Description of Medical ServiceThe proposed medical service builds on the existing BRAF MBS item code, code 73336 (illustrated below), and simply requests that the word “unresectable” be removed. This change would provide reimbursed access to the BRAF test for all patients with Stage III and Stage IV metastatic melanoma; and thereby, reimbursed access for eligible patients to combination dabrafenib and trametinib in the adjuvant setting when the combination is approved for listing on the PBS. This change is in line with the results collected in the COMBI-AD trial, which demonstrates that patients with resectable Stage III and Stage IV melanoma treated with combination dabrafenib and trametinib experienced a significant reduction in their risk of relapse.
Description of Medical ConditionCutaneous melanoma is the most aggressive form of all skin cancers and has the highest rate of increasing incidence worldwide. It has been estimated that approximately 50% of melanomas harbour BRAF pathway-activating mutations. The introduction of the BRAF mutation inhibitors, dabrafenib and vemurafenib for the treatment of unresectable stage III and stage IV melanoma have led to significant progress (significant improvements in progression free survival and overall survival) for the treatment of these patients. Surgical resection is the treatment of choice for localised melanoma, and frequently cures patients with Stage I and Stage II disease. However, for patients diagnosed with resectable stage III melanoma, the outcomes are still poor, with estimated 5 year survival rates for Stage IIIA, IIIB and IIIC being 20%, 20% and 11% respectively. Consequently, adjuvant therapy is indicated for these patients with the intent of treating micrometastatic disease and reducing the risk of local and distant relapse.
Reason for ApplicationAmendment to MBS item
Medical Service TypeInvestigative
Previous Application NumberNot Applicable
Application FormApplication Form (Word 181 KB)
Application Form (PDF 793 KB)
Consultation SurveyConsultation Survey (Word 508 KB)
Consultation Survey (PDF 307 KB)
Public Summary DocumentPublic Summary Document (Word 69 KB)
Public Summary Document (PDF 815 KB)