The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

Why Does Adverse Event Reporting to FAERS Continue to Accelerate?

Posted by Brian Overstreet on Oct 20, 2016 10:30:00 AM

Seventy two hours after 2016 Q2 FDA Adverse Event Reporting System (FAERS) data were publicly released by FDA, our RxFilter® process had it standardized and loaded into the Evidex platform.  Based on the volume of data in Q2, it looks like we’re well on the way to yet another record year of adverse events reported into FAERS. 

Here is a chart of new case reports (including our estimate for full year 2016).  Note that these numbers are based on a clean dataset; de-duplicated, primary suspect cases only).

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Topics: FAERS

Uncover Hidden Data Points with an Evidence Aggregation Platform

Posted by Jim Davis on Oct 13, 2016 11:00:00 AM

Clinical data transparency has been under fire for years. There are documented cases of negative clinical trial results not being reported, leading to organizations like Trial end-points are often a moving target, being changed mid-trial, leading to organizations like And it’s not only manufacturer sponsored research either. As STAT pointed out, most research institutions routinely fail to meet reporting requirements as well.

Furthermore, negative data and important safety issues are often “hidden” in publications, outside of the requirements of reporting laws and standard practices. The lack of full transparency leads to evidence based medicine without all of the evidence, and makes pharma CI's job of fully understanding competitors’ data especially difficult.

One form of hidden data points are adverse events that are not listed as “serious” in clinical trials because they do not lead to death, hospitalization, or life-threatening situations. 

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Topics: Evidex, real world data, evidence aggregation platform, clinical trial results, pharma CI, hidden data

How HEOR Can Demonstrate Cost Burden of Drug Adverse Events

Posted by Jim Davis on Oct 6, 2016 11:00:00 AM


Health Economics and Outcomes Research (HEOR) teams are using evidence aggregation platforms to conduct observational and retrospective studies using both clinical trial results and real world data. Whether a single database is being used for analysis or a combination of multiple datasets are combined, the best evidence aggregation platforms will incorporate standardized analytics that allow for efficient and effective insight generation. One of the key resources a HEOR team needs is the ability to standardize the downstream medical costs of drug adverse events.

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Topics: RxCost, Evidex, HEOR, real world data, evidence aggregation platform, cost of drug adverse events, clinical trial results, adverse events

Monitoring Biosimilars with an Evidence Aggregation Platform

Posted by Jim Davis on Sep 27, 2016 11:00:00 AM

In August 2016, CVS Healthcare announced its 2017 formulary exclusion list. The formulary exclusion list is a list of drugs that pharmacy benefits managers (PBM) like CVS Healthcare have decided to stop paying for in favor of a different, preferred drug. While preferred drugs may be chosen for safety or efficacy reasons, oftentimes economics plays a strong role.

One of those exclusions sent shockwaves throughout the pharmaceutical drug industry—the exclusion of Lantus (insulin glargine recombinant) in favor of its biosimilar Basaglar. That exclusion by CVS is expected to significantly impact Lantus’ sales. EvaluatePharma shows revenue for Lantus dropping from $7 billion in 2015 to $2.9 billion in 2022. 

To prepare for more exclusions and continued pressure by payers that favor biosimilars, pharma CI, Medical teams, HEOR, and other commercial and R&D teams within drug manufacturers need to be prepared to fully understand any potential differences the biosimilar may show compared to the reference product. The data will be used for competitive insight as well as evidence generation to position the reference product as a safer choice, as soon as any potential differences are seen.

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Topics: Evidex, real world data, evidence aggregation platform, clinical trial results, biosimilars, pharma CI

HHS Says they are Finally Going to Enforce Clinical Trial Reporting. Will Anything Really Change?

Posted by Brian Overstreet on Sep 22, 2016 10:30:00 AM

Last December, Stat News wrote a scathing report on the chronic under reporting of clinical trial results.  We followed that up in July with our own blog post, highlighting specific under reporting rates we’ve found in just a handful of indications.

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Topics: Clinical Trials, Clinical Evidence

Construct More Accurate Drug Forecasts using Clinical Trial Results and Real World Data

Posted by Jim Davis on Sep 15, 2016 11:00:00 AM

Constructing accurate drug and competitive market forecasts is a vital function of pharmaceutical commercial teams. A model that combines patient-based and event-based assumptions provides for a stronger understanding of the drug’s market, and accounts for potential scenarios that could affect what patient populations are treated. A lot of data need to be synthesized to create the best forecast possible. Evidence aggregation platforms are well suited to this task.

Let’s examine the case of a new drug entering a market which is claiming superior safety and efficacy vs. standard of care. While it is expected to quickly take market share, there are concerns that the advantages may only be seen in certain patient demographics.  If true this would significantly alter patient-based forecasts and market penetration models.

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Topics: Evidex, real world data, evidence aggregation platform, drug forecasts, clinical trial results, pharma CI

Seeing the Competitive Landscape with Clinical Trial Results Linked to Real World Data

Posted by Jim Davis on Sep 8, 2016 11:00:00 AM

Pharmaceutical Competitive Intelligence (CI) teams within pharma have always been early adopters of data driven insight. Individual data points aggregated into an interconnected dataset allow pharma CI professionals to access, manipulate, and keep up with constant change. 

As such, it’s come as no surprise that evidence aggregation platforms have found strong use cases in this area of pharma, helping manufacturers generate new insight on market dynamics which aids them in fully understanding the competitive landscape.

A case study of how an evidence aggregation platform has been used should be a helpful example.

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Topics: Evidex, real world data, evidence aggregation platform, clinical trial results, pharma CI

Drug Safety Snail Mail. Really?

Posted by Brian Overstreet on Sep 1, 2016 10:30:00 AM

Last week the U.S. Surgeon General Vivek Murthy sent a letter to every doctor in the U.S. to warn them of the dangers of opioid addiction.  While certainly well intentioned, I have to ask - in this age of technology, is this the best we can do?  Why not fax or, even better, send a Western Union cable?

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Topics: Drug Safety, opioids, healthcare

What is an Evidence Aggregation Platform?

Posted by Jim Davis on Aug 25, 2016 11:00:00 AM

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.

For example, an evidence aggregation platform can read adverse event data points from multiple clinical trial results and perform on-demand meta-analyses to better understand side effect rates for drugs. The evidence aggregation platform can then compare side effect rates from clinical trial results to side effect rates found in real world data such as pharmacy claims data or electronic health records (EHR).

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Topics: Evidex, real world data, evidence aggregation platform, clinical trial results

The Drug Pricing Battle Wages On

Posted by Brian Overstreet on Aug 19, 2016 10:30:00 AM

The battle over drug pricing took an interesting turn here in California this week.  On the heels of such negative publicity about high priced prescription drugs, giant price spikes for certain medications, and general bad behavior among certain high profile biotech executives, it’s not surprising that regulators and government bodies are starting to weigh in on ways to regulate or control drug price increases.

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Topics: drug pricing

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