Can Real-World Evidence (RWE) Drive European, UK, and US Payer Decisions in the Reassessment of Oncology Therapies?

Author(s)

Bharmal M1, Katsoulis I2, Chang J3, Graham A4, Palencia R5, Stavropoulou A4, Pashos C6
1EMD Serono, Research & Development Institute, Inc., an affiliate of Merck KGaA, Rockland, MA, USA, 2Market Access Transformation, Fleet, HAM, UK, 3Pfizer, New York, NY, USA, 4Market Access Transformation, Fleet, UK, 5Merck Healthcare KGaA, Darmstadt, HE, Germany, 6Genesis Research, Winchester, MA, USA

Presentation Documents

OBJECTIVES: To understand how health technology assessment (HTA) bodies and payers perceive the use and value of RWE when reassessing oncology therapies, and their perceptions on its most desired attributes.

METHODS: A web-based survey was administered via the Rapid Payer Response (RPR) online portal in May 2022, among 30 national and regional payer decision-makers from France, Germany, Spain, the UK, and the US. Responses were collected through RPR in 5 days on the importance of evidence types, use cases of RWE, ranking of RWE attributes, and preference of endpoints, among other considerations. Payer responses were analyzed using descriptive statistics.

RESULTS: While clinical trial evidence was confirmed as being of greatest importance during reassessments, decision-makers ranked RWE as the next most important among various payer considerations. Specifically, most responders agreed that confirming the real-world effectiveness (27 of 30 responders, 90%) and safety (80%) of oncology therapies are the primary use cases. Payers also noted that RWE was used to confirm treatment utilization (63%) as well as healthcare resource use and economic benefit (53% each). Demonstrating clinical benefit to subpopulations and comparing with standard of care (SOC) were also highly rated during reassessment. Especially because of the lack of longer-term data at launch and the relatively short duration of registrational trials, payers looked to RWE at reassessment to provide meaningful data on overall survival, incidence of adverse events, and comparative clinical and economic data vs SOC. RWE from prospective observational studies and product/disease registries were considered of higher value, while peer-reviewed published data that are transparently presented as part of industry dossiers were considered to be of highest quality.

CONCLUSIONS: RWE can contribute significantly to HTA and payer reassessment decisions on coverage and reimbursement of oncology therapies, especially if meeting certain quality standards.

Conference/Value in Health Info

2022-11, ISPOR Europe 2022, Vienna, Austria

Value in Health, Volume 25, Issue 12S (December 2022)

Acceptance Code

P36

Topic

Health Policy & Regulatory

Topic Subcategory

Coverage with Evidence Development & Adaptive Pathways, Reimbursement & Access Policy, Risk-sharing Approaches

Disease

no-additional-disease-conditions-specialized-treatment-areas

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