 |
| Follow-up to preliminary review sent to Applicant | 21/04/2021 |
| NCPE assessment re-commenced | 30/04/2021 |
| Factual accuracy sent to Applicant | 28/05/2021 |
| NCPE assessment re-commenced | 04/06/2021 |
| NCPE assessment completed | 24/06/2021 |
| NCPE assessment outcome | The NCPE recommends that nintedanib (Ofev®) 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.