Value frameworks in healthcare: prospects and limitations

Guaranteeing the maximum possible value in patient care: more and more often this is one of the basic objectives, if not the primary objective, in healthcare. But what does it mean when we talk about “value” in the context of healthcare?

From a conceptual standpoint, value in healthcare can be defined as the synthesis of what patients care about combined with the interests of all the stakehoders who play a part in the system. Although this definition is shared by many, finding a way to translate this into practice is more complicated. In other words, we need to identify the systems and indicators that effectively enable us to measure the value delivered by drugs, technologies and treatments.

With this aim in mind, there are a growing number of organisms and associations in the healthcare sector that have developed or are developing value frameworks. These are systems of standards and assessment tools utilized to measure the value generated by healthcare technologies and policies in concrete terms. Given the variety of frameworks that are available today, it’s useful to draw a comparison between them to analyze their common elements and unique features, and to understand what motivations and objectives behind their development.

To explore what value frameworks are currently available and study* their characteristics, we researched the keywords used in the main online scientific databases. From our findings we came up with seven frameworks developed by various types of actors: three were scientific or professional associations, three were scientific institutions or networks, and one was an association of biomedical firms.

The theoretical principles that inspired the value framework movement are not far distant from the drivers of cost-effectiveness and cost-benefit assessments in healthcare that were popular a few decades ago. Value frameworks take a seemingly more holistic approach to measuring value and strategically modifying the classic relationship between incremental costs and benefits, placing the latter in the numerator. From theory to practice, however, the socio-economic context of the country where these models came to be has no doubt shaped the way they were developed. Another influential factor is the institutional mission of the organizations advancing a given framework; since they serve different purposes and have different goals, each has created their own framework.

In any case, the common denominator for all models is the desire to contribute to better, more sustainable healthcare systems. So it is no coincidence that six of the seven frameworks were developed in the US, a country where access to care is a hot button issue, and where price setting for drugs is primarily determined by market mechanisms. In fact, the proposed frameworks would seem to focus on offering standardized, transparent mechanisms to allow physicians, producers and payers to evaluate drugs or technologies, and to negotiate the price on the basis of the value they generate. What emerges is a conception of value in the healthcare sector that is not perfectly reconciled with the dynamics that distinguish universal healthcare systems like we have in Europe.

Emblematic of this is the fact that the voice of the patient – central to the theory of value in healthcare – ends up falling on deaf ears, to some extent, when defining value in the various models. In most of the cases we analyzed, in fact, patients only had a limited say in the development phase of these frameworks. What’s more, when assessing healthcare interventions, the patient perspective is only incorporated in an intermediate way, on the basis of interviews with physicians. In most cases, the fundamental criteria adopted to define value are the results of clinical trials; so once again, less attention is paid to the actual experiences of patients. Although all the frameworks underscore factors such as toxicity, side effects, short- and long-term impacts on patients’ lives, the weight of these aspects in evaluation models varies significantly from framework to framework. We find this also when cancer treatments are the object of the evaluation. It would seem that this heterogeneity for the most part is due to diverse perspectives and priorities of the different organizations that developed the frameworks in question. This means that the generalizability of specific frameworks and their application on a vast scale appears to be limited.

As evidence of the contigent perspective that still marks current frameworks, many of them focus primarily on quantifying the value of drug therapies, in particular in oncology. This tendency is in part a response to the issue of the cost of cancer treatments, which has skyrocketed in recent years.

Shaping the way the various frameworks are structured is not only the therapeutic context of reference, but also the end users: in some cases, these will be physicians (to facilitate the choice of the most appropriate and efficient therapies), or political decision-makers (to enable them to make an informed evaluation of costs/benefits of treatments and technologies to invest in) or producers (to help offer a better understanding of demand and an accurate estimation of prices).

Lastly, in most cases, we find there is little transparency in the process of framework development: the reason why a certain value concept is embraced is not made explicit; the stakeholders involved in designing tools are unknown, and future directions for updated or revising frameworks are unclear. Moreover, some the development process in some cases seems to take place almost entirely internally, which could suggest that the organizations proposing a given framework might have a tendency toward self-referentialism.

The conception of value is changing in all health systems: it’s no longer simply about achieving the best possible clinical result. Instead a more holistic approach is becoming more widely accepted, seeing the patient and the care system from a comprehensive perspective, while encompassing considerations regarding management and financial sustainability as well. Most existing value frameworks originated in the US; as a result they reflect the criticalities and needs of that country. In Europe, the Health Technology Assessment paradigm has been widely used for far longer. Similar to modern theories on measuring value, this paradigm advances economic rationality and cost-effectiveness in allocating resources in healthcare, parameters which are likely to be better suited to universal healthcare systems.

New frameworks can certainly curb descretionlity and promote greater transparency and efficiency in clinical choices and resource allocation decisions. And in future these new models will find a place in other healthcare systems as well. However, the definition of value that underpins these frameworks should be spelled out more clearly than it is now. Specifically, the focus needs to shift from the hyper-standardized context of clinical trials to measuring outcomes and performances based on real world data, encouraging the involvement and listening to the opinions of not some – but all – stakeholders.

*The research was conducted on behalf of the Italian Ministry of Health Directorate General for Medical Devices, Pharmaceutical Services and Safety in Healthcare.