Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests Workshop Summary (2014) / Chapter Skim
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5 Perspectives of Payers and Regulators
5 Perspectives of Payers and Regulators
Pages 41-48
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From page 41... ...
• Next-generation sequencing presents a challenge for making payment decisions because collecting extra information is not traditionally covered unless it is shown to be safe and useful, regardless of any potential cost savings. Several regulators, legal consultants, and payers present at the workshop, offered unique perspectives on how co-developed companion diagnostics should be regulated -- exclusively by FDA or exclusively through CLIA or via a combined approach in which FDA determines which tests need further review and which can enter the market under CLIA.
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From page 42... ...
for laboratory-developed tests." In the current regulatory environment, it is the third-party payers, the practitioners of evidence-based medicine, or the guideline developers that are evaluating the clinical utility of tests, but, Gutman said, "this work is unfortunately non-standardized, non-coordinated, and is performed with variable transparency." As a starting point for the regulatory oversight of companion diag ostics, n Gutman provided what he called a "modest proposal" -- that FDA, CLIA, and third-party payers should be allowed to "do their jobs." CLIA should regulate laboratories to "assure a quality operation and to allow for a sampling of evidence that analytically valid systems are in place," but CLIA should not be expected to regulate medical devices pre- or post-market because the Centers for Medicare & Medicaid Services (CMS) lacks the authority, experience, and resources for this additional regulation.
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From page 43... ...
(held to CLIA standards) Premarket review and approval Yes, for higher risk tests No for tests Manufacturing tests under a Yes No quality system, e.g., • Design controls • Process controls • Complaint handling Reporting adverse events Yes No Annual reports Yes, for higher risk tests No Establishing clinical validity Yes Noa before using test Establishing clinical utility Yes, as needed No before using tests Regulation of test performance Higher standards Lower standards claims (FDA and FTC requirements)
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From page 44... ...
Strengthening CLIA, as proposed by ACLA, would require premarket notifications, including clinical validity information, so that laboratories could use tests immediately following the submission of these notifications, Thompson said. If clinical validity evidence is not available and there is an immediate health risk, CMS could then prohibit the use of a test.
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From page 45... ...
However, Debra Leonard, workshop co-chair and, at the time of the workshop, professor and vice chair for laboratory medicine at Weill Cornell Medical Center of Cornell University, said that the distribution, use, and payment models that govern IVD companies and clinical laboratories are different, and therefore they need different regulatory environments. A more robust CLIA is needed to bring the existing CLIA up to date, she said, but there is a role for FDA in regulating products that will be sold by companies.
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From page 46... ...
Managing medical costs while optimizing value is important; as a country, we are currently spending much more on health care costs than we can currently afford. "We need to make sure that the products that are put out there and that are promoted actually can reduce total costs in the real world," Armstrong said.
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From page 47... ...
could advance the concept of value-based purchasing because those in the system would decide which test should be paid for, Armstrong said. In this system, the payment moves from the payer to the health care delivery system (perhaps an integrated one)
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From page 48... ...
If a biomarker is safe, effective, and has clinical utility, it will be covered, she said. With a panel of tests that contains a biomarker of interest but other information as well, the additional information collected will not be covered unless it has been shown to be safe, effective, and useful, regardless of whether it was more cost-effective to order a whole panel versus a single test.
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