UNDERSTANDING THE IMPACT OF REAL WORLD EVIDENCE ON REIMBURSEMENT DECISIONS ACROSS EU5 COUNTRIES USING A WEB-BASED PORTAL TO ENGAGE PAYERS

Author(s)

Kumar Singh K1, Clapton GS1, Rebelo de Sousa C1, Tripathi S2
1Market Access Transformation, Fleet, UK, 2Market Access Transformation, Gurugram, India

OBJECTIVES: Real World Evidence (RWE) studies support RCTs by demonstrating that the trial outcomes are generalizable to clinical practice. This research was completed to understand the impact of RWE on reimbursement decision-making and formulary inclusion, the current challenges and the future value of RWE across the EU5 countries. METHODS: A web-based survey was administered through the Rapid Payer Response™ online portal (RPR®) to 25 payers with experience in HTA and reimbursement decision-making in France, Germany, Italy, Spain and UK, 5 payers per country. Payer profiles included former members of NICE and the SMC in the UK, ex-CEPS and ex-TC payers in France, ex-GBA and SHI payers in Germany, and both national and regional level payers in Italy and Spain. Responses were collected through RPR® in 5 days and analysed via Microsoft™ Excel. RESULTS: Payers considered RWE to be most impactful when used for post-authorization safety studies or when long term follow-up studies are required to ascertain the efficacy or cost-effectiveness of the product, particularly in chronic diseases; however, payers highlighted several concerns associated with RWE, including the robustness of the methodology, inherent bias, alignment with local clinical practice and the administrative burden of tracking patients. Payers acknowledged that registries can provide an excellent resource for RWE in the long-term, however the initial set-up requires both time and financial investment. CONCLUSIONS: Currently, RWE studies have a limited influence on most of the reimbursement decisions taking place across the EU5; however payers expect RWE to become more impactful in the future, once the methodological and logistical challenges are mitigated. In addition, use of RWE in the EU5 is expected to increase due to the growing number of patient access schemes in place.

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PHP245

Topic

Health Policy & Regulatory, Study Approaches

Topic Subcategory

Registries, Reimbursement & Access Policy

Disease

Multiple Diseases

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