Viral Load Reimbursement Information from Chiron Reimbursement Service

Testing for the number of copies of HIV RNA (the "viral load"
test) is becoming more common in medical practice. But this
test is not yet officially approved for use in managing
patients. Therefore, health insurance and managed-care plans
often refuse to pay for it. (Some do pay, perhaps because
they realize that the test can cost less than continuing to
use antiviral drugs which are not working for the patient).

Chiron Corporation of Emeryville, California, one of the
companies which makes a viral load test, has recently started
a reimbursement hotline which may help patients and
physicians get third-party reimbursement for the test, which
costs about $200 each. "Chiron Reimbursement Service...
provides reimbursement information and support to patients,
providers, and payers involved in the delivery of the HIV-1
RNA assay. CRS offers assistance with benefit verification,
appeals of denied or suspended claims, pre-authorizations of
coverage, and insurance payment and policy information."

The Chiron Reimbursement Service can be reached at 800/775-
7533.

Note that Chiron is one of three major companies which make
competing viral load tests. The other comparable tests are
(1) quantitative PCR (by Hoffmann-La Roche), and (2) NASBA
(by Organon Teknika), which is less well known in the U.S.
than the others. Chiron has been more aggressive than the
other companies in getting its test into clinical use.

Comment

Viral load testing is controversial, in that conservative
researchers and physicians think its use is not justified
until there is definitive proof that such use benefits
patients. The problem is that the most definitive proof will
take a long time to get, since "strategy" trials are may to
be required. In these trials, which have not started yet,
some patients will be randomly assigned to have their doctors
use viral load in making decisions about what drugs they
should use, while others will be randomly assigned to not use
viral load.

Even if nothing goes wrong with these trials, they will take
a long time because they will have to wait for people to die
or get sick, so that there can be a clinical difference
between the two patient groups. But much could go wrong. Who
will want to be in the control group and not know their viral
load for years? What will stop them from secretly getting the
test on their own, and then either dropping out, or changing
their treatment without telling the researchers, if the
results are bad?

A more fundamental problem is that such a trial can only test
one, or at most a few, strategies for using the viral load
test. But we are in the early stages of learning how to use
the test well. What result, for example, should be considered
high enough to require a change in drug therapy? And when
therapy is changed, should the patient add a new drug to his
or her ongoing regimen, or change to different drugs, or try
an entirely new class of antiviral such as protease
inhibitors? If the strategy chosen for the viral load
strategy trial happens to be a poor one -- which could easily
happen, especially since the antiretroviral drugs now
available are not very good -- it could take a long time to
show its superiority (if any) over not using viral load
testing at all.

Given the current unknowns, it is likely that we will learn
more about this test in the next several years through its
flexible use in clinical practice, than by conducting any
feasible set of rigid protocols.

The FDA already accepts viral load testing for showing that a
drug has antiviral activity in patients, for purposes of
accelerated approval of the drug. And the available evidence
-- plus all generally accepted theories -- strongly suggest
that having a low level of virus in the blood is better than
having a high level. We believe it is better to take a very
small chance of being wrong, than to delay for years before
using the best method available for quickly determining which
antivirals are working for a particular patient.