Value assessment frameworks: A conversation with Jason Spangler, MD, MPH, FACPM

As a preventive medicine physician with a degree in public health, I had a good knowledge base in epidemiology and economics, but I didn’t use it often in my early career. Eventually, my work in health policy focused more on the HTA space with related policy issues. Amgen was an early supporter of IVI, and around 2015, I began incorporating more health economics and value assessment into my work.

IVI was founded by Precision Health Economics as an incubator for novel methods of clinical value assessment, and it became a nonprofit research organization in 2019. There has been a lot of growth and changes recently, and I was excited by the opportunity to lead IVI into its next phase as a nonprofit.

With the Inflation Reduction Act allowing Medicare to negotiate with manufacturers on drug pricing, I see it as a sign that the U.S. is moving toward an HTA or value assessment environment, similar to what’s established in other countries. Of course, it will look different since we have a mix of private and public health coverage. IVI’s work will help shape that environment — particularly for patients.

We anticipate the development of more policies that dictate how innovations are valued and what payers — both government and private insurers — should reimburse clinical innovators for drugs, devices and diagnostics. Recently, there’s been an uptick in interest around valuing diagnostics due to the growth in targeted therapies and digital health. Better ways to value innovations like gene editing technologies are also on our radar — it’s not just science fiction anymore.

Considering these new advancements, we need to explore the true value to patients, their families and their caregivers. Once we decide on how to value these tests and treatments, we as a society need to consider how we can continue to afford to develop these innovations.

IVI develops methodologies and modeling, but we aren’t a health technology assessment organization. We don’t do assessments like ICER, where we review a class of drugs or therapies. We’ve been called both a competitor and a watchdog to ICER, but that’s not accurate. We try to equip everyone doing value assessments with better, more holistic ways of doing the work. We ask the question, how can we incorporate other aspects of value that aren’t traditionally included?

For example, ICER takes a specific class of drugs and puts them into their model to generate a price range for what they think those drugs should cost. That’s not IVI’s role. We’re seeking to advance the science and the methodologies of health technology assessment. Generally, an HTA prioritizes clinical outcomes, cost-effectiveness and budget impact, and they assess these things primarily from a payer’s perspective.

IVI looks at new or adapted health technology assessment methods that incorporate other aspects of value, including those that account for the patient perspective. In fact, our open-source models allow people to input their own data. I’d like to think that our work has helped to influence some health technology assessment frameworks to make them more patient-centric and transparent.

We started developing distinct methodologies and models for evaluating treatments in rheumatoid arthritis and non-small cell cancer. We’ve continued to refine those models, but our evolution is in our macro work — especially around health equity. It’s less about any one aspect of the methodology than it is about calling attention to one of our guiding principles of health technology assessment writ large.

We hope our framework can help the industry better understand the ways that health disparities impact the patient community. This can help us eventually find ways of reducing those disparities, especially when it comes to access and outcomes. A lot of those challenges, such as housing and transportation issues, involve costs typically not covered by health insurance. But they’re costs to the patients themselves and have real impact on their healthcare.

We’re finding that addressing health equity isn’t about tweaking a model or adding to your framework. The process must be completely changed — starting upstream with its roots in power structures and accountability.

This question takes me back to the need for more qualitative patient-focused data. To find that evidence, we need to directly engage with patients to understand their experiences and where they find value. While there are some commonalities, it’s going to differ for various diseases.

There’s also a health equity component because underserved populations aren’t receiving the care they need and remain underrepresented in clinical trials. This inequity translates to gaps in the data we use to build our models and analyses. So even beyond the lack of experiential data, we still don’t have all the clinical data we need to represent the populations who could benefit from the clinical innovations in the market. It’s vital to look at underserved populations and consider the missing qualitative and quantitative data.

When it comes to incorporating the evidence and data that we have into analytical models, it can get messy and complicated. However, we believe that complexity is not an excuse. The data doesn’t need to be perfect and we’re doing the best we can with a “mixed methods” approach. In health economics speak, that basically means we’re combining both qualitative and quantitative data in our models and methodologies. For example, in our work on major depressive disorder, we are incorporating responses to therapy based on a score from a depression scale with patient-reported outcomes.

For the kind of public policy work that CMS is doing around its Medicare drug negotiations, we hope it will be transparent in its efforts. In addition to the health economics and provider perspectives, CMS is making sure that the patient’s voice is represented in their approaches. There’s more work to be done, but it’s a promising start. If CMS does decide to use assessment models or frameworks, we would encourage it to use those that are more holistic in its approach and incorporate value components beyond just cost-effectiveness and budget impact.

This is one of the reasons we’re continuing to develop new methods to move this field forward. As an industry, there’s been little change in the past 50 years. We need to figure out what we don’t know, create a plan for getting that information and improve our models.

We recently convened our 4th Annual IVI Methods Summit, bringing together patients, providers, payers and other stakeholders. The purpose was to identify actionable changes and outline immediate actions, roles and accountability metrics needed for substantive change to achieve health equity and true value in health technology assessment. We strongly believe that collaboration is key to accelerating our understanding of value, and our members are key in shaping the future of health equity. Value assessment remains a journey, but we’re headed in the right direction.