The combination of dabrafenib and trametinib (Tafinlar and Mekinist) will be added to the PBS from November 1 for adjuvant treatment of patients with completely resected BRAF V600 mutation positive Stage IIIB, IIIC or IIID malignant melanoma.
Patients with Stage III resected melanoma who may be eligible for the adjuvant treatment will also have MBS reimbursed access to the necessary mutational testing.
The evidence supporting the effectiveness of the combination therapy includes the COMBI-AD study, led by Professor Georgina Long, which demonstrated a 53% reduction in risk of disease recurrence in Stage III melanoma patients.
Fewer patients treated with the combination therapy had distant metastases or died compared to the patients in the placebo group, the study reported in 2017.
The oral targeted therapies were recommended for PBS listing at the July 2019 PBAC meeting.
However the announcement was overshadowed by criticism from the Melanoma Institute Australia that the PBAC had chosen not to also support subsidisation of immunotherapies.
As previously reported in the limbic, the Committee deferred making a recommendation on nivolumab and did not recommend listing of pembrolizumab.
“It is a sad irony that Australia has the highest melanoma rates in the world, yet we risk falling behind the USA and many European countries where this immunotherapy preventing melanoma recurrence in the majority of these high risk patients is already available and subsidised,” Professor Long said at the time.