For the last few years, we have been working continuously to turn post-market patient data from the FDA’s Adverse Reporting system (FAERS) into insight that can be used by healthcare providers to quantify the costs and risks associated with the drugs that their patients are prescribed. Along the way, we have had a number of “naysayers” tell us it cannot be done.
They have told us things like:
“The FAERS database is too messy and complicated”
“There is no “denominator” to the adverse event incidence data provided by FAERS”
“There is no way to quantify the expense that negative outcomes from adverse event reports in FAERS”
The naysayers have kept us motivated to answer all of these standard complaints while coming up with a rigorous rating system called RxScoreä that quantifes these drug risks. This month, the culmination of all of that work by my colleague Dr. Keith Hoffman and our analyst team has been validated. The Academy of Managed Care Pharmacy's (AMCP's), Journal of Managed Care and Specialty Pharmacy (JMCP) published our groundbreaking study entitled “A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes” in its December issue.
In this study, Dr. Hoffman et al highlighted the problems with relying just on clinical trial information to establish drug risk profiles. The small homogenous patient populations in clinical trials along with general industry bias against making negative disclosures creates an incomplete risk picture from clinical trials. Therefore, real world patient data is vital in quantifying relative risks of commonly prescribed drugs, prompting the need for our RxScore system.
With RxScore, Advera Health has finally given healthcare decision makers a unique view into the true safety profiles of drugs, without manufacturers data sanitization. And why is this unbiased data needed – simply, if a patient takes a drug, has a serious side effect, and ends up in the hospital, that’s an added burden to the system (the hospital, the patient, and the insurer). If millions of patients are taking that drug and any sort of decent percentage of patients is experiencing that sort of outcome, the systemic costs are exponential. By quantifying the risk profile, healthcare decision makers are able to make better-informed decisions that result in safer drugs being made available to prescribers and patients. By optimizing their formularies, they are able to reduce harm and improving their financial outcomes.
Hundreds of hospitals and health systems, such as Memorial Herman and University of Utah are already using these data to identify the unforeseen medical costs linked to serious non-labeled adverse events and to make formulary and prescription changes as a result. I invite you to read our study in depth but to summarize how the RxScore works, here are the steps we went through to create it:
- First, we cleaned the patient case report data that comes from FAERS. As our naysayers would tell you, the database is messy and disorganized. Indeed, it is. For example, there are hundreds of thousands of misspellings and alternative names for all of the drugs in the database. Which is exactly why our team spent over a year systematically developing processes to correct those issues. Once all of the drug data were cleaned and categorized properly, we focused on the serious adverse events caused by these drugs and assigned a cost to them using a study completed by the Agency for Healthcare Research and Quality (AHRQ). For each patient case report in the FAERS database, we used the highest costing adverse event to estimate what it cost to treat that particular patient.
- Using annual patient utilization data from our partner Evaluate Pharma as our denominator, we then determined an average amount of downstream costs per patient caused by a drug’s serious adverse events.
- At that point, we applied a formula to all of those average costs per drug to create a logarithmic scale of risk scores from 1 to 100, with 100 being the most risky. This is the essence of RxScore, which provides an easy to understand number which allows payers and providers to compare the safety of one drug versus another.
To those who said it wasn’t possible, we’ve happily proven them wrong. We are proud that a positive impact can be made both in terms of costs and outcomes by reacting to these data.
Follow this link to find out more about how RxScore and other Advera Health risk assessment insight can help your organization make better decisions.