Abstract
Introduction
Next-generation diagnostics promise to offer an enhanced ability to diagnose
disease and to provide moretargeted drug therapy to patients. However, for
manufacturers of these new technologies, navigating the current pricing and
reimbursement structure of major payers in the United States is a tremendous
challenge.
In this report, Catherine Shaffer, M.Sc., lends her expertise in biotechnology
to provide a comprehensive overview of current next-generation diagnostics.
Neil Grubert, M.A., director of pricing and reimbursement research at Decision
Resources, Inc., presents a thorough analysis of the current U.S. pricing and
reimbursement environment for diagnostics with a special focus on Medicare
policies. The discussion includes strategies that diagnostics companies may
employ in the quest to bring products to market successfully and to achieve a
favorable reimbursement status.
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- Next-generation diagnostic tests build upon existing molecular
technologies, resulting in either a greatly enhanced version of older
technology or in a completely new approach. Which novel diagnostics have
received approval, and what improvements do they offer over existing
technologies?
- The greatest diffi culty in entering the market with a novel diagnostic
test is navigating the existing pricing and reimbursement structure of the
major payers. How do Medicare and private payers determine coverage for
diagnostic tests? Which private payer has the most transparent coverage
policies for diagnostics?
- Manufacturers of diagnostic tests must meet rigorous requirements for
patient outcomes data and showcase a test' s clinical value before payers,
particularly Medicare, will approve reimbursement. How has Genomic Health
successfully secured coverage for its product Oncotype DX, a test that
quantifi es the likelihood of recurrence of breast cancer?
- Similar to the controversy surrounding personalized medicine, which calls
into question the notion of market restriction with the use of targeted
therapies, there is limited fi nancial incentive to invest in developing a
diagnostic test. What strategies can companies employ to increase the
uptake of a diagnostic test during commercialization?
Scope
- Birth of next-generation diagnostics: overview and description of
diagnostic tests that improve upon existing immunoassay and nucleic acid
testing (NAT) technologies.
- Next-generation diagnostics approved since 2001: coverage of select
diagnostics for indications such as drug metabolism, chemotherapy side
effects, oncology, cystic fi brosis, and HIV.
- Current pricing and reimbursement environment for diagnostics: path
to market, challenges of collecting health outcomes data, and
commercialization strategies.
- Medicare' s role in the reimbursement of diagnostics: description of
the agency' s policies in determining coding, coverage, and payment levels.
- Private payers' role in the reimbursement of diagnostics: overview
of private payers' policies.
- Outlook: a look at the future pricing and reimbursement environment
for next-generation diagnostics.
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