Dabrafenib plus Trametinib (Tafinlar® plus Mekinist®)
Dabrafenib, in combination with trametinib, is indicated for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection.
| NCPE Assessment Process | Complete |
| Rapid Review commissioned | 30/01/2019 |
| Rapid Review completed | 21/03/2019 |
| Rapid Review Outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of dabrafenib plus trametinib (Tafinlar® plus Mekinist®) compared with the current standard of care.
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| Full pharmacoeconomic assessment commissioned by HSE | 09/04/2019 |
| Pre-submission consultation with Applicant | 28/05/2019 |
| Submission received from Applicant | 02/09/2019 |
| Preliminary review sent to Applicant | 09/04/2020 |
| NCPE assessment re-commenced | 18/05/2020 |
| Factual accuracy check sent to Applicant | 10/07/2020 |
| NCPE assessment re-commenced | 20/07/2020 |
| NCPE assessment completed | 19/08/2020 |
| NCPE assessment outcome | The NCPE recommend that dabrafenib and trametinib 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 December 2021.