OBJECTIVES: Health technology assessment (HTA), pricing and reimbursement (P&R) processes, and cost-containment strategies in France, Germany, Italy, Spain, and the UK, are increasingly stringent. This study explored the resulting impact on high-cost oncology brands, and carved out specific market access levers and barriers. METHODS: Across the EU5, 500 medical or hematological oncologists were surveyed regarding their current and expected prescribing patterns, and 30 payers who influence reimbursement at national or regional level were interviewed. RESULTS: Some 68-83% of surveyed oncologists in France, Italy, Spain, and the UK, and 44% in Germany report that the average time taken by their healthcare authority to review newly approved cancer treatments and settle reimbursement terms delays availability for prescribing by ≥6 months. Thereafter, country-specific prescribing restrictions impede uptake; e.g., 18% of German hematologists surveyed report that their indicative prescribing budget prevents use of ponatinib in >20% of their chronic myeloid leukemia patients, while 30% of Italian medical oncologists say the national oncology drugs register monitoring use of costly agents severely restricts prescribing of erlotinib and gefitinib for non-small-cell lung cancer. Interviewed payers stress, however, that well-designed pivotal trials considering increasing focus on added benefit over direct comparators will help optimize HTA and P&R terms, with those in Italy and the UK, especially, advocating cost-sharing schemes to secure market entry. Furthermore, demonstrable downstream cost savings, locally targeted marketing campaigns, and manufacturer estimates of patient population size to aid regional/local budget planning are specified as uptake levers