The RxView Blog

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

Advera Health Analytics, Inc.

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

How Information on Health Care’s Value is Currently Shared

Posted by Jim Davis on Aug 9, 2016 8:00:00 AM

On August 1, 2016, Dan Leonard, the President of the National Pharmaceutical Council published an opinion piece for Morning Consult, laying out his reasons for FDA to provide guidance on how biopharmaceutical companies can utilize and share real-world evidence with healthcare decision makers. He argues that due to shortcomings and ambiguities in existing laws, the exchange of information is limited, and stakeholders are making decisions without access to all of the pertinent information.  His solution is more regulation and guidance from FDA.

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Topics: Real World Evidence, Evidex

Express Scripts’ 2017 Exclusions – Analysis Using Real World Data

Posted by Jim Davis on Aug 2, 2016 4:30:28 PM

It has become tradition at Advera Health to look closely at the annual formulary exclusions that the large payers such as Express Scripts introduce every August. Using our safety scoring and costing algorithms we are able to quickly provide a top-line view into the effects of their decisions. 

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Topics: Drug Safety, Drug Formulary, Express Scrips, RxCost

Summer Slowdown? No, Summer Build!

Posted by Brian Overstreet on Jul 29, 2016 10:30:00 AM

As we hit the end of July, it seems that the summer slowdown is in full effect.  For every ten emails I send out I get back at least six “out of office” replies.  As with any organization focused on building and supporting a client base, it’s hard not to get a little anxious in August when calls aren’t returned, contracts aren’t processed, and just about everything grinds to a halt.

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