April 19th, 2018
The CMS National Coverage Decision on NGS
New Insights: As a result of the recent CMS National Coverage Decision on NGS, the MolDX® program of Palmetto GBA® is now actively considering cover...
Test adoption is defined as the consistent use of a test or testing approach by physicians as part of routine clinical practice.
Question: For which of the following applications, if any, have you ordered or recommended molecular diagnostics in the past 12 months?
Example: HER2 testing and Herceptin
|Signal stability||Archivable||Fades over time||Archivable|
|Protocol length||Overnight + 3hr, 55min||Overnight + 3hr, 12min||3hr, 2min|
|Amount of training required||Medium||High||Low|
|Market adoption by oncologists in 2008||1-2%||20-40%||100%|
The best test is not always the most successful test.
Example: Labceutics Delphi study with leading EU Mol Dx labs
What aspects would make you consider changing your method or technology for a particular test? Sort the list below giving a number from 1 to 10 (being 1 the least important one and 10 the most important)
When planning for CDx development, ensure a thorough understanding of all relevant stakeholders’ needs and expectations from the test – avoid slow adoption due to 'secondary issues'.
|Six main test adoption drivers||Critical pharma activities|
|Reduce perceptions of complexity||Education of physicians to order tests; direct stakeholder promotion|
|Guidelines||Minimum weight of publications in the clinical domain|
|Lab–physician interface||Timely inclusion of test in treatment- and/or test-specific policy frameworks|
|Stakeholder reimbursement||Effective test reimbursement which ensures profitability for service providers|
|Direct education||Hands-on trial to enable familiarity with testing and support education|
|Hands-on use||Facilitation of office laboratory / test provider set-up|
Example: HER2 testing and Herceptin
When launching a CDx program into the marketplace, ensure the test allows for easy, straightforward integration into clinical routine and is positioned as such in relevant guidelines and policies.
Example: Survey of US Oncologists
Specific workstreams with the lab or pathologist are required to optimize sample and report logistics.
|Incorporation into Guidelines||Initial work with relevant KOLs can occur by including it in clinical studies and early hands-on work|
Guideline work with diagnostic and relevant professional organizations within TA can be initiated when clear clinical utility for the test is established in the literature
|At least 2-3 years before test launch depending on cycle of major guidelines|
|Stakeholder Education and Direct Detailing to Labs||Stakeholder education to establish clinical utility of novel biomarker prior to test launch|
Laboratory Dx sales effort starts at launch
|Approx 1-2 years pre-launch to 18-months post-launch in each market|
|Hands-on Studies||Ideally, hands-on studies can begin before full commercial launch - definitely want to have these in place at launch||Approx 1 years pre-launch|
|Reimbursement / Test Cost Subsidy||Any necessary HE studies should be part of pre-launch planning and execution|
Ensure pragmatic, barrier-free funding solution is in place
|Up to 2 years pre-launch|
|Publications||Dx publication strategy should be part of pre-launch planning and execution, as well as ongoing, to accommodate Dx lifecycle plans||Up to 2 years pre-launch through lifecycle of test|
|Set-up of Testing at Target Labs||Long term plan to minimize technical sales support costs in balance with need to have instrumentation in place||At launch through completion of lab footprint|