following a full submission
dabrafenib (Tafinlar) is accepted for use within NHSScotland.
Indication under review: In combination with trametinib for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
Relapse-free survival was significantly longer in the dabrafenib plus trametinib group compared with placebo in a phase III study of patients with completely resected, stage III melanoma with BRAF V600E or V600K mutations.
This SMC advice takes account of the benefits of a Patient Access Schemes (PAS) that improves the cost-effectiveness of dabrafenib and trametinib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
Medicine details
- Medicine name:
- dabrafenib (Tafinlar)
- SMC ID:
- SMC2131
- 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
- Pharmaceutical company
- Novartis Pharmaceuticals UK Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 11 February 2019