The RxView Blog

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

Advera Health Analytics, Inc.

What happens when a Safety Signal contradicts Clinical Trial data?

By Bob Kyle on August 4, 2017

Last month, FDA released their quarterly watch list of ongoing drug safety concerns. My colleague Jim wrote a blog post on some of the major talking points around the update, not on the drugs or the risks themselves, but general pharmacovigilance themes. Our post this week focuses on one of the risks that was specifically discussed by FDA on the SGLT-2 class of diabetes drugs. The SGLT-2's had triggered a safety signal for nephrolithiasis (aka kidney stones). Evidex RxSignal analysis had also predicted this safety signal for most of these SGLT-2 drugs, with many of the signals being triggered more than a year prior to this alert.

However, unlike the 12 other safety issues in this same alert, the FDA quickly determined that despite the safety signal shown in the postmarketing data, “no action is necessary at this time, based on available information”. In other words, the FDA does not believe that kidney stones should be disclosed as a risk to the labels of these medications.

Why did the FDA make this determination so quickly? What information did the FDA use?

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Topics: FDA, Clinical Evidence, Evidex

Evidex Alerts After 3 Months: What We’ve Learned

By Bob Kyle on April 7, 2017

It has now been one full quarter since we launched Evidex Alerts, the service which keeps our clients on top of the latest Drug Label Changes, Regulatory Alerts and Clinical Safety Data in real-time.   Evidex Alerts have been a smashing success and our clients have openly thanked us making this information easier to follow.  One client in particular was amazed at how well we untangle the mess that is a drug label and pull out the important pieces of information that they need to know, when they need to know it.

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Topics: FAERS, Clinical Evidence

Calculating the Reporting Rate of Adverse Events in FAERS – A New Methodology

By Brian Overstreet on March 24, 2017

It’s been an exciting week for drug safety with articles in both USA Today and FiercePharma examining the five-fold rise in reporting of serious adverse events into FDA’s Adverse Event Reporting System over the past twelve years.  We were thrilled to see Advera Health featured prominently in both of those articles.

Despite the significant reporting increase, limitations in the use of FAERS data for post-market surveillance remain.  One of the biggest limitations is that not all adverse events are reported.  As a spontaneous (i.e., voluntary) reporting system, it’s simply not possible for every adverse event to be recorded.  This is different from a controlled clinical trial where all adverse events and outcomes are recorded.

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Topics: FAERS, Clinical Evidence

Using FAERS Data and Clinical Evidence to Compare HER2+ Antagonists

By Andrea Demakas on February 9, 2017

Recently, Advera Health released a comparative safety report of the HER2+ Antagonists. In this drug review, we analyzed FDA Adverse Event Reporting System (FAERS) and clinical trial data to better understand how the drugs in this class stacked up.

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Topics: FAERS, Clinical Evidence, Drug / Indication Information

Real-Time Drug Safety Analysis with Evidex Alerts

By Bob Kyle on January 20, 2017

This week we launched Evidex Alerts, a new feature that provides our clients with real-time updates on the latest impactful drug safety news. This is a project that our development and analyst teams have worked on diligently for the last three months, and I am excited to announce that it became a reality this week. 

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Topics: Drug Safety, Clinical Evidence, Evidex

Looking Ahead - Drug Safety in 2017

By Brian Overstreet on December 16, 2016

As 2016 winds down, am I the only one who feels exhausted? 

Between pharma-bro inspired drug pricing madness, a political season that felt like a Bravo reality TV show, and Leicester City robbing my beloved Tottenham Hotspur of their first shot at a Premiere League championship in a very long time, I think John Oliver summed up this year best in this video.

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Topics: Drug Safety, Clinical Evidence, Evidex

How Memorial Hermann Uses an Evidence Aggregation Platform

By Jim Davis on December 8, 2016

Healthcare systems are generally slow to adopt new technologies. For all the talk about leveraging “Big Data,” the industry has been even slower to adopt analytics to make those data actionable. In fact, not one state Medicaid agency currently uses an evidence aggregation platform with post-approval adverse drug events intelligence when creating preferred drug lists, writing prior authorization criteria, negotiating supplemental rebates, educating prescribers and dispensers, or performing prospective, concurrent, or retrospective drug utilization reviews. This is in spite of the fact that millions of patient lives are put at risk and billions of dollars are spent every year from adverse drug events. Yet there is no mandate to use readily available, reliable data to inform making decisions about prescription medicines.

Fortunately there are the outliers - innovators and early adopters that see things differently. They know that they can make a difference by incorporating new ideas and approaches to improve patient outcomes and their own bottom lines.

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Topics: Drug Safety, Managed Care, Clinical Evidence, Evidex, Drug Pricing, Pharmacovigiance 2.0

Mitigating Drug Litigation Risk with an Evidence Aggregation Platform

By Jim Davis on December 1, 2016


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: Drug Safety, Clinical Evidence, Evidex, Pharmacovigiance 2.0

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

By Jim Davis on November 17, 2016


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: Drug Safety, Managed Care, Clinical Evidence, Evidex, Pharmacovigiance 2.0

Establish Adverse Event Benchmarks with a Drug Safety Data Aggregation Platform

By Jim Davis on October 27, 2016

 


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, Clinical Evidence, Evidex, Pharmacovigiance 2.0

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