Enhanced integration of the patient’s voice in health care is the next step in the evolution of a patient-centered delivery system. To remain in line with this evolution, value assessment should incorporate the patient’s perspective and adopt transparent methods. We believe the Innovation and Value Initiative’s (IVI) development of the Open Source Value Platform (OSVP) referenced in Dr Dangi-Garimella’s article is a promising development. However, the open source approach to value assessment may struggle to make value judgments, as there is not a consensus definition of value, and participants may pursue their own motivations to different ends. Regardless of the theoretical strengths and weaknesses of an open source approach, commitment to openness and transparency in the value assessment process promotes patient autonomy, a bedrock principle of patient centeredness.
Much of the recent focus on containing the rising costs of American health care has been on pharmaceuticals. But a focus on cost containment without due attention to quality, including quality from the patient’s perspective, threatens to negatively affect patient outcomes and erode value. While methods have been established for value assessment, accounting for the patient’s perspective on what constitutes quality and value remains a challenge. Better capturing the patient’s voice in care is the next step in the evolution of a patient-centered delivery system. Value assessment should incorporate the patient’s perspective and adopt transparent methods to be in step with this evolution.
The primacy of diverse patient preferences fueled the patient-centered care movement in the 1980s.1 Proponents held that care delivery should be respectful of and responsive to individual patient preferences and ensure that patient values guide all clinical decisions. The movement drove increased focus on patient engagement, spurring shared decision-making and measurement of patient experience.2
But for a drug or device to make it to the patient bedside as a treatment option for patients and their clinicians to consider, it must travel the long road from product development to regulatory approval to payer coverage to payment policy. Though there are opportunities for patient involvement throughout the product development pipeline, the decision-making processes for regulatory approval and payer coverage are ripe for enhanced patient input.3,4 We believe that the mandate is particularly clear for a stronger patient voice in payer coverage decisions, including in the value assessments that inform those decisions.
The United States is unique among nations in that value assessments are privately financed.5 The most influential voice from a crowded field has been the Institute for Clinical and Economic Review (ICER), characterized as “perhaps the first major US attempt to complete and publicly share comprehensive health technology assessments.”6 ICER uses a range of established cost-effectiveness analysis approaches to assess long-term value while attempting to limit short-term budget impact.7 ICER also hosts a series of regional forums and public comment periods to solicit input, most recently requesting public input on their 2020 Value Assessment Framework.8
Since their first reviews in 2006, ICER’s assessments of pharmaceutical value have gained significant momentum. Payers increasingly cite ICER reports during drug price negotiations and when making formulary decisions, such as requiring prior authorization.9,10 In a major development, CVS Caremark has given employer groups the option to pick a formulary excluding drugs that do not meet a $100k per quality-adjusted life year benchmark based on ICER analysis.11 It remains to be seen how many employers will choose this approach. Though a full accounting of ICER’s purpose and methods is beyond the scope of this article, it should be noted that the organization has drawn criticism from some observers who call their methods opaque and worry that the results may unduly restrict patient choice.10,12,13
Notwithstanding the exhaustive debate about value assessment methods, the ascendency of ICER suggests that the American health care system, less than a decade removed from a manufactured crisis about “death panels,” is on the cusp of taking value assessment seriously. This marks a critical juncture for the engagement of patient perspectives and calls for the implementation of inclusive and open value assessment methods.
We believe the IVI development of the OSVP referenced in Dr Dangi-Garimella’s article is a promising development. Early signs indicate that its methods are rooted in consideration of diverse patient perspectives and align with well-founded recommendations from the National Pharmaceutical Council to include patient perspectives in the value assessment process.14
Open source development approaches emphasize transparency and have demonstrated considerable success, including the recent open source development of an artificial pancreas system.15 Open source approaches are generally most successful in addressing technical problems faced by the developers themselves. For example, computer programmers developed the Linux operating system. Successful open source developers have a deep understanding of the project requirements and the technical ability to meet those requirements, and they are generally motivated by an intricate network of participants.16,17
Value assessment is ultimately a complex mixture of technical measurement and value judgments. An open source approach is well suited to the technical components of the problem, such as developing novel methods to account for patient perspectives and for collection or manipulation of datasets. However, the open source approach to value assessment may struggle to make value judgments, as there is not a consensus definition of value, and participants may pursue their own motivations to different ends.
Regardless of the theoretical strengths and weaknesses of an open source approach, commitment to openness and transparency in the value assessment process promotes patient autonomy, a bedrock principle of patient centeredness. Initiatives like the OSVP should be developed with patient input and with patient users in mind. Clear, lay-friendly explanation of the data and assumptions made during a value assessment can help patients make informed decisions that are right for them. Informed patient decision-making is particularly important given the recent growth of consumer directed health plans, which share costs with patients to encourage cost-conscious decisions about when and where to seek care.18 Ongoing research has questioned the clinical consequences of these plans.19
Development of more patient-centered value assessment methods are necessary, but not sufficient, as improving care at the bedside and improving value across the care system requires effective application of the assessment results. Whether informed by ICER or the IVI, consequential drug coverage decisions made downstream by payers should actively solicit patient perspectives when applying value assessment results. The National Institute for Health and Care Excellence, the United Kingdom entity responsible for assessing value and making coverage decisions for their National Health Service, holds all deliberations in public and solicits input from patients and patient organizations.20 As IVI and ICER seek to refine their value assessment processes, we challenge them to solicit input from patients, build in sensitivity to patient preferences, and commit to full transparency.
To read the initial Viewpoint, click here.
References
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