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01.11
The Reimbursement Landscape for Novel Diagnostics: Current Limitations, Real-World Impact, and Proposed Solutions
Contributing Authors:
Kristin Pothier, Partner; Gary Gustavsen, Associate; Kerry Philips, Senior Analyst with support from BIO
Personalized medicine has the potential to revolutionize patient care. The fundamental goal in advancing our healthcare
system through personalized medicine is to deliver the right treatment to the right patient at the right time. Novel
diagnostics hold great promise as tools that allow physicians to differentiate patient-specific characteristics, design
personalized treatment approaches, and ultimately improve patient outcomes. The successful delivery of novel diagnostics
is the foundation of personalized medicine in our evolving healthcare system.
However, the success of personalized medicine is dependent on the healthcare industry's ability to overcome several
clinical, economic, and logistical challenges to commercialization. Some of the most pressing challenges relate to
the reimbursement system, specifically in obtaining affirmative coverage, appropriate coding, and value-based payment
for novel diagnostics.
The current reimbursement system was designed to support relatively simple diagnostic tests that formed the basis
of the traditional diagnostics industry. The system was not designed to support novel complex diagnostics, and
research suggests that its shortcomings are compromising the progress of personalized medicine today. This report
offers stakeholders a clear description of the current reimbursement system, its limitations, and an examination
of how these limitations impact investment in novel diagnostics and may ultimately impede patient access to
personalized medicine. Finally, this report offers a critical exploration of potential solutions for reform.
 read the report now (PDF: 1.8MB).
request a paper copy of the report.
read BIO's press release.
learn more about our expertise in diagnostics.
09.10: Point-of-Care Journal
Has Point-of-Care Come of Age?
Contributing Authors:
Health Advances: Kristin Pothier, Vice President and Sonia Gupta, Former Consultant
LipoScience: Mark Kirtland, Vice President of Strategy and Business Development
The prospect of point-of-care (POC) testing, enabling near immediate diagnosis and subsequent
treatment, has been alluring to clinicians for years. Science and technological progression, evidence
based clinical and economic drivers for POC use, and the current health care system's demand for
streamlined options suggest that POC products should be instrumental in today's diagnostic paradigm.
Nevertheless, relatively few POC tests have attained commercial success. The article reviews the
current barriers to the use of POC, the emerging success factors, and the evolving future of this space.
request a reprint.
learn more about Health Advances' expertise in diagnostics.
04.10: Future Medicine Journal
Advocacy in Personalized Medicine: A Developing Strength in a Complex Space
Contributing Authors:
Health Advances: Kristin Pothier, Vice President and Michael Dunn, Senior Analyst
bioMérieux: Iain Miller, Senior Director, Oncology Strategy and Theranostics Business Unit
Multiple stakeholders play a role in the adoption of personalized medicine, including payers, patients,
policy makers, diagnostic manufacturers and providers, and clinicians. These stakeholders span multiple
positions, institutions and points of view, and are interested in making sure that each diagnostic launch
covers a particular, sometimes contradictory, market need. A growing number of advocacy groups have emerged
to unify these stakeholders in this increasingly complex marketplace. This article identifies examples of
these advocacy efforts in personalized medicine today. It discusses how far these groups have been able to go,
what they are currently pursuing, and how they and others can continue to work to move personalized medicine
from concept to reality.
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learn more about Health Advances' expertise in diagnostics
03.10: IVD Technology Magazine
Manufacturing Obstacles in IVD Product Development —
Perspectives from Health Advances and KMC Systems Inc.
(an Elbit Systems of America company)
Contributing Authors:
Health Advances: Donna Hochberg, Ph.D., Manager
KMC Systems: Walter Gilde, Business Development Manager
With the IVD market changing rapidly, the pressure to deliver new products to market less expensively and more
efficiently is mounting. The changes in the IVD industry are being driven by increased laboratory test volumes
and growing pressure to lower turnaround times (TAT) with fewer skilled lab technicians. Any new product launch
must be able to address this demanding environment. Such sweeping demands in the industry are accelerating the
development of three specific areas of advancement: point-of-care (POC) technologies, automation, and graphical
user interfaces. To reduce costs and shorten product development cycles, some OEMs and start-up companies have
been turning to contract instrument developers and manufacturers for their guidance and relevant experience to
overcome common development challenges. This article will examine these trends, outline common obstacles
associated with them, and discuss how working with contract partners can overcome product development challenges
by showing examples of instruments that were introduced to the market with the help of a contract partner.
Also available is an audio discussion with Donna Hochberg and Walter Gilde.
request a reprint.
listen to discussion (mp3).
learn more about our expertise in Diagnostics.
03.09: In Vivo Magazine
How to Earn the Economic Payback Diagnostics Companies Deserve
By Gary Gustavsen and Kristin Pothier
For most diagnostics companies, the prospect of premium pricing has been an evasive
dream. The health care landscape is peppered with expensive novel drugs priced to
underscore their clinical impact on patient care. A similar strategy for pricing
novel diagnostics with significant clinical impact makes sense, especially since
many of them are driving the decisions to deploy novel drugs in the first
place. But logic has only recently translated into reality for most novel
diagnostics. The existence of an antiquated CPT code system which bases
reimbursement for diagnostics largely upon the cost of their underlying
laboratory procedures, rather than on their benefit, made for a slow
start. In addition, many diagnostic companies did not fund studies to
document their products' ability to affect clinical outcomes. However,
strong system economics arguments are becoming more mainstream and payers
are beginning to reward companies with reimbursement of their premium priced
tests. Rewards are based upon rigorous clinical arguments supporting the
diagnostics' benefits to clinical decision-making and compelling economic
arguments customized to each major payer. Identifying and documenting these
arguments for each product is the key to attaining sustainable premium
pricing in diagnostics.
request a reprint
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