Ring of light-colored tablets on U.S. $20 bills.jpegManaged Care Organizations are reviewing drugs well before a product is approved. According to a survey conducted by Dymaxium (the company behind the AMCP eDossier System) and presented in a recent webinar, two out of three healthcare decision makers begin to evaluate a drug at least six months prior to approval. The survey also indicates that the primary source of information that payers are using for these pre-approval evaluations is clinicaltrials.gov (CT.gov), and that manufacturers are not always responsive to requests for information pre-approval.

To summarize:

  • Healthcare decision makers need pre-approval data and evidence
  • Current sources of that data are not optimal
  • Manufacturers have yet to consistently address this information gap

As discussed in a recent article, there are roughly sixty drugs up for approval in 2016. With it taking up to one week to gather the data needed for a proper evidence review, chances are that not all decision makers will actually provide a proper review on all of the new drugs coming to market. This leads to strained resources and often times missed opportunities to change a treatment paradigm for the better.

In addition to the time burden this puts on managed care organizations, there are significant implications for the manufacturer as well. Slow or delayed reviews can lead to poor market access for a new product and slower than anticipated uptake.

In order to address this issue, manage care organizations need to take an aggressive approach to evidence aggregation, not solely relying on manufacturers’ release of information. An evidence aggregation platform can combat the time crunch, by doing the heavy lifting that is involved in extracting data from CT.gov and published research. With these tools, resources can be freed and allocated to conducting more thorough (and higher volume) reviews.

An evidence aggregation platform is a web based software-as-a-service (SaaS) application that takes multiple, disparate sources of data, or evidence, and combines those data together using analytics to create new insight.

Manufacturers also need to step in and do their part. When preparing for a new drug launch, data needs to be presented early and often by both clinical data teams and HEOR, and not just for the soon-to-be-launched drug. Collecting and aggregating evidence on the current standards of care and providing that data in easy-to-consume ways for the healthcare decision maker is vital.


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, see our comprehensive guide to using FARES data.


Jim Davis, EVP Advera Health Analytics

Topics: Drug Safety, Managed Care, 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.