Defining Value of Cancer Therapeutics—A Health System Perspective

Defining Value of Cancer Therapeutics—A Health System Perspective Abstract Because of the rising costs of cancer care and ongoing challenges in ensuring access to quality care, there is an increasing need to prioritize spending and define the benefits of therapy in proportion to costs. The term “value” has gained favor as means to define the relative utility of a medical intervention in terms of benefits, risks, and financial costs, which in turn can help clinicians, patients, and policy makers prioritize “high-value” care. While numerous value concepts have been proposed, a comprehensive discussion of value initiatives along the care continuum is missing. In this Commentary, we propose a health system taxonomy of value initiatives in cancer care to discuss what the field needs to progress. Over the last decade, we have witnessed a shift in focus of the US health system discourse from an initial paradigm of improving outcomes to a growing emphasis on cost containment and most recently to a focus on “value”—defined most succinctly as health care outcomes per dollar spent (1). This evolution is driven by the urgent need to ensure that care is beneficial, accessible, and sustainable in times of rising societal health care spending, uncertain access to care in many settings, and substantial financial burdens for patients (2,3). The concept of value promises to capture both the clinical importance of patient care and the relative costs of that care in proportion to its benefits (4–6). However, it is far from clear, especially in cancer care, that patients, providers, payers, and other stakeholders have a common understanding of value and are ready to base clinical and policy decisions on this metric. While in other high-income countries national payer organizations or other governmental agencies (such as health technology assessment organizations) (7) are coordinating assessment and utilization of cancer care interventions, value concepts have developed organically in the fragmented US health care system. State, professional, academic, and industry groups have proposed differing definitions of value and plans for operationalizing this concept. The approaches share common elements but differ in important aspects ranging from clinical outcomes considered, definitions of costs, sources of data, and intended uses and audiences (4,6,8). The resulting confusion and lack of consensus threaten to undermine the important impetus for this work: to promote equitable access to high-quality cancer care at costs that are sustainably affordable to individual patients and society. Taking a Health System Perspective We believe it is important to consider these initiatives from a health system perspective, considering the steps in development, deployment, and coverage for interventions where value assessment can inform decision-making. This analysis is intended to highlight the role of available frameworks, where they do or do not apply, and to identify gaps or contradictions in the field that must be addressed. To show a path out of the current thicket, we assess value initiatives from a health system perspective to identify what exists and what is missing for value assessments to support a health system that provides high-value cancer care. Several steps in the development and utilization of cancer care interventions where a value assessment might be applied can be considered; these include 1) regulation: initial evaluation and consideration for approval by regulatory agencies; 2) reimbursement pricing, which includes 2a) health technology assessment: estimation of the value (often expressed in financial thresholds) of new interventions by comparing health benefits and costs to existing interventions and 2b) price setting: agreeing on a reimbursement price of a drug or a service by weighing health and other outcomes and costs; 3) benefit design: tiering of patient cost-sharing depending on the value of the treatment; 4) point of care, which includes 4a) care delivery: restructuring of provider payments by taking patient-centered care into account and 4b) treatment decisions: shared decision-making based on comparing health outcomes and costs of different treatments with patient preferences. Along this health system continuum from regulating to evaluating, pricing, prescribing, reimbursing, and taking cancer treatments, we have developed a taxonomy of national value initiatives that are likely to shape the policy and treatment landscape in cancer care. Previous discussions of value frameworks have focused on parts of the continuum (health technology assessment and shared decision-making) (4,6,9). Our taxonomy classifies the leading initiatives by proposed target audiences, content, and real-world use in cancer care and where in the health system continuum they would be applied (and “have value”) (Figure 1, Table 1). Table 1. Sources for the health system’s taxonomy of value initiatives along the cancer care continuum* Initiative Organization Source 2nd Panel on Cost-Effectiveness in Health and Medicine A consortium of experts https://healthpolicy.duke.edu/2ndpanelcea ASCO PCOP American Society for Clinical Oncology Patient-Centered Oncology Payment https://am.asco.org/asco-patient-centered-oncology-payment-program ASCO value framework American Society for Clinical Oncology http://www.asco.org/practice-guidelines/cancer-care-initiatives/value-cancer-care DrugAbacus Drug Pricing Lab, Memorial Sloan Kettering https://drugpricinglab.org/ ICER Institute for Clinical and Economic Review https://icer-review.org/final-vaf-2017-2019/ ISPOR International Society for Pharmacoeconomics and Outcomes Research https://www.ispor.org/ValueAssessmentFrameworks/Index NCCN Evidence Block National Comprehensive Cancer Network https://www.nccn.org/evidenceblocks/ Oncology Care Model Center for Medicare and Medicaid Innovation https://innovation.cms.gov/initiatives/oncology-care/ PP value framework Faster Cures http://www.fastercures.org/programs/patients-count/patient-perspective-value-framework/ V-BID Institute for Healthcare Policy and Innovation, University of Michigan http://ihpi.umich.edu/initiatives/value-based-insurance-design Initiative Organization Source 2nd Panel on Cost-Effectiveness in Health and Medicine A consortium of experts https://healthpolicy.duke.edu/2ndpanelcea ASCO PCOP American Society for Clinical Oncology Patient-Centered Oncology Payment https://am.asco.org/asco-patient-centered-oncology-payment-program ASCO value framework American Society for Clinical Oncology http://www.asco.org/practice-guidelines/cancer-care-initiatives/value-cancer-care DrugAbacus Drug Pricing Lab, Memorial Sloan Kettering https://drugpricinglab.org/ ICER Institute for Clinical and Economic Review https://icer-review.org/final-vaf-2017-2019/ ISPOR International Society for Pharmacoeconomics and Outcomes Research https://www.ispor.org/ValueAssessmentFrameworks/Index NCCN Evidence Block National Comprehensive Cancer Network https://www.nccn.org/evidenceblocks/ Oncology Care Model Center for Medicare and Medicaid Innovation https://innovation.cms.gov/initiatives/oncology-care/ PP value framework Faster Cures http://www.fastercures.org/programs/patients-count/patient-perspective-value-framework/ V-BID Institute for Healthcare Policy and Innovation, University of Michigan http://ihpi.umich.edu/initiatives/value-based-insurance-design * ASCO = American Society for Clinical Oncology; ICER = Institute for Clinical and Economic Review; ISPOR = International Society for Pharmacoeconomics and Outcomes Research; NCCN = National Comprehensive Cancer Network; PP = patient preference; PCOP = Patient-Centered Oncology Payment; V-BID = value-based insurance design. Table 1. Sources for the health system’s taxonomy of value initiatives along the cancer care continuum* Initiative Organization Source 2nd Panel on Cost-Effectiveness in Health and Medicine A consortium of experts https://healthpolicy.duke.edu/2ndpanelcea ASCO PCOP American Society for Clinical Oncology Patient-Centered Oncology Payment https://am.asco.org/asco-patient-centered-oncology-payment-program ASCO value framework American Society for Clinical Oncology http://www.asco.org/practice-guidelines/cancer-care-initiatives/value-cancer-care DrugAbacus Drug Pricing Lab, Memorial Sloan Kettering https://drugpricinglab.org/ ICER Institute for Clinical and Economic Review https://icer-review.org/final-vaf-2017-2019/ ISPOR International Society for Pharmacoeconomics and Outcomes Research https://www.ispor.org/ValueAssessmentFrameworks/Index NCCN Evidence Block National Comprehensive Cancer Network https://www.nccn.org/evidenceblocks/ Oncology Care Model Center for Medicare and Medicaid Innovation https://innovation.cms.gov/initiatives/oncology-care/ PP value framework Faster Cures http://www.fastercures.org/programs/patients-count/patient-perspective-value-framework/ V-BID Institute for Healthcare Policy and Innovation, University of Michigan http://ihpi.umich.edu/initiatives/value-based-insurance-design Initiative Organization Source 2nd Panel on Cost-Effectiveness in Health and Medicine A consortium of experts https://healthpolicy.duke.edu/2ndpanelcea ASCO PCOP American Society for Clinical Oncology Patient-Centered Oncology Payment https://am.asco.org/asco-patient-centered-oncology-payment-program ASCO value framework American Society for Clinical Oncology http://www.asco.org/practice-guidelines/cancer-care-initiatives/value-cancer-care DrugAbacus Drug Pricing Lab, Memorial Sloan Kettering https://drugpricinglab.org/ ICER Institute for Clinical and Economic Review https://icer-review.org/final-vaf-2017-2019/ ISPOR International Society for Pharmacoeconomics and Outcomes Research https://www.ispor.org/ValueAssessmentFrameworks/Index NCCN Evidence Block National Comprehensive Cancer Network https://www.nccn.org/evidenceblocks/ Oncology Care Model Center for Medicare and Medicaid Innovation https://innovation.cms.gov/initiatives/oncology-care/ PP value framework Faster Cures http://www.fastercures.org/programs/patients-count/patient-perspective-value-framework/ V-BID Institute for Healthcare Policy and Innovation, University of Michigan http://ihpi.umich.edu/initiatives/value-based-insurance-design * ASCO = American Society for Clinical Oncology; ICER = Institute for Clinical and Economic Review; ISPOR = International Society for Pharmacoeconomics and Outcomes Research; NCCN = National Comprehensive Cancer Network; PP = patient preference; PCOP = Patient-Centered Oncology Payment; V-BID = value-based insurance design. Figure 1. View largeDownload slide A health system’s taxonomy of value initiatives along the cancer care continuum. ASCO = American Society for Clinical Oncology; CE = cost-effectiveness; CEA = cost-effectiveness analysis; CMS = Centers for Medicare and Medicaid Services; CS = cost-sharing; HTA = Health Technology Assessment; ICER = Institute for Clinical and Economic Review; ISPOR = International Society for Pharmacoeconomics and Outcomes Research; NCCN = National Comprehensive Cancer Network; PP = patient preference; PCOP = Patient-Centered Oncology Payment; QALY = quality-adjusted life year; V-BID = value-based insurance design. Figure 1. View largeDownload slide A health system’s taxonomy of value initiatives along the cancer care continuum. ASCO = American Society for Clinical Oncology; CE = cost-effectiveness; CEA = cost-effectiveness analysis; CMS = Centers for Medicare and Medicaid Services; CS = cost-sharing; HTA = Health Technology Assessment; ICER = Institute for Clinical and Economic Review; ISPOR = International Society for Pharmacoeconomics and Outcomes Research; NCCN = National Comprehensive Cancer Network; PP = patient preference; PCOP = Patient-Centered Oncology Payment; QALY = quality-adjusted life year; V-BID = value-based insurance design. Regulation The Food and Drug Administration’s mandate does not include the consideration of value, as emphasis is solely on efficacy and safety. In fact, the current trend in oncology of granting accelerated approval for many cancer treatments based on marginal average benefits (as measured by overall survival or progression-free survival) and uncertain effectiveness in a broader population seems to indicate that long-term value is not prioritized at this level (10–12). Health Technology Assessment Three groups are leading the development of assessment methods in the United States: the 2nd Panel on Cost-Effectiveness (CE) Analysis in Health and Medicine (13), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) (9), and the Institute for Clinical and Economic Review (ICER) (14). The methods developed by these groups are designed for application in all disease areas (including oncology) and target policy makers, payer organizations, and industry. While each initiative has generated its own set of value measures, all acknowledge the need to distinguish between measures from the perspectives of the broader health system and society and measures of aspects of care that go beyond health. The latter include ability to return to work or the value of hope or ethical, legal, or societal priorities that are important but difficult to quantify (15). ISPOR’s framework closed the public review of its proposed methodology in August 2017, and the 2nd Panel on CE published its methodology earlier in 2017. Suitability to real-world use of either method in cancer care is unknown. ICER’s methodology has been used for several years with a recent update to its methodology accounting for long-term value for money and short-term affordability and a current public discussion on an adjusted methodology for ultra-orphan drugs (14). As of January 2018, ICER has published six assessments of cancer-related services (16). These reports are critically discussed in stakeholder meetings that include patients, providers, payer organizations, and pharmaceutical industry and are intended to build the basis for value-based pricing and reimbursement decisions by payer organizations. ICER’s assessment reports have been used by payer organizations in price negotiations (17). Price Setting The Drug Pricing Lab at Memorial Sloan Kettering, which developed the DrugAbacus, is among the methodological thought leaders in this field. The DrugAbacus is an interactive web-based tool that allows users to compare the published price of more than 50 cancer medicines to prices based on value, whereby value includes aspects of safety, novelty of the product, rarity of the disease, costs, and population burden (18). Thus far, the DrugAbacus represents an academic model to determine value-based pricing. We are not aware of its use to determine manufacturers’ prices, insurers’ reimbursements, clinicians’ prescribing or patients’ decisions on using a medication. However, as of April 2017, value-based pricing is no longer a theoretical concept in the United States as New York State became the first public payer to move toward implementing limits on prescription drug costs based on their therapeutic value (19). For the first time, public payer price negotiations for high-cost drugs in any therapeutic area are linked to value assessments. Other initiatives launched by larger private payers are outcomes-based risk-sharing agreements (also referred to as value-based contracting), in which payers negotiate the price of new treatments with pharmaceutical industry, accounting for the real-world effectiveness of the treatment. If a treatment does not lead to expected outcomes, the manufacturer is obliged to grant discounts to the payer (20,21). However, critics have raised concerns that risk-sharing agreements do not consider the comparative value of products (as assessed, eg, by ICER) and have no influence on list prices, which are the prices that uninsured patients pay and that are the basis for patients’ co-insurance (20). Further, experiences from other countries show that high administration costs can outweigh financial gains from outcome-based risk-sharing contracts (22). Examples in oncology include an agreement between Genentech and Priority Health for Avastin (bevacizumab) in the treatment of patients with non–small cell lung cancer, in which Genentech agreed to pay discounts if progression-free survival in individual patients is not achieved (23); another example is Novartis’ and the Centers for Medicare and Medicaid Services’ (CMS’) approach for Kymriah, the new chimeric antigen receptor T-cell therapy—that pediatric and young adult patients whose cancers do not respond within the first month of treatment will not be charged for the therapy (24,25). Benefit Design Payers’ are implementing value-based insurance designs (V-BID), which structure patient cost-sharing into tiers according to the likely value of a medication. In cancer care, several plans incentivize the use of generic equivalents by placing them in tier 1 category with lowest cost-sharing (26), imatinib being one example (27). However, Dr. Fendrick from the University of Michigan pointed out that “benefits should not be static because clinical medicine, and particularly cancer care, changes over time” and therefore suggested a dynamic benefit design that rewards patients who are diligent about following the protocols with a lower cost-share for the expensive agent when that treatment becomes necessary (28). In addition, plans are offering closed formularies including only drugs that showed clinical effectiveness and are affordable (29). In 2017, Massachusetts filed a waiver with the CMS to exclude drugs with “limited or inadequate evidence of clinical efficacy,” including many new expensive cancer drugs (30). Effects of real-world implementation of V-BID in cancer care remain to be studied. Health Care Delivery One approach of integrating value into care delivery has been to reform provider payments from fee-for-service to value-based approaches. The Medicare Access and CHIP Reauthorization Act of 2015 (31) set the basis for the American Society of Clinical Oncology’s (ASCO’s) Patient-Centered Oncology Payment model, in which payments for oncology care are bundled. The other approach has been to put emphasis on person-centered care. An example is ASCO’s COME HOME program, a patient-centered medical home that integrates oncology care with symptom management, which resulted in a reduction of emergency room visits by 11.7%, hospital admissions by 6.7%, and 30-day hospital readmissions by 12.5% while achieving 98.1% patient satisfaction (32). The most recent care delivery model combines payment reforms and patient-centered care: the Oncology Care Model, which was introduced in 2016 by the CMS with 195 participating practices and 17 payer organizations (33). The Oncology Care Model reimburses practices monthly for meeting cost savings and value-based practice milestones (eg, the implementation of a 13-component care plan outlined in a 2013 Institute of Medicine report [34]) and provides additional reimbursement every six months based on quality measures and on the extent to which practices save money beyond expectations. It is too early to say how this new payment and care delivery model will impact quality, effectiveness, and costs of care. Independent experts are currently assessing its impact. Value-Based Treatment Decision Numerous initiatives by private companies, payers, and professional organizations seek to develop aids for value-based patient-provider decision-making. We describe three nationally relevant initiatives: ASCO developed a conceptual framework for comparison of treatments based on survival, toxicity, and cost data (35,36). The National Comprehensive Cancer Network (NCCN) Evidence Block is based on the NCCN guidelines (37) and includes a ranking of treatments based on efficacy, safety, evidence strength, and total treatment costs. While both initiatives target patient-provider treatment decision-making, neither takes aspects of patient-centered care (such as patient preferences or other goals of care) or actual costs to patients into account (38). The third initiative, the Patient Perspective Value Framework (PPVF), developed by FasterCures and Avalere Health, took a more patient-centered approach by developing metrics that reflect patient preferences and patient-centered outcomes. The PPVF can be applied to all disease areas. While the ASCO framework and the PPVF are still conceptual, the NCCN Evidence Block is available for 46 cancer types (as of January 2018). Suitability for real-world use and acceptance by clinicians and patients is not known for any of the three approaches. In summary, experts from diverse organizations have invested substantial effort into developing methods to assess value of therapeutics along the continuum from regulation to policy to care delivery. To varying degrees, value assessment has now been formally adopted at all levels except in the domain of regulation. However, there has been a lack of clarity regarding how and when existing frameworks should be applied and which framework should be used, and there is little information on real-world use with respect to price setting, benefit design, and treatment decisions. While the public debate calls for measures to identify treatments that offer higher value, it is unclear to what extent the cancer community, including policy makers, payer organizations, clinicians, and patients, is ready to use value measures. Moving Forward To move toward real-world implementation, we propose the following research agenda: to use this system framework to assess the perspectives of different stakeholders on the definition of value, proposed tools, and their experience with use; to develop transparent data sources with real-world comparative effectiveness data and actual drug price data that, to the extent possible, include information on contracts for value-based pricing and information at the point of care of actual patient out-of-pocket co-payment liabilities, which depend on a patient’s insurance plan and whether or not an insured patient has met a deductible at that time; to evaluate the process and outcomes of integrating value measures in routine treatment decisions before scaling this approach; and to develop training programs for care teams (nurses, social workers, and providers) and patients and their families to wisely use comparative effectiveness and cost data in treatment decisions. In conclusion, current initiatives have moved the conversation on value forward but have yet to be fully integrated into the health system for oncology care. Value is an important concept. We need to develop a consensus on the components of value among major stakeholders, including patients, providers, and payers, and clarify the role of value assessment at each step in the process from regulatory drug approval to bedside decision-making. Funding This project was supported by a research development fund of the Department of Population Medicine as well as by an Erwin Schroedinger stipend to Dr. Leopold of the Austrian Science Fund (FWF, project number J3684). Notes Affiliations of authors: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA (CL, AKW); Massachusetts General Hospital Cancer Center, Boston, MA (JMP); Duke Cancer Institute, Margolis Center for Health Policy, Durham, NC (SYZ). Disclosures: Christine Leopold: Sanofi (Honoraria received) Jeffrey M. Peppercorn: GlaxoSmithKline (Employment [spouse]); Genentech (Consulting/advisory relationship); Novartis (Research Fund); Ownership Interest: GlaxoSmithKline (Ownership interest [spouse]); S. Yousuf Zafar: Genentech (Honoraria received); HealthWell Foundation (Research Fund). The other authors indicated no financial relationships. The funders had no role in the writing of the Commentary or decision to submit it for publication. References 1 Porter ME. What is value in health care? N Engl J Med . 2010 ; 363 26 : 2477 – 2481 . 2 Peppercorn J. Financial toxicity and societal costs of cancer care: Distinct problems require distinct solutions . Oncologist . 2017 ; 22 2 : 123 – 125 . 3 Zafar SY , Peppercorn JM , Schrag D et al. , . The financial toxicity of cancer treatment: A pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience . The Oncologist. 2013 ; 18 4 : 381 – 390 . 4 Chandra A , Shafrin J , Dhawan R. Utility of cancer value frameworks for patients, payers, and physicians . JAMA. 2016 ; 315 19 : 2069 – 2070 . 5 Scheurer D , Crabtree E , Cawley PJ , Lee TH. The value equation: Enhancing patient outcomes while constraining costs . Am J Med Sci. 2016 ; 351 1 : 44 – 51 . 6 Neumann PJ , Cohen JT. Measuring the value of prescription drugs . N Engl J Med. 2015 ; 373 27 : 2595 – 2597 . 7 Makady A , Ham RT , de Boer A , Hillege H , Klungel O , Goettsch W. Policies for use of real-world data in health technology assessment (HTA): A comparative study of six HTA agencies . Value Health. 2017 ; 20 4 : 520 – 532 . 8 Basch E. Toward a patient-centered value framework in oncology . JAMA. 2016 ; 315 19 : 2073 – 2074 . 9 US Value Assessment Frameworks Initiative . International Society for Pharmacoeconomics and Outcomes Research (ISPOR). https://www.ispor.org/ValueAssessmentFrameworks/Index. Accessed July 21, 2017. 10 Gellad WF , Kesselheim AS. Accelerated approval and expensive drugs — a challenging combination . N Engl J Med. 2017 ; 376 21 : 2001 – 2004 . 11 Gee AW , Balogh E , Patlak M , Nass SJ. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: National Academies of Sciences, Engineering, and Medicine; 2017 . http://nap.edu/24742. Accessed July 20, 2017. 12 Fojo T , Mailankody S , Lo A. Unintended consequences of expensive cancer therapeutics—the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: The John Conley Lecture . JAMA Otolaryngol Neck Surg. 2014 ; 140 12 : 1225 . 13 Neumann PJ , Sanders GD. Cost-effectiveness analysis 2.0 . N Engl J Med. 2017 ; 376 3 : 203 – 205 . 14 ICER . Final value assessment framework for 2017-2019. https://icer-review.org/final-vaf-2017-2019/. Accessed October 27, 2017. 15 Conti RM , Lakdawalla DN. Putting more value into biopharmaceutical value assessments . Health Aff Blog . January 2018 . https://www.healthaffairs.org/action/showDoPubSecure?doi=10.1377%2Fhblog20171227.196339&format=full&. Accessed January 10, 2018. 16 ICER . ICER final report: Poly ADP-ribose polymerase (PARP) inhibitors for ovarian cancer. 2017 . https://icer-review.org/wp-content/uploads/2017/02/MWCEPAC_OVARIAN_FINAL_EVIDENCE_REPORT_10112017.pdf. Accessed January 6, 2018. 17 Good CB , Emmendorfer T , Valentino M. VA responds to concerns about collaboration with ICER . Health Aff Blog . October 2017 . http://www.healthaffairs.org/do/10.1377/hblog20171024.745943/full/. Accessed January 6, 2018. 18 DrugAbacus . Drug Pricing Lab, Memorial Sloan Kettering. http://www.drugabacus.org/. Accessed July 22, 2017. 19 Hwang TJ , Kesselheim AS , Sarpatwari A. Value-based pricing and state reform of prescription drug costs . JAMA. 2017 ; 318 7 : 609 – 610 . 20 Kaltenboeck A , Bach PB. Outcomes-based drug contracts do not move us closer to value. Morning consult. https://morningconsult.com/opinions/outcomes-based-drug-contracts-not-move-us-closer-value/. Accessed July 25, 2017. 21 Seeley E , Kesselheim AS. Outcomes-based pharmaceutical contracts: An answer to high U.S. drug spending? September 27, 2017 . http://www.commonwealthfund.org/publications/issue-briefs/2017/sep/outcomes-based-contracts-high-drug-spending. Accessed October 27, 2017. 22 Ferrario A , Kanavos P. Dealing with uncertainty and high prices of new medicines: A comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden . Soc Sci Med. 2015 ; 124 : 39 – 47 . 23 Fox J , Watrous M. Overcoming challenges of outcomes-based contracting for pharmaceuticals: Early lessons from the Genentech—Priority Health Pilot . Health Aff Blog . April 2017. https://www.healthaffairs.org/do/10.1377/hblog20170403.059442/full/. Accessed January 10, 2018 . 24 Centers for Medicare & Medicaid Services . CMS: Innovative treatments call for innovative payment models and arrangements. Press releases. August 30, 2017 . https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-08-30-2.html. Accessed January 24, 2018. 25 Dentzer S , Hubbard T. Value-Based Contracting for Oncology Drugs: A NEHI White Paper. Boston, MA: Network for Excellence in Health Innovation; 2017 . https://www.nehi.net/writable/publication_files/file/nehi_vbconcology_final.pdf. Accessed January 24, 2018. 26 de Souza JA , Ratain MJ , Fendrick AM. Value-based insurance design: Aligning incentives, benefits, and evidence in oncology . J Natl Compr Cancer Netw. 2012 ; 10 1 : 18 – 23 . 27 UnitedHealthcare . Drug coverage guidelines. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/oxford/drug_coverage_guidelines.pdf. Accessed January 25, 2018. 28 Fendrick AM. The impact of value-based insurance design on oncology drugs . Clin Adv Hematol Oncol. 2016 ; 14 1 : 14 – 16 . 29 Harvard Pilgrim Health Care . Changes to premium formulary for 2018 . https://www.harvardpilgrim.org/portal/page?_pageid=253,11536203&_dad=portal&_schema=PORTAL. Accessed January 30, 2018. 30 Sachs R. Drug policy: The year in review, and the year ahead. Health Aff Blog. January 2018 . https://www.healthaffairs.org/do/10.1377/hblog20180103.276023/full/. Accessed January 20, 2018. 31 Burgess M. Text - H.R.2 - 114th Congress (2015-2016): Medicare Access and CHIP Reauthorization Act of 2015. 2015 . https://www.congress.gov/bill/114th-congress/house-bill/2/text. Accessed July 26, 2017. 32 ASCO launches COME HOME Initiative to give oncology practices concrete path toward alternative payment system. The ASCO Post. November 3, 2016 . asco.org/advocacy-policy/asco-in-action/asco-launches-come-home-initiative-give-oncology-practices-concrete. Accessed July 20, 2017. 33 Centers for Medicare and Medicaid Services. Innovation Center - oncology care model. July 2016 . https://innovation.cms.gov/initiatives/oncology-care/. Accessed July 19, 2016. 34 Levit L , Balogh E , Nass S , Ganz PA et al. , . Delivering high-quality cancer care: Charting a new course for a system in crisis. 2013 . http://www.commed.vcu.edu/Chronic_Disease/Cancers/2014/CancerCare2013_IOM.pdf. Accessed April 19, 2016. 35 Schnipper LE. American Society of Clinical Oncology. Value in Cancer Care. ASCO Value Framework. https://www.asco.org/practice-guidelines/cancer-care-initiatives/value-cancer-care. Accessed January 6, 2018. 36 Schnipper LE , Schilsky RL. Are value frameworks missing the mark when considering long-term benefits from immuno-oncology drugs? JAMA Oncol. 2018 ; 4 3 : 333 – 334 . 37 National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with NCCN Evidence BlocksTM. NCCN Guidelines & Clinical Resources. 2016 . http://www.nccn.org/evidenceblocks/. Accessed January 6, 2016. 38 Tseng EK , Hicks LK. Value based care and patient-centered care: Divergent or complementary? Curr Hematol Malig Rep. 2016 ; 11 4 : 303 – 310 . © The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JNCI: Journal of the National Cancer Institute Oxford University Press

Defining Value of Cancer Therapeutics—A Health System Perspective

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Abstract

Abstract Because of the rising costs of cancer care and ongoing challenges in ensuring access to quality care, there is an increasing need to prioritize spending and define the benefits of therapy in proportion to costs. The term “value” has gained favor as means to define the relative utility of a medical intervention in terms of benefits, risks, and financial costs, which in turn can help clinicians, patients, and policy makers prioritize “high-value” care. While numerous value concepts have been proposed, a comprehensive discussion of value initiatives along the care continuum is missing. In this Commentary, we propose a health system taxonomy of value initiatives in cancer care to discuss what the field needs to progress. Over the last decade, we have witnessed a shift in focus of the US health system discourse from an initial paradigm of improving outcomes to a growing emphasis on cost containment and most recently to a focus on “value”—defined most succinctly as health care outcomes per dollar spent (1). This evolution is driven by the urgent need to ensure that care is beneficial, accessible, and sustainable in times of rising societal health care spending, uncertain access to care in many settings, and substantial financial burdens for patients (2,3). The concept of value promises to capture both the clinical importance of patient care and the relative costs of that care in proportion to its benefits (4–6). However, it is far from clear, especially in cancer care, that patients, providers, payers, and other stakeholders have a common understanding of value and are ready to base clinical and policy decisions on this metric. While in other high-income countries national payer organizations or other governmental agencies (such as health technology assessment organizations) (7) are coordinating assessment and utilization of cancer care interventions, value concepts have developed organically in the fragmented US health care system. State, professional, academic, and industry groups have proposed differing definitions of value and plans for operationalizing this concept. The approaches share common elements but differ in important aspects ranging from clinical outcomes considered, definitions of costs, sources of data, and intended uses and audiences (4,6,8). The resulting confusion and lack of consensus threaten to undermine the important impetus for this work: to promote equitable access to high-quality cancer care at costs that are sustainably affordable to individual patients and society. Taking a Health System Perspective We believe it is important to consider these initiatives from a health system perspective, considering the steps in development, deployment, and coverage for interventions where value assessment can inform decision-making. This analysis is intended to highlight the role of available frameworks, where they do or do not apply, and to identify gaps or contradictions in the field that must be addressed. To show a path out of the current thicket, we assess value initiatives from a health system perspective to identify what exists and what is missing for value assessments to support a health system that provides high-value cancer care. Several steps in the development and utilization of cancer care interventions where a value assessment might be applied can be considered; these include 1) regulation: initial evaluation and consideration for approval by regulatory agencies; 2) reimbursement pricing, which includes 2a) health technology assessment: estimation of the value (often expressed in financial thresholds) of new interventions by comparing health benefits and costs to existing interventions and 2b) price setting: agreeing on a reimbursement price of a drug or a service by weighing health and other outcomes and costs; 3) benefit design: tiering of patient cost-sharing depending on the value of the treatment; 4) point of care, which includes 4a) care delivery: restructuring of provider payments by taking patient-centered care into account and 4b) treatment decisions: shared decision-making based on comparing health outcomes and costs of different treatments with patient preferences. Along this health system continuum from regulating to evaluating, pricing, prescribing, reimbursing, and taking cancer treatments, we have developed a taxonomy of national value initiatives that are likely to shape the policy and treatment landscape in cancer care. Previous discussions of value frameworks have focused on parts of the continuum (health technology assessment and shared decision-making) (4,6,9). Our taxonomy classifies the leading initiatives by proposed target audiences, content, and real-world use in cancer care and where in the health system continuum they would be applied (and “have value”) (Figure 1, Table 1). Table 1. Sources for the health system’s taxonomy of value initiatives along the cancer care continuum* Initiative Organization Source 2nd Panel on Cost-Effectiveness in Health and Medicine A consortium of experts https://healthpolicy.duke.edu/2ndpanelcea ASCO PCOP American Society for Clinical Oncology Patient-Centered Oncology Payment https://am.asco.org/asco-patient-centered-oncology-payment-program ASCO value framework American Society for Clinical Oncology http://www.asco.org/practice-guidelines/cancer-care-initiatives/value-cancer-care DrugAbacus Drug Pricing Lab, Memorial Sloan Kettering https://drugpricinglab.org/ ICER Institute for Clinical and Economic Review https://icer-review.org/final-vaf-2017-2019/ ISPOR International Society for Pharmacoeconomics and Outcomes Research https://www.ispor.org/ValueAssessmentFrameworks/Index NCCN Evidence Block National Comprehensive Cancer Network https://www.nccn.org/evidenceblocks/ Oncology Care Model Center for Medicare and Medicaid Innovation https://innovation.cms.gov/initiatives/oncology-care/ PP value framework Faster Cures http://www.fastercures.org/programs/patients-count/patient-perspective-value-framework/ V-BID Institute for Healthcare Policy and Innovation, University of Michigan http://ihpi.umich.edu/initiatives/value-based-insurance-design Initiative Organization Source 2nd Panel on Cost-Effectiveness in Health and Medicine A consortium of experts https://healthpolicy.duke.edu/2ndpanelcea ASCO PCOP American Society for Clinical Oncology Patient-Centered Oncology Payment https://am.asco.org/asco-patient-centered-oncology-payment-program ASCO value framework American Society for Clinical Oncology http://www.asco.org/practice-guidelines/cancer-care-initiatives/value-cancer-care DrugAbacus Drug Pricing Lab, Memorial Sloan Kettering https://drugpricinglab.org/ ICER Institute for Clinical and Economic Review https://icer-review.org/final-vaf-2017-2019/ ISPOR International Society for Pharmacoeconomics and Outcomes Research https://www.ispor.org/ValueAssessmentFrameworks/Index NCCN Evidence Block National Comprehensive Cancer Network https://www.nccn.org/evidenceblocks/ Oncology Care Model Center for Medicare and Medicaid Innovation https://innovation.cms.gov/initiatives/oncology-care/ PP value framework Faster Cures http://www.fastercures.org/programs/patients-count/patient-perspective-value-framework/ V-BID Institute for Healthcare Policy and Innovation, University of Michigan http://ihpi.umich.edu/initiatives/value-based-insurance-design * ASCO = American Society for Clinical Oncology; ICER = Institute for Clinical and Economic Review; ISPOR = International Society for Pharmacoeconomics and Outcomes Research; NCCN = National Comprehensive Cancer Network; PP = patient preference; PCOP = Patient-Centered Oncology Payment; V-BID = value-based insurance design. Table 1. Sources for the health system’s taxonomy of value initiatives along the cancer care continuum* Initiative Organization Source 2nd Panel on Cost-Effectiveness in Health and Medicine A consortium of experts https://healthpolicy.duke.edu/2ndpanelcea ASCO PCOP American Society for Clinical Oncology Patient-Centered Oncology Payment https://am.asco.org/asco-patient-centered-oncology-payment-program ASCO value framework American Society for Clinical Oncology http://www.asco.org/practice-guidelines/cancer-care-initiatives/value-cancer-care DrugAbacus Drug Pricing Lab, Memorial Sloan Kettering https://drugpricinglab.org/ ICER Institute for Clinical and Economic Review https://icer-review.org/final-vaf-2017-2019/ ISPOR International Society for Pharmacoeconomics and Outcomes Research https://www.ispor.org/ValueAssessmentFrameworks/Index NCCN Evidence Block National Comprehensive Cancer Network https://www.nccn.org/evidenceblocks/ Oncology Care Model Center for Medicare and Medicaid Innovation https://innovation.cms.gov/initiatives/oncology-care/ PP value framework Faster Cures http://www.fastercures.org/programs/patients-count/patient-perspective-value-framework/ V-BID Institute for Healthcare Policy and Innovation, University of Michigan http://ihpi.umich.edu/initiatives/value-based-insurance-design Initiative Organization Source 2nd Panel on Cost-Effectiveness in Health and Medicine A consortium of experts https://healthpolicy.duke.edu/2ndpanelcea ASCO PCOP American Society for Clinical Oncology Patient-Centered Oncology Payment https://am.asco.org/asco-patient-centered-oncology-payment-program ASCO value framework American Society for Clinical Oncology http://www.asco.org/practice-guidelines/cancer-care-initiatives/value-cancer-care DrugAbacus Drug Pricing Lab, Memorial Sloan Kettering https://drugpricinglab.org/ ICER Institute for Clinical and Economic Review https://icer-review.org/final-vaf-2017-2019/ ISPOR International Society for Pharmacoeconomics and Outcomes Research https://www.ispor.org/ValueAssessmentFrameworks/Index NCCN Evidence Block National Comprehensive Cancer Network https://www.nccn.org/evidenceblocks/ Oncology Care Model Center for Medicare and Medicaid Innovation https://innovation.cms.gov/initiatives/oncology-care/ PP value framework Faster Cures http://www.fastercures.org/programs/patients-count/patient-perspective-value-framework/ V-BID Institute for Healthcare Policy and Innovation, University of Michigan http://ihpi.umich.edu/initiatives/value-based-insurance-design * ASCO = American Society for Clinical Oncology; ICER = Institute for Clinical and Economic Review; ISPOR = International Society for Pharmacoeconomics and Outcomes Research; NCCN = National Comprehensive Cancer Network; PP = patient preference; PCOP = Patient-Centered Oncology Payment; V-BID = value-based insurance design. Figure 1. View largeDownload slide A health system’s taxonomy of value initiatives along the cancer care continuum. ASCO = American Society for Clinical Oncology; CE = cost-effectiveness; CEA = cost-effectiveness analysis; CMS = Centers for Medicare and Medicaid Services; CS = cost-sharing; HTA = Health Technology Assessment; ICER = Institute for Clinical and Economic Review; ISPOR = International Society for Pharmacoeconomics and Outcomes Research; NCCN = National Comprehensive Cancer Network; PP = patient preference; PCOP = Patient-Centered Oncology Payment; QALY = quality-adjusted life year; V-BID = value-based insurance design. Figure 1. View largeDownload slide A health system’s taxonomy of value initiatives along the cancer care continuum. ASCO = American Society for Clinical Oncology; CE = cost-effectiveness; CEA = cost-effectiveness analysis; CMS = Centers for Medicare and Medicaid Services; CS = cost-sharing; HTA = Health Technology Assessment; ICER = Institute for Clinical and Economic Review; ISPOR = International Society for Pharmacoeconomics and Outcomes Research; NCCN = National Comprehensive Cancer Network; PP = patient preference; PCOP = Patient-Centered Oncology Payment; QALY = quality-adjusted life year; V-BID = value-based insurance design. Regulation The Food and Drug Administration’s mandate does not include the consideration of value, as emphasis is solely on efficacy and safety. In fact, the current trend in oncology of granting accelerated approval for many cancer treatments based on marginal average benefits (as measured by overall survival or progression-free survival) and uncertain effectiveness in a broader population seems to indicate that long-term value is not prioritized at this level (10–12). Health Technology Assessment Three groups are leading the development of assessment methods in the United States: the 2nd Panel on Cost-Effectiveness (CE) Analysis in Health and Medicine (13), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) (9), and the Institute for Clinical and Economic Review (ICER) (14). The methods developed by these groups are designed for application in all disease areas (including oncology) and target policy makers, payer organizations, and industry. While each initiative has generated its own set of value measures, all acknowledge the need to distinguish between measures from the perspectives of the broader health system and society and measures of aspects of care that go beyond health. The latter include ability to return to work or the value of hope or ethical, legal, or societal priorities that are important but difficult to quantify (15). ISPOR’s framework closed the public review of its proposed methodology in August 2017, and the 2nd Panel on CE published its methodology earlier in 2017. Suitability to real-world use of either method in cancer care is unknown. ICER’s methodology has been used for several years with a recent update to its methodology accounting for long-term value for money and short-term affordability and a current public discussion on an adjusted methodology for ultra-orphan drugs (14). As of January 2018, ICER has published six assessments of cancer-related services (16). These reports are critically discussed in stakeholder meetings that include patients, providers, payer organizations, and pharmaceutical industry and are intended to build the basis for value-based pricing and reimbursement decisions by payer organizations. ICER’s assessment reports have been used by payer organizations in price negotiations (17). Price Setting The Drug Pricing Lab at Memorial Sloan Kettering, which developed the DrugAbacus, is among the methodological thought leaders in this field. The DrugAbacus is an interactive web-based tool that allows users to compare the published price of more than 50 cancer medicines to prices based on value, whereby value includes aspects of safety, novelty of the product, rarity of the disease, costs, and population burden (18). Thus far, the DrugAbacus represents an academic model to determine value-based pricing. We are not aware of its use to determine manufacturers’ prices, insurers’ reimbursements, clinicians’ prescribing or patients’ decisions on using a medication. However, as of April 2017, value-based pricing is no longer a theoretical concept in the United States as New York State became the first public payer to move toward implementing limits on prescription drug costs based on their therapeutic value (19). For the first time, public payer price negotiations for high-cost drugs in any therapeutic area are linked to value assessments. Other initiatives launched by larger private payers are outcomes-based risk-sharing agreements (also referred to as value-based contracting), in which payers negotiate the price of new treatments with pharmaceutical industry, accounting for the real-world effectiveness of the treatment. If a treatment does not lead to expected outcomes, the manufacturer is obliged to grant discounts to the payer (20,21). However, critics have raised concerns that risk-sharing agreements do not consider the comparative value of products (as assessed, eg, by ICER) and have no influence on list prices, which are the prices that uninsured patients pay and that are the basis for patients’ co-insurance (20). Further, experiences from other countries show that high administration costs can outweigh financial gains from outcome-based risk-sharing contracts (22). Examples in oncology include an agreement between Genentech and Priority Health for Avastin (bevacizumab) in the treatment of patients with non–small cell lung cancer, in which Genentech agreed to pay discounts if progression-free survival in individual patients is not achieved (23); another example is Novartis’ and the Centers for Medicare and Medicaid Services’ (CMS’) approach for Kymriah, the new chimeric antigen receptor T-cell therapy—that pediatric and young adult patients whose cancers do not respond within the first month of treatment will not be charged for the therapy (24,25). Benefit Design Payers’ are implementing value-based insurance designs (V-BID), which structure patient cost-sharing into tiers according to the likely value of a medication. In cancer care, several plans incentivize the use of generic equivalents by placing them in tier 1 category with lowest cost-sharing (26), imatinib being one example (27). However, Dr. Fendrick from the University of Michigan pointed out that “benefits should not be static because clinical medicine, and particularly cancer care, changes over time” and therefore suggested a dynamic benefit design that rewards patients who are diligent about following the protocols with a lower cost-share for the expensive agent when that treatment becomes necessary (28). In addition, plans are offering closed formularies including only drugs that showed clinical effectiveness and are affordable (29). In 2017, Massachusetts filed a waiver with the CMS to exclude drugs with “limited or inadequate evidence of clinical efficacy,” including many new expensive cancer drugs (30). Effects of real-world implementation of V-BID in cancer care remain to be studied. Health Care Delivery One approach of integrating value into care delivery has been to reform provider payments from fee-for-service to value-based approaches. The Medicare Access and CHIP Reauthorization Act of 2015 (31) set the basis for the American Society of Clinical Oncology’s (ASCO’s) Patient-Centered Oncology Payment model, in which payments for oncology care are bundled. The other approach has been to put emphasis on person-centered care. An example is ASCO’s COME HOME program, a patient-centered medical home that integrates oncology care with symptom management, which resulted in a reduction of emergency room visits by 11.7%, hospital admissions by 6.7%, and 30-day hospital readmissions by 12.5% while achieving 98.1% patient satisfaction (32). The most recent care delivery model combines payment reforms and patient-centered care: the Oncology Care Model, which was introduced in 2016 by the CMS with 195 participating practices and 17 payer organizations (33). The Oncology Care Model reimburses practices monthly for meeting cost savings and value-based practice milestones (eg, the implementation of a 13-component care plan outlined in a 2013 Institute of Medicine report [34]) and provides additional reimbursement every six months based on quality measures and on the extent to which practices save money beyond expectations. It is too early to say how this new payment and care delivery model will impact quality, effectiveness, and costs of care. Independent experts are currently assessing its impact. Value-Based Treatment Decision Numerous initiatives by private companies, payers, and professional organizations seek to develop aids for value-based patient-provider decision-making. We describe three nationally relevant initiatives: ASCO developed a conceptual framework for comparison of treatments based on survival, toxicity, and cost data (35,36). The National Comprehensive Cancer Network (NCCN) Evidence Block is based on the NCCN guidelines (37) and includes a ranking of treatments based on efficacy, safety, evidence strength, and total treatment costs. While both initiatives target patient-provider treatment decision-making, neither takes aspects of patient-centered care (such as patient preferences or other goals of care) or actual costs to patients into account (38). The third initiative, the Patient Perspective Value Framework (PPVF), developed by FasterCures and Avalere Health, took a more patient-centered approach by developing metrics that reflect patient preferences and patient-centered outcomes. The PPVF can be applied to all disease areas. While the ASCO framework and the PPVF are still conceptual, the NCCN Evidence Block is available for 46 cancer types (as of January 2018). Suitability for real-world use and acceptance by clinicians and patients is not known for any of the three approaches. In summary, experts from diverse organizations have invested substantial effort into developing methods to assess value of therapeutics along the continuum from regulation to policy to care delivery. To varying degrees, value assessment has now been formally adopted at all levels except in the domain of regulation. However, there has been a lack of clarity regarding how and when existing frameworks should be applied and which framework should be used, and there is little information on real-world use with respect to price setting, benefit design, and treatment decisions. While the public debate calls for measures to identify treatments that offer higher value, it is unclear to what extent the cancer community, including policy makers, payer organizations, clinicians, and patients, is ready to use value measures. Moving Forward To move toward real-world implementation, we propose the following research agenda: to use this system framework to assess the perspectives of different stakeholders on the definition of value, proposed tools, and their experience with use; to develop transparent data sources with real-world comparative effectiveness data and actual drug price data that, to the extent possible, include information on contracts for value-based pricing and information at the point of care of actual patient out-of-pocket co-payment liabilities, which depend on a patient’s insurance plan and whether or not an insured patient has met a deductible at that time; to evaluate the process and outcomes of integrating value measures in routine treatment decisions before scaling this approach; and to develop training programs for care teams (nurses, social workers, and providers) and patients and their families to wisely use comparative effectiveness and cost data in treatment decisions. In conclusion, current initiatives have moved the conversation on value forward but have yet to be fully integrated into the health system for oncology care. Value is an important concept. We need to develop a consensus on the components of value among major stakeholders, including patients, providers, and payers, and clarify the role of value assessment at each step in the process from regulatory drug approval to bedside decision-making. Funding This project was supported by a research development fund of the Department of Population Medicine as well as by an Erwin Schroedinger stipend to Dr. Leopold of the Austrian Science Fund (FWF, project number J3684). Notes Affiliations of authors: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA (CL, AKW); Massachusetts General Hospital Cancer Center, Boston, MA (JMP); Duke Cancer Institute, Margolis Center for Health Policy, Durham, NC (SYZ). Disclosures: Christine Leopold: Sanofi (Honoraria received) Jeffrey M. Peppercorn: GlaxoSmithKline (Employment [spouse]); Genentech (Consulting/advisory relationship); Novartis (Research Fund); Ownership Interest: GlaxoSmithKline (Ownership interest [spouse]); S. Yousuf Zafar: Genentech (Honoraria received); HealthWell Foundation (Research Fund). The other authors indicated no financial relationships. The funders had no role in the writing of the Commentary or decision to submit it for publication. References 1 Porter ME. What is value in health care? N Engl J Med . 2010 ; 363 26 : 2477 – 2481 . 2 Peppercorn J. Financial toxicity and societal costs of cancer care: Distinct problems require distinct solutions . Oncologist . 2017 ; 22 2 : 123 – 125 . 3 Zafar SY , Peppercorn JM , Schrag D et al. , . The financial toxicity of cancer treatment: A pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience . 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Accessed July 20, 2017. 33 Centers for Medicare and Medicaid Services. Innovation Center - oncology care model. July 2016 . https://innovation.cms.gov/initiatives/oncology-care/. Accessed July 19, 2016. 34 Levit L , Balogh E , Nass S , Ganz PA et al. , . Delivering high-quality cancer care: Charting a new course for a system in crisis. 2013 . http://www.commed.vcu.edu/Chronic_Disease/Cancers/2014/CancerCare2013_IOM.pdf. Accessed April 19, 2016. 35 Schnipper LE. American Society of Clinical Oncology. Value in Cancer Care. ASCO Value Framework. https://www.asco.org/practice-guidelines/cancer-care-initiatives/value-cancer-care. Accessed January 6, 2018. 36 Schnipper LE , Schilsky RL. Are value frameworks missing the mark when considering long-term benefits from immuno-oncology drugs? JAMA Oncol. 2018 ; 4 3 : 333 – 334 . 37 National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with NCCN Evidence BlocksTM. NCCN Guidelines & Clinical Resources. 2016 . http://www.nccn.org/evidenceblocks/. Accessed January 6, 2016. 38 Tseng EK , Hicks LK. Value based care and patient-centered care: Divergent or complementary? Curr Hematol Malig Rep. 2016 ; 11 4 : 303 – 310 . © The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

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JNCI: Journal of the National Cancer InstituteOxford University Press

Published: May 18, 2018

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