Clinical OMICS

JAN-FEB 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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18 Clinical OMICs January/February 2018 www.clinicalomics.com Diagnostics disability, morbidity, and mortality. Products that usually don't require clinical data, such as tests subject to 510(k) clearance, do not benefit from the efficiencies designed into the Par- allel Review program, the agencies acknowledged. "The program is most suitable for newer tests and technolo- gies, for which Medicare coverage is questionable, and the decision com- plex," Klein said. He noted that the program is restricted to high–risk (Class III) devices, whether due to risk or lack of a predicate device to support 510(k) clearance. "One would expect that the two categories from which the two partic- ipating tests arise—screening tests for life threatening diseases that utilize new technologies and complex tests that are directly tied to drug thera- pies—would be categories for which the program would be particularly well-suited," Klein added. "This is because both types of tests typically require premarket approval, and can have highly involved, uncertain cov- erage issues." The FDA and CMS initiated the program in 2011 as a pilot designed to reduce the time between FDA approval of a pre-market application and subsequent NCD by CMS. Three years later, the agencies approved and agreed to cover Exact Sciences' Cologuard, the first noninvasive DNA screening test for colorectal cancer. "The greatest efficiencies and cost reductions are likely to be realized when manufacturers contact FDA and CMS very early in the development process, so that clinical trials can be designed that will satisfy both agen- cies," said Harry Glorikian, consultant in the life sciences/healthcare industry. Developers, Labs 'Have Shied Away' During its pilot phase, parallel review accepted just two devices for review— Cologuard and Medtronic's Sym- plicity Renal Denervation System, which failed a pivotal trial in 2014 but launched a new pivotal study last year. "Overall, test developers and labs have shied away from the Paral- lel Review program," said Glorik- ian, author of Commercializing Novel IVDs: A Comprehensive Manual for Success. "Medicare coverage and reimbursement can be obtained even in the absence of a National Cover- age Determination, through regional CMS authorities such as Palmetto GBS which has implemented the MolDX program. Neither CMS coverage, nor private payer coverage and reim- bursement require FDA approval or clearance. "For the majority of molecular diag- nostics manufacturers that develop their test under CLIA guidelines instead of an FDA regulatory path- way, there hasn't necessarily been a lot of incentive to use the parallel review program," Glorikian added. In October 2016, the FDA and CMS agreed to fully implement parallel review, extending the program indef- initely. Since then, there have been 10 requests for consideration for Parallel Review designation, according to the FDA. "As word of Foundation Medicine's approval spreads, interest in the pro- gram may increase," Klein said. "People are likely to watch Foundation Medi- cine's experience closely. If this is very positive, it seems likely to stimulate interest in the program." However, despite the extension, pro- gram resources remain limited; only five candidates are accepted annually for Parallel Review. "Expanding the parallel review pro- gram will take the agencies fixing some of the issues inherent to the approval and clearance processes more gener- ally," Glorikian said. "Delays are com- mon. Unless review personnel are added and budgetary constraints loos- ened, the number of products accepted into the parallel review program is likely to remain small, regardless of the demand." (continued from previous page) The FDA Center for Drug Evaluation and Research.

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