OBJECTIVES: An increasing number of combination therapies are poised to enter the EU5 (France, Germany, Italy, Spain, UK) oncology markets, where they will compete with biomarker-driven and immune checkpoint inhibitor monotherapies. This research explored the EU5 market access landscape that emerging combination therapies will face in malignant melanoma.

METHODS: Across the EU5, 10 payers who influence reimbursement nationally or regionally were interviewed, and 501 oncologists were surveyed. Secondary research analyzed HTA reviews conducted by national and regional HTA agencies in the EU5.

RESULTS: Surveyed oncologists expressed a strong willingness to prescribe combination therapies. Notably, they indicated that a majority of BRAF wildtype malignant melanoma patients received combination treatment (either nivolumab/ipililumab or a BRAF inhibitor plus MEK inhibitor) in the first-line setting across all the EU5 countries, with few indicating that the increased cost of a combination treatment was an influential factor in selecting treatment for malignant melanoma patients. Interviewed payers stressed the potential cost burden of combination therapies, will all 10 agreeing that all emerging brands must unequivocally show robust superiority, ideally in terms of overall survival. Several current combination therapies in malignant melanoma have received sup-optimal HTA ratings across the EU5, affecting uptake in those countries, as reflected in surveyed physician prescribing of those agents. Payers indicate that manufacturers must ensure flawless trial design for their emerging agents to satisfy the stringent HTA demands, and to ensure uptake among oncologists who require compelling clinical data.

CONCLUSIONS: Interviewed payer and surveyed medical oncologist opinion across the EU5 clearly shows that appropriate clinical trial design for novel combination agents is crucial to achieving optimal access and reimbursement. Manufacturers of combination therapies aiming to enter the crowded malignant melanoma market will increasingly find that focusing on defined subpopulations optimizes clinical benefit, thereby having a significant impact on HTA and price negotiations.