Therese M. Mulvey

American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options

Health care costs in the United States present a major challenge to the national economic well being. The Centers for Medicare and Medicaid Services (CMS) has projected that US health care spending will reach

American Society of Clinical Oncology Guidance Statement: The Cost of Cancer Care

4.3 trillion and account for 19.3% of the national gross domestic product by 2019.1 This growth in spending—both in absolute terms and as a proportion of our gross domestic product—has not been accompanied by commensurate improvements in health outcomes, despite expenditures far exceeding those of other countries.2–4 One of the fastest growing components of US health care costs is cancer care, the cost of which is now estimated to increase from

American Society of Clinical Oncology Identifies Five Key Opportunities to Improve Care and Reduce Costs: The Top Five List for Oncology

125 billion in 2010 to

Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received

158 billion in 2020.1 Although cancer care represents a small fraction of overall health care costs, its contribution to health care cost escalation is increasing faster than those of most other areas because of several factors: the increasing prevalence of cancer due to the overall aging of the population and better control of some causes of competing mortality; the introduction of costly new drugs and techniques in radiation therapy and surgery; and the adoption of more expensive diagnostic tests. In some cases, the adoption of newer, more expensive diagnostic and therapeutic interventions may not be well supported by medical evidence, thereby raising costs without improving outcomes.5 Coupled with, or even driving, some of these rising costs are sometimes unrealistic patient and family expectations that lead clinicians to offer or recommend some of these services, despite the lack of supporting evidence of utility or benefit.6 Historically, most individuals in the United States were shielded from the acute economic impact of expensive care because they had health insurance. However, current trends suggest that patients will find themselves increasingly responsible for a greater proportion of the cost of their health care. Cost shifting or sharing can occur through the increased use of high-deductible policies and larger copayments. These increased costs are already commonplace and may not be affordable for many families. Indeed, health care expenditures are cited as a major cause of personal bankruptcy,7 and the term financial toxicity has entered the vernacular as a means of describing the financial distress that now often accompanies cancer treatment.8 Like other toxicities of cancer treatment, financial toxicity resulting from out-of-pocket treatment expenses can reduce quality of life and impede delivery of high-quality care.9,10 Patients experiencing high out-of-pocket costs have reported reducing their spending on food and clothing, reducing the frequency with which they take prescribed medications, avoiding recommended procedures, and skipping physician appointments to save money.10,11 These unintended consequences risk an increase in health disparities, which runs counter to some of the key goals of health care reform. In many communities, the high costs associated with cancer care have created a difficult situation for patients and the oncologists who care for them. Addressing this situation will require greater understanding of all the risks and benefits of various treatment options as well as the consequences of specific choices. In this regard, studies have shown that patients specifically want financial information about treatment alternatives along with information about medical effectiveness and treatment toxicity. However, they often do not receive it. Closing this knowledge gap will require educated providers who are able to sensitively initiate a dialogue about the cost of care with their patients when appropriate.12,13 Patients with cancer are often surprised by and unprepared for the high out-of-pocket costs of treatments. They also overestimate the benefits of treatments that sometimes extend life by only weeks or months or not at all. Oncologists are generally aware of this conundrum but uncertain about whether and how the cost of care should affect their recommendations.14 Although raising awareness of costs and providing tools to assess value may help to manage costs while maintaining high-quality care, some oncologists see this as being in conflict with their duty to individual patients.15 Recent American Society of Clinical Oncology Efforts Motivated by our responsibility to help oncologists deliver the highest-quality care to patients everywhere, the American Society of Clinical Oncology (ASCO) formed the Task Force on the Cost of Cancer Care in 2007. Its mission includes educating oncologists about the importance of discussing costs associated with recommended treatments, empowering patients to ask questions pertaining to the anticipated costs of their treatment options, identifying the drivers of the rising costs of cancer care, and ultimately developing policy positions that will help Americans move toward more equal access to the highest-quality care at the lowest cost.16 In 2012, through the work of the Task Force, ASCO responded to the Choosing Wisely Campaign of the American Board of Internal Medicine Foundation and identified specific instances of overuse in the delivery of cancer care. ASCO used a deliberative consensus process to identify five common clinical practices that are not supported by high-level evidence. A second list of five was developed using the same process and submitted to the Choosing Wisely Campaign in 2013. ASCO amplified the evidence basis for both top-five lists in two publications17,18 and is now developing measures to evaluate the use of these practices as part of its Quality Oncology Practice Initiative. These exercises have provided opportunities to develop a rigorous but flexible approach to assessing efficacy across diagnostic and treatment domains.

American Society of Clinical Oncology National Census of Oncology Practices: Preliminary Report

Advances in early detection, prevention, and treatment have resulted in consistently falling cancer death rates in the United States. In parallel with these advances have come significant increases in the cost of cancer care. It is well established that the cost of health care (including cancer care) in the United States is growing more rapidly than the overall economy. In part, this is a result of the prices and rapid uptake of new agents and other technologies, including advances in imaging and therapeutic radiology. Conventional understanding suggests that high prices may reflect the costs and risks associated with the development, production, and marketing of new drugs and technologies, many of which are valued highly by physicians, patients, and payers. The increasing cost of cancer care impacts many stakeholders who play a role in a complex health care system. Our patients are the most vulnerable because they often experience uneven insurance coverage, leading to financial strain or even ruin. Other key groups include pharmaceutical manufacturers that pass along research, development, and marketing costs to the consumer; providers of cancer care who dispense increasingly expensive drugs and technologies; and the insurance industry, which ultimately passes costs to consumers. Increasingly, the economic burden of health care in general, and high-quality cancer care in particular, will be less and less affordable for an increasing number of Americans unless steps are taken to curb current trends. The American Society of Clinical Oncology (ASCO) is committed to improving cancer prevention, diagnosis, and treatment and eliminating disparities in cancer care through support of evidence-based and cost-effective practices. To address this goal, ASCO established a Cost of Care Task Force, which has developed this Guidance Statement on the Cost of Cancer Care. This Guidance Statement provides a concise overview of the economic issues facing stakeholders in the cancer community. It also recommends that the following steps be taken to address immediate needs: recognition that patient-physician discussions regarding the cost of care are an important component of high-quality care; the design of educational and support tools for oncology providers to promote effective communication about costs with patients; and the development of resources to help educate patients about the high cost of cancer care to help guide their decision making regarding treatment options. Looking to the future, this Guidance Statement also recommends that ASCO develop policy positions to address the underlying factors contributing to the increased cost of cancer care. Doing so will require a clear understanding of the factors that drive these costs, as well as potential modifications to the current cancer care system to ensure that all Americans have access to high-quality, cost-effective care.

Time to focus on inpatient safety: revision of the American Society Of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards.

Lowell E. Schnipper, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; Thomas J. Smith, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD; Derek Raghavan, Levine Cancer Institute, Carolinas HealthCare System, Charlotte, NC; Douglas W. Blayney, Stanford Cancer Institute, Stanford University School of Medicine, Stanford; Patricia A. Ganz, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA; Therese Marie Mulvey, Southcoast Center for Cancer Care, Southcoast Health System, New Bedford, MA; Dana S. Wollins, American Society of Clinical Oncology, Alexandria, VA.

Quality-of-care implications of improving physician communication through a Web-based tool (Teamwork).

The mission of American Society of Clinical Oncology (ASCO) is to conquer cancer through research, education, and promotion of the highest quality patient care. Toward fulfillment of this goal and at the direction of its board of directors, the ASCOValue in Cancer Care Task Force set out to develop a framework that would enable a physician and patient to assess the value of a particular cancer treatment regimen given the patient’s individual preferences and circumstances. The rationale that served as the impetus for this initiative is many faceted. Substantial progress has been made in translating our knowledge of the biologic characteristics of cancer into novel therapies. Some of these therapies have led to major improvements in outcomes for specific diseases, and others have produced only modest advances. There is now a wide array of choices for treating many cancer types, and these treatment choices often differ by only small degrees in clinical effectiveness and toxicity. Yet, there is often a wide disparity in cost to patients and payers. Because patients are often confronted with enormous expenses when receiving cancer care, the goal of describing a relationship between the cost of an agent or regimen and the clinical benefits it delivers takes on great importance. As the primary advisor to the patient, the oncologist has an important role in providing a comparative assessment of the various treatment options available; in the spirit of shared decision making, the patient should have transparent information about the clinical impact that can be expected from the different options presented and their relative financial implications. The value framework has been constructed as a conceptual model that incorporates the elements of clinical benefit, toxicity, and symptom palliation as derived from a comparative clinical trial and combines these elements into a score termed the net health benefit (NHB). Ultimately, deployment of the framework as a software application is planned, enabling a patient to modify the weight attributed to any of the elements included in the NHB depending on his or her personal preferences and circumstances. The final NHB will therefore reflect the priorities that are most important to the patient and will be arrived at through guidance from the physician. Information on the cost of the regimens will also be presented so the patient can consider the relative financial impact of his or her treatment options. Two versions of the framework have been created: one for advanced disease and the other for potentially curable (adjuvant therapy) clinical presentations. The original framework versions are shown in Appendix Tables A1 and A2 (online only). The key elements included in the framework— namely, clinical benefit and toxicity—are also those that are regularly reported in the scientific literature when discussing the outcome of a clinical trial that compares two or more therapies. The importance of relying on high-quality, quantifiable evidence cannot be overstated, and this is most often provided by a well-designed, well-conducted prospective randomized trial. The task force recognizes that a limitation of this approach is that it does not readily permit cross-trial comparisons. Such analyses are important to patients and remain a goal for future versions of the value framework. The task force is well aware that there are many elements that might be important to individual patients in assessing the relative value of their treatment options that are not taken into account in our model. These include the convenience of receiving therapy, the avoidance of interrupting the flow of activities of daily living, and the impact of a treatment on quality of life

Treatment plan and summary templates: the experience of one practice.

In response to reports of increasing financial and administrative burdens on oncology practices and a lack of systematic information related to these issues, American Society of Clinical Oncology (ASCO) leadership started an effort to collect key practice-level data from all oncology practices in the United States. The result of the effort is the ASCO National Census of Oncology Practices (Census) launched in June 2012. The initial Census work involved compiling an inventory of oncology practices from existing lists of oncology physicians in the United States. A comprehensive, online data collection instrument was developed, which covered a number of areas, including practice characteristics (staffing configuration, organizational structure, patient mix and volume, types of services offered); organizational, staffing, and service changes over the past 12 months; and an assessment of the likelihood that the practice would experience organizational, staffing, and service changes in the next 12 months. More than 600 practices participated in the Census by providing information. In this article, we present preliminary highlights from the data gathered to date. We found that practice size was related to having experienced practice mergers, hiring additional staff, and increasing staff pay in the past 12 months, that geographic location was related to having experienced hiring additional staff, and that practices in metropolitan areas were more likely to have experienced practice mergers in the past 12 months than those in nonmetropolitan areas. We also found that practice size and geographic location were related to higher likelihoods of anticipating practice mergers, sales, and purchases in the future.

Results of the 2013 American Society of Clinical Oncology National Oncology Census

In 2009, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) jointly published a comprehensive set of chemotherapy safety standards. The project was the end result of a highly structured multistakeholder process and the sole focus was on outpatient chemotherapy administration in the facilities in which most adult cancer chemotherapy is administered. In 2011, ASCO and ONS convened a workgroup to revise the standards. The revised standards are published in the January 2012 issue of Journal of Oncology Practice (JOP). In addition to clarifying language, the workgroup voted unanimously to extend the standards to encompass the inpatient setting. Inpatient chemotherapy administration, especially in the community setting, is believed to pose a silent but growing threat to patient safety. Most patients with cancer prefer to be managed as outpatients, and ambulatory management of cancer is more costeffective than inpatient management. Indeed, some insurers now require justification to admit a patient to the hospital solely to receive chemotherapy. The trend, then, of shifting adult medical oncology care from the hospital to the outpatient setting reflects patient-centered, cost-effective care. It has occurred gradually during the last decades of modern cancer chemotherapy, accompanied by shifts in care from academic centers to the community, where it is estimated that at least 80% of adult cancer care is provided. The change reflects at least three major advances. First, medical oncologists have become skilled in the management of highly toxic agents. Predictable toxicities of chemotherapeutic agents have been defined and risk factors have been identified, allowing for the prevention or amelioration of most serious adverse effects. Pretreatment assessment of renal function in conjunction with aggressive hydration, for example, has allowed cisplatin to be routinely administered in the outpatient setting. Second, the availability of highly active antiemetics and better-tolerated chemotherapeutic agents has additionally reduced the need for inpatient administration. Third, technologic advances that enable the safe delivery of continuous chemotherapy infusions in the home permit the ambulatory administration of complex regimens that previously required supervision in an inpatient setting. Community oncology practices have also become adept at managing the consequences of cancer and cancer treatment on an ambulatory basis. They have developed comprehensive care systems that rely on highly experienced nursing and pharmacy staff. Certification requirements for nursing and pharmacy staff along with the availability of supportive services that include nutritionists and social workers complement these practices. Patients who experience venous thromboembolic events, for example, are routinely managed with low molecular weight heparin as outpatients. Patients with low-risk chemotherapyinduced fever and neutropenia are managed with close observation and oral antibiotics. Patients who experience treatmentrelated GI toxicity are managed with ambulatory or home fluid resuscitation, and those with hypercalcemia receive potent parenteral bisphosphonates. Each of these patient groups are now routinely spared the risks and inconvenience of hospitalization. The consequence of these advances in the ambulatory care of patients with cancer is the disintegration of trained, cohesive chemotherapy teams in many hospitals; this problem is compounded by flaws in the transfer of data between outpatient and inpatient systems. The advances made in ambulatory practices (electronic chemotherapy order entry, for example) are inconsistently reflected in the inpatient setting. Fundamental changes in hospital staffing have occurred, with fewer dedicated nurses and pharmacists who are skilled in chemotherapy protocols and more hospitalists providing inpatient cancer care. Because of declining inpatient censuses and declining revenue, many hospitals have had to eliminate dedicated inpatient oncology units. This scenario may create a perfect storm in which very ill hospitalized patients are exposed to high-risk procedures (chemotherapy) that are provided by staff with diminishing expertise and without the needed infrastructure. JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L S VOLUME 30 NUMBER 10 APRIL 1 2012

Increasing clinical trial enrollment with the use of incentives in a community oncology practice.

310 Background: Our practice is a community-based multidisciplinary oncology-hematology outpatient clinic located in Northeastern Brazil serving a population of three million. Hospitalizations are frequent events for treatment of complications and for palliative care. Patients are distributed in several different units across five hospitals. A team of oncologists, hematologists and other clinicians is organized in daily shifts for ambulatory consults and hospital visits. The group meets every Monday morning in rounds for case discussion and planning. The number of patients, physicians and hospitals involved poses a communication challenge. METHODS In order to improve communication and quality of care, we created a internet application (Teamwork) which provides a patient table sorted by hospital, room number, assistant physician, last visiting doctor, diagnosis and treatment plan. This information is easily accessible from any internet connected computer, tablet or smartphone with a friendly graphic interface. The doctor who admits or consults with the patient is responsible for daily updates. All the multidisciplinary teams may consult and add information. RESULTS Data from our program between March 2011 and June 2012 demonstrated that on average 7 physicians visited a mean of 21.8 patients daily in 5 different hospitals. With the use of the online application (Teamwork) improvements in quality of care were noticed, including: 1) Admitted patient information was rapidly available for the team, anywhere; 2) Doctors could immediately identify the physician responsible for the most recent visit, improving communication, optimizing time and reducing uneccessary phone calls to make decisions; 3) Doctors out of town could obtain updated information about their patients and contribute to their care; 4) Statistical information was readily available, providing data for improvement of team organization. CONCLUSIONS The use of a simple online database, easily accessible and updatable represents a major step forward in the quality of care as measured by enhanced communication among providers, making it possible to assist patients in several hospitals, in a large city, with minimal communication stress.