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Advera Health Analytics, Inc.

Payers Need Better Access to Clinical Trial Results Prior to Drug Approval

Posted by Jim Davis on April 15, 2016
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Managed 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, 2 out of 3 healthcare decision makers begin to evaluate a drug at least 6 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 we discussed in a recent post, there are roughly sixty drugs up for approval in the remainder of the year. With it taking up to 1 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. New tools are being introduced to the market that 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.

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, 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.

With the annual AMCP conference approaching April 19-22, I invite both sides of the aisle to engage in conversation around ways to make evidence more readily available, and even more importantly, actionable.

Please stop by the Advera Health Analytics booth 539 at the AMCP conference or request a meeting with our representatives to learn more on how pre-approval evidence is generated with our Evidex platform.

Also stop by our VP of Scientific Affairs, Keith Hoffman’s poster presentation, Predicting FDA Alerts: A Pharmacovigilance Signaling System based on Past Regulatory Action, poster T02 on Thursday April 22 from 11:45 – 2:45 and on Friday April 23 from 9:30 – 11:00.

 

Jim Davis, EVP Advera Health Analytics, Inc.

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Topics: Clinical Evidence, AMCP, Evidex

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