Researchers
from the University of Mississippi School of Pharmacy and St. Jude Children’s
Research Hospital have taken on one of the crucial barriers remaining in the
movement of pharmacogenetic testing to the clinic--coverage and reimbursement
of the preemptive pharmacogenetic testing by health insurance payers. The
results appeared recently online in Genetics in
Medicine.
Reimbursement
of pharmacogenetic testing varies widely across settings and payers. Little is known about reimbursement for preemptive
pharmacogenetic testing where testing is completed proactively and integrated
into the electronic health record to be available to clinicians at the point of
prescribing. The current study provides an in-depth look into the decision making processes
of insurance payers regarding the coverage policies for preemptive
pharmacogenetic testing.
In-depth
interviews with pharmacy and medical directors from a variety of regional and
national health plans as well as pharmacy benefit management companies were
conducted. The authors were interested in these decision-makers’ knowledge and
opinions on the preemptive testing model for pharmacogenetic testing. Numerous
issues from the clinical, economic, and policy domains were identified that
impact coverage decisions for preemptive pharmacogenetics.
Although insurance payers understood the
potential clinical and economic benefits for both patients and the health
system by using preemptive pharmacogenetics, payers seemed reluctant to cover germ-line
pharmacogenetic testing because of the difficulty in seeing an immediate return
on the investment in the testing cost.
Payers often think in a one-year time frame, but the value of preemptive
testing accrues over years. Payers found great value in the work of the Clinical
Pharmacogenetics Implementation Consortium (CPIC) to guide clinical decision making for
pharmacogenetics. (CPIC is an
international consortium interested in facilitating use of pharmacogenetic
tests for patient care.) CPIC is focused
on providing clinicians guidance when pharmacogenetic information is available,
but many of the payers wanted an organization such as CPIC to define who should
be tested.
Payers were asked about the clinical
evidence they needed to cover preemptive pharmacogenetics. Some payers remained focused on randomized
controlled trials (RCT). Others expressed a willingness to consider alternative
study designs, and some found value in learning from the experiences of sites
currently implementing pharmacogenetics.
The
costs of the medications that would be modified based on pharmacogenetic information
entered into the decision making process for these payers. They expressed a willingness for a
trial-and-error approach when the medication is inexpensive. However, there was
great interest in pharmacogenetics for expensive medications where the testing may
indicate if the patient should receive the medication. For
most other medications, potential downstream economic benefits and improved
patient safety are important predictors of utility to some payers.
Government
entities like the Centers for Medicare & Medicaid Services (CMS) and the US
Food & Drug Administration (FDA) were key reference points for the payers
interviewed. The workings of the CMS “coverage with evidence development”
program was used a benchmark to discuss similar programs among payers. While
some thought themselves willing to take on pilot-type studies, others believed
that CMS would have to lead the setting of coverage policies in this space and
others would follow suit. FDA labeling remains an important reference for
coverage to these payers even though the FDA label may not always contain all
the information needed to guide pharmacogenetic testing. One payer noted the
United States Preventive Services Task Force (USPSTF) could identify
pharmacogenetic testing as a priority for routine screening. An endorsement from a group like the USPSTF
would prompt reimbursement and could be a mechanism for widespread coverage.
This
study brings to light the mental model of payers and their remaining barriers
and facilitators to coverage in preemptive pharmacogenetics. The pharmacogenetics
community will likely find the results of this study valuable as they continue
to design and implement the research and implementation projects that demonstrate
the clinical and economic utility of pharmacogenetics.
Blog by James M. Hoffman, PharmD, MS
See
more about CPIC guidelines on PharmGKB and the CPIC website. See more about FDA
labels with PGx information on PharmGKB.
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