Pharmacogenetic testing eventually can lead to an overall decrease in the cost of health care…”.
The Importance of Pharmacogenetic Testing & the role PGx testing has in reducing readmissions
-There are more than 2 million avoidable ADR hospitalizations per year
-There are over 100,000 avoidable ADR deaths per year. That equates close to 1 avoidable death every 5 minutes!
-FDA report states in excess of $136+ billion in avoidable annual cost for ADRs
-Also said that over 350,000 Nursing Home ADRs per year
Study concluded … of 3,695 hospitalized patient episodes for ADRs, over half of them were definitely avoidable
-The more drugs a patient is taking, the more chance of an ADR
-The average Medicare patient takes 5-8 drugs with some as high as 20+ drugs per day
-Over 50% of Nursing Home patients take 5+ drugs and placed on at least one psychiatric drug within 2 weeks
-Patients taking over 11 drugs have a 96% chance of an ADR
Pharmacogenetics Testing can significantly reduce these statistics, yet we are unnecessarily subjecting our patients to avoidable ADRs… and even deaths
Pharmacogenetic Testing…Now!
In 2015 the following institutions implemented PGx testing: Cornell, Columbia, Georgetown, Harvard, Mayo Clinic, Scripps, Stanford, Vanderbilt… to name a few.
The Science behind our product
Pharmacogenomics is the study of genetic variations that influence individual response to drugs. Knowing whether a patient carries any of these genetic variations can help prescribers individualize drug therapy, decrease the chance for adverse drug events, and increase the effectiveness of drugs.
Pharmacogenomics has the potential to provide tailored drug therapy based on genetically determined variation in effectiveness and side effects. This will mean:
More powerful medicines - Pharmaceutical companies will be able to produce therapies more targeted to specific diseases, maximizing therapeutic effects while decreasing damage to nearby healthy cells.
Better, safer drugs the first time - Recovery time will go down and safety will go up as the likelihood of adverse reactions goes down or is eliminated altogether.
More accurate methods of determining appropriate drug dosages - Current methods of basing dosages on weight and age will be replaced with dosages based on a person's genetics --how well the body processes the medicine and the time it takes to metabolize it
The Results of Pharmacogenomics Enzyme expression in the body can be measured and be placed into the following 4 categories:
1. Extensive Metabolizer: This is a normal level of enzyme production or expression
2. Intermediate Metabolizer: This is a less-than-normal level of enzyme expression
3. Poor Metabolizer: This is a very low level of enzyme expression
4. Ultra-rapid Metabolizer: This is a very high level of enzyme expression
Adverse Drug Events: (ADEs)
Approximately 66% of readmissions are caused by adverse drug events (ADEs) where patients are prescribed medication’s they can’t metabolize or the wrong dose based on their metabolic ratios.
Pharmacogenetics is bringing a revolution in medicine whereby physicians and clinicians can examine the molecular genetics and the biology of each patients’ drug action.
Pharmacogenomic Testing:
Relevance in medical practice and why drugs work in some patients but not in others
This shows the discrepancy of proper dosage in a person based on their ability to metabolize a given drug.
A patient who is a poor metabolizer of Paxil may be dosed at 60 mg, whereas if that same patient were an ultra-rapid metabolizer the patient should be dosed at 135.
How could you know this without a PGx test?
Precision (Personalized) Medicine
FDA's Role in the Precision Medicine Initiative
“Most medical treatments are designed for the “average patient ” as “one-size-fits-all-approach,” that is successful for some patients but not for others.
Precision medicine, sometimes known as "personalized medicine" is an innovative approach to disease prevention and treatment that takes into account differences in people’s genes, environments and lifestyles.”
Advances in precision medicine have already led to powerful new discoveries and several new FDA-approved treatments that are tailored to specific characteristics of individuals, such as a person’s genetic makeup, or the genetic profile of an individual’s tumor.
Patients with a variety of cancers routinely undergo molecular testing as part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.
To advance these developments, President Obama’s Precision Medicine Initiative seeks to identify genetically-based drivers of disease in order to develop new, more effective treatments.
FDA’s role is to ensure the accuracy of genetic tests, many of which are derived from next generation sequencing, a rapid and fairly inexpensive technology that collects data on a person’s entire genome.
Researchers are combing through segments of this data to look for genetic variants, potentially meaningful differences that might eventually result in a treatment.”
Prescription Drugs: Trial & Error Consequences
What We Don't Know Yet: Costs of Health Care
“Health care costs in the U.S. have skyrocketed in past decades because of runaway medical costs that often don't lead to improved patient health.
In 2013 alone, the U.S. spent $9 million on hospitals — doubling from 2000. In 2014, health care spending grew 5.3 percent, up from 2.9 percent growth in 2013, according to the Centers for Medicare and Medicaid Services.
In total, the country spends $3 trillion on health care or 17.5 percent of the nation's gross domestic product.” href="http://www.usnews.com/news/blogs/data-mine/2016/02/04/as-the-3rd-open-enrollment-ends-a-look-at-how-obamacare-is-doing"target="_blank">http://www.usnews.com/news/blogs/data-mine/2016/02/04/as-the-3rd-open-enrollment-ends-a-look-at-how-obamacare-is-doing
Budget Breakers by: Kimberly Leonard
“Prescription drugs are costly and most Americans agree that they pay too much for them. Recent headlines illustrate that point clearly – from presidential candidates' promising to tackle the issue, to a CEO initially announcing a jump in the cost of a parasitic-fighting medicine.
And with America's total spending on prescription medicine reaching its highest rate in 13 years, policy groups are listening and are coming up with their own plans for reining in costs.
But while citizens are feeling the burden of drug costs, so is the government through publicly funded insurance plans. In 2015, government actuaries project drug spending will reach $305 billion, and it will likely get even worse because of trends in the industry.
Pharmaceutical companies recently have invested more in specialty medicines called biologics, which are complex, injected drugs rather than conventional medicines like pills.
Though these specialty drugs offer promise of treatment for serious chronic diseases – some even offering cures – the list price can be difficult to afford.” href="http://www.usnews.com/news/the-report/articles/2015/09/24/expensive-drugs-a-drag-on-consumers-and-government">http://www.usnews.com/news/the-report/articles/2015/09/24/expensive-drugs-a-drag-on-consumers-and-government
Black Box Warning Label
FDA has posted 130 Black Box Warnings where manufacturers recommend pharmacogenomics testing prior to or soon after initiation of therapy.
Of those, over 100 drugs require pharmacogenetic testing prior to prescribing, or it is highly recommended..
The FDA and Black Box Warnings: being or containing a warning of a serious or life-threatening side effect (as stroke, muscle damage, or suicidal tendencies) that is highlighted by a black border.
A high percentage of pharmaceutical drugs containing Black Box Warning Label- strongly suggest or require pharmacogenomic testing prior to subscribing.
Anticoagulant and Antiplatelet Drugs prescribed without pharmacogenomic testing increase the likelihood of a patient having a ADR (Adverse Drug Reaction).
Contact us today
Insurance and Medicare cover the cost to patients with medical necessity! Bion will show you how to easily begin with no cost to you!