Value assessment is the comparison of the relative benefits to the costs of a given technology or service for a specific person or population.
One significant ongoing challenge in healthcare today is the measurement of value. Most healthcare providers, payers, and patients would agree the cost of medication, treatment, or medical service should reflect the value it delivers. And yet, consensus does not yet exist about the component perspectives, methods, and data that should be used to define value. This status quo demands better answers to the questions, “How do you measure value? And for whom?”
The Innovation and Value Initiative is a 501(c)(3) nonprofit research organization committed to advancing the science, practice, and use of value assessment in healthcare to make it more meaningful to those who receive, provide, and pay for care. Governed by a Board of Directors with significant input from its Patient Advisory Council and Scientific Advisory Panel, IVI invests in research that emphasizes patient perspectives on value and strives to improve the flexibility and application of value assessment methods and models. IVI’s work is delivered in an open-source environment that fosters collaborative, dynamic exploration and testing, and provides creative, common-good resources to support healthcare decision-making.
IVI’s goal is to build a platform that facilitates robust and rigorous patient-centered value assessment of health technologies tailored to the needs and interests of individual decision makers.
The need for better information on the relative value of healthcare interventions is increasingly clear as the American healthcare system moves towards value-based payment models – but existing and conventional methods of value assessment are not sufficient for the complexity of modern healthcare and do not adequately reflect patient perspectives on value. Foremost, we need a better approach to value assessment that puts patients at the center. As part of this we also need a more transparent and collaborative approach toward building the models we use to assess value.
IVI is working to drive innovation in value assessment through collaborative research on patient preferences, novel methods of value, and value assessment model development. We work with patients, payers, and providers to assess what value means to them, and serve as a laboratory for testing new methods to improve value assessment. Our Open-Source Value Project (OSVP) allows for a transparent, dynamic, and flexible testing venue as we seek to improve how we assess value.
We are firmly committed to including patients in the entire value assessment process, and especially from the start. And we are clear about the purpose of value assessment and for whom, as we consider the needs of those who receive, pay for, and provide care. Finally, we recognize the importance of accounting for patient diversity, and that optimal interventions or sequences of interventions, vary by patient characteristics. Patient and intervention heterogeneity is both a challenge and an opportunity.
Researchers, innovators, and payers need to do more with patients and patient communities to define the factors that matter to them – in terms of desired outcomes for a treatment, factors that affect well-being, treatment experience and overall cost to the patient, and factors that influence their choice and adherence to a potential treatment.
Defining the gaps and limitations in the existing value assessment approaches and practices:
- Identifying the component elements of value and conducting methods research on how to measure and apply those components to next-generation value assessment
- Improving understanding of how to aggregate those components and incorporate them into value assessment models
- Facilitating application and use of novel value assessment methods to real-world decision contexts
- Building an independent, research-driven organization dedicated to transparency, patient-centeredness, and relevance of value assessment to real-world decisions and experiences of all stakeholders
For more information, please visit the What We Do section.
No. Existing value frameworks are important first steps toward synthesizing the many determinants of value, but the reality is that we do not have the scientific methods or necessary data to capture the complexity of value in the real world. Patients are diverse, in terms of both clinical factors and their personal priorities and hopes. Value means something different to different decision-makers – what is important to Medicare, for example, is very different from what defines value to a large employer. Value assessment should be flexible and localized to reflect the contexts of individual decision makers.
IVI is working to move the field forward so that decision makers can get the most relevant, credible, and transparent information on value for their particular needs.
Our research priorities reflect our principles and help us achieve our goals. They include:
- Developing methods to better account for and incorporate outcomes that matter to patients. Improving the ability of value assessments to yield viewpoints that reflect real patient experiences will inform optimized treatment regimens and improved outcomes for patients.
- Advancing analytical methods and flexible models that account for the impact of patient heterogeneity on the value of treatment sequence choices. Better understanding value for specific populations and local contexts supports decision-making that optimizes value-based decisions for both payers and patient subgroups.
- Establishing modeling approaches that allow users to better assess scientific uncertainty by illuminating how vulnerable analyses are to structural assumptions and enabling the inclusion of new or subgroup-specific evidence. Such modeling flexibility supports greater confidence in value assessment.
- Advancing multiple analytic frameworks for estimating value, most notably multi-criteria decision analysis (MCDA). MCDA is an established approach for assessing value based on the relative importance of multiple attributes. Approaches like MCDA present an important alternative framework for value-based decision-making, with particular potential for capturing patient preferences.
- Providing thought leadership to improve value assessment by highlighting needs, asking provocative questions, energizing stakeholders of all types, and continuing to push the boundaries beyond “safe” topics. For example, IVI explores novel value measures in IVI models as augmented cost-effectiveness analysis.
- Demonstrating the importance of incorporating sources of real-world evidence in value assessment. In addition, IVI promotes the collection of real-world data in standardized formats and the use of best practices in designing and conducting real-world data studies.
- Establishing IVI’s open-source and collaborative approach to value assessment as the standard for the field, fulfilling a market need for transparency to all actors and supporting rapid-cycle model development and testing that informs population-level decision-makers.
- Conducting and publishing case studies with model end-users to assess the relevance and impact of IVI’s novel, collaborative approach to value assessment.
Transparency and scientific rigor are core principles of IVI. To ensure our work is transparent and free from bias, IVI makes all of its research and software publicly available for download and use to the greatest extent possible:
- Disease-specific OSVP models are developed with review and guidance from external clinical experts and representatives from the patient community; subsequent revisions and improvements of these models are determined by feedback and recommendations received as part of the public comment period following each model’s release, with specific improvements identified and prioritized by an objective Technical Expert Panel. All model code is open-source and publicly available, along with the R statistical package and detailed documentation.
- In the case of IVI’s methodological and patient-focused research projects, research materials (e.g. survey instruments), protocols, analytic code, data (when possible), and research reports are made publicly available under Creative Commons Attribution 4.0 International License via the Open Science Framework website.
All IVI research projects are subject to peer review:
- Research papers are submitted to peer-reviewed journals undergo review requirements as specified by the journal.
- Research reports that are released through the IVI website are reviewed by independent academics or subject-matter experts, whose reviews and evaluations are made public alongside the research report of interest.
Commentaries and opinion pieces are edited according to the standards of the publishing outlet; these typically do not include academic peer review.
As a membership-based nonprofit organization, IVI depends on the support of its members for funding. IVI seeks members from across the healthcare spectrum, including self-insured employers, insurers, providers, manufacturers, and patient advocacy groups.
All member funding supports IVI’s overall operations and is not tied to a specific activity or objective.
Who can I contact to get more information about IVI or to request further details on an IVI project?
For all inquiries, please contact us at [email protected] and we will connect you with the right team member.
IVI is actively seeking partnerships with stakeholders across the healthcare industry and we welcome your collaboration. You can get more involved if you:
- Join IVI. IVI’s work is only possible with the support of people and organizations like you. Members of IVI are key partners in advancing the science and practice of value assessment. For more information about membership, please visit our membership page or e-mail us at [email protected].
- Subscribe to Receive IVI Updates. If you subscribe today, we will share important updates about IVI projects, opportunities to get involved in value assessment, and upcoming events.
- Partner with IVI. IVI is seeking new partnerships to:
- Augment current research projects;
- Improve the use and understanding of real-world data;
- Improve collaborations with patient organizations, employers, industry, clinicians, payers, and other stakeholders.
- Use and Test the OSVP disease-specific models. Public comment on disease-specific OSVP models is the driving force behind the ongoing improvement of these models and helps to shape IVI’s research strategy. Learn more here.
IVI is a qualified 501(c)(3) tax-exempt organization and donations are tax-deductible to the full extent of the law. IVI’s tax ID #83-2257857.
IVI is a membership-funded nonprofit, and IVI’s ability to achieve its goal depends on the support of forward-thinking organizations and individuals. By joining IVI, you will connect with a growing collaborative community of researchers, patients, payers, employers, and clinicians committed to modern and flexible value assessment.
IVI welcomes both individuals and organizational members, and just some of the benefits of membership include:
- Opportunities to collaborate with IVI on research, strategic planning, public speaking, and communications work;
- Offer scientific and lived-experience insight to inform IVI’s research agenda;
- Contribute to governance via service on the Board of Directors or its Patient Advisory Council;
- And connect with a growing community committed to building a more meaningful understanding of value in healthcare.
For more information please visit our membership webpage or e-mail us at [email protected].
Any individual or organization interested in advancing the science and improving the practice of healthcare value assessment is welcome to become a member of IVI.
Visit our membership page for more information about the options for membership. To become a member or learn more, contact us at [email protected].
Healthcare decision makers are increasingly concerned about making choices based on value – but they need reliable information on value to do so. More importantly, they need information that is specific to them and reflects the context of the actual decision. Fields like cost-effectiveness analysis provide a strong foundation, but the reality is that existing methods are unable to generate the context- and decision maker-specific information needed.
The Open-Source Value Platform (OSVP) was started to move toward the next generation of value assessment. The OSVP provides a transparent process to accelerate learning and the creation of customizable models and other tools for value assessment that is inclusive, scientifically credible, and relevant. The OSVP is a democratic, open, collaborative environment for:
- Methods research and development
- Research on patient perspectives on value and methods to quantify them
- Disease-focused model development and application testing
- Development of tools to facilitate localized decision making (for payers, clinicians, patients, and employers)
To learn more, visit the Open-Source Value Platform page.
Multiple OSVP-based resources are available:
- Disease-specific decision models: IVI has released two disease-specific OSVP decision models for simulating outcomes and assessing relative value of treatment sequences in rheumatoid arthritis (IVI-RA) and EGFR+ non-small cell lung cancer (IVI-NSCLC). The models are open-source, and source code and R packages are free to download and customize. Users can also interact with the models through multiple web interfaces.
- Facilitated applications: OSVP models are intended to provide real-world decision makers with value assessments tailored to their own perspective, context, and objectives. This is new ground for value assessment experts and decision makers alike, and IVI is available to facilitate application of its OSVP models with organizations interesting in partnering in this effort. Contact us for more information.
- Forum for debate: There are as many perspectives on value as there are stakeholders in the U.S. healthcare system. The OSVP is intended to give all stakeholders – from patients and providers to insurers and employers – an equal voice in how the science and practice of value assessment evolve. Learn more here.
How do OSVP value assessment models differ from value assessment frameworks such as those from ASCO, ICER, or NCCN?
IVI’s OSVP value assessment models have a number of key advantages over these other approaches:
- Rigorous quantitative analysis: Health benefits, risks and costs are quantified explicitly in OSVP models, making comparison of treatment options more straightforward for decision-makers.
- Patient-centricity: One of IVI’s primary goals is to improve the ability of value assessment to quantify and incorporate patient-level determinants of value. IVI partners with patients throughout the development of OSVP models, including qualitative research (e.g. focus groups) to understand patient perspectives on value and partnership with patient advocates. Input from patients helps to identify key determinants of value for patients. OSVP models then incorporate these patient-centered factors to the extent possible. In particular, OSVP models include a multi-criterion decision analysis (MCDA) module for value analysis (in addition to a cost-effectiveness module), which makes it possible to include patient-identified factors and calculate relative value based on patient preferences.
- Transparency: OSVP models are completely transparent. All the underlying code is made available free online along with detailed technical documentation. In addition, the public comment, review, and revision process is transparently reported and publicly available.
- Flexibility: IVI models allow stakeholders to tailor what value means for their particular situation. For instance, employers may care a lot about worker productivity, whereas policymakers may care about broader societal costs and benefits. Whether using one of our flexible online interfaces or an R statistical package, users can add in or remove different value components based on whether they are relevant to their particular decision at hand. Further, stakeholders can customize the value measurement based on the patient population most relevant to them.
There are many ways to use IVI’s open-source models to compare the value of treatment sequences in specific diseases (currently rheumatoid arthritis and EGFR+ non-small cell lung cancer). These include:
- Web-based Value Tools: Two apps, designed for different kinds of user, are available for each model:
- Basic: Streamlined tool designed for a general user and requiring no existing expertise.
- Advanced: Expanded interface that provides control over all model settings
- R Packages: Downloadable statistical packages for customized analysis
- Source Code (on GitHub): For programmers and others who wish to contribute improving the code or adapting it to a unique context
IVI’s disease-specific models currently focus on the relative value of drug therapies and do not include other types of intervention (surgery, for example). To model the relative efficacy of different treatments or interventions, we must first know how the various options compare to one another, which requires reliable clinical evidence from randomized control trials (RCTs). Because of FDA drug approval requirements, RCTs are much more common for drug therapies than for other technologies (e.g. devices) or interventions (e.g. specific surgical techniques). IVI hopes to eventually include all types of interventions, but significant gaps in clinical evidence must first be addressed.
Yes! When beginning the development of a disease-specific OSVP model, IVI recruits a Clinical Scientific Advisor with relevant expertise to join the modeling team. Dr. Jeff Curtis, a rheumatologist and professor at the University of Alabama Birmingham, serves in this capacity on the IVI-RA decision model. For the IVI-NSCLC decision model, this clinical expertise is provided by Dr. Karen Reckamp co-director of the Lung Cancer and Thoracic Oncology Program at City of Hope.
In addition, other providers and provider groups are consulted during initial model development, and providers are strongly encouraged to provide feedback during public comment periods. Clinicians also serve on each model’s Technical Expert Panel, an objective group of subject-matter experts that reviews public comments and develops recommendations for improvement of IVI’s models.
To ensure that simulated outcomes reflect outcomes in routine practice, baseline events rates (i.e., the rate of disease progression, the mortality rate, the rate at which patients discontinue treatment), patient preferences, and costs are modeled using real-world data.
To enhance validity, relative treatment effects relative treatment effects (e.g., relative risks, odds ratios, and hazard ratios) are, when possible, based on randomized clinical trials (RCTs).
We aim to develop models that capture all aspects of value important to the patient. This starts with providing input on our disease-specific models, currently available for rheumatoid arthritis and EGFR+ non-small cell lung cancer. Any feedback you can provide during public comment periods for our models will be considered in modifying the existing versions and ensuring that the models becomes even more patient-centered over time. To learn more and to share your perspective, click here.