How to use Real World Evidence in your EU Market Access Strategy?
Although randomized clinical trials (RCTs) are the primary tool used for drug approval data requirements, real-world evidence (RWE) holds future promise.
Key takeaways:
Using Real-world data (RWD) to generate RWE means using health-related data derived from a diverse human population in real-life settings. RWD can be medical health records, registries, biobanks, administrative data, health surveys, observational studies, health insurance data, data generated from mobile applications, etc. Real-world studies document the actual care that patients receive in the clinic and involve a diversity of patient cases (e.g., patients suffering from several diseases) without the limitation of strict inclusion and exclusion criteria typical of the RCTs.
Thus, real-world studies can generate long-term data on health interventions' effectiveness and safety while also providing valuable inputs for health economic analyses.
Many managed entry agreements or risk-sharing deals in Europe rely on the gathering of RWD.
What does RWE aim to do?
Moreover, understanding real-world experience and outcomes are critical to ensuring safe, efficacious products to patients in any given market.
Although randomized clinical trials (RCTs) are the primary tool used for drug approval data requirements, real-world evidence (RWE) holds future promise.
Key takeaways:
- Justifying access via cost-effectiveness and budget impact analysis
- Observational trials in conjunction with or as a continuation to an RCT
- Monitoring post-market safety and make regulatory decisions.
- Safety by Benefit/Risk Assessment
- Generating insights on the safety and effectiveness of innovative products
Using Real-world data (RWD) to generate RWE means using health-related data derived from a diverse human population in real-life settings. RWD can be medical health records, registries, biobanks, administrative data, health surveys, observational studies, health insurance data, data generated from mobile applications, etc. Real-world studies document the actual care that patients receive in the clinic and involve a diversity of patient cases (e.g., patients suffering from several diseases) without the limitation of strict inclusion and exclusion criteria typical of the RCTs.
Thus, real-world studies can generate long-term data on health interventions' effectiveness and safety while also providing valuable inputs for health economic analyses.
Many managed entry agreements or risk-sharing deals in Europe rely on the gathering of RWD.
What does RWE aim to do?
- Facilitate development and Access to medicines
- Evaluate applications for marketing authorization
- Reduce costs to payers
- Monitor the safety of medicines across the life cycle
- Provide reliable information to patients and the public
Moreover, understanding real-world experience and outcomes are critical to ensuring safe, efficacious products to patients in any given market.
