OBJECTIVES

: The health technology assessment (HTA) bar is rising across the EU5 (France, Germany, Italy, Spain, UK). As payers’ balance clinical need with budgetary constraints, proving added benefit over currently available therapies is vital for new agents entering high-cost therapeutic markets). Focusing on non-small cell lung cancer (NSCLC), this study examined payer and physician perspectives on the importance of biomarkers in HTA, reimbursement and prescribing.

METHODS

: Across the EU5, 251 medical oncologists were surveyed regarding their current and expected prescribing patterns, and 10 payers who influence pricing and reimbursement nationally or regionally were interviewed.

RESULTS

: For interviewed payers, robust head-to-head overall survival (OS) data showcasing benefit over appropriate existing agents are key to optimal reimbursement. These payers advise that focusing on biomarker-defined subpopulations can be an effective means of optimizing clinical benefit to meet HTA demands in competitive markets. This study also finds the focus on biomarker-defined populations to influence the prescribing of almost all surveyed oncologists to some extent. Approximately one-third of physicians indicated that having to administer a biomarker diagnostic test had a negative influence on their prescribing, due to associated burdens, such as reimbursement hurdles and delay in treatment. The results were mixed across the EU5, with 40% of surveyed oncologists in France indicating that nothing restricts their prescribing, while only 14% indicated that same lack of restriction in the UK and Italy. Ultimately, OS and progression-free survival (PFS) as co-primary end points, appropriate comparator choice, and robust safety data were the key prescribing drivers identified by physicians surveyed.

CONCLUSIONS

: Meeting well-considered end-points, ideally improvement in OS versus existing standard-of-care, were the key factors for favorable reimbursement and strong uptake of NSCLC agents in the EU5. However, both payers and physicians indicated that targeting biomarker-defined subpopulations allows for an advantage in HTA, pricing and reimbursement negotiations and prescribing.