Dabrafenib plus Trametinib (Tafinlar® plus Mekinist®)

Assessment Status NCPE Assessment Process Complete
Drug Dabrafenib
Brand Tafinlar® plus Mekinist®
Indication 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.
Assessment Process
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
Full pharmacoeconomic assessment commissioned by HSE 09/04/2019
Pre-submission consultation with Applicant 28/05/2019
Full submission received from Applicant 02/09/2019
Preliminary review sent to Applicant 09/04/2020
NCPE assessment re-commenced 18/05/2020
Factual accuracy 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 203

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations December 2021.