To have true utility, value models to assess the worthiness of treatments must have robust processes in place to incorporate the patient voice.
Value: a fair return or equivalent in goods, services, or money for something exchanged; the monetary worth of something; the relative worth, utility, or importance.1
Value models (also known as frameworks) have emerged as the latest tools to help healthcare stakeholders assess the worthiness of new treatments. But who defines what is of “value” in healthcare? What are the criteria for determining that a drug or treatment is valuable? And valuable to whom?
In 2015, 4 organizations—the American Society of Clinical Oncology (ASCO), the Institute for Clinical and Economic Review (ICER), the National Comprehensive Cancer Network (NCCN), and Memorial Sloan Kettering Cancer Center—released frameworks that the developers described as intended to support physicians and/or payers in assessing the value of treatments.2-5
However, value means different things to different people, and subsequently, establishing a definition of value that is broadly supported across the healthcare system has been elusive.
The value of a treatment is commonly viewed by healthcare payers (ie, both public and private insurers) in terms of its effectiveness and cost.6 For patients, value is individualized and disease-dependent, and can evolve with the disease trajectory or stage of a patient’s life. For example, a recent study of patients with metastatic breast cancer showed that more patients emphasize value in terms of their personal benefit—such as being able to maintain rich relationships with family members—than in economic terms.7
If we measure value incorrectly by not incorporating the patient perspective, we run the risk of making misguided and potentially costly decisions. Billions of dollars were spent on the development of Exubera, an inhalable form of insulin, but it was removed from the market after only 1 year because the product was big, cumbersome, and socially awkward to use. When individuals with diabetes did not see a real benefit from Exubera, it was no surprise that they viewed it as having little value.8
We need robust processes in place to incorporate the patient voice into the development of value models. Such action is particularly urgent if physicians and payers look to these frameworks to inform decisions that can affect the treatment options available to a patient.
In February 2016, the National Health Council brought together patient, consumer, provider, and pharmaceutical representatives to discuss value models, review patient-engagement rubrics, and consider the characteristics of a patient-centered framework.9 These roundtable participants agreed that because perceptions of value to patients are likely to differ significantly from perceptions of value to payers, providers, and consumers, value models must integrate the patient voice to have practical utility. The participants also agreed that any value model must be constructed with 6 key domains in mind:
A key result of the roundtable was the creation of the Patient-Centered Value Model Rubric.9 This tool can be used by the patient community, physicians, health systems, and payers to evaluate the patient-centeredness of value models, and to guide value model developers on the meaningful incorporation of patient engagement throughout their processes.
The Rubric provides characteristics of meaningful engagement that illustrate efforts for incorporation of the patient voice. For example, the tool addresses the need for models to be translated into usable, meaningful information that patients, family caregivers, and clinicians can use to improve shared decision making. In addition, thoughtful consideration should be given to differences in patient perceptions of value across relevant patient subpopulations, including populations at-risk and those with early- and late-stage disease. There should also be a clear link between the outcomes incorporated into the model and their importance to patients.
Another section outlines considerations to enhance the patient-centeredness of the model in general. Patients, providers, and payers can apply this section to evaluate the extent to which additional steps, beyond engagement efforts, have been taken throughout the development of the value model to involve patients. Some of the examples include vetting a draft model with a broad coalition of stakeholders (including patients), having a process to identify/incorporate new knowledge over time regarding patient subpopulations and disease trajectory, and considering economic inputs in the context of a patient’s experience.
Value frameworks can help advance the national dialogue on value, but only if they incorporate the patient voice. A collaborative effort from all stakeholders in the health ecosystem to utilize the National Health Council’s Patient-Centered Value Model Rubric will greatly assist in the creation of frameworks that ensure patient centeredness in value decisions and that patients and the families can rely on.
REFERENCES
1. Value [definition]. Merriam-Webster website. http://www.merriam-webster.com/dictionary/value. Accessed March 25, 2016.
2. Schnipper LE, Davidson NE, Wollins DS, et al; American Society of Clinical Oncology. American Society of Clinical Oncology statement: a conceptual framework to assess the value of cancer treatment options. J Clin Oncol. 2015;33(23):2563-2577. doi: 10.1200/JCO.2015.61.6706.
3. Value Assessment Project. Institute for Clinical and Economic Review website. http://icer-review.org/methodology/icers-methods/icer-value-assessment-framework/. Accessed April 21, 2016.
4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) with NCCN Evidence Blocks. National Comprehensive Cancer Network website. http://www.nccn.org/evidenceblocks/. Accessed March 25, 2016.
5. Welcome to DrugAbacus. Memorial Sloan Kettering Cancer Center, DrugAbacus website. http://www.drugabacus.org/drug-abacus-tool/. Accessed March 25, 2016.
6. Porter ME. What is value in health care? N Engl J Med. 2010;363(26):2477-2481. doi: 10.1056/NEJMp1011024.
7. Longacre ML, Charap ES, Buzaglo JS, Kennedy V, House L. Defining value in oncology: perspectives from patients with metastatic breast cancer. Poster presented at: Association for Value-Based Cancer Care, 5th Annual Conference; May 3-6, 2015; Washington, DC. http://www.cancersupportcommunity.org/sites/default/files/uploads/our-research/presentations/access-to-care/avbcc_value_poster_.pdf/. Accessed March 25, 2016.
8. Heinemann L. The failure of Exubera: are we beating a dead horse?
. 2008;2(3):518-529.
J Diabetes Sci Technol
9. The patient voice in value: the National Health Council Patient-Centered Value Model Rubric. National Health Council website. http://www.nationalhealthcouncil.org/sites/default/files/Value-Rubric.pdf. Published March 2016. Accessed March 29, 2016.
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