The Innovation and Value Initiative (IVI), led by Executive Director Jennifer Bright, is a non-profit organization that occupies a unique place in the value assessment landscape. It is a dynamic laboratory for testing expanded approaches to value assessment, including new methods for gathering and incorporating patient perspectives, testing how novel elements of value can be included, and developing model prototypes that address common challenges, such as accounting for uncertainty and patient heterogeneity. Such investigation and investment are central to IVI’s mission to advance the science, practice, and use of value assessment in healthcare to make it more meaningful to those who receive, provide, and pay for care.
IVI demonstrates its learning and exploration through building disease-specific Open Source Value Project (OSVP) models. To date, IVI has created open-source models to examine value in rheumatoid arthritis and EFRG + non-small cell lung cancer (NSCLC) and recently began its third value model examining major depressive disorder.
Under Ms. Bright’s leadership, IVI has been advancing value assessment practice by convening stakeholders to build consensus, identify priorities for research and methods improvement, and advance efforts to incorporate patient perspectives in value assessment. The organization hosted its inaugural Methods Summit in February 2020 that explored unmet needs and gaps in value assessment methods development. Together, a diverse group of experts and stakeholders identified priorities for improving data, methods, and models, so that value assessment is more meaningful for everyone, but most especially for patients.
In addition, IVI partners with other organizations to foster dialogue about the future of value assessment. This week IVI joins ISPOR, the leading professional society for health economics and outcomes research, to host the second of a five-part webinar series examining value assessment in the COVID-19 era. This webinar, COVID-19: Are Our Methods Up to the Task?, will be moderated by the University of Washington’s Lou Garrison, PhD, and will focus on what changes in value assessment methods may be needed to assess value among rapidly developing interventions, including vaccines, treatments, tests, and non-medical care. The webinar will be from 1:00 p.m. -2:15 p.m. EST on Thursday, August 27. Register for the webinar via the ISPOR website.
We also caught up with Ms. Bright to learn more about IVI’s work and views on value assessment practices.
NPC: Why is it important to include patient perspectives in value assessments, and how can we ensure that there is consistent patient engagement throughout the value assessment process?
JB: Thank you very much for this opportunity to talk about the issue that is fundamental to IVI. Despite widening agreement among experts that we must do more to include input from patients in value assessment, the voice of patients is still often muted by the perspective of other actors and the lack of consistent, accessible data about health outcomes that matter to them. My true north as a patient advocate, in public policy, and in value assessment has always been how do we use all the science, technology, data AND the insights from the patient to improve health and wellbeing?
IVI ensures consistent patient engagement through a steadfast commitment to always put patient perspectives at the beginning of all value assessment methods and model development research. When IVI builds a disease-specific model, our first action is to engage a diverse group of patients to give us insights exploring what matters most to patients; how patient diversity and perspectives on care might not be well represented in value dialogue; and opportunities to challenge conventional thinking about the calculation of cost-effectiveness. Such insight may serve to define critical research and data gaps that must be prioritized, and certainly informs what attributes we want to include in a value assessment model. We know this is complex work, but it is also vital because these inputs from patient communities will lead us to identify tangible steps to improve value assessment in a meaningful way.
We’re currently partnering with RAND on research that tests an existing method for defining and measuring attributes of care important to patients. We hope to apply this work to demonstrating consistent methods for patient preference research and its translation into value assessment approaches like multi-criteria decision analysis (MCDA).
NPC: How is IVI working with employers to ensure its value assessments are useful for informing employer decisions?
JB: This is an incredibly important aspect of value assessment that the field hasn’t gotten right yet. The standard operating procedure for employers has been to rely on their plans, PBMs, and consultants to make recommendations about coverage and formularies, and define the metrics that determine value. As medical science innovates, the cost of all healthcare interventions increases, and real-world data becomes more actionable, there is a growing gap between the analysis by these “middle actors” and the factors that employers consider elements representing their value perspective.
Engaging employers and employer communities will help us better understand their decision needs and the factors that drive value for them and for the lives they cover. That’s why we’re joining with the National Health Council and the National Alliance for Healthcare Purchaser Coalitions to host a series of roundtables for patient and employer groups to explore the alignment between patient and employer needs related to value in healthcare. This formative dialogue and research are just two examples of how IVI will identify opportunities to better reflect patient and employer preferences, inputs and needs in future value assessment frameworks.
NPC: IVI and other organizations have pointed to the need for transparency in the assessment process – what are you doing to address these concerns? How does an open-source environment help with that?
JB: Assessing the value of medical technologies relies on complex mathematical models that provide estimates of benefits, costs, and risks of different options – all before we even arrive at the question of how to define “value.” The typical opaqueness of value assessment assumptions and calculations contributes to lack of consensus and conflicting results that generates confusion, controversy and lack of trust among decision-makers.
This is exactly why IVI invests in open-source model development through the Open-Source Value Project (OSVP). Inspired by open-source software development process, IVI models are accessible and replicable using open-source code and technical documentation and are intended to support creative research advancement among modelers and researchers for the modest contribution of attribution and shared learning via publication or publishing of model enhancements or modifications. By creating an open laboratory, IVI also accelerates the testing of new methods for assessing value, including multi-criteria decision analysis (MCDA) and novel aspects of value (e.g., value of hope, insurance value) that are uniquely patient focused and largely absent from conventional approaches to cost-effectiveness analysis.
NPC: Why is “one size fits all” value assessment a problem? How can value assessment models be flexible?
JB: It may be expedient and convenient to think we can use one approach, one model to arrive at one answer, but we all know that doesn’t align with the real world in which scientific learning evolves, decisions about resource allocation transcend just one treatment or one care setting, and patients respond differently based on gender, color, age and the constellation of their health conditions.
Adopting an active learning system to build value assessment models or frameworks is essential, so that multiple, tailored approaches can be built that will more accurately account for differences in patient population and priorities in decision making. Collaboration is key to ensure that such approaches are both scientifically defensible and also reflect the inputs from multiple communities, including patients. Another aspect of flexibility is the ability to modify elements of the analysis based on unique decision needs. For example, IVI models can be adjusted to address patient characteristics or to prioritize evaluation of certain treatment sequences. Further testing of this approach is needed to help value assessors understand how models might support decision-making beyond pricing and contracting, to include benefit design or clinical pathway development, for example.
NPC: During the pandemic, there has been a heightened awareness of productivity and caregiver burden. How should we account for novel value inputs like productivity and caregiver burden in assessments?
JB: The pandemic has laid bare many gaps in value assessment and in our collective understanding and definition of value. For example, while consensus is growing that novel value inputs matter, traditional frameworks and models are often too rigid to account for them or even study them further. Developing models in a transparent environment allows exploration of how to manage scientific uncertainty and how to incorporate novel value elements (e.g., fear of contagion, insurance value, equity). We’ve seen many discussions recently about how to address value assessment in the context of the current pandemic, and more work needs to be done to test new ideas and methods so that we address the impact of potential tests, treatments and vaccines on our economic productivity and on our public health infrastructure, for example. Further, aspects important to patients, including impact on caregivers and functioning and its impact on ability to work, need to be incorporated into value assessments, for example using methods such as MCDA.
When ISPOR’s special task force examining value assessment frameworks first published the “value flower,” which outlined the various novel value elements that had been proposed, it advanced the collective understanding why these elements could be important to the practice of value assessment. Now we must understand how these novel elements can be measured, analyzed and used within economic models to improve and advance patient-centered value assessment.
NPC: Thanks so much for speaking with us.