Cancer care innovation is accelerating, powered by an explosion of transformative cancer treatments and breakthrough diagnostics. The introduction of immune-checkpoint inhibitors led to a flood of approvals, including tumor-agnostic indications based on patient biomarkers rather than tumor type. Chimeric antigen receptor T-cell (CAR-T) treatment accelerates personalized medicine, fighting cancer with genetically engineered immune cells created for individual patients. As science rapidly advances, physicians are challenged with integrating emerging evidence and clinical guidelines into practices, while payers are pressuring them to improve value.
Measure developers and measurement program implementers seeking to drive quality and assess the value of care strive to ensure that measures reflect the current practice standard and desired patient outcomes. Because measures historically have been based on clinical guidelines, measure developers sometimes wait to modify or create new measures until guidelines are updated, a process which can take 2 years or more. Guideline development rigor, the range of stakeholders who should be engaged, and sluggish dissemination can all impact how rapidly new recommendations—which may ultimately have a short shelf-life—are produced. In lung cancer, for example, treatment algorithms can become outdated within 6 months based on newly identified driver mutations.
Measure development is a similarly complex and lengthy process. According to CMS, measure prioritization, conceptualization, specification, testing, endorsement, selection, and implementation can take more than 2 years. Taking the processes of guideline development and measure development sequentially, it could take more than 4 years before quality measures relevant to a given novel treatment are available to benchmark quality, support accurate payment based on performance, and steer quality improvement. When existing evidence changes, lags in measure refinement can impact physicians’ ability to use that evidence for quality measurement and improvement. Measure developers should consider strategies to ensure that payers and physicians can meaningfully evaluate and improve care by: (1) more closely aligning measure development to evidence generation and guideline development, (2) using cross-cutting cancer outcome measures, and (3) measuring structures of care or using clinical pathways where outcome and process measures are not feasible.
Aligning Measure Development With Guideline Development and Changing Evidence
Guideline developers should flag emerging evidence of substantial variation in care delivery so that measure developers can prioritize creating or refining meaningful and actionable measures. Better aligning guideline and measure developer processes can help avoid an overabundance of process measures that are burdensome to report and become outdated as treatment evolves. Importantly, every aspect of a guideline does not need accompanying measures or measure refinement.
Guideline and measure developers can also use real-world evidence (RWE) to speed the process of integrating emerging evidence into clinical practice. Developers can fill gaps in current guidelines by generating data about how effective treatments are outside of clinical trial settings and identifying treatment challenges that can be measured and improved. Appropriate use of RWE to inform care decisions may also become a measurement topic. During a recent NCCN Policy Summit, panelists suggested that future quality measures may evaluate whether physicians correctly apply new evidence in practice and use RWE to inform decision-making when randomized clinical trial data are not available.
Using Cross-Cutting Measures of Cancer Outcomes
Measure developers should identify the most durable outcome measures that cut across guidelines and cancer populations. Process measures that are focused on specific aspects of treatment are closely tied to guidelines and therefore may need to change frequently with rapidly changing evidence. In the personalized medicine era, these measures could become focused on narrow, biomarker-specific populations, resulting in denominators that are too small to measure. Cross-cutting clinical outcome measures, on the other hand, are unlikely to change dramatically as guidelines change and can be adopted to decrease the number of measures that need to be tracked. CMS is already prioritizing oncology outcomes for measurement such as cure rate, survival rate, and patient-reported outcomes (PROs), including health-related quality of life. NQF’s partners leveraging its Measure Incubator™ are also developing and testing survival and PRO performance measures (PRO-PMs) for lung, melanoma, and prostate cancer.
While there is a push for more outcome measures, implementing them is challenging because of data collection feasibility as well as accuracy of risk adjustment and attribution. PRO-PMs are complex due to patient and provider data collection burden and potential biases that impact the data based on patient sociodemographic and clinical characteristics. Safety measures related to cancer “never events,” such as dosing errors or avoidable treatment-related loss of bodily function, may be cross-cutting measurement alternatives to more complex outcomes.
Leveraging Pathways and Structure Measures to Assess Quality of Care
Rapid development of outcome or process measures in accordance with emerging evidence and new clinical standards is not always feasible, and measurement of clinical pathway use and adherence or structure measures—such as PRO data collection—could serve as a stepping stone toward more robust measurement. Pathways should be rapidly updated to reflect new evidence, and their use can support point-of-care decision-making in ever-changing complex clinical scenarios. Measures that track use of, and concordance with, recognized pathways could remain static while the pathways themselves change. These measures should specify that pathways be developed through a transparent and evidence-based process that meet criteria established by oncology leaders.
Policymakers should consider implementing structure measures for cancer that assess whether providers have systems in place to account for patients’ perspectives. Measures that evaluate whether physicians collect and use PRO data and/or facilitate meaningful shared decision-making conversations to guide personalized treatment could inform the next generation of quality measures. Notably, the CMS Innovation Center included gradual implementation of electronic PROs in its recent Request for Information about the next version of their Oncology Care Model.
Appropriate clinical standards of care should be defined through thorough evidence- and consensus-based processes. While necessary, this creates a barrier to rapid quality measure development and refinement when transformative treatments are introduced and existing measures become outdated. Streamlining guideline and measure development processes while integrating RWE, focusing on cross-cutting outcomes that are guideline agnostic, and creating measures that recognize pathway use could mitigate the measurement challenges associated with rapid innovation.
Read other installments from the Quality Outlook series.
Carlos A Perea, MD: Thoughtful article, making excellent points that should influence investigators, statisticians, Insurance industry Executives and Government Policy-makers.
When speaking of innovation in Oncology and Precision Medicine we should not ignore the impact of recent developments such as Image Guided Radiation Therapy, Stereotactic Radiation Therapy or Proton/ Particle Irradiation, with demonstrated benefit on normal tissue side effect and quality of life with potential for enhancing local/regional tumor control.
I agree on the importance o of well designed outcome studies, with relevant parameters that sometimes are vexing and difficult to quantify. The inclusion of Patient reported Quality of Life endpoints is highly relevant, as are Technology Assessment, Cost Utility and Added Value in a Quality Evaluation Program. Needless to emphasize the need for solid data collection, which is not only critical, time consuming and expensive.
Obviously to assess quality in Oncology, as in other disciplines a coordinated e plan, adequate financial support, discipline and perseverance are crucial to success.
About the Quality Outlook Commentary Series
Breakthrough treatments in cancer care, including precision therapies tailored to specific patient factors, are driving rapid changes in the definitions of oncology quality and value. Efforts to implement value-based care models in oncology must meet the demands of evolving science, new best care practices, and shifting patient priorities. Quality measures must be up-to-date and relevant. Payment models must recognize the challenges and costs of managing complex patient populations with diverse needs. In this JCP blog series, Quality Outlook, Discern Health will explore key issues in oncology quality and value through posts focused on measurement, value-based payment, and quality improvement.
About Tom Valuck, MD, JD
Tom Valuck is a Partner at Discern Health. He is a thought leader on health care system transformation and helps lead the firm’s focus on achieving better health and health care outcomes at a lower cost. Tom’s work at Discern includes facilitating the exploration of next-generation measurement and accountability models for health care delivery systems. He also helps clients develop strategies to achieve success within the value-based marketplace.
About David Blaisdell
David Blaisdell, a Director at Discern Health, leads and manages client projects, providing insight and subject matter expertise, particularly on quality landscape analyses and measure gap identification. David has led and contributed to projects focused on oncology quality measurement to identify key gaps in measures used in accountability programs and opportunities for measure development. Through this experience, David helps clients navigate measurement and value-based payments and define strategies for success.
About Theresa Schmidt
Theresa Schmidt has more than a decade of experience in health care policy, quality, and health information technology. As a Director at Discern, she leverages a strong background in non-acute care, analytics, quality measures and quality improvement, value-based payment, and research to help Discern clients and partners achieve their business goals. Theresa has a diverse health care background and has held prior positions at the National Partnership for Hospice Innovation, Healthsperien, Avalere Health, and eHealth Data Solutions. She serves on the board of the Advancing Excellence in Long Term Care Collaborative.
About Discern Health
Discern Health is a consulting firm that works with clients across the private and public sectors to improve health and health care through quality-based payment and delivery models. These models align performance with incentives by rewarding doctors, hospitals, suppliers, and patients for working together to improve health care while lowering total costs.