Real-World Outcomes and Value of First-Line Therapy for Metastatic Non-Small Cell Lung Cancer†.

Although physicians rely on clinical trial data to guide cancer treatment decisions, patient characteristics and outcomes often differ between real-world and clinical trial populations. We analyzed retrospective clinical data collected from a prior authorization (PA) tool linked with payer claims data to describe outcomes of first-line treatment for metastatic non-small cell lung cancer among 2,108 patients. Duration of therapy was shorter than observed in clinical trials. Healthcare costs and hospitalizations varied substantially by regimen. PA clinical data linked with administrative claims enable head-to-head comparisons of contemporary cancer treatments used in routine clinical practice, which are not available from clinical trials.

Policy Challenges and Opportunities to Address Changing Paradigms in Cancer Care Delivery.

Multiple factors are forcing the healthcare delivery system to change. A movement toward value-based payment models is shifting these systems to team-based integration and coordination of care for better efficiencies and outcomes. Workforce shortages are stressing access and quality of care for patients with cancer and survivors, and their families and caregivers. Innovative therapies are expensive, forcing payers and employers to prioritize resources. Patients are advocating for care models centered on their needs rather than those of providers. In response, payment policies have recently focused on the promotion of alternative payment models that incentivize coordinated, high-quality care with consideration for value and controlling the increasing overall costs associated with cancer and its treatment. Given the multitude of factors confounding cancer care, NCCN convened a multistakeholder working group to examine the challenges and opportunities presented by changing paradigms in cancer care delivery. The group identified key challenges and developed policy recommendations to address 4 high-visibility topics in cancer care delivery. The findings and recommendations were then presented at the NCCN Policy Summit: Policy Challenges and Opportunities to Address Changing Paradigms in Cancer Care Delivery in September 2018, and multistakeholder roundtable panel discussions explored these findings and recommendations along with additional items. This article encapsulates the discussion from the NCCN Working Group meetings and the NCCN Policy Summit, including multistakeholder policy recommendations on delivery issues in cancer care designed to help inform national policies moving forward.

The Affordable Care Act: where are we now? An NCCN roundtable.

The Affordable Care Act (ACA) is a transformational event for health care in the United States, with multiple impacts on health care, the economy, and society. Oncologists and other health care providers are already experiencing many changes-direct and indirect, anticipated and unanticipated. A distinguished and diverse panel assembled at the NCCN 19th Annual Conference to discuss the early phase of implementation of the ACA. The roundtable touched on early successes and stumbling blocks; the impact of the ACA on contemporary oncology practice and the new risk pool facing providers, payers, and patients; and some of the current and future challenges that lie ahead for all.

Roundtable--the changing oncology landscape: evolution or revolution?

Complex challenges face all players in the oncology landscape, from health care policy leaders and third-party payers, to practicing physicians and nurses, to patients and their families. In these unsteady economic times, possible answers proposed by some may represent part of the problem to others. A distinguished panel assembled at the NCCN 18th Annual Conference: Advancing the Standard of Cancer Care to explore the changing oncology landscape. This article is the synopsis of that discussion, with panelists shedding light on such issues as the astronomic cost of medical care, the need for clinicians to think outside the formulary, and the therapeutic decision-making process in the new world of "big data."

Unsupported off-label chemotherapy in metastatic colon cancer.

BACKGROUND: Newer systemic therapies have the potential to decrease morbidity and mortality from metastatic colorectal cancer, yet such therapies are costly and have side effects. Little is known about their non-evidence-based use. METHODS: We conducted a retrospective cohort study using commercial insurance claims from UnitedHealthcare, and identified incident cases of metastatic colon cancer (mCC) from July 2007 through April 2010. We evaluated the use of three regimens with recommendations against their use in the National Comprehensive Cancer Center Network Guidelines, a commonly used standard of care: 1) bevacizumab beyond progression; 2) single agent capecitabine as a salvage therapy after failure on a fluoropyridimidine-containing regimen; 3) panitumumab or cetuximab after progression on a prior epidermal growth factor receptor antibody. We performed sensitivity analyses of key assumptions regarding cohort selection. Costs from a payer perspective were estimated using the average sales price for the entire duration and based on the number of claims. RESULTS: A total of 7642 patients with incident colon cancer were identified, of which 1041 (14%) had mCC. Of those, 139 (13%) potentially received at least one of the three unsupported off-label (UOL) therapies; capecitabine was administered to 121 patients and 49 (40%) likely received it outside of clinical guidelines, at an estimated cost of $718,000 for 218 claims. Thirty-eight patients received panitumumab and six patients (16%) received it after being on cetuximab at least two months, at an estimated cost of $69,500 for 19 claims. Bevacizumab was administered to 884 patients. Of those, 90 (10%) patients received it outside of clinical guidelines, at an estimated costs of $1.34 million for 636 claims. CONCLUSIONS: In a large privately insured mCC cohort, a substantial number of patients potentially received UOL treatment. The economic costs and treatment toxicities of these therapies warrant increased efforts to stem their use in settings lacking sufficient scientific evidence.

The Problem of Cancer Drugs Costs: A Payer Perspective.

Chemotherapy and supportive drugs constitute 70% of a cancer patient's medical costs during active therapy. Payers use several approaches to keep those costs affordable including paying lower margins for "buy and bill" oncologists, prior authorization, pathways, or performance-based compensation. Payers also utilize financial tools such as deductibles, copayments, or coinsurance to shift more of the cost of health care coverage to employees or the insured. The strengths and weaknesses of those approaches are reviewed in this article. Policy changes that address drug protection from competition or negotiation, monopoly status of health care systems, and Food and Drug Administration approval of new medications will affect how effective any payer strategy will be in the future.

An Insurer's Program To Incentivize Generic Oncology Drugs Did Not Alter Treatment Patterns Or Spending On Care.

The high and rising costs of anticancer drugs have received national attention. The prices of brand-name anticancer drugs often dwarf those of established generic drugs with similar efficacy. In 2007-16 UnitedHealthcare sought to encourage the use of several common low-cost generic anticancer drugs by offering providers a voluntary incentivized fee schedule with substantially higher generic drug payments (and profit margins), thereby increasing financial equivalence for providers in the choice between generic and brand-name drugs and regimens. We evaluated how this voluntary payment intervention affected treatment patterns and health care spending among enrollees with breast, lung, or colorectal cancer. We found that the incentivized fee schedule had neither significant nor meaningful effects on the use of incentivized generic drugs or on spending. Practices that adopted the incentivized fee schedule already had higher rates of generic anticancer drug use before switching, which demonstrates selection bias in take-up. Our study provides cautionary evidence of the limitations of voluntary payment reform initiatives in meaningfully affecting health care practice and spending.

Development and Feasibility of Bundled Payments for the Multidisciplinary Treatment of Head and Neck Cancer: A Pilot Program.

PURPOSE: Despite growing interest in bundled payments to reduce the costs of care, this payment method remains largely untested in cancer. This 3-year pilot tested the feasibility of a 1-year bundled payment for the multidisciplinary treatment of head and neck cancers. METHODS: Four prospective treatment-based bundles were developed for patients with selected head and neck cancers. These risk-adjusted bundles covered 1 year of care that began with primary cancer treatment. Manual processes were developed for patient identification, enrollment, billing, and payment. Patients were prospectively identified and enrolled, and bundled payments were made at treatment start. Operational metrics tracked incremental effort for pilot processes and average payment cycle time compared with fee-for-service (FFS) payments. RESULTS: This pilot confirmed the feasibility of a 1-year prospective bundled payment for head and neck cancers. Between November 2014 and October 2016, 88 patients were enrolled successfully with prospective bundled payments. Through September 2017, 94% of patients completed the pilot with 6% still enrolled. Manual pilot processes required more effort than anticipated; claims processing was the most time-consuming activity. The production of a bundle bill took an additional 15 minutes versus FFS billing. The average payment cycle time was 37 days (range, 15 to 141 days) compared with a 15-day average under FFS. CONCLUSION: Prospective bundled payments were successfully implemented in this pilot. Additional pilots should study this payment method in higher-volume cancers. Robust systems are needed to automate patient identification, enrollment, billing, and payment along with policies that reduce administrative burden and allow for the introduction of novel cancer therapies.

Transforming Prior Authorization to Decision Support.

PURPOSE: To evaluate a computer-based prior authorization system that was designed to include and test two new concepts for physician review: (1) the tool would minimize denials by providing real-time decision support with alternative options if the original request was noncompliant, and (2) the tool would collect sufficient information to create a patient registry. METHODS: A new prior authorization tool incorporating real-time decision support was tested with a large national payer. The tool used the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as the content for decision making. Physicians were asked to submit the minimal amount of clinical data necessary to reach a treatment-decision node within the National Comprehensive Cancer Network Guidelines. To minimize denials, all available recommended treatments were displayed for physician consideration and immediate authorization was granted for any compliant selection. RESULTS: During a 1-year pilot in a Florida commercial health plan, 4,272 eligible cases were reviewed with only 42 denials. Chemotherapy drug costs for the prior authorization pilot were compared with a similar time period in the previous year for the state of Florida, as well as for the Southeast region and for the nation, which served as controls. The percentage change between the time periods was -9% in Florida, 10% for the national costs, and 11% for the Southeast region costs. The difference between the regional increase and the Florida decrease represented a savings of $5.3 million dollars for the state of Florida in 1 year. CONCLUSION: There is significant opportunity to reduce the costs of therapy while being compliant with nationally accepted guidelines for cancer chemotherapy.

How Should We Intervene on the Financial Toxicity of Cancer Care? One Shot, Four Perspectives.

The median price of a month of chemotherapy has increased by an order of magnitude during the past 20 years, far exceeding inflation over the same period. Along with rising prices, increases in cost sharing have forced patients to directly shoulder a greater portion of those costs, resulting in undue financial burden and, in some cases, cost-related nonadherence to treatment. What can we do to intervene on treatment-related financial toxicity of patients? No one party can single-handedly solve the problem, and the solution must be multifaceted and creative. A productive discussion of the problem must avoid casting blame and, instead, must look inward for concrete starting points toward improvement in the affordability and value of cancer care. With these points in mind, the authors-representatives from the pharmaceutical industry, insurance providers, oncologists, and patient advocacy-have each been asked to respond with a practical answer to the provocative hypothetical question, "If you could propose one thing, and one thing only, in terms of an action or change by the constituency you represent in this discussion, what would that be?"

The patient-centered medical home in oncology: from concept to reality.

In recent years, the cost of providing quality cancer care has been subject to an epic escalation causing concerns on the verge of a health care crisis. Innovative patient-management models in oncology based on patient-centered medical home (PCMH) principles, coupled with alternative payments to traditional fee for service (FFS), such as bundled and episodes payment are now showing evidence of effectiveness. These efforts have the potential to bend the cost curve while also improving quality of care and patient satisfaction. However, going forward with FFS alternatives, there are several performance-based payment options with an array of financial risks and rewards. Most novel payment options convey a greater financial risk and accountability on the provider. Therefore, the oncology medical home (OMH) can be a way to mitigate some financial risks by sharing savings with the payer through better global care of the patient, proactively preventing complications, emergency department (ED) visits, and hospitalizations. However, much of the medical home infrastructure that is required to reduced total costs of cancer care comes as an added expense to the provider. As best-of-practice quality standards are being elucidated and refined, we are now at a juncture where payers, providers, policymakers, and other stakeholders should work in concert to expand and implement the OMH framework into the variety of oncology practice environments to better equip them to assimilate into the new payment reform configurations of the future.

Myths and realities in cancer care: another point of view.

Cancer care is advancing, and the cancer community is right to celebrate that progress. Simultaneously, however, the cost of cancer therapy is rising along with all medical costs. In a matter of just a few years, the cost of health coverage is projected to reach heights that are simply unsustainable for most American families, overshadowing every other daily expense. Such an overwhelming burden will continue to undermine the progress made in developing new, more effective treatment and care for cancer patients. There cannot be a celebration of discoveries if there is no way to pay for them. It is from that perspective that I react and respond here to the commentary of Dana Goldman and Tomas Philipson, who debunk five myths in cancer care. I concur with the authors' assessment of the value and impact of progress in cancer care. However, I also argue that researchers and policy makers must pay more attention to the impact of cost on patients' adherence and experience and the speed with which new treatment and care are being developed.