Barriers to clinical adoption of next generation sequencing: Perspectives of a policy Delphi panel

Abstract

This research aims to inform policymakers by engaging expert stakeholders to identify, prioritize, and deliberate the most important and tractable policy barriers to the clinical adoption of next generation sequencing (NGS). A 4-round Delphi policy study was done with a multi-stakeholder panel of 48 experts. The first 2 rounds of online questionnaires (reported here) assessed the importance and tractability of 28 potential barriers to clinical adoption of NGS across 3 major policy domains: intellectual property, coverage and reimbursement, and FDA regulation. We found that: 1) proprietary variant databases are seen as a key challenge, and a potentially intractable one; 2) payer policies were seen as a frequent barrier, especially a perceived inconsistency in standards for coverage; 3) relative to other challenges considered, FDA regulation was not strongly perceived as a barrier to clinical use of NGS. Overall the results indicate a perceived need for policies to promote data-sharing, and a desire for consistent payer coverage policies that maintain reasonably high standards of evidence for clinical utility, limit testing to that needed for clinical care decisions, and yet also flexibly allow for clinician discretion to use genomic testing in uncertain circumstances of high medical need.

Insurance Coverage Policies for Pharmacogenomic and Multi-Gene Testing for Cancer

“…The guidelines that recommended multi-gene tests were NCCN [ 18 ], CMTP [ 19 ], ASCO [ 20 ], and ACMG [ 21 ], with NCCN and CMTP specifically recommending the tests for NSCLC. The CMTP also recommended such tests for other conditions including rare, uncommon, or stage IV solid tumors, e.g., lung and pancreatic cancers.…”

Individualized medicine comes to the liver clinic

“…Third, there are third party payers who do not cover WES testing in adult patients on a diagnostic odyssey because of scepticism regarding the clinical impact of such testing. 12 This impression is likely going to change in the future when we, as the academic community, publish more studies to emphasize the cost savings of medical evaluations that incorporate WES testing early in the diagnostic process. Of note, the current cost of clinical grade WES testing and interpretation is comparable to other tests/procedures we already use in practice (i.e., MRI, endoscopy, etc.…”

Barriers to Clinical Adoption of Next-Generation Sequencing: A Policy Delphi Panel’S Solutions

“…As reported elsewhere [13], a total of 29 prospective policy challenges were presented to the panelists for evaluation, encompassing: 19 challenges across the domains of coverage and reimbursement, intellectual property, and regulation framed by the project team based on preliminary research and the content expertise of project team members, and ten additional challenges suggested by the panelists in round one without restriction as to domain. The four challenges identified in the first two rounds of the Delphi as most important were:

Payer variation in evidence standards: different payers have different evidentiary standards for assessing clinical utility, leading to inconsistent policies on coverage and reimbursement for NGS-based testing.

Proprietary databases: diagnostic companies are able to maintain proprietary databases on the substantial variety of clinically meaningful mutations found in patients.

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“…We used a multistakeholder panel of experts to identify and rank the most important policy challenges and deliberate about solutions to the top four challenges. The first two rounds of this study (reported elsewhere) established the group’s collective judgement about which barriers were most important to address and most tractable [13]. Here we report the results of the second two rounds, which explored a series of potential policy solutions to the challenges previously identified as most important to address for effective clinical adoption of NGS.…”