Meet your clinical, economic, and regulatory needs throughout a product's lifecycle using U.S. real world solutions.
With clinical innovation accelerating, more drugs are obtaining marketing authorization for narrowly defined patient populations and early-stage disease. This can pose challenges in clinical evidence development, as fewer patients may be available for recruitment and generating mature outcomes can be prohibitively long.
Real-world evidence (RWE) has the potential to fill this gap by complementing and supplementing clinical trial evidence, as well as reducing health technology assessment (HTA) body uncertainties that can delay reimbursement decisions. As the momentum around RWE use strengthens, examples emerge where it has contributed to positive reimbursement decisions and therefore patient access to innovative therapies. However, acceptance of RWE in HTA evaluations and its impact on HTA outcomes remains limited and highly variable among countries.
This report explores the use of RWE in HTA evaluations to inform factors that are critical to the final pricing and reimbursement decision. It presents an overview of the current role of RWE in oncology HTAs, where unmet need and obstacles to developing clinical evidence are particularly high. The report then explores key drivers and barriers of historic RWE acceptance, which builds upon work presented at ISPOR Europe 2022 of 20 examples in oncology where RWE contributed to a positive HTA outcome. Considering the value of RWE in overcoming payer uncertainties and allowing for faster patient access, the report concludes with a discussion of initiatives and strategies to standardize and optimize the way RWE is evaluated across Europe.
Meet your clinical, economic, and regulatory needs throughout a product's lifecycle using U.S. real world solutions.
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