In the past several months, there has been a series of events that have focused the spotlight on the gap in the type and quality of evidence pharmaceutical manufacturers are providing to Managed Care Organizations regarding their market ready drugs. Just today another example was publicized when it was announced that Express Scripts will be excluding several drugs from their approved 2016 formulary.

These events demonstrate not just a need but a demand for better and more, drug safety data. And fortunately, for the benefit of patients and the healthcare system as a whole, this demand is no longer being ignored by pharma. In fact, it has become clear that Market Access teams have become acutely aware that real world data and analytics must be used when communicating the value of their products or risk billions of dollars in lost or competitively stolen revenue.

However, realizing there is a problem and a demand that needs to be met, and knowing what the best solution are two different issues.

Water, water everywhere, but not a drop to drink.

Or in our case, data, data everywhere…

There is a tremendous amount of data available – everything from the FDA Adverse Event Reporting System (FAERS) to claims, EHR, social media and patient forum data -- all of which have the promise to add a significant layer to identifying drug safety concerns, and all of which in some form should be considered as potential data sources.

However all data are not the same. It is vital that the appropriate real world data, and the analytics around those data, be chosen to demonstrate drug safety. And when considering active surveillance databases, for demonstrating economic value as it relates to drug safety, there are two main considerations to keep in mind. First, as outlined in The State of Drug Safety Systems data from FDA Adverse Event Reporting System (FAERS) remains the best source of actionable data, over claims, EHR, and social. Over the past 5 years, the number of case reports provided to FAERS has increased by 71%, with approximately 900,000 in 2014. Second, with proper methodologies to account for limitations, and advanced analytics to translate safety concerns into economic burden, FAERS is by far the most usable, and immediately actionable source of real world data for Market Access teams to tap into.


Related Read: FAERS - Myths vs. Realities


The gap is not only in the lack of quantifiable data provided to those in managed care by pharma, but also in the area of trust. Pharma has a massive trust issue – not just with the public but with their clients in managed care as well. The push for profits at all costs and the high stakes consequences of producing block buster drugs has caused the integrity of pharma companies to be questioned repeatedly. As pharma has come to terms with this reality, they have in turn embraced third party data such as RxCost®, which calculates the downstream medical costs of drug side effects, to provide unbiased, independent analysis that managed care organizations demand.


Related Read: The Cost of Drug Safety


As we are thrust into the age of not only big data but LOTS OF data, it is critical to ensure the RIGHT data are being chosen for market access strategies. Connect with us today to learn more about how we help innovative and progressive pharmaceutical companies tell their drug safety story.


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Jim Davis

Jim Davis

Executive Vice President

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Jim Davis

Written by Jim Davis

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