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Pricing and Reimbursement of Next Generation Diagnostics in the United States
Decision Resources, Inc., Dec 2007, Pages: 20
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 favourable reimbursement status.
Get the Answers You Need to Shape Your Strategy
- 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 difficulty 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 quantifies 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 financial 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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