Los Angeles, May 17, 2020 - Members of the Lydion Research Alliance including Jennifer Hinkel, MSc, Sirtaj Singh Brar, and Arka Ray presented their work on “A Conceptual Framework for Valuation and Utility of Non-Clinical Outcomes” at the annual meeting of the International Society for Pharmacoeconomic and Outcomes Research (ISPOR), which took place virtually due to the COVID-19 pandemic.

Quantifying the value of non-clinical outcomes in health care settings is a challenge for health system stakeholders including organizations responsible for setting pricing and reimbursement parameters. Undervaluing such outcomes may lead to unintended consequences that have negative downstream economic as well as clinical impacts to patients and health care systems.

“In health economics, we have become more organized in our approaches to establish the value of clinical interventions over the past several decades,” said Jennifer Hinkel, MSc, lead author of the study. “However, we have not always been able to quantify the value of non-clinical outcomes, such as the time and resources saved if we can move a patient from treatment in a hospital setting to an outpatient or home setting, or the capacity we can free up if a treatment changes from a six-hour weekly infusion therapy to a two-hour therapy, or even to a once-monthly injection. Oftentimes, these more efficient delivery methods seem to carry higher up-front price tags because they are using new, safer technologies for drug delivery, but we do not always account for the immense value we can save in administrative or financial resources, or in freeing up capacity and services for other patients.”

“At this time during a pandemic, I think that there’s a new relevance to looking at health systems as a whole and understanding how to quantify the value of outcomes including freeing up clinical staff time, freeing up hospital capacity, and similar, because we know in the US and many other countries that we do not have a lot of flex capacity in our systems,” said co-author Arka Ray. “We are interested in developing mechanisms to evaluate the true value of both clinical and non-clinical outcomes, particularly when these outcomes are the result of new and innovative technologies coming out of the biotech sector.”

The authors found that non-clinical outcomes are often not accounted for in regulatory approvals for new technologies, and that frameworks attempting to assess value, quality, and downstream impact of non-clinical outcomes, particularly those that may be administrative, quality of care, patient experience, or efficiency related, are often limited in their applicability. The team prototyped a taxonomy and scientific framework for the assessment of non-clinical outcomes and data points that measure such outcomes, including (1) patient-reported or patient-generated digital data via apps or devices, (2) efficiency and quality measurements for practice performance and care delivery, and (3) access to care metrics, including the removal of geographic and financial access barriers.

The researchers found that non-clinical data, particularly when collected in an observational manner, is difficult to attribute to specific causal factors, making downstream analyses difficult, and raising the risk of assuming false correlation. A related finding is that the lack of downstream attribution of impacts often prohibits associating credit or incentives to the components in the health care ecosystem that enable the non-clinical outcomes. These factors, while impossible to completely mitigate in real world data (RWD) scenarios, can potentially be accounted for with methods that apply weighting or discounting to datapoints depending on contextual factors.

Through their work within the Lydion Research Alliance, the authors are collaborating to further develop and test this taxonomy using data economic models alongside industry partners in the life sciences, biotech, and health technology sectors. The study abstract, also published in the journal Value in Health, is available online here. About the Lydion Research Alliance:

The Lydion Research Alliance is a consortium of scientists, engineers, economists, technologists, artists, and futurists dedicated to the advancement of the scientific field of Data Economics and the commercialization of Data Economic technologies.