Greater Alignment Among Oncology Clinical Pathways is Needed
A single, consensus-driven approach to oncology clinical pathways shared across payers appears to be a logical step if these approaches are to be indeed evidence-based and if administrative burden is to be managed efficiently.
Oncology clinical pathway (OCP) programs are instituted with an aim to contain cost of care while also protecting optimal treatment outcomes by increasing conformity to evidence-based medicine. Members of the provider and payer communities both genuinely care about these aims. However, implementation of cost-containing strategies has differential impact on the various stakeholders, and there is understandable tension between payers and providers with respect to how to balance accomplishing these aims.
To address these concerns, the American Society for Clinical Oncology (ASCO) recently provided formal recommendations for oncology clinical pathways initiatives, published in ASCO’s official journal, the Journal of Clinical Oncology.1 This document is authored by members of the ASCO Task Force on Clinical Pathways, and the content appears in the format of a consensus statement. As appropriate and expected, given ASCO’s role as the pre-eminent medical society representing oncology physicians and other clinicians, the recommendations focus mainly on provider-centric concerns about OCP programs. This ASCO statement appears to be a preliminary attempt to lay out ground rules and boundaries to govern how payers and providers work together to accomplish the stated benefits of OCPs.
The unsustainable increases in the costs to deliver cancer care, as well as debate on the best ways to address the problem, have been a topic of discussion for many years. An indication that we have reached a crisis point is underscored by introduction of the term “financial toxicity” to a mainstream US news audience through a segment of the popular TV news program “60 Minutes” in October of 2014.2 The out-of-pocket costs for patients to cover their portion of treatment costs has been linked to increasing rates of bankruptcy3 as well as patient decisions to skip doses of their oral chemotherapy drugs.4 Programmatic efforts to reduce health care costs in other disease states are decades old, but the complexity of cancer care has made it an exception to these cost-containing solutions. There is now broad consensus that health care costs for cancer care need to be contained or reduced. The current zeitgeist defines the context for this change as moving from a fee-for-service payment model (ie, one that incentivizes quantity of care) to a value-based care model (ie, linking incentives to outcomes and cost-reduction measures).
Enforcing the use of approved regimens through OCP programs is one approach that has been demonstrated to reduce cost. The aim of an OCP is to determine the most cost-effective treatment in common therapeutic indications (eg, first-line treatment of metastatic HER2+ ER- PR- breast cancer) by evaluating the efficacy and toxicity of all approved regimens. In theory, the regimen(s) with the best outcomes, least toxicity, and lowest cost are included in the approved clinical pathway. The aim to more uniformly implement treatment based on evidence-based medicine is one that appears necessary as a starting point in the process of moving to value-based care, and so it has gained traction. US Oncology has conducted analyses of their pathways program in non-small cell lung cancer (NSCLC) and in colorectal cancer (CRC).5,6 Patients with NSCLC treated “on-pathway” versus “off-pathway” are reported to have a 35% reduction in cost with equivalent overall survival. In CRC, costs for treatment of “on-pathway” patients were less than for “off-pathway” patients, according to a large national claims database as well as in a separate analysis using an electronic health record (EHR) database.
The ASCO statement outlines 9 recommendations centered primarily on 2 important topics: (1) protecting the autonomy of physicians to make treatment decisions that are informed by knowledge of patient-centered priorities and are consistent with up-to-date, evidence-based medicine; and (2) decreasing the administrative burden imposed by the need to accommodate a variety of OCPs with differing requirements and reporting standards.
PROTECTING PHYSICIAN AUTONOMY
A common concern for providers is the extent that OCPs decrease autonomy in their clinical decision-making. The level of flexibility in allowing selection of “on-pathway” treatments as well as the magnitude of barriers in allowing “off-pathway” treatment vary among pathway programs and are a focus for provider satisfaction with the program. The physician has legal and ethical accountability for all care decisions, and the extent that the latitude to make optimal decisions is actually or even perceived to be constrained increases the potential for an oppositional relationship between payers and providers.
One of the paradoxes of the current emphasis on broad implementation of OCPs is that the rapid evolution of targeted therapies and other new treatment approaches (eg, immuno-therapies) increases both the potential benefit of OCPs and the complexity of implementing them effectively. The benefits of a compendium of best practices informed by scientific evidence are greater when common therapeutic indications have increasing numbers of approved regimens and ways to sequence these regimens. Additionally, some new agents are enormously costly, so judicious use is even more needed if we are to attenuate “financial toxicity.” It was arguably easier to design, implement, and monitor an OCP a decade ago when there were fewer approved therapies. OCPs need to take into consideration a rapidly changing and growing scientific literature in order to stay current, or the use of “off-pathway” treatment decisions will increase as well-informed physicians embrace more effective treatments that have not yet been integrated into the pathways.
The additional stratification needed to correctly prescribe “on-pathway” use of new therapeutics is harder to balance with the role of provider judgment taking into consideration patient-specific features. Additionally, a comprehensive OCP should not only identify the best treatment for a given patient in a therapeutic indication but also establish best practices for molecular diagnostics, imaging, and other required components of oncology care. Diagnostics for molecular genomics are evolving both in conjunction with treatments (eg, companion diagnostics for new agents) as well as independently (eg, new technologies to better assess established biomarkers). This means that the aims of implementing evidence-based medicine along with cost containment required a multi-disciplinary solution. Medical oncologists are at the forefront of chemotherapy decisions, but OCPs require increased coordination with surgical oncology, radiation oncology, pathology, and radiology across therapeutic and financial domains.
DECREASING ADMINISTRATIVE BURDEN TO PHYSICIANS
Another key recommendation made in the ASCO statement in support of providers using OCPs is that the industry work to “…remove unsustainable administrative burdens…” associated with implementation and documentation of compliance with OCPs. As new OCPs enter the market, increased variability requires providers to learn nuances between OCPs for patients with the same disease characteristics. Establishing standard approaches to workflows across OCPs is essential for effective implementation.
Implementing an OCP through an oncology practice is a daunting task. The use of tools for communicating all aspects of the “on-pathway” care plans to clinical staff is only one component of the implementation process. A much larger component is the documentation of compliance, related performance measures, and patient outcomes. Understanding and meeting administrative requirements when a patient is treated “off-pathway” is another domain requiring education and support. Then, consider the challenges when two or three different OCPs must be implemented for patients with the same therapeutic indication. Workflows in clinics have not historically been set up to treat patients differently according to the third-party payer. Even small differences between OCPs will create problems for providers to show compliance according to individual insurance program requirements. The investment in infrastructure needed to successfully implement OCP programs is fixed overhead for a practice; therefore, OCPs impose a differential burden on smaller practices. This burden creates pressure for small practices to join larger groups or hospitals.
THE NEED FOR GREATER ALIGNMENT AMONG OCPS
Currently, pathway developers are not incentivized to align their recommendations, processes, or reporting tools. Each of these developers understandably wishes to distinguish itself as a superior solution; thus, there will be heterogeneity across OCPs that negatively affects the provider community. A single, consensus-driven approach to OCPs shared across payers appears to be a logical step if these approaches are indeed evidence-based and if administrative burden is to be managed efficiently.
Adoption of a uniform OCP across payers would also potentially benefit patients. To the extent that there is variation between OCPs across payers, a patient’s decision on which insurance provider to choose would need to be informed of the implications of this variation. This requirement is unlikely to be met; currently, there is little transparency in the terms of the medical coverage offered by different payer plans.
Patients are important constituents in the discussion on OCP development in other ways. There is a need to balance the decision between a more costly regimen that is well-tolerated and provides higher quality of life as compared with an equally effective regimen with more toxicity. This methodology exists and has been used in the UK and Europe but does not have the same history in the US.
Uniform implementation of value-based care generally, and OCPs specifically, also affect drug manufactures. Value-based care models will exert downward pressure on drug pricing, but to what extent? Decisions on drug development will need to be informed by these changes in the market. For example, if there is a compound expected to have efficacy equal to an approved treatment but a markedly better toxicity profile, is it wise to launch a program to develop that compound? Will oral drugs be preferred for development due to an assumption that the lower administration cost will give these agents a significant advantage in a value-based model?
A final consideration is that implementation of an OCP program is only the leading edge of the shift to value-based care models. Innovation will continue to find improved ways to elicit the best outcomes in cancer care while containing costs. One recent example describes an OCP program that included a patient support services component aimed specifically at avoiding chemotherapy-related ER visits and hospitalizations.7 The enhanced patient support included symptom monitoring through systematic collection of patient-reported outcomes and calls from nurses to elicit information about new or ongoing toxicities. Major aims of the project were met as the patient support group had higher adherence to pathways, fewer ER visits and days in hospital, and lower cost of care.
The recommendations described in ASCO’s statement for successfully creating and implementing OCP programs do not break new ground, but they do posit important ground rules if OCPs are to meet the needs of the provider community and encourage stakeholders to work together to ensure OCPs provide value for everyone involved.
1. Zon RT, Frame JN, Neuss MN, et al. American Society of Clinical Oncology Policy Statement on Clinical Pathways in Oncology [published online ahead of print January 12, 2016]. J Oncol Pract. 2016. pii: JOPR009134.
2. 60 Minutes. The Cost of Cancer Drugs [video]. October 5, 2014. CBS News website. http://www.cbsnews.com/news/the-cost-of-cancer-drugs/. Accessed February 29, 2016.
3. Himmelstein DU, Thorne D, Warren E, Woolhandler S. Medical bankruptcy in the United States, 2007: results of a national study. Am J Med. 2009;122:741–746.
4. Schwartzberg L, Streeter SB, Hussain N, Johnsrud M. Abandoning oral oncolytic prescriptions at the pharmacy: patient and health plan factors influencing adherence. Poster presented at the American Society of Clinical Oncology Annual Meeting, 2011.
5. Neubauer MA, Hoverman JR, Kolodziej M et al. Cost-effectiveness of evidence-based treatment guidelines for the treatment of non-small-cell lung cancer in the community setting. J. Onc. Pract. 2010;6:12-18.
6. Hoverman JR, Cartwright TH, Patt DA, et al. Pathways, outcomes, and costs in colon cancer: retrospective evaluations in two distinct databases. J Onc Pract. 2011;7:52S-59S.
7. Hoverman JR, Klein I, Harrison DW, et al. Opening the black box: the impact of an oncology management program consisting of Level I pathways and an outbound nurse call system. J Onc Pract. 2014;10:63-68.