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Diagnostic survival test

Why CMS may demand outcomes data to justify reimbursement of cancer diagnostics

Based on advice being given to the Centers for Medicare & Medicaid Services, it looks like molecular diagnostics are about to find themselves on the horns of the same dilemma as therapeutics - the data required for approval may not be sufficient for reimbursement, and the data payers want may be difficult to obtain even in the postmarket setting.

In this case, CMS could issue a National Coverage Determination (NCD) for DNA- and RNA-based tests for cancer of unknown primary site and use its Coverage with Evidence Development policy to allow access only to patients enrolled in clinical trials or registries while the companies collect outcomes data.

If the agency does so, the NCD would supersede decisions by local carriers who are currently paying for the tests.

On May 1, CMS's Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) concluded there are not sufficient data to demonstrate the tests affect patient outcomes.

Asked to rate the level of evidence to support use of the tests to change survival outcomes, nine of 12 panel members voted 1 or 2 on a five-point scale - where 1 is low confidence, 3 is intermediate and 5 is high confidence.

Committee members wanted data from randomized controlled trials showing use of the tests led to improved survival.

In the U.S. there are at least three marketed DNA- or RNA-based tests for cancer of unknown primary (CUP), including the miRview mets2 assay from Rosetta Genomics Ltd. and Precision Therapeutics Inc.; the Tissue of Origin test from Pathwork Diagnostics Inc. and the CancerTYPE ID test from bioMerieux S.A.

Academics who spoke at the meeting said obtaining outcomes data in this population is a challenge in the U.S. because clinicians do not want to enroll patients into a trial where they

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