US NESTcc requests medical device test cases for using real world evidence

The National Evaluation System for health Technology Coordinating Centre (NESTcc) has released three requests for proposals to help build the case for using real world evidence (RWE) for regulatory and coverage decisions for medical devices.

NESTcc was established in 2016, supported by a $3 million grant to the Medical Device Innovation Consortium (MDIC) by the US Food and Drug Administration’s (FDA) centre for Devices and Radiological Health (CDRH).

The mission of the centre is to establish pathways through which timely, reliable and cost-effective evidence can be established using real world data. NESTcc is expected to be fully operational by 2019.

NESTcc has asked for input from medical device manufacturers for test cases using RWE that could be implemented with NESTcc’s nine initial data partners that represent more than 100 million patients.

The goals of the test cases are to:

  • Explore the feasibility for industry to use real-world data sources offered by NESTcc’s initial set of partners. Other sources of real-world data could be explored if needed (e.g. registries, de-identified claims data, patient-generated data).
  • Identify areas where NESTcc could play a role in reducing transaction costs (e.g. contracting, IRB, data sharing agreements, publication policies).

NESTcc says it will select up to 10 viable test cases by February 2018, with plans to begin executing the contracts in April 2018.

To view the opportunities for engagement with NESTcc, please click here.