Posts Tagged Adverse Events

Removing Bias from HEOR: Standardizing the Costs of Adverse Events

Jim Davis

By Jim Davis

What are the total costs of prescribing a particular drug? At its core, all health economics and outcomes research (HEOR) studies are designed to answer this fundamental question. And it is this answer that helps to remove barriers to market access. However, economic models are often cited as the least helpful aspect of dossiers that are provided to Managed Care.

Why? It’s simple – bias. In a recent survey conducted by Dymaxium via the AMCP eDossier system, presented at the May 2015 ISPOR Philadelphia Workshop session, “Making Better Use of Company Pharmacoeconomic Models”, the top reason for not using models provided by life sciences organizations is over concern with potential bias.

Historically, hard to calculate data points that power economic assessments, such as the costs of drug side effects, have come solely from manufacturers which because of their inherent conflict of interest, makes it fundamentally flawed. It is just smart marketing to ensure the numbers work out in favor of the manufacturer’s product. However, healthcare decision makers involved in reimbursement decisions are smart. They saw through attempts to spin data, and subsequently have paid little attention to HEOR that is sponsored by pharma. This however, did not negate their desire and need for unbiased HEOR data.

In order to fill this need and to correct for this bias, managed care has sought out independent data sources. Sources that rely on big data and real world evidence that have allowed for comparative effectiveness (including safety) research to take great leaps forward.  The inherent bias and the availability of these independent, real world data, has pushed value assessment outside of the control of manufacturers and in turn, healthcare decision makers simply no longer have to rely on manufacturer controlled data.

In a world where the payer has more control over the success, and more importantly the failure, of manufacturers’ products, it is of vital importance to give the customer what they want.  We’ve seen this first hand in our business at AdverseEvents. Upon launch in January 2014, pharma was less than thrilled with our disruption of the drug safety status quo. But as uptake at managed care organizations has grown, we are now seeing those same detractors looking for ways to use our data and analytics in their studies.

Why is standardized data, such as the costing of adverse events so valuable? Because making comparisons by class, indication, or mechanism of action are direct and plain. Methodologies are transparent and replicable. And most importantly healthcare decision makers can more quickly and accurately make important decisions.

In the case of a standardized adverse event costing metric such as RxCost®*, which calculates the average downstream medical cost from adverse events, it allows the user to track the economic results of emerging safety issues in new drugs, compare those to more established drugs, and even quickly formulate a financial model for novel developments like biosimiliars.

The ability to quickly obtain, easily review, and plug these data into cost effectiveness models, budget impact models and other supporting information for formulary decisions will dramatically improve patient outcomes and lower downstream medical costs. It’s that simple. And with an estimated $25 billion in avoidable serious events and negative patient outcomes from drug adverse events hitting the U.S. healthcare system in 2013, it seems the introduction of standardized costing methodologies, and other independent, real world evidence is right on time.

To learn more, download the RxCost white paper or contact us directly.

*RxCost® is part of the AdverseEvents Explorer platform that is being used by managed care organizations to ensure that healthcare decision makers have vital independent adverse event and outcomes costing data available during their drug purchasing and formulary management processes. This means they now have the tools to be proactive instead of reactive in their attempts to mitigate this enormous cost burden that adverse events have on their bottom lines.

 

Written by Jim Davis

jim@adverseevents.com

EVP, AdverseEvents

As Executive Vice President, Jim manages the company’s global sales and business development efforts. Jim brings over 12 years of experience in commercial strategy, global sales management and execution, business development, and product development. He has over 9 years of specific domain expertise in biopharma market research, intelligence, and data.

– See more at: http://www.healtheconomics.com/blog/#sthash.sRXMQ4hJ.dpuf

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21st Century Cures and Off-Label Promotion Benefit HEOR and Drug Safety

Jim Davis

By Jim Davis

As my writing for the AdverseEvents Blog can attest, I’m in favor of data transparency. In my view, no organization should have monopolistic control over important information that limits the ability for healthcare decision makers to perform unbiased, objective comparative effectiveness research (CER). Furthermore, transparency leads to data and information being exchanged more freely, which will lead to an overall benefit to drug safety.

Pharmaceutical companies have historically had a bad reputation when it comes to transparency. In a large study conducted in 2004, of over 100 clinical trials, 65% of harms and outcomes were incompletely reported. However, in the past couple of years there has been a marked transformation by pharmaceutical companies to be completely transparent in publishing the results of all research conducted. Just searching Google for “pharmaceutical company transparency”, page one results show the public transparency policies of major manufacturers such as Janssen, UCB, and Takeda. This movement shows no signs of stopping and I believe it will be the rule, rather than the exception in short time.

It is now time for FDA to lift the remaining obstacles to transparency they have put in pharma’s way. And several ongoing initiatives may do just that.

The 21st Century Cures legislation attempts to provide a clear picture of what manufacturers can, and cannot, communicate with healthcare decision makers. New research from Avalere Health suggest that if approved, this could result in better evidence on cost-effectiveness, comparative benefit, and real-world outcomes for payers determining patient access to these medications. In addition to 21st Century Cures, on May 7 2015 Amarin Corporation, Plc filed a lawsuit against FDA, looking to lift restrictions  on marketing products based on claims that are currently not on a drug’s FDA approved label.

Pharmaceutical companies are the chief sponsor for most late stage and post-marketing drug research and they have the most to gain, and more importantly, lose, if their data fails to meet healthcare decision maker and market demands. Even though payers are demanding more real world data studies and health economics and outcomes research (HEOR), only 43% of respondents from a recent EY survey, agreed with the statement that “pharmaceutical companies have data that is credible for measuring and improving outcomes”.

There are good reasons why the amount of research in this area, and the acquisition of independent data sources by manufacturer sponsors have been limited. The results of such studies, and the use of independent data carry risks of coming to conclusions that can’t be readily commercially used. If a claim that is derived from the study is not in-line with the approved label, then the time, effort, and money spent on the study has effectively been wasted. By providing guidance and allowing for off-label promotion, FDA effectively incentivizes market access and brand teams to fund differentiated and alternative research, as well as seek out independent data sources. Thus providing healthcare decision makers with types of data that they are asking for to make fully informed CER decisions. With more research being conducted as a result of restrictions being lifted on off-label promotion, the transparency push will lead to more data being published, both positive and negative, leading to a less biased data pool.

All of the potential benefits from off-label promotion are contingent on FDA making smart decisions in the coming months that balance the need for a centralized authority on drug safety with the need for increased flow of data and information. It will be interesting to see the results of the open meeting they hold this summer on the topic.

In the meantime, we at AdverseEvents will continue to provide healthcare decision makers the independent, unbiased comparative safety research they demand. Click here for a Cost Comparison and Safety Analysis of Eylea vs. Lucentis for Diabetic Retinopathy.

 

Written by Jim Davis

jim@adverseevents.com

EVP, AdverseEvents

As Executive Vice President, Jim manages the company’s global sales and business development efforts. Jim brings over 12 years of experience in commercial strategy, global sales management and execution, business development, and product development. He has over 9 years of specific domain expertise in biopharma market research, intelligence, and data.

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