CLINICA 1356 December 24 2009

MARKETS & REGULATORY – INTERNATIONAL

Japanese system needs toevaluate “the true value of IVD”
The Japanese reimbursement system is failing to recognise the contribution made bytechnological advancements in the IVD field, Dr Isao Ikeda, chairman of the American
Medical Devices and Diagnostics Manufacturers’ Association’s (AMDD’s) IVD
committee, tells Clinica

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Clinical testing, especially in vitro
A new reimbursement system needs to be created that will
diagnostics (IVDs), has evolved
reﬂect the actual value of new technologies and biomarker
considerably since the late 1960s,tests with respective clinical indications to clinical care andwith significant advance in theoverall healthcare cost. Furthermore, it needs to ensure that
discovery and development of new
the right tests of appropriate quality will be made available totests, as well as improvements inall people in Japan at the right time and place.
medical technology. Clinical testing
Timingbecame such an essential part ofTesting at the right time involves two dimensions: the timing
medical practice that a new term ofof disease progression and the timing from test request to“laboratory medicine” was formed.
the availability of a result.
However, since the 1990s, theThe use of IVDs should have an increasingly important
Japanese healthcare system has
Dr Isao Ikeda
role in earlier phases of disease progression and ideallyrarely carried out appropriate
identify early risk factors that will allow us to prevent aevaluations of the true value ofdisease.
IVDs and its contribution to medical practice. For that reason
In that regard, the introduction of metabolic syndrome
clinical testing fees havescreening tests infallen sharply since2008 is a positive
1990, while healthcare
Figure 1. Healthcare cost and clinical testing fees in Japan
example. For better
costs continue to risepatient management(see ﬁgure 1).
in acute diagnosis andThe 2008 revision of
appropriate triage andmedical reimbursement
treatment decision,
fees in Japan madeit is important toan effort to reﬂect
make results available
the value of IVDs
sooner, thus to shift
and indicated a more
appropriate testing frompromising future trend.
centralised locations
While the need andto hospital-based
importance of reviewing
laboratories.
the value of IVDs forJapanese healthcare
Price and value
was acknowledged andClinical testing fees dopartially reﬂected in
not reflect the value ofthe revision, it failed
the products used, andto differentiate theprovide no incentive,
valuable contributions
but rather aof technologicaldisincentive, for new
advancements and ofproduct developments.
new clinical indications for existing biomarker tests.
The current Japanese reimbursement system does not
The healthcare system in Japan faces many signiﬁcant
reﬂect the beneﬁcial impact of advanced medical technologies
challenges including the advancement of medical andcompared to those based on older technologies.
scientiﬁc technologies. In recent statements, government
The current reimbursement for HIV testing is a good
representatives have highlighted the need to correctly assess
example of such a mismatch in value recognition (see ﬁgure 2).
the following:
While new generations of test performance provide theopportunity to detect an increasing number of variationst How will these technologies improve the quality ofof the virus, and better sensitivity (thus allowing for earlier
medical care in Japan?
disease detection), there is no incremental reimbursementt How will they improve patients’ quality of life (QOL)?
for these superior test generations available. Instead,t How will they impact the overall medical cost, including
reimbursement is lower for advanced tests today than it
longer term economic benefits?
was for older generations a few years ago. All of this is being
compounded by increasing regulatory requirements, which
In order to secure innovation and enhancement of IVDs
add to the cost of introducing new products into Japan. Infor new, valuable contributions to the Japanese healthcare
many cases, such products have already undergone thoroughsystem, it is obligatory to revise the current reimbursement
tests and have been certiﬁed (CE mark).
p18
system.
© Informa UK Ltd 2009www.clinica.co.uk

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