Happy Holidays! In what many describe as the most exciting countdown of the year, here are the top free downloads from Advera Health for 2017!

#5 Using FAERS Data as a Proxy to Determine Medical Costs for TNF alpha Inhibitors


Using FAERS Data as a Proxy to Determine Medical Costs for TNF alpha Inhibitors

Presented at the ISPOR conference in May 2017, this poster and abstract:

  • Pairs FAERS data with specific claims data to determine downstream medical costs of adverse events associated with TNFa Inhibitors Humira (adalimumab), Enbrel (etanercept), Cimzia (certolizumab pegol), Remicade (infliximab), Simponi (golimumab), and Simponi Aria (golimumab).
  • Uses Advera’s Evidex platform to validate a hypothesis that the reporting rate of pneumonia as an adverse event in FAERS would be similar to the incidence rate of pneumonia as an adverse event in the WEA Trust medical claims database
  • Concludes that higher incidence of pneumonia caused by certain TNF alpha inhibitors would result in higher downstream medical costs


# 4 Evidex Alert: Approval of Ocrevus (ocrelizumab) for Multiple Sclerosis

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By Downloading this Evidex Alert you will access:

  • A comprehensive review of the full safety data from Ocrevus' clinical trials, including pooled analyses
  • A detailed analysis of Ocrevus' label
  • A thorough investigation of adverse events that were seen in clincial trials, but NOT included in Ocrevus' label


#3 Evidex Alert: Analysis of Q1 2017 FDA Safety Signals

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By Downloading this Evidex Alert you will access:

  • An analysis of the 14 safety signals FDA commented on based on Q1 2017 FAERS data
  • Disproportionality analysis using Advera Health's Evidex platform
  • Contextual data and analysis that can not be found anywhere else


#2 Adverse Drug Event Reporting Rates: Comparing FAERS to Clinical Trials


Presented at the Association of Managed Care Pharmacy (AMCP) conference in March, 2017, this poster and abstract:

  •  Compares the rate of adverse drug events (ADEs) for individual drugs from pre-approval clinical trials to post-approval reporting to FDA’s Adverse Event Reporting System (FAERS).
  • Provides a new methodology to calculate ADE reporting rates and examine whether reporting rates differ by indications.


#1 Drug Safety Data to Support the Entire Life-Cycle: An Introduction to Drug Safety Evidence Aggregation Platforms

Drug safety evidence aggregation platforms are becoming a vital tool for pharmacovigilance departments at pharmaceutical manufacturers. Throughout this guide, specific use cases for will be provided for a drug safety data aggregation platform designed for all functions within a pharmacovigilance department, including signal detection, safety science, and epidemiology.

Drug safety data to support the entire lifecycle

Chapters in this guide include:

  1. What is a Drug Safety Evidence Aggregation Platform?
  2. How is an Evidence Aggregation Platform Different from Traditional Signal Detection Software?
  3. Case Study- Signal Detection Utilizing FAERS Data
  4. Case Study- Analyzing the Safety Landscape of Oral vs. Injectable Drugs
  5. Case Study - Establishing Drug Safety Benchmarks for a Clinical Stage Product
  6. Why choose Advera Health’s Evidex™ as Your Drug Safety Evidence Aggregation Platform


Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.