Value assessment for health services and procedures: a call to action in a new political climate

A series of barriers complicates the conduct of value assessments for services and procedures, encompassing challenges related to data, methods and incentives. Unlike pharmaceuticals, for which US FDA requires rigorous clinical safety and efficacy trials for market authorization, comparable efficacy data are frequently lacking for services and procedures. In many cases, services and procedures are widely adopted before generation of robust evidence of their efficacy, making it challenging to conduct credible value assessments.

Furthermore, while general guidelines for value assessment exist, there are distinct challenges in quantifying the value of services and procedures. For instance, there is little guidance on how to account for variations in physician learning and technique – whether these variations are intrinsic to the value of a service or merely factors that influence its outcomes. Additionally, the substantial variation in prices for services and procedures across institutions and regions adds another layer of complexity.

Unlike pharmaceuticals, services and procedures typically lack an intellectual property holder to champion their development and evaluation. In the pharmaceutical industry, intellectual property rights incentivize manufacturers to take risks and invest in studies that demonstrate the value of their products and support market authorization, access and pricing. However, for many services and procedures, no single entity stands to gain directly from demonstrations of value. Furthermore, procedures and services involve personnel time and facility costs that may add considerable uncertainty to value assessments. A final barrier is that, for hospitals and other institutions, shining a light on low value services and procedures may threaten capital investments and employment.

In large part, the way forward must involve the research community. Researchers should continue to mine real-world evidence to further value assessments even in the absence of clinical trial data. Differences across regions and practices in how a service or procedure is delivered and performs in the real world are common, and researchers can use these natural variations to estimate the impact of a service or procedure on health outcomes and costs [5]. Assessments can leverage robust statistical methods and a wealth of routinely-collected administrative and clinical data from sources such as claims, registries and electronic health records to estimate an intervention’s effectiveness and costs. Our recent analysis revealed that more than half of published cost–effectiveness analysis (CEAs) evaluating services or procedures used observational data as their main efficacy input, while for pharmaceutical CEAs, this percentage was less than 15% [6].

The research community should also strive to improve standards for assessing the value of services and procedures. One question ripe for additional work is how to account for incremental innovation, physician learning and differences in practices and prices. Organizations such as ISPOR – the Professional Society for Pharmacoeconomics and Outcomes Research could convene task forces to develop guidelines on these issues, for example. Researchers should monitor and track the publication and quality of value assessments, information that can help to identify gaps and areas for improvement. Finally, engaging patients in the development of these guidelines, and in the value assessments themselves, is vital to ensure that their preferences and priorities are reflected.

Policymakers should also accelerate their efforts. Ideally, public entities would fund value assessments on services and procedures in areas of high spending and with greater prospects to make a difference. Lakdawalla and colleagues have proposed creation of a publicly funded Institute for Health Technology Assessment (IHTA), which would be independent from political and industry influence [7]. The IHTA would not replace private sector efforts but would complement them by ensuring the quality and consistency of existing assessments and by conducting evaluations in areas where private efforts fall short, such as non-drug interventions. The IHTA could play a key role in data collection, standardizing methodologies and ensuring that a diverse range of stakeholder perspectives – including patients, payers and providers – are considered in the evaluation process.

Realistically, federal funding for such initiatives seems quite unlikely in the current political climate. Thus, private organizations must step into the void. For instance, the Institute for Clinical and Economic Review (ICER), while primarily funded by a private foundation, has historically focused on pharmaceuticals. Given its visibility on the national stage, ICER should broaden its scope to evaluate a wider range of services and treatments. Expanding its efforts could also contribute to methodological standards and should include perspectives from diverse stakeholders. Similarly, initiatives like Choosing Wisely should extend its focus beyond clinical criteria to incorporate value-based evaluations of healthcare services and procedures, ensuring that these assessments align with broader healthcare goals.

Private payers could also play a more active role, both in funding organizations like ICER, and in conducting value assessments themselves. Current reimbursement models, which often prioritize the volume of services provided rather than effectiveness or value, contribute to inefficiency and wasteful spending. As the healthcare industry shifts toward value-based care, payers have a unique opportunity to lead efforts that enhance the quality and scope of value assessments for services and procedures.

M Li and P Neumann were responsible for all aspects of the paper.

This work is funded by the National Pharmaceutical Council. The paper was developed as part of The Broader Value Initiative, managed by researchers at Tufts Medical Center and funded by PhRMA, to advance system-wide value assessment by raising awareness of its critical importance for health services and procedures.

M Li and P Neumann are members of the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center; the Center receives funding from government, private foundation and pharmaceutical industry sources. M Li and P Neumann have consulted with pharmaceutical companies, including companies working on issues related to health economics and outcomes research. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

No funded writing assistance was utilized in the production of this manuscript.

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