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QURE for Clinical Utility

Procuring clinical utility evidence faster, cheaper, and more reliably.

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Demonstrating Clinical Utility Among Practicing Physicians

Securing payer coverage and reimbursement hinges on one critical, final step: proving clinical utility. Because of the context-dependent nature of assessing clinical utility, this step often represents the greatest hurdle for MedTech companies.

Clinical utility, in essence, measures how a technology or practice influences health outcomes by expanding treatment options, improving implementation feasibility, and/or increasing cost-effectiveness.

Envision a diagnostic test or health technology that can:

  1. Simplify or streamline the monitoring and reporting of results
  2. Accelerate the revelation of actionable insights
  3. Deliver more accurate results, avoiding ineffective treatment plans and reducing the risk of misdiagnosis
  4. Minimize harm compared to alternatives, such as biopsies
  5. Prevent unnecessary spending on hospital admittance, follow-ups, or unwarranted referrals

QURE Clinical Utility Studies align with standards set by the Centers for Medicare and Medicaid Services (MolDX Program and all A/B MACs) and private payers. Our studies consider the Social Security Act’s “medically reasonable and necessary” clause, technical assessment protocols (ECRI, Hayes), and various clinical utility frameworks endorsed by expert organizations, including the  CDC’s Office of Genomics and Precision Health (ACCE Model)s, the Association for Molecular Pathology, the Medical Device Innovation Consortium, and the Personalized Medicine Coalition.

Clients have leveraged QURE peer-reviewed publications featuring the impact of their test to meet technical assessment requirements ultimately securing coverage and reimbursement in a dynamic payer landscape.

QURE’s Approach

QURE has created a landmark strategy by merging de novo virtual patients with real-world patient chart abstractions into a randomized control trial (RCT) design.

  • Virtual patients that are scientifically validated and fully customizable, are presented in unique clinical scenarios to national samples of providers, measuring care decisions swiftly and accurately.
  • Chart abstractions confirm that patient outcomes are improved in a real-world setting.
  • Lastly, downstream budget impacts on the payer system are projected for economic sustainability.

The result is evidence of a clear progression from provider decision-making, to improved patient outcomes, to economic value to the payer – the gold standard of clinical utility evidence.

Benefits of Using Virtual Patients

The diversity of the “patients” that study participants care for can be designed to be reflective of demographic and epidemiological realities within a given patient population. This reduces confounding related to how patients may be differentially treated based on social or ethnoracial factors. Virtual patients also don’t require consent, which can add complexity to the design and IRB approval processes, slowing study times and increasing overhead costs.

Virtual patients can be devised for a broad range of disease areas and outcomes. This means less time sourcing and recruiting patient study participants, particularly in the case of rare diseases.  Virtual patient design also allows for a direct comparison of health outcomes because disease factors can be tailored and controlled across patients.

We can create nationwide samples of practitioners within diverse medical specialties and practice settings. Also, the statistical power needed to reach significance thresholds requires far lower sample sizes, since participants care for the same patients, eliminating interpatient variability.

There is a reduced time commitment and effort required by healthcare providers, as studies typically span three to six months of engagement, and virtual patient cases take only 15-20 minutes to complete. Providers receive fair market value honoraria for their participation.