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By Dan Leonard, President and CEO, NPC

Much of the biopharmaceutical industry this week is focused on the J.P. Morgan Healthcare Conference (JPM), where business leaders are investing in science and technologies with the potential to transform human health. It’s clear that there is great value in the development of these transformative therapies, such as cell and gene therapies, because they can offer life-changing benefits, if not cures, for patients. And it’s also clear that the debate over “value” will only gain in importance during this election year, fueled in large part by heated rhetoric over drug pricing and an interest in leaning on value assessment frameworks as tools to ascribe value to new therapies.

As these debates continue to take center stage not only at JPM, but across our health care system, new approaches to how we measure and consider value will be a key part of nearly every conversation.

In the U.S., value assessment is still a young and evolving field, with a number of frameworks in development and being tested. What’s concerning, however, is that some organizations — like the Institute for Clinical and Economic Review — are making a broader push for payers to use these developing frameworks in deciding whether patients should have access to life-changing treatments. These decisions could have profound implications for patients, our health care system and incentives for future innovation.

To better understand these implications and the current state of value assessment, the National Pharmaceutical Council released an analysis of seven U.S. value assessment frameworks, comparing the strengths and limitations associated with each framework.

That effort, “Current Landscape: Value Assessment Frameworks,” examined existing frameworks through the lens of six broad categories: development process, measures of benefit, measures of cost, methodology, evidence and assessment process.

Our findings support the idea that there is no one “best” framework. They have different purposes, methods, inputs and outputs. Some have a narrower scope, focusing only on certain types of treatments; some are intended for insurers to use; and others are meant as shared decision-making tools to be used between patients and their physicians. Instead of looking to one framework to inform health care decisions, decision-makers should leverage multiple approaches in measuring value, thus providing a more robust understanding of a treatment and its implications for patient health.

Frameworks certainly have the potential to be useful tools for decision-makers, but there are limitations that must be addressed first. Importantly, many frameworks lack patient-centeredness. Instead of offering a one-size-fits-all determination, frameworks need to do a better job incorporating patient and caregiver values.

Another challenge is that many frameworks lack methodological transparency, making their models and conclusions nearly impossible to replicate. Some of these methods are untested and lack external validation.

There are also questions about the types of evidence — such as clinical studies and real-world data — that framework users include in making value assessments. They should use a wide range of high-quality evidence, and as new data becomes available, incorporate it into assessments or update previous ones.

Additionally, frameworks often provide confusing outputs instead of providing a clear readout that makes it easy for decision-makers to understand and consider whether to incorporate the measurement results as one of many data points in their own review processes.

Moreover, measurement is only applied to a limited scope of health care services, not the broad range of services needed to provide patients with high-value care. Putting this into perspective, just 16% of what we spend on health care in this country goes to medicine — it’s important to address the other 84% of health spending, too.

As the value measurement field matures, we must be aware of the weaknesses and strengths of existing measurement tools; we also must be wary of any entity wanting to be the sole arbiter of value. Optimal patient health requires a health care system that is patient-focused and sustainable, and value assessment should support this vision. Otherwise, the debates over value — at JPM and nationwide — will have been for naught.