The RxView Blog

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

Advera Health Analytics, Inc.

Mitigating Drug Litigation Risk with an Evidence Aggregation Platform

Posted by Jim Davis on Dec 1, 2016 11:00:00 AM

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.

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

Use Clinical Trial Results Linked to Real World Data for Better Formulary Reviews

Posted by Jim Davis on Nov 17, 2016 11:00:00 AM

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, 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.

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Topics: Formulary, Drug Formulary, Evidex, real world data, evidence aggregation platform, clinical trial results, adverse events

When Things Go Right in Healthcare

Posted by Brian Overstreet on Nov 11, 2016 7:30:00 AM

In these blog posts we’re often guilty of highlighting the worst in healthcare (see, for example, here, here, and here).  That attitude shouldn’t be totally surprising when we started Advera Health Analytics with a mission to correct a glaring problem in the healthcare system – the lack of transparent drug safety and efficacy data.   That said, it seems only fair to give credit where it’s due when things go exactly right.  This is one of those stories.

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Topics: healthcare

A Drug Safety Data Point That No One Knows About

Posted by Bob Kyle on Nov 3, 2016 11:00:00 AM

In the Q3 2014 FDA Adverse Event Reporting System (FAERS) data file, FDA quietly added a new field that links a patient and case report to a literature reference. Or in other words, there is additional information on the adverse event (AE) report that previously was not available. These literature references can provide beneficial context to the patient case report, validate or refute a causal relationship to an adverse event, and often times bring to the surface data that is otherwise undiscoverable.

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Establish Drug Safety Benchmarks with an Evidence Aggregation Platform

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

 

Drug safety is often equated with post-marketing pharmacovigilance, something that is required by manufacturers only after their drug is approved. But when drug safety data are presented in an evidence aggregation platform there are very strong use cases in pharmaceutical competitive intelligence, health economics and outcomes (HEOR), and R&D. An evidence aggregation platform takes multiple sources of information and boils it down into actionable insight. That insight often has use cases that span all departments and can meet the demands of various priorities. 

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Topics: Drug Safety, Evidex, benchmarks, real world data, evidence aggregation platform, clinical trial results, adverse events

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 AllTrials.net. Trial end-points are often a moving target, being changed mid-trial, leading to organizations like Compare-Trials.org. 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

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