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In the United States, ADRs create up to $100 billion in costs
annually, and over 120,000 deaths every year. Accordingly,
ADRs have been described as the fourth leading cause of
death in the United States, only surpassed by heart disease,
cancer and strokes. Studies attribute 6.5% of hospital admissions
to ADRs, with the average hospital stay estimated at
four days. On average, ADRs extend patient hospital visits up
to four days, which result in additional fees of up to $46,000;
so for a 350 bed hospital, managed care costs associated with
ADRs are approximately $2.8 million annually. Addressing
the health and cost implications of ADRs, personalized medicine
facilitates cost containment while improving patient
Genelex has been a leader in pharmacogenetic testing
since 2000. Our high-complexity laboratory facilities
feature robotic DNA extraction and testing, proprietary
test platforms and methodologies, rapid-turnaround,
and test validation across multiple platforms.
care and quality of life. Aside from the resulting financial
burden, ADRs significantly impact health outcomes; patients
Pharmacogenomics testing
reviews individual genetic
makeup to identify the likelihood
of ADRs, thereby reducing
occurrences among the patient
population;
report decreased quality of life, which often results in more
testing to identify the cause of their symptoms. An often overlooked
consequence of ADRs is the impact on patient adherence.
Patients neglect to follow prescription guidelines due to
their lack of faith in drug efficacy or the belief that they are
prone to side effects from their medications.
A solution to ADRs and lack of medication efficacy is pharmacogenomics.
Pharmacogenomics testing reviews individual
genetic makeup to identify the likelihood of ADRs, thereby reducing
occurrences among the patient population; increasing
drug efficacy; increasing adherence through patients’ first hand
positive experiences, encouraging treatment continuity; and
reducing healthcare costs incurred from ADRs, poor efficacy
and lack of patient adherence. Pharmacogenetics is the study
of how a person’s genetic makeup affects the metabolism of
medications.
Pharmacogenetic testing (PGx) detects normal and single
nucleotide polymorphism (SNPs) in the alleles of genes
and their associated enzymes. PGx results therefore predict
a person’s ability to metabolize certain medications. From a
patient effectiveness standpoint, it’s the next major breakthrough
in medicine. Pharmacogenetic testing (PGx) results
provide physicians with concise, medically actionable information
about a patient’s genotype, thus allowing them to
make effective treatment decisions. Because a patient’s genotype
remains constant, PGx results can be used to inform
medical treatment throughout their lifetime. Utilization of
PGx tests by physicians and healthcare providers will drive
the reduction of patient ADRs, while concurrently increasing
drug efficacy and patient adherence. As such, adoption of proactive
pharmacogenomics testing will lower healthcare costs
and improve patient quality of life.
Pharmacogenetics testing can be particularly
useful in:
· Chronic pain management
· Knowing a patient’s genotypes prior to prescribing pain and
other medicine
· Minimizing debilitating side effects
· PGx testing can mean the difference between a treatment
failure and a successful outcome.
You will know the following critical information for your patient:
· Which medication will work BEST
· Which medication will NOT work
For some insight to what awaits us, here is a 4-minute video,
The Era of Personalized Medicine, featuring the ‘Father of Pharmacogenomics’,
Dr. Richard Weinshilboum, the Director of
Pharmacogenomics at Mayo Clinic, and a 2-minute Mayo Clinic
video, The Importance of Pharmacogenetics: 2 min - Mayo
Clinic - Importance of Pharmacogenetics 4.5 min - The Era of
Personalized Medicine
Drug-gene testing is also called pharmacogenomics, or
pharmacogenetics.
All terms characterize the study of how your genes affect your
body’s response to medications. The word “pharmacogenomics”
is combined from the words pharmacology (the study of
the uses and effects of medications) and genomics (the study
of genes and their functions).
Your body has thousands of genes that you inherited from
your parents. Genes determine which characteristics you have,
such as eye color and blood type. Some genes are responsible
for how your body processes medications. Pharmacogenomic
tests look for changes or variants in these genes that
may determine whether a medication could be an effective
treatment for you or whether you could have side effects to
a specific medication.
Patient Information: Pharmacogenomics –
Finding the Right Medication for You
Pharmacogenomic testing is one tool that can help your
health care provider determine the best medication for you.
Your health care provider also considers other factors such as
your age, lifestyle, other medications you are taking and your
overall health when choosing the right treatment for you.
WHAT PHARMACOGENOMICS
TESTING DOES
The purpose of p harmacogenomic testing is to find out if a
medication is right for you. A small blood or saliva sample can
help determine:
Whether a medication may be an effective treatment for you
What the best dose of a medication is for you
Whether you could have serious side effects from
a medication
The laboratory looks for changes or variants in one or more
genes that can affect your response to certain medications.
Each person would need to have the same specific pharmacogenomic
test only once because your genetic makeup does
not change over time. However, you may need other pharmacogenomics
tests if you take another medication. Each medication
is associated with a different pharmacogenomics test.
Keep track of all your test results and share them with your
health care providers.
The need for pharmacogenomics testing is determined
on an individual basis. If your pharmacogenomic test results
suggest you may not have a good response to a medication,
your family members may have a similar response.
Mayo Clinic recommends you share this information with
your family members. Your health care provider can also provide
recommendations for family members who may benefit
from having testing.
CURRENT LIMITATIONS OF
PHARMACOGENOMICS TESTS
Current limitations of pharmacogenomics testing include:
One single pharmacogenomic test cannot be used to determine
how you will respond to all medications. You may need
more than one pharmacogenomic test if you are taking more
than one medication.
Pharmacogenomic tests are not available for all medications.
Because pharmacogenomic tests are available only for
certain medications, your health care provider determines if
you need to have a pharmacogenomic test prior to beginning
a specific treatment.
There are currently no pharmacogenomic tests for aspirin and
many over-the-counter pain relievers.
PHARMACOGENOMICS TESTING
COSTS AND COVERAGE
The cost of pharmacogenomics testing varies depending on
which test is ordered and your health insurance coverage. To
help you determine test costs and coverage:
Mayo Clinic’s Patient Account Services may be able to provide
Most drugs are broken down (metabolized) in the body
by various enzymes. In some cases, an active drug is
made inactive (or less active) through metabolism. In
other cases, an inactive (or less active) drug is made
more active through metabolism. The challenge in drug
therapy is to make sure that the active form of a drug
stays around long enough to do its job.
an estimate by phone.
Some insurance companies may cover pharmacogenomic testing,
depending on the policy and reasons for testing.
Contact your insurance provider about coverage prior to testing
if cost and coverage are concerns.
It may be helpful to get the ICD-9/ICD-10 procedure and CPT
billing codes for the specific lab tests from your health care
provider before calling the insurance company.
A federal law called the Genetic Information Nondiscrimination
Act (GINA) generally makes it illegal for health insurance
companies to discriminate against you based on your genetic
information. This federal law does not protect you against genetic
discrimination by life insurance, disability insurance
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