| Assessment Status | Assessment process complete |
| HTA ID | – |
| Drug | Osimertinib |
| Brand | Tagrisso® |
| Indication | For the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor [EGFR] T790M mutation positive non-small cell lung cancer [NSCLC]. |
| Assessment Process | |
| Rapid review commissioned | 26/02/2016 |
| Rapid review completed | 22/03/2016 |
| Rapid review outcome | Reimbursement not recommended at this point in time |
| Updated clinical evidence submitted by the Applicant | 21/12/2016 |
| Rapid Review completed | 10/01/2017 |
| Rapid Review outcome | Full pharmacoeconomic assessment recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 30/01/2017 |
| Pre-submission consultation with Applicant | 20/03/2017 |
| Full submission received from Applicant | 02/06/2017 |
| Preliminary review sent to Applicant | 28/07/2017 |
| NCPE assessment re-commenced | 24/11/2017 |
| Factual accuracy sent to Applicant | 21/12/2017 |
| NCPE assessment re-commenced | 16/01/2018 |
| NCPE assessment completed | 16/01/2018 |
| NCPE assessment outcome | An updated submission incorporating new clinical evidence, a new cost-effectiveness model and budget impact model was submitted by the applicant at the end of the NCPE assessment process, during the factual accuracy check of the NCPE’s final report. This submission will be considered following a re-commissioning of the full pharmacoeconomic assessment by the HSE. |
| Full pharmacoeconomic assessment re-commissioned by HSE | 18/01/2018 |
| NCPE assessment commenced | 19/01/2018 |
| Preliminary review sent to Applicant | 23/02/2018 |
| NCPE assessment re-commenced | 06/03/2018 |
| Factual accuracy sent to Applicant | 06/04/2018 |
| NCPE assessment re-commenced | 13/04/2018 |
| NCPE assessment completed | 03/05/2018 |
| NCPE assessment outcome | The NCPE recommends that osimertinib (Tagrisso®) 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; July 2020.