Putting Patients at the Heart of what Value Means
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- Dana Carroll
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1 November 19, 2015 Robert Carlson, MD Chief Executive Officer National Comprehensive Cancer Network 275 Commerce Drive, Suite 300 Fort Washington, PA Dear Dr. Carlson, The undersigned organizations represent many segments of the oncology advocacy community including patients, researchers and providers. We appreciate your recent engagement with many of our groups through forum discussions around National Comprehensive Cancer Network s (NCCN) Evidence Blocks. We would like to offer our perspectives on the recently launched Evidence Blocks to assess the costs versus benefits of available therapies and thank NCCN for consideration of our feedback. Putting Patients at the Heart of what Value Means According to NCCN s stated principles, value has many definitions, but the patient s perspective is the most important. This perspective is of utmost importance as the organization begins to roll out Clinical Practice Guidelines in Oncology that include Evidence Blocks. Our organizations support a highly patient-centric approach to treatment that fosters patient choice as well as clinical judgment. We believe both oncologists and patients are best served by using value assessment tools that encourage patient-centered care through a shared decision making process and not a static, standardized evaluation. The IOM defines patient-centered as providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions. (Institute of Medicine 2001). Moreover, new insights into patient values support the importance of looking at patient preferences through a variety of nontraditional means. For example, new findings from the Cancer Support Community presented at the 2015 conference of the Association of Value-Based Cancer Care 1 show that the women with metastatic breast cancer in their registry define their goals for cancer care in terms of personal value. Of the women surveyed, only 7.4% defined value in an economic context. The rollout of the first NCCN Evidence Blocks for chronic myelogenous leukemia (CML) and multiple myeloma treatment presents both an opportunity and a challenge. NCCN has designed a new valueassessment tool that is based on clinical treatment guidelines for each cancer and relays complex information about alternative cancer treatments in an easy-to-read format. We understand that this 1 Cancer Support Community. Study Finds Discrepancy in Value Definition in Cancer Care. May 4, Accessible at 1
2 tool is meant to serve as a conversation starter and not a treatment determinant. While we understand that it is not NCCN s intention, patient access to treatments may suffer as payers use the value assessment provided in the Evidence Blocks to justify coverage decisions even though a patient s individual experiences regarding value and affordability may be very different from what is depicted in the blocks. We feel that the patient perspective could be dramatically enhanced and we urge NCCN to identify and implement a process for capturing and incorporating patients perceptions of value especially when determining affordability. More specifically, we would like to see NCCN actively seek the views of the patient advocacy community and patients themselves as the organization develops future Evidence Blocks. Addressing the Total Costs of Cancer Care The Institute of Medicine s report, Cancer Care for the Whole Patient, 2 recognizes that cancer therapies are by no means the only drivers of increasing costs to patients and encourages members of the care team to discuss the total and out-of-pocket costs of cancer care with patients. According to estimates from the Agency for Healthcare research and Quality (AHRQ), of the $88.7 billion in direct costs for cancer treatment in 2011, 50% was for hospital outpatient or doctor office visits, 35% involved inpatient hospital stays, and 11% covered the cost of prescription drugs 3. Among roughly 23,000 cases, the top five financial issues patients asked Patient Advocate Foundation s (PAF) case managers for help with in 2014 were transportation expenses (15.2%), co-pay assistance associated with hospital and doctor visits (14%), co-pay assistance for pharmaceutical products (12.5%), inability to afford rent or mortgage payments (9.3%) and inability to afford utilities for (8.7%). Recent survey data from PAF noted that the following six healthcare costs were identified by at least 40% of respondents as a source of financial hardship: office visits to physicians (56%), laboratory services (53%), prescriptions (53%), visits to other medical providers (52%), radiology services (43%), and surgery (40%). It s apparent that to patients, the cost of their cancer care is much more than the cost associated with one particular aspect of treatment. If not already planned, we encourage NCCN to develop companion materials for use with the Evidence Blocks so providers can initiate a discussion prior to treatment regarding the range of expenses the patient is likely to incur for cancer care. To expedite the process, several of the patient advocacy organizations listed below would be pleased to offer NCCN input based on their experience with providing direct support and information to patients for their financial and medical debt issues. 2 National Academies Press Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs. ISBN-13: American Cancer Society. Economic Impact of Cancer. Accessible at 2
3 Because affordability is perhaps the most unique and individualized variable that NCCN is attempting to assess, patient advocacy groups with real world experience helping patients with their financial issues are uniquely positioned to assist in finding the most meaningful way to measure this domain on a 1 to 5 scale. Providers certainly have some appreciation for the cost of various treatments. However, we feel that for affordability to be relevant to an individual patient in a shared-decision making care model, the rating of such should be informed by those who are knowledgeable about the full range of costs patients are likely to incur when undergoing a particular treatment. Each patient s ability to afford a treatment option varies by geography, insurance, individual financial circumstances and other personal factors. We would appreciate more clarity has to how a standard 1 to 5 score on affordability based on average costs of various clinical items can be made relevant to an individual patient, since their ability to pay costs associated with a specific treatment is so unique and personal. We have tremendous respect for those clinicians who contributed their time and wisdom to develop NCCN s first set of Evidence Blocks, but physicians alone are not sufficiently familiar with patients financial issues to assess the affordability of a treatment. Basing the affordability of a treatment on an average sense of overall costs across a handful of factors may provide some general guidance, however we fear that this perspective will confuse and potentially mislead an individual patient. Physicians are trained in the areas of clinical safety and efficacy, and thus well suited to assess the evidentiary basis for evaluating such domains using clinical judgment. NCCN s guidelines and the Evidence Blocks reflect that expertise. Those in the best position to assess affordability for patients based on the total cost of care include social workers, economists, and trained financial counselors. Patients and the advocacy groups that focus on navigating them through their financial challenges stand ready to work with NCCN to further develop its affordability assessment in ways that we think most accurately reflect the patient experience. Impact on Patient Access Because of the great respect commanded by NCCN and the NCCN guidelines process, there is strong likelihood that the Evidence Blocks will influence patient access as a host of stakeholders and decision makers in the healthcare system try to limit access to new and existing cancer therapies based on different estimations of value For this and other reasons explained in this letter, we implore NCCN to engage the patient community in assisting to further refine certain aspects of this tool in ways that will optimize its utility in patient-centric care and decision-making. We share the common goal of creating tools to support both patients and clinicians in making informed treatment choices that reflect a personalized assessment of each patient s circumstances, values and priorities. Communication with the Patient As organizations engaged in advocacy on behalf of oncology patients, we have several recommendations about the methodology and presentation of the Evidence Block information. When patients are confronted with this tool in a clinical setting, it must be clear, relevant and understandable. If not already planned, we encourage companion communications tools that can address key questions including: 3
4 What is the explanation of a one block difference in affordability and what are the thresholds? Do these ratings account for out-of-pocket costs to patients? Will the patient understand that affordability is a rough estimate of the cost of the regimen generally and not for them individually? How can the patient find out whether this treatment will be affordable to them? We also believe that the Evidence Blocks should be formally pilot tested among multiple myeloma and CML patients so that any areas of confusion or ambiguity can be addressed before introducing additional cancer treatment guidelines with Evidence Blocks. Concerns about the Limitations of NCCN s Evidence Block Methodology To develop the Evidence Blocks for each cancer, NCCN s methodology relies on a 5-point scale to assess the efficacy, safety, data quality, data consistency, and affordability of a therapy option. These measures are then presented in a simple graphic for ease of use and understanding. As stated previously, our collective organizations appreciate the emphasis NCCN placed on simplicity when designing this graphic tool, in order to convey complex information to patients in an understandable way. At the same time, we share a number of concerns about the the Evidence Blocks that may limit or impede a patient-centric approach to treatment planning: The Evidence Blocks use survival as the primary endpoint in determining efficacy, when progression-free survival and improved quality of life measures are important factors to patients and should not be discounted. NCCN s scoring system does not take into account patients varying levels of tolerance for safety and therefore, may present a low level of safety when patients with hard-to-treat and rare cancers may be willing to accept greater risk. Unless the methodology behind the Evidence Blocks is designed to make value determinations based on a patient s race, gender and income, the scores will reflect a standardized view based on the average patient even though the circumstances for each cancer patient differ significantly. In its present form, the graphic tool does not allow for a personalized assessment of the affordability of alternate treatments based on the patient s insurance policy and coverage benefits. The unintended consequence is that patients may perceive a treatment to be unaffordable and opt not to be treated with an appropriate and effective therapy even though their insurance plan would cover the cost Clearly, extensive time and rigor has gone into developing the Evidence Blocks with the goal of creating a tool that is intended to catalyze a productive conversation between providers and patients about the value and costs of cancer treatment options. We would welcome the opportunity to work with NCCN to address the questions and concerns raised in this letter prior to building future Evidence Blocks. Such an effort we hope would lead to a more relevant and helpful tool for patients and their cancer care providers. 4
5 Thank you again for your consideration of these views. Sincerely, American Association for Cancer Research Association of Community Cancer Centers Bladder Cancer Advocacy Network CancerCare Cancer Support Community Colon Cancer Alliance Community Oncology Alliance Cutaneous Lymphoma Foundation Fight Colorectal Cancer Friends of Cancer Research Leukemia and Lymphoma Society LUNGevity Lung Cancer Alliance National Patient Advocate Foundation Oncology Nursing Society Ovarian Cancer National Alliance Pancreatic Cancer Action Network The National Prostate Cancer Awareness Foundation 5
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