The Genetic Benefits Risk Management Study was commissioned by TPA Network and will investigate the practical, efficient, compliant and cost-effective use of pharmacogenomic (DNA) testing by self-funded plan sponsors. It will be conducted by academic researchers affiliated with some of the nation’s leading universities and involve testing 100,000 participants of ERISA-regulated plans administered by a select group of forward-leaning TPAs. The study...believed to be the largest real-world evidenced-based pharmacogenomic study ever conducted...from a payor's perspective, will be overseen by an independent fiduciary, guided by the industry’s most trusted regulatory compliance law firm, …and financed with private and foundational funds (Investment and sponsorship opportunities still available).
Background: The Problem
Pharmacogenomics (or PGx testing) is the application of science to the trial-and-error prescribing process. It uses a clinically actionable test that accurately predicts a drug's effectiveness, guides dosage and improves patient safety by determining the effectiveness of most commonly-prescribed medications given a patient’s unique DNA. PGx testing, soon to be commonplace, will change the way medicine is practiced by becoming the starting point of medicine and treatment…making precision medicine the foundation of value-based healthcare.
Payors cover “medically necessary” genomic testing for those high-cost patients fortunate enough to have one of the few physicians who is familiar with PGx testing; willing to argue medical necessity with a UR firm; and confident enough to follow or support the test’s actionable results. In practice, this process is the equivalent of restricting access to mammograms to only those women who evidence signs of cancer: it is reactive rather than pro-active and simply makes no sense. Ergo, most agree: encumbering access to this game-changing science is unfair, unethical, nonsensical, wasteful and a possibly violation of ERISA.
The Study: Optimizing Pharmacogenomics
At issue is how to optimize the use of this important prescribing, diagnostic and care management tool to benefit a more expansive and appropriate patient population and use plan assets in a more fair, equitable and prudent way. Today, we can identify those individuals who will benefit most from PGx testing (including emerging high-risk patients who are not yet high-cost claimants). We can invite them (with their physician’s consent) to have a simple PGx test performed; and have the results interpreted and conveyed to the patient and prescribing physicians by a genomic scientist along with a scientifically-adjusted medication plan. When carefully selected and case managed, more than 80% of those patients who complete a targeted proactive PGx testing program have a change made to optimize their medication regimen. Understanding this, we will study exactly how it is that proactive pharmacogenomic testing can be optimally deployed in a value-oriented self-funded, ERISA-regulated setting.
In the emerging value-based paradigm, where efficacy and cost-effectiveness alone no longer define “value”, experts agree that this type of bench-to-bedside “translational research” is best conducted using a hybrid “pragmatic” study approach and “real world evidence”. Understanding this, theGenetic Benefits Risk Management Study team consists of researchers, scientists, physicians and professors affiliated with many of the country’s leading academic universities and research institutions (including the Duke University School of Medicine; the Salk Institute; MIT, Drake University and the Uniformed Services University of Health Sciences)…supported by an operations team having the unique blend of pharmacogenomic knowledge, expertise and experience necessary to perform a patient engagement, provider outreach and genomic case management project of this type, complexity and scale. The study will use only top-tier genomic laboratories and be supported by the services of the nation’s leading genomic medicine practices.
For consistency, efficiency and speed-to-deployment various collaborative arrangements are being made to involve the industry’s leading health data/analytics/technology vendors to create a secure, study-specific data collection, warehousing and interoperability capability to centralize all enrollment, health claim, pharmacy and genetic data for patient, physician, plan sponsor and researcher study participants.
For more information about the Genetic Benefits Risk Management Study contact Richard@ResearchConsortium.org or see www.ResearchConsortium.org
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