Overview

We collaborated over an extended period with a leading Fortune 50 pharmaceutical company for the launch of a molecular point-of-care in vitro diagnostic test. This test was specifically developed for the differential diagnosis of COVID-19 and influenza A/B, aiming to streamline and improve diagnostic accuracy at the point of care. It was considered a high-priority for the client, with enterprise-wide implications.

Client Challenges

The client was faced with several critical hurdles:

Demonstration of Clinical Validity and Clinical Utility for the purposes of securing coverage and reimbursement. There was limited published data demonstrating the tests clinical validity and utility, necessitating generation of evidence of the tool's superior sensitivity, specificity, and usability, in specified use cases. There was also a need to evaluate the test’s ability to improve outcomes as a consequence of enhanced provider decision-making.

Demonstration of Economic Value for Market Acceptance. From the perspective of healthcare systems and health plans, it was essential to not only showcase the test’s clinical validity and utility, but to also model the economic value that could be created, compared to alternatives. How the client’s innovative test could integrate into existing healthcare pathways and be readily supported by payers, would be critical for product success.

Dream Big Health's Solution

To address the clients’ multifaceted challenges, DBH employed a comprehensive, multi-pronged approach:

1. Decision Tree Analysis (DTA). We developed a sophisticated decision tree model that mapped various patient care pathways based on diagnostic outcomes. This model helped to elucidate the potential impacts of the diagnostic tool on clinical decision-making and patient outcomes over the course of an episode of care.

2. Dynamic Simulation Modeling (DSM). This modeling technique was pivotal in simulating the clinical and economic impacts of the test, providing clarity to payers, who would like to understand potential risks and benefits. DSM was also employed for scenario analyses, to explore different clinical and economic uses and outcomes based on varying levels of test adoption and utilization.

3. Multi-Criteria Decision Analysis (MCDA). We utilized MCDA for its robust capability to integrate and balance multiple decision-making criteria, including clinical and economic outcomes, thereby providing a balanced evaluation of the diagnostics’ value.

4. Cost-Effectiveness Analysis (CEA). Our CEA incorporated both incremental cost-effectiveness ratios (ICERs) and cost-utility assessments to quantify economic benefits relative to improvements in patient quality of life, compared to alternative approaches.

DBH was able to provide the client with four major products, namely, a meta-analysis (based on a systematic literature review), a dynamic pricing model (software that continually adjusts to real-time inputs), a Value and Evidence Report, and a 75-page technical disclosures document.

Impact to Client

The integrated use of DTA, DSM, MCDA, and CEA provided a purpose-built suite of evidence that not only demonstrated the clinical validity and utility of the client’s tool, but also showcased its economic benefits to patients, healthcare systems, and health plans alike. The client utilized the products created by DBH to increase stakeholder and KOL engagement and position themselves for broad coverage and reimbursement.

If you have a need for in-depth clinical and economic evaluation, please reach out!

DBH's tailored analytical approach provides a robust foundation for evaluating and showcasing the value of healthcare tools. If your organization is exploring the need for a customized suite of evidence to be prepared for market entry, consider how our expertise in health economics and clinical data can support your goals.