OBJECTIVES: Melanoma, also known as malignant melanoma, is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. The primary cause of melanoma is ultraviolet light exposure in those with low levels of the skin pigment melanin. Treatment is typically removal by surgery. In those with slightly larger cancers, nearby lymph nodes may be tested for spread (metastasis). Most people are cured if spread has not occurred. For those in whom melanoma has spread, immunotherapy, biologic therapy, radiation therapy or chemotherapy may improve survival.

METHODS: The international HTA database Prismaccess® includes benefits assessments, including various countries. The focus in this evaluation was set on Germany. All decisions on melanoma therapies launched in Germany in the last 10 years were considered for a systematic reimbursement analysis, excluding reassessments of older drugs.

RESULTS: 22 decisions have been considered by the G-BA with overall 34 IQWiG assessments. Within the submissions 16 phase III studies were submitted, four phase II and 2 phase I study evidence. For 11 evaluated subgroups a considerable added benefit was granted, two subgroups have shown a non-quantifiable added benefit, 21 subgroups did not show an added benefit, and in two subgroups, the G-BA has decided on a lesser benefit. Overall, the 22 decisions ended up in 12 recommendations without limitations, in nine recommendations with limitation and in and Nivolumab in combination with ipilimumab in non-pretreated patients with a BRAF V600 wild-type tumor did not achieve a positive added benefit. Anyhow, all drugs are available in Germany. Main drivers for evaluation dissimilarities are different appropriate comparator therapies, patient populations and evidence quality.

CONCLUSIONS: The analysis showed overall positive added benefit assessments in melanoma especially compared to other indications in Germany. However, some differences exist. Reasons vary and need to be taken into account in future market access submissions.