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Product liability insurers protect pharmaceutical companies from legal actions associated with their drugs.  They have a significant economic incentive to scientifically assess and understand the scope of litigation risk.   Experienced underwriters use an evidence aggregation platform to better understand if a manufacturer’s drug is causing severe side effects that could lead to potential litigation. They also use an evidence aggregation platform to adopt and employ a simplified and unified process of assessing side effect risk with proven statistical measures via a simple interface that deploys in minutes.

Understanding where drug litigation risk exposure lies at the insurer and portfolio level is vital to making underwriting decisions. An evidence aggregation platform enables a view of risk from side effects that have been shown in clinical trial results as well as those that are emerging in real world data, to fully understand not only drug and company specific risk, but aggregate risk for an insurer’s entire life science portfolio.

Take for example an insurer with a relatively small team that had limited direct life sciences backgrounds. The President of the life sciences division has had difficulty in developing a risk assessment platform for their portfolio. Already utilizing the FDA’s Adverse Event Reporting System (FAERS) data they were still limited by their inability to interpret the data and understand how to analyze their risk exposure. They struggled with the decision to spend countless hours and resources building a tool in-house or utilizing an evidence aggregation platform.

The President determined that a hybrid evidence aggregation platform, one that incorporated curated data sets as well as their own portfolio of insureds, was the best ready-to-use solution. The simple web interface allowed her and her team to quickly access a clean and standardized set of FAERS data side-by-side with clinical trial results. Utilizing proprietary analytics, she was able to quickly assess the risk of drug side-effects, and plug standardized outputs into a simple model to aggregate the risk on a company and portfolio level. She was able to refine her litigation risk models to account for side effects that were on/off label, and adjust for differences seen in clinical trial results vs. real world data.

As a result, her business unit was able to more appropriately set premiums when underwriting pharmaceutical drugs and ensure a balanced, risk mitigated portfolio of insureds.

Advera Health’s Evidex™ is an evidence aggregation platform that makes evidence collection and generation easy though a simple to use, yet powerful web-based application. To learn more about specific use cases of evidence aggregation platform's like Evidex for pharmaceutical companies, managed care organizations, hospitals, and product liability insurers, download our new White Paper, Use Cases for a Pharmaceutical Evidence Aggregation Platform- Combining Clinical Trial Results with Real World Data.


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Jim Davis, EVP Advera Health Analytics

Topics: Drug Safety, Clinical Evidence, Evidex, Pharmacovigiance 2.0

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.