We are now in the longest, most dramatic period of cancer care innovation that we have ever seen. In the early days of cancer research, the victories came slowly, painfully, and at a pace that left far too many patients and their families seeking answers that would never come in time.

The initial dramatic victories achieved through the development of combination chemotherapy, increasingly precise radiation therapy, and more effective surgical strategies also came with the realization that even these marvelous technologies could not cure every patient. Over the past decade, however, we have seen the traditional anticancer armamentarium grow in extraordinary ways, with new technologies that were targeted with increased precision against the molecular and protein biology at the core of cancer. With the advent of highly effective therapeutics like the tyrosine kinase inhibitors, monoclonal anticancer antibodies, checkpoint inhibitors, and the rapidly growing myriad of gene-mutant targeted agents, patients’ hopes for more effective treatments and a greater chance for cure (or long-term containment) of their cancer are increasingly realized.

Yet, what is it about this extraordinary period in cancer care innovation that is so disquieting? Inasmuch as the promise of increasingly effective cancer care brings a growing sense of hope, the extraordinary growth of the costs of delivering this care provokes anxiety about whether these therapies can be delivered in a financially sustainable, equitable way. Many, including authors in 

™), have written about the growing level of healthcare expenditures in the United States ($3.3 trillion in 2016)

and the extraordinary costs of new targeted anticancer drugs (as of 2014 the average monthly cost for a new anti-cancer oral agent was $11,325)

. These factors, coupled with the rise in patient-borne costs of cancer care and the resulting “financial toxicity” crisis

, beg the question of how can we restore order, equitability, effective access, and financial sustainability to our care delivery system? 

It is impossible to imagine that any single “magical” fix to the healthcare system can make any of these issues go away. Moreover, the current level of political rhetoric surrounding the question of “fixing” the ills of the healthcare system is more likely to provoke gastrointestinal distress than real, meaningful systemic change. The hope of getting this right lies in the ability of the key healthcare stakeholders to more effectively align patient risk, therapeutic strategy, and reimbursement in a way that more effectively rewards better, more effective care, while ensuring that those healthcare systems/providers who provide appropriate care for high-risk/high-cost patients are not penalized financially for doing so. In their seminal article, “The Strategy That Will Fix Health Care,” Porter and Lee review a series of systemic realignments in care delivery that could help to address the issue of financial sustainability while also allowing for better transparency (and financial rewards) for delivering excellent care.

This clinical/quality/financial realignment is one in which those providing care accept financial risk in the process, but do so in a way that is financially sustainable and provides an effective reward system for doing it well. 

While we understand the right sensibilities in creating a sustainable care delivery, we have not yet created the ideal model for delivering this consistently, at scale, across a nation of more than 325 million individuals. We do, however, have evidence of progress in this pursuit through the development of advanced alternative payment systems (AAPM). The Medicare Access and CHIP Reauthorization Act (MACRA) has helped push physicians and care systems into greater numbers of 2-sided risk—bearing payment models in the hopes of better aligning reimbursement with effective care delivery. While the number of initial AAPM choices for oncologists under MACRA were quite limited, we are beginning to see growing numbers of new, innovative models gaining acceptance by the Physician Focused Payment Model Technical Advisory Committee (PTAC).

What some of the emerging models have in common include rigorous financial risk-grouping of patients around both diagnosis and clinical risk, alignment of financial risks around costs that physicians can actually control, and more meaningful outcome measures than those used in the current Physician Quality Reporting System (PQRS).

, we examine some of the innovators in the cancer care domain.  Kashyap Patel, MD, and his coauthors review the practice transformation at Carolina Blood and Cancer Care Associates, in addressing the issues of adapting to 2-sided risk and expanding patient access. In a paper from the Network for Excellence in Health Innovation, we review the concept of value-based contracting for oncology drugs. A pilot program between Regional Cancer Care Associates and New Jersey’s largest payer that will use COTA clinical risk assessment software will create a template for more effective care delivery using nurse navigators. 

Inasmuch as innovations in care technology promise patients greater hope when faced by a life-threatening cancer, innovation in the care delivery and payment systems may help create new strategies for delivering this care sustainably. Although the idea of a chimeric antigen receptor (CAR) T-cell therapeutic costing more than $400,000 is a new reality, a fundamental realignment of our care and payment system around the patients’ needs can help ground us in ensuring that those patients who need and will benefit from these technologies can receive the best care possible.

Centers for Medicare and Medicaid Services. National Health Expenditure Data. CMS website. 

cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html

. January 8, 2018. Accessed April 9, 2018.

Silverman E. Cancer drug prices are high at launch and stay that way. Stat website. 

statnews.com/pharmalot/2016/05/02/cancer-drug-prices-keep/

Published May 2, 2016. Accessed April 9, 2018.

National Cancer Institute. Financial toxicity and cancer treatment PDQ health professional version. 

cancer.gov/about-cancer/managing-care/track-care-costs/financial-toxicity-hp-pdq

. Published January 30, 2018. Accessed April 9, 2018.

Porter M, Lee T. The strategy that will fix healthcare. 

 hbr.org/2013/10/the-strategy-that-will-fix-health-care. Published October 2013. Accessed April 9, 2018.

Pecora A, Hervey J. Oncology bundled payment program using CNA-guided care. HHS website. Hackensack Meridian Health System and Cota Inc. aspe.hhs.gov/system/files/pdf/255906/OncologyBundledPaymentProgramCNACare.pdf. Submitted March 24, 2017. Accessed November 27, 2017.

Articles

Evidence-Based Oncology

Dr Alvarnas is editor-in-chief and director of Value-Based Analytics at City of Hope, Duarte, California.

From the Editor in Chief: A Game of Risk

ASCO Review Finds Clinical Pathway Programs Adhere to Guidelines

On February 7, 2018, the American Society of Clinical Oncology (ASCO) published

 its review of the leading oncology pathway vendors in the United States in the Journal of Oncology Practice. The report showed that overall, the prominent commercial pathway programs in the United States are aligned with ASCO’s evaluation criteria.

The report examined clinical pathways offered by 6 commercial vendors using the organization’s set of 15 interrelated criteria.

 “ASCO conducted this assessment to provide more complete information about how current pathway programs are developed, implemented, and analyzed by specific pathway vendors. Equipped with this information, the oncology community will be better able to evaluate and use these pathways in practice,” ASCO President Bruce E. Johnson, MD, FACP, FASCO, said in a statement.

Although ASCO’s Task Force on Clinical Pathways found some differences among the oncology clinical pathways and decision support tools that were evaluated, largely due to unique vendor business models and different customers, it also discovered that all vendors met key ASCO criteria for being expert driven, patient focused, up-to-date, and comprehensive. Vendors also offered integrated decision support and provided outcomes-driven results.

However, the ASCO review found that as a group, oncology clinical pathways met fewer aspects of the criteria in terms of having clear and achievable expected outcomes and public reporting of performance metrics. This shows that as pathway programs enter the healthcare delivery system, more information should be provided about the specific cancer type the pathway is intended to cover as well as what indicates on-pathway versus off-pathway treatment. Additionally, the review found that there is a need to ensure that pathway programs offer more in-depth reporting that reflects when the provider has gone off pathway.

ASCO’s task force also evaluated the vendors’ products against the criteria for high-quality clinical pathways based on publicly available information and in collaboration with the vendors. Some vendors actually modified their processes during the review, potentially based on the ASCO criteria or as a result of interactions with task force members.

“We are encouraged to see that, by and large, prominent pathway programs are adhering to ASCO’s criteria for high-quality clinical pathways. We hope our assessment of the pathways landscape will help these programs make further refinements, with the ultimate goal of improving the care of our patients,” said the chair of ASCOs task force, Robin Zon, MD, FACP, FASCO.

1. Daly B, Zon RT, Page RD, et al. Oncology clinical pathways: charting the landscape of pathway providers [published online February 7, 2018]. 

2. ASCO releases criteria for high-quality clinical pathways in oncology. American Society of Clinical Oncology website. asco.org/advocacy-policy/asco-in-action/asco-releases-criteria-high-quality-clinical-pathways-oncolo- gy?et_cid=40009433&et_rid=873267314&linkid=criteria. Published November 16, 2016. Accessed February 13, 2018.

3. ASCO examines the current oncology clinical pathways landscape [press release]. Alexandria, VA: ASCO; February 7, 2018. asco.org/about-asco/press-center/news-releases/asco-examines-current-oncology-clinical-pathways-land- scape. Accessed February 16, 2018.

Roche Acquires Flatiron Health for $1.9 Billion

On February 15, 2018, Roche acquired Flatiron Health, a leader in oncology-focused electronic health decision-making software and data storage. Flatiron, which taps a network of community oncology practices and research centers across the country, possesses tools

that practices need to pursue the value-based care models that Medicare and commercial payers believe are essential to rein in the escalating cost of healthcare as the population ages.

This is especially true in cancer care, and a statement

 on Roche’s acquisition touts Flatiron’s leadership as a data curator as it pursues a personalized healthcare strategy, while vowing that Flatiron will maintain its independence.

“We believe that regulatory grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments,” Daniel O’Day, CEO of Roche Pharmaceuticals, said in the statment.

 “Flatiron Health is best positioned to provide the technology and data analytics infrastructure needed not only for Roche, but for oncology research and development efforts across the entire industry.”

The statement stated that Flatiron “has worked with industry leaders and regulators to develop new standards for how real-world evidence is used in regulatory decisions,” including the creation of novel endpoints. “A key principle of this is to preserve Flatiron’s autonomy and their ability to continue providing their services to all existing and future partners,” O’Day said.

Roche made a similar move in the diabetes sector in 2017 when it acquired mySugr,

 a diabetes app with 1 million users that had earned a loyal following among those who track personal data to manage their condition.

, Flatiron co-founder and CEO Nat Turner discussed the barriers to providing oncology care that the company seeks to dismantle, leading to democratization of care.

“For access, it’s really hard, as a community practice, to attract great clinical trials. You can if you have a local affiliation with a hospital, but if you’re just a small independent practice, access to clinical research can be rough,” Turner said. Flatiron’s technology can also help independent practices stay that way, even in an era of shrinking margins and payer pressure, he said.

While Flatiron helps the smallest players, Roche touts its size as the world’s largest biotech company, with a footprint in oncology, immunology, infectious disease, ophthalmology, diabetes management, diagnostics, and central nervous system disease.

Roche already had a stake in Flatiron, and today, Turner said, “Roche has been a tremendous partner to us over the past 2 years and shares our vision for building a learning healthcare platform in oncology, ultimately designed to improve the lives of cancer patients. This important milestone will allow us to increase our investments in our provider-facing technology and our services platform, as well as our evidence-generation platform, which will remain available to the entire healthcare industry.”

Flatiron expects to keep its current business model in the deal, maintaining the segregation of patient protected health information and provider-facing life science initiatives.

Fargnoli B, Holleran R, Kolodziej M. Why oncologists need technology to succeed in payment models. 

Roche to acquire Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer [press release]. New York, NY: Roche; February 15, 2018. roche.com/media/store/releases/ med-cor-2018-02-15.htm. Accessed February 16, 2018.

Caffrey M. Roche acquires mySugar digital diabetes app. 

 website. june 30, 2017. ajmc.com/newsroom/roche-acquires-mysugr-digital-diabetes-app. Accessed February 16, 2018.

Nat Turner on the main barriers for Flatiron Health in providing care in oncology. 

 website. February 15, 2018. ajmc.com/interviews/nat-turner-on-the-main-barriers-for-flatiron-health-in-provid- ing-care-in-oncology. Accessed February 15, 2018.

ASCO reviews clinical pathways; Flatiron Health acquired

Medical World News: Managed Care Updates

Experts Emphasize the Value of Cancer Care Integration at ACCC Meeting 

Care coordination and integration of multiple care teams are vital to a seamless experience for a patient being treated for cancer. It can help break down silos and allow for a continuum of care, which can, in turn translate into improved outcomes.

At the Association of Community Cancer Centers’ (ACCC) 44th Annual Meeting & Cancer Center Business Summit, March 14-16, 2018, in Washington, DC, panelists discussed the most powerful forces that are reshaping cancer care to be more multidisciplinary.

Thomas Asfeldt, MBA, RN, director, Outpatient Cancer Services, Sanford Cancer Center, joined Robin Hearne, RN, MS, director, Cancer Services, The Outer Banks Hospital; Kavita Patel, MD, MS, FACP, nonresident senior fellow, Brookings Institution; and outgoing president of ACCC Mark S. Soberman, MD, MBA, FACS, Monocacy Health Partners, on this panel.

“Cancer care continues to get complex,” Soberman said. He said that cancer care was already at a point where patients and primary care physicians (PCPs) needed help to deliver the care, and “care teams keep getting complicated.” However, he noted that care coordination is typically not reimbursed, neither are psychosocial care or social work services. “How do we develop platforms that can do all this while ensuring that the patient remains at the center?” Soberman asked.

In his opinion, community-based providers need to collaborate among themselves, as well as with health systems, to better coordinate their patient’s care and provide them with options. An important consideration, in Soberman’s opinion, is “How do we assign responsibility for survivorship care? Does it require training the PCPs?”

Asfeldt has helped build Sanford Cancer Center’s cancer program from the ground up. He informed the audience on the struggles, the changes, and the outcomes that he has witnessed along the way. He particularly highlighted their cancer extenders program, which stemmed out of a grant from ACCC and the BMS Foundation.

“We are currently testing the Oncology Care Collaborative Model at 7 sites,” Asfeldt said. “The program was developed from an assessment tool for optimal care coordination. Oncology care includes a team of researchers, radiation oncologists, medical oncologists, pharmacists, nurse practitioners,” along with others. “Therefore, integrating [the services of these providers] is important.”

At Sanford, champions and commitment among team members are important to help ensure care integration, Asfeldt said. The champion does not necessarily need to be a physician, he emphasized—it can be a nurse navigator, a clinical pathologist, a social worker, or a dietitian. “If someone is not a natural champion, you can try to nurture them, because without a champion, such programs cannot fly,” he added.

Providing a contrast perspective for a smaller, more rural practice, Hearne presented a case study of a program to advocate a prospective peer review for radiation oncology treatments, “Which is difficult for rural [health] systems like ours.”

“Our radiation oncologist championed a project for prospective peer review across our region and he brought in experts from the various centers to develop a standard framework for care,” she said. The peer review group emphasized the importance of evidence-based guidelines, and developed metrics to measure the impact of implementing the process over time. “This was then turned into a scoring tool. We achieved 100% prospective peer review over a period of 1 year and documented a reduction in treatment variability, and better outcomes,” Hearne said.

How do you find the resources for this? Patel asked. 

“We can bucket resources,” Soberman said, “such as for people (navigators, coordinators, information technology, etc), technology resources (platforms needed to communicate, data, etc), or site of care.” Additionally, if there are prospects for collaborations or affiliations with other practices or health systems, it presents opportunities for outside resources, he added.

Motivation can be a big driver, Asfeldt said, adding that the scaling up is not a big concern for an integrated cancer care team. There also needs to be clarity around the depth of services that a cancer care team can provide in-house and which services would require either collaboration with another practice or a referral.

Resource allocation decisions require evidence-based guidance on what adds value to the care and services. “We need to make sure our upper management understand the appropriate value of the cancer service line,” Asfeldt said, which will assist with informed decisions.

He also highlighted the importance of philanthropy as an important funding resource. “Philanthropy should be an active part of your revenue stream. One of our other goals is to get 25% of our revenue from areas that are not taking care of sick people, which includes offering weight management programs, licensing on innovation, and commercial real estate.” Sanford Health System’s CEO has been emphasizing this avenue as a resource stream across their health system.

The Price of Innovation When Improving Cancer Care Delivery 

Improving patient outcomes, ensuring the cost of care remains in check, and not losing site of the patient at the center of it all—healthcare can be tough. And this transition to value-based care requires innovative approaches to care delivery by all involved.

At the Association of Community Cancer Center’s 44th Annual Meeting & Cancer Center Business Summit, March 14-16, 2018, in Washington, DC, payer and physician representatives shared the stage with the president of a cancer foundation that is striving to break the barriers that prevent easy healthcare information exchange and access to cancer care. Participants included Roy A. Beveridge, MD, chief medical officer, Humana; Barbara McAneny, MD, FASCO, MACP, president, American Medical Association (AMA); Anand Shah, MD, MPH, chief medical officer, Center for Medicare and Medicaid Innovation (CMMI); and Greg Simon, JD, president, Biden Cancer Initiative. Harlan Levine, MD, City of Hope moderated the discussion.

Levine asked the panelists to provide context to the audience, asking them, “Why are you on this panel?” on innovation in cancer care delivery.

McAneny said that AMA is working to create tools that would make things easier for physicians. “We are designing the workflow that physicians use to be the center piece. There’s a tremendous influx of data and we do not want to drown in it, but use it smartly,” McAneny said. She added that interopera- bility is a buzz word, but doctors want all the information on wherever their patients have been treated. “AMA has taken this up by setting a consortium to sort and transfer patient information within sites of care,” she added.

McAneny then moved on to discuss the influence of social determinants of health (SDH) on patient outcomes and cost of healthcare. There has been growing realization, not just among health policy researchers who have been studying this for a while, but also among providers that environmental factors and where we stay have a big influence on our treatment outcomes.

“SDH is also high on our agenda. We are not measured based on a patient’s zip code,” McAneny said, but efforts are underway to develop measures, and a code, that account for SDH. “We need to level the playing field, to accounting for disparities,” McAneny added.

Payers recognize the influence of interoperability on efficiency, according to Beveridge. “The inability to exchange data is profound...we have been working with CMS to figure out ways to break data exclusivity and improve sharing [among stakeholders],” he said. He agreed with McAneny on the influence of SDH on not just outcomes, but also the cost of care. “In patients with malignancies, cost of care ranges about 2-6 times higher [among patients who face social challenges],” Beveridge said.

For Simon and his team at the Biden Cancer Initiative, interoperability is incredibly important. “We need to develop data-sharing models, launch virtual clinical trials, and we should conduct trials where people are,” Simon emphasized. He also underscored the importance of cross-pollinating innovative care models between health systems and community-based practices. “How can we let big cities know what’s happening in the community? We need to work toward creating standardized systems, and connectivity is key,” Simon said.

“CMMI is constantly trying to test new models and services, which can potentially reduce burden, because they require scale and the burden could potentially lead to consolidation. My role [at CMMI] is to make the system more accessible, affordable, and multi-stakeholder—driven for care providers,” Shah said.

Changing Trends in Oncology Practice: Value-Based Care and an Empowered Patient 

What are the biggest drivers of change in oncology care and what needs most attention? This was the crux of the discussion during an early panel at the Association of Community Cancer Centers’ (ACCC) 44th Annual Meeting & Cancer Center Business Summit, held March 14-16, 2018, in Washington, DC.

Deirdre Saulet, PhD, practice manager, Advisory Board, led the discussion by introducing findings from the 2017 Trending Now in Cancer Care Survey, which was developed through a partnership among ACCC, the Oncology Roundtable, and the Advisory Board. Saulet was joined on the panel by Jo Duszkiewicz, MSA, vice president and administrator, Renown Health Institute for Cancer; and Mark Liu, director of strategic initiatives, Mount Sinai Health System.

There were several key takeaways from the survey, which had a majority of respondents from nonteaching community hospitals, followed by teaching hospitals and academic medical centers: 

The cost of drugs or new treatment modalities (68%), as well as physician alignment around services and program goals (47%), were top threats to the growth of future cancer program growth.

Respondents felt that clinical standardization (63%) and drugs (62%) presented a significant opportunity for cost savings.

Market consolidation was a common theme among survey respondents, with 75% reporting that their group had partnered with an existing hospital or health system and 36% had merged with a private oncology practice.

Regarding information technology, data abstraction and interoperability of electronic health records were listed as significant challenges.

Just over half (51%) agreed that prior authorization had significantly increased in the 12 months prior to the survey.

There exist staff shortages, especially for oncology nurses, medical oncologists, and advanced practitioners.

Saulet then invited Duszkiewicz to share how Renown Health Institute for Cancer has adapted to the changes.

Renown’s health system is a combination of acute care, transitional care, network services, and insurance services, Duszkiewicz said.

“Understanding where patients are, where they got their treatment, drawing out specifics of treatment into EPIC, and then ensuring we have all the information is difficult,” she explained. It is further complicated by the fact that Renown works with many rural community practices, which may be 200 to 300 miles away.

“We do practice oncology telemedicine for a few of our communities, in parallel with medical oncologists conducting site visits,” Duszkiewicz said. “We also link with primary care in those areas. However, we found out that primary care physicians were struggling with diagnosis and the tests that were needed.” Consequently, these struggles resulted in an extended time to diagnosis.

To unscramble this situation, Renown developed a solution: the intake oncology coordinator (IOC) process, which included conducting a phone triage first, then a chart review, and finally, bringing the patient in for a clinic visit.

“On evaluating the data, we see that 31% of patients get phone advice, and 25% do a chart review, but 44% of patients who are referred come to see the advance practice nurse,” Duszkiewicz said, adding that IOC has resulted in a very successful clinic.

Duszkiewicz then presented trends within the fee-for-service reimbursement model from 2013 to 2022, which show that productivity adjustments have been increasing, from $4 billion to $94 billion, she said. The shift now is toward value-based contracts, such as the Oncology Care Model (OCM), alternate payment models, and others.

However, Duszkiewicz asked, are shared savings feasible in oncology? She shared data from the Miami Cancer Institute on the results of adopting a value-based approach to care:

First-year savings were modest: $354 per patient per year (PPPY)

She explained that clinical pathway adherence had a significant impact on the savings seen over the first to the third year. However, the diminishing returns of savings in year 4 have triggered more cost savings initiatives within the institute that are focused specifically on the inpatient population.

Next, Liu spoke of Mount Sinai’s practice changes. To be able to provide high-value care and broaden patient access, the hospital has developed several projects and programs, including creating disease management teams (DMTs), building clinical pathways programs, establishing a chemo council, and using Epic Beacon to monitor the clinical pathways being used.

DMTs, Liu said, are focused on quality metrics, value-based care, care pathways, tumor boards, and clinical trials. They are also tasked with narrowing down the quality metrics to avoid overlap and integrating OCM quality metrics with disease-specific metrics for tracking and decision making.

Saulet then spoke about the changing dynamic between the patient and the provider. “Cancer patients are acting independently and asking questions,” she said. “Patients are taking more responsibility for their healthcare costs. Patients have information available at hand on sites of care as well as drugs and treatment. Plus, the patient—provider relation is changing—there are rising expectations on service, with patients feeling more empowered and being skeptical about the care they receive.”

Saulet said that patients with cancer are doing their research: 25% of patients who were surveyed said that they are spending an hour on average reviewing oncologists and 41% said they had researched their treatment options.

Precision medicine is also evolving rapidly, Saulet said, with 92% conducting predictive tests, 92% conducting single-gene tests, 72% conducting small panel tests, and 31% conducting whole-genome sequencing.

Coverage from the Association of Community Cancer Centers’ 44th Annual Meeting & Cancer Center Business Summit, March 14-16, 2018, in Washington, DC.

Conference Coverage: Association of Community Cancer Centers 

Medicaid Expansion Led to Earlier Stage at Diagnosis of Testicular Cancer 

When Medicaid expansion began in 2014, under the Affordable Care Act (ACA), there started to be fewer uninsured patients and a shift to earlier-stage cancer at the time of diagnosis for patients with testicular cancer in states that adopted the expansion, according to findings presented February 9, 2018, at the American Society of Clinical Oncology Genitourinary Cancers Symposium, which was held in San Francisco, California.

“We all know insurance status is a key determinant of cancer outcomes,” said Xinglei Shen, MD, radiation oncologist, University of Kansas Medical Center. “People who don’t have insurance do poorly, and the ACA sought to improve outcomes by improving access to insurance.”

Shen and his co-author hypothesized that Medicaid expansion would lead to earlier diagnoses and more guideline-concordant treatment for patients with testicular cancer. They looked at the Surveillance, Epidemiology, and End Results (SEER) data from 2010 to 2014, which provides information on cancer statistics, and identified 12,731 cases of testicular cancer during the time period. The time frame of 2010 to 2013 was used as the pre-expansion group.

The expansion states included in the analysis were California, Connecticut, Hawaii, Iowa, Kentucky, Michigan, New Jersey, New Mexico, and Washington. Nonexpansion states included Arkansas, Georgia, Louisiana, and Utah.

Looking at Medicaid enrollment numbers for the SEER states that did not expand coverage, there was a modest increase in the amount of people on Medicaid versus a robust increase in those enrolled in expansion states, said Shen. The biggest change was seen in New Mexico, which had a 50.3% increase.

For insurance status at time of diagnosis, Shen et al found that in expansion states, there was a significant drop in patients who were uninsured at the time of diagnosis: from 8.7% to 4.3%, and a corresponding increase in the proportion of people enrolled in Medicaid: from 14.8% to 19.4%.

In nonexpansion states, there were no significant changes, according to Shen.

There was also an effect on the stage at diagnosis. In states that expanded Medicaid, 20.2% of patients had stage III cancer at the time of diagnosis, down from 27.1% before expansion. There was also a corresponding increase in the proportion of patients diagnosed at stage I, according to Shen. For states that did not expand coverage, 29.2% of patients had stage III cancer at the time of diagnosis, up from 23.2% before 2014.

Lastly, they look to see if there was an effect on quality of care, but the results did not indicate a significant difference. Shen concluded by indicating that longer-term follow-up is needed to study how Medicaid expansion would affect cancer outcomes and survival. 

Shen X, TenNapel M. Impact of Medicaid expansion on diagnosis and management of patients with testicular cancer. 

. 2018;36(suppl 6S; abstr 551) meetinglibrary.asco.org/record/157230/abstract.

Combining Radiation and Immunotherapy in Patients With Bladder Cancer 

"I think this is an exciting time in the treatment of bladder cancer and really oncology in general, because we’re learning to harness the body’s immune system against malignancies,” said Abhishek Solanki, MD, MS, assistant professor, Radiation Oncology, Loyola University of Chicago, during a February 9, 2018, session at the American Society of Clinical Oncology Genitourinary Cancers Symposium. The meeting took place in San Francisco, California.

While discussing the role of immunotherapy in patients undergoing radiation therapy for bladder cancer, Solanki emphasized that it’s also an exciting time because there’s a lot of preclinical data that have led to us evaluating this approach. Radiation is a local therapy, delivered for local purposes, like treating a primary tumor and in a bladder preservation case, he said. It’s also known that immune invasion is a critical hallmark of cancer and the main mechanisms by which tumors grow, progress, and metastasize.

According to Solanki, there’s emerging evidence that suggests that one of the reasons radiation is effective is because it is immune driven. Cytotoxicity related to radiation releases tumor antigens, which leads to activation of antigen-presenting cells and migration to the lymph nodes and, in turn, priming of T cells. There’s also a release of cytokines that lead to T-cell trafficking back to the tumor and an increased expression of major histocompatibility complex, class I, known as MHC1, within tumor cells. All of these things together lead to cell-mediated death, said Solanki.

However, radiation itself rarely leads to long-term immune memory and the ability to prevent late recurrences. Additionally, there’s emerging data that suggest that radiation can lead to upregulation of programmed cell death-1/programmed death ligand-1 (PD-L1) and regulatory T-cell infiltration into the tumor cell, suggesting that there may be some immunosuppressant effect of radiation.

“This brings us to the hypothesis that we can combine radiation immu- notherapy to improve local control through radiosensitization by bypassing those resistance mechanisms,” said Solanki. “Potentially, by combining these modalities, we can improve systemic response and have long-lasting immune memory when we combine these agents.”

Solanki cited what he said is one of the only studies of bladder cancer specifically looking at the question of the combination of radiation immunotherapy. Investigators implanted bladder cancer tumors in mice and then separated them into 2 groups: one treated with radiation alone and the other treated with radiation and an anti—PD-L1 antibody. With radiation, there was a decrease in the size of the tumor, but it started growing again shortly after. In the combination group, there was more durable and more significant tumor control. 

“This leaves us with 2 clinical questions,” said Solanki. “The first is with our traditional paradigms of bladder preservation and definitive chemoradiation therapy. Can we use immunotherapy to improve the outcomes? On the flipside, for patients who have metastatic disease who are being treated with checkpoint inhibitors and for palliation, can we use local radiation to augment that effect and give them more mileage with the available therapies?” Although there is not a lot of data available for bladder cancer, Soalnki said that we can turn to some non—small cell lung cancer (NSCLC) studies that can provide leads on benefits observed.

In the PACIFIC trial, patients with stage III NSCLC receiving definitive chemoradiation with cisplatinum-based chemotherapy were randomized to be administered either placebo or up to 12 months of durvalumab. Investigators found a clear difference in progression-free survival (PFS) that favored the durvalumab group. Also, in the metastatic setting, in the KEYNOTE-001 study, UCLA investigators assessed their NSCLC cohort and found that radiation prior to pembrolizumab was associated with PFS and overall survival.

“Bringing things back to bladder cancer, one of the reasons why it’s hypothesized that immunotherapy’s so successful in NSCLC is because of the high somatic tumor mutation burden, and bladder cancer is right up there,” said Solanki. “And we already have a track record of success with immunotherapy in bladder cancer with [Bacillus Calmette-Guerin] for nonmuscle invasive disease and checkpoint inhibitors for metastatic disease. So I’d argue that bladder cancer is the ideal setting [in which] to investigate the combination of radiation immunotherapy.”

Solanki explained that while there is a lot of clinical and preclinical rationale to combining immunotherapy and radiation for bladder cancer, there’s a lot we don’t know, and the unknown at this time is bigger than the known.

He concluded: “I think it’s up to us, as a community, to find out exactly how best to combine radiation with immunotherapy to augment the effects of both modalities.”

Docetaxel Plus Hormone Therapy Improved Quality of Life, Cost-Effectiveness in Prostate Cancer 

The addition of docetaxel to first-line long-term hormone therapy in patients with prostate cancer is associated with improved quality of life (QoL) and cost-effectiveness, according to study results presented February 8, 2018, at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California. 

Nicholas James, MBBS, PhD, Queen Elizabeth Hospital, presented results from the STAMPEDE trial, which looked at patients with M0 and M1 disease. The primary outcome of the trial was overall survival, and secondary endpoints included failure-free survival (FFS), progres- sion-free survival (PFS), metastatic PFS, skeletal-related events (SREs), toxicity, cost-effectiveness, and QoL.

“Docetaxel produced a very consistent improvement in FFS across the whole trial,” said James. “The other thing that was very consistent across the whole trial was a 40% reduction in symptomatic skeletal events.”

The researchers used a standard model-based approach, explained James. All patients started hormone sensitive and progressed to M0 castration-resistant prostate  cancer(CRPC) or M1 lymph node disease, CRPC with bone metastases, CRPC with bone metastases with a SRE, or CRPC visceral. The STAMPEDE trial data were used to determine how much time each patient spent in each cate- gory and what were the QoL implications. The researchers also assessed cost-effectiveness.

Because patients with M0 disease have a 40% delay in the time to relapse, the patients getting docetaxel up front spend more time hormone sensitive than patients in the control arm, said James. Thus, the onset of CRPC M0 or M1 lymph-node only disease is delayed, and patients live fewer months with these conditions or with bone metastases, with or without an SRE. This correlates to a longer period of relatively good QoL and less time with poor QoL. For the metastatic setting, the same effects were observed. Patients spend more time in the hormone-sensitive state, which means less time with the factors that harm your QoL and increase your costs, said James.

“For metastatic patients where there’s a survival advantage, not surprisingly you see a quality-adjusted life years [QALYs] gain as well,” said James. “In other words, the benefits of not relapsing, not having SREs, wipes out the quality-of-life penalty that you incur from your up-front chemotherapy.” 

The same effect was seen in patients with M0 disease. Although there wasn’t a robust survival advantage in this setting, there is still a QALY gain.

Over the course of the trial, treatment with docetaxel didn’t change end-of-life costs substantially. But docetaxel costs increased, management costs generally went up, and the costs of other life prolonging therapies went up. However, there’s been big changes over the duration of the trial with the emergence of androgen receptor—targeted therapies, said James.

The researchers remodeled the data using patients who had enrolled later in the trial and who were getting abiraterone/enzalutamide for M1 CRPC. When they did that, there were still increases in docetaxel and management costs and little effect on end-of-life care. However, there was a significant reduction in the use of other life-prolonging therapies compared with the control arm. When looking at net total costs, there was a reduction in overall lifetime care costs in M0 disease from the up-front addition of docetaxel. And although there was a net increase for the metastatic setting, the total cost was approximately £3000 over the lifetime of the patient.

“Up-front docetaxel results in robust gain in quality-adjusted life years in all subgroups,” concluded James. “It supports existing healthcare policy in metastatic patients, but it also supports the use of docetaxel in high-risk nonmetastatic patients.”

Use of Biomarkers to Identify Patients, Therapies for Neoadjuvant Chemotherapy

James N, Woods B, Sideris E, et al. Addition of docetaxel to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Long-term survival, quality-adjusted survival, and cost-effectiveness analysis.

. 2018;36(suppl 6S; abstr 162). meetinglibrary.asco.org/record/157020/abstract. 

During the 2018 American Society of Clinical Oncology Genitourinary Cancers Symposium, Peter Black, MD, professor, Department of Urologic Sciences, University of British Columbia, discussed 3 clinical biomarkers that have potential use to select patients and therapies for neoadjuvant chemotherapy (NAC). 

Black began the discussion by explaining that there are multiple prospective randomized trials and meta-analyses that demonstrate a survival advantage from NAC. The 2 main limitations with NAC are: Only about 40% of patients seem to be benefiting from the treatment, with the other 60% are potentially suffering from adverse effects from chemotherapy and unnecessary delay in definitive radical cystectomy, and NAC has not been widely adopted in North America or in Europe.

“I think one of the ways forward, to overcome both of these limitations, is with biomarkers,” said Black. “If we have a biomarker that would tell us which patients are likely to respond or not to respond, we can avoid using NAC in the likely nonresponders, and if we had better patient selection, we’d also probably have better buy in for adoption of NAC. “Black identified 3 clinical biomarkers that are in development and close to potential clinical implementation.

Several research groups have identified a molecular taxonomy for bladder cancer based on RNA expression. The key classifications are basal and luminal cell lines; with basal tumors having a gene expression profile that resembles the basal layer of the urothelium; it’s more stem-like and less differentiated. The luminal tumors, on the other hand, have a gene expression profile that resembles more differentiated luminal cells, Black explained.

According to Black, these subtyping systems have a limitation in that a patient cohort is needed to create a cluster so that an individual patient can be classified in one of the subtypes, which is not practical in clinical practice. So, Black’s team developed a single-patient classifier called a genomic sequencing classifier, or GSC.

It includes 4 cohorts: luminal, luminal-infiltrated, basal, and claudin-low. They next gathered a multicentric cohort of 305 patients, all of whom were receiving NAC, which included 269 patients who received cisplatin-based chemotherapy who were used for all survival analyses. The control population of almost 500 patients who did not receive NAC was based on publicly available data and literature.

“The bottom line with this classifier was, and if you look at the non-NAC patient population, you can see that the luminal patients clearly do better than everyone else,” said Black. “The other 3 cohorts are relatively closer together. In the NAC data set, you can see they jump up the most; they get the most benefit from NAC with respect to survival.” 

A research team at the University of Virginia developed the Coxen model, which is currently being evaluated in a clinical trial. The model was initially based on the National Cancer Institute 60 cell line (NCI-60) panel of cancer cell lines, none of which were bladder cancer; however, it’s a comprehensive database of gene expression and IC50 values for over 100,000 compounds, said Black. The team was able to integrate bladder cancer data, gene expression data and a panel of bladder cancer cell lines, and through bioinformatics techniques, was able to come up with a predictive model for any given drug based on gene expression. 

Genomic Alterations, Mutations, and Copy Number Changes

A research team led by Eliezer Van Allen, MD, from Dana-Farber Cancer Institute, and Jonathan Rosenberg, MD, from Memorial Sloan Kettering Cancer Center, examined EERC2 mutations in a cohort of 50 patients. The team compared 25 patients who received cisplatin-based chemotherapy and had a complete response with 25 who had residual muscle-invasive disease. According to Black, the ERCC2 gene was predominant in the responders, while nonre- sponders did not carry ERCC2 mutations. 

Black concluded by demonstrating what would happen if the subtyping and mutation biomarkers were put together. “One-third of patients are basal, and if you add in the patients who have the DNA repair gene mutations, you end up with about 50% of patients who we would predict would respond well to cisplatin-based chemotherapy based on a combination of mutations and subtyping,” said Black. 

Coverage from the American Society of Clinical Oncology Genitourinary Cancers Symposium, held February 8-10, 2018, in San Francisco, California

Conference Coverage: ASCO Genitourinary Cancers Symposium

The US healthcare system is in a state of crisis. Compared with other economically developed countries, the United States has been shown to be drastically overspending on healthcare while outcomes remain inferior. A 2013 report by the Institute of Medicine (IOM)—now The National Academies of Sciences, Engineering, and Medicine&mdash;described the US healthcare system as one that leads to “shorter lives, poorer outcomes.”

 While the United States leads in innovation for cancer therapies, the IOM report pointed out that the nation’s “increasingly chaotic and costly” cancer care system is in crisis and fails to deliver consistent care that is patient-centered, evidence-based, and coordinated.

Cancer care is among the fastest-growing segments of the US healthcare system, outpacing many other subspecialties. In the United States, total spending on cancer care has increased from $27 billion in 1990 to $124 billion in 2010, with spending projected to reach about $157 billion by 2020.

 Total costs of cancer care for the US population are predicted to increase across all phases of care: Cost drivers include technological innovation, rising costs of hospitalization, and a population-level increasing susceptibility to malignancy due to an aging demographic and increasing life span.

 Global spending on oncology and supportive care drugs reached $100 billion in 2014, with targeted therapy expenditures accounting for almost 50% of this amount.

 In the United States, oncology drug expenditures, excluding supportive care agents, increased by 18.0% from 2014 to 2015.

Along with payers, employers, and the government, patients, caregivers, and family members shoulder an increasing share of these rising costs due to changes in benefit design, which now combine higher out-of-pocket costs with rising premiums and deductibles.

Cancer treatment can have a substantial financial impact on patients and their families; in fact, financial toxicity has been cited as a contributing factor to adverse outcomes in patients with cancer.

One possible way to reduce overall cost, improve patient experience, and improve outcomes is to shift the focus of healthcare delivery away from volume and toward value. Patient-centered cancer care (PCCC) holds the promise of addressing these issues. The Oncology Care Model (OCM), developed by CMS’ Center for Medicare & Medicaid Innovation (CMMI), is a leading pilot that has been in place for over a year and seeks to test the efficacy of PCCC for Medicare beneficiaries over the next 5 years.

At Carolina Blood and Cancer Care Associates (CBCCA), we began exploring our practice’s journey from volume to value in 2013 by understanding the concept of patient-centered care and taking the steps necessary to acquire accreditation as a patient-centered specialty practice (PCSP) through the National Center for Quality Assurance (NCQA). Our path for NCQA accreditation primed us for the transition, as NCQA has many common denominators with OCM. Under the practice transformation requirements of expanded access leading to PCSP accreditation (a corresponding OCM requirement), we realized that expanded access would lower expenses, improve patient experience, and likely improve outcomes. We found that expanded access, including same-day appointments and weekend access, prevented unnecessary emergency department (ED) visits and hospitalizations.

As a part of the transition to PCSP, CBCCA started providing patients the convenience of same-day appointments and walk-in access. Our 2 clinic locations each have 2 slots per day reserved for walk-in patients. In addition to recruiting staff to accommodate additional patients, we created a triage process and pathways, and we trained both clinical and nonclinical staff to learn the relevance of these process changes. This initial investment is paying off in multiple ways. We have documented a significant increase in office visits resulting from phone triage (Figure 1). Initially, this seemed burdensome, as it required the allocation of additional resources. However, upon analysis of overall trends, we noticed a more than-50% increase in overall revenue from additional office visits over the 3-year period from 2014 to 2016 (Figure 2). For patients, same-day access and expanded access reduced the number of hours waiting in the ED, leading to both improved outcomes and quality of life (Figure 3), along with a reduced likelihood of after hours ED visits and hospitalizations (Figures 4-6). Additionally, patients were able to spend more time at home with their loved ones. Overall, patients and their caregivers received better quality of care. Patient satisfaction is being measured and data will be released later this year.

For payers, the increased quality of life for beneficiaries was coupled with a reduction in spending and a reduced likelihood of healthcare-associated conditions, as well as hospitalizations and visits to the emergency department.

OCM is the first major initiative by CMMI to pilot the transition from fee-for-service (FFS) toward value-based care. CMMI has been relatively flexible and accommodating of changes made to the program in response to stakeholder input. While OCM encourages oncologists to assume 2-sided risk, in which the practice is exposed to the possibility of both receiving shared savings and experiencing shared losses, the significant disparity between negative risk and upward reward is a barrier that has discouraged participating oncology practices from considering 2-sided risk. Additionally, fulfilling the data registry requirements in terms of data entry is both arduous and labor-intensive, and a high degree of technical expertise is required to do so.

Nevertheless, OCM is a first positive shift away from volume-based care to the value-driven path. Indeed, this transition into patient-centered care delivery will inevitably lead us down the path to fulfill the triple aim of better care, lower expenses, and improved patient experience. While Part B drug utilization is somewhat hard to regulate due to multiple factors, improving access to care— particularly, offering same-day access as well as slots to walk-ins&mdash;is low-hanging fruit, relatively easy to reach to help achieve the triple aim of healthcare reform.

Patient-centered care offers a definite option to address some of the challenges posed by ever-rising healthcare costs and deteriorating quality of care (Figure 7). The goal of value-based care in oncology is to improve the quality of care, while containing costs. Advanced APMs, such as the Medicare Shared Savings Program, 2-sided risk models, and OCM are examples of a shift away from the traditional volume-based FFS model. For the OCM, this objective targets Medicare beneficiaries through an episode-based payment model that financially incentivizes high-quality, coordinated care. In moving toward a value-based specialized care system, payers recognize and reward providers who proactively seek to improve the patient experience and health outcomes.

Kashyap Patel, MD, is president at Carolina Blood and Cancer Care Associates, based in Rock Hill, South Carolina. He is secretary of the Community Oncology Alliance and a trustee of the Association of Community Cancer Centers. Dr Patel is the past president of the South Carolina Oncology Society and the former chief of staff of Springs Memorial Hospital. Maharshi Patel, MBA, is practice administrator, CarolinaBlood and Cancer Care Associates. Asutosh Gor, MD, is board-certified inhematology, oncology, and internal medicine. and has been with CarolinaBlood and Cancer Care since 2004. Sashi Naidu, MD, is board-certified inhematology, oncology, and internal medicine and has been with CarolinaBlood and Cancer Care since 2005. Niyati Nathwani, MD, is board certifiedin internal medicine, hematology and medical oncology and has been with Carolina Blood and Cancer Care since August 2007. Radhee Kothadia, BS, is a student at Brody School of Medicine at Eastern Carolina University, North Carolina. Saheli Parekh is a student at North Carolina State University, Class of 2020. Eric Singhi, MD, is a second-year resident at Vanderbilt University School of Medicine who received his medical degree from the Medical College of South Carolina.

 In addition, Carolina Blood and Cancer Care Associates would like recognize interns Arya Patel, Resha Kodali, and Sagan Gor for their roles in practice transformation from 2014-2017. Patel is a senior at Ardrey Kell High School, in Charlotte, North Carolina; Kodali is a senior at the University of North Carolina, Chapel Hill; and Gor is a junior at Providence Day High School, Charlotte, North Carolina.

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de Souza JA, Yap BJ, Wroblewski K, et al. Measuring financial toxicity as a clinically relevant patient-reported outcome: the validation of the COmprehensive Score for financial Toxicity (COST). 

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One possible way to reduce overall cost, improve patient experience, and improve outcomes in cancer care is to shift the focus of healthcare delivery away from volume and toward value. Patient-centered cancer care holds the promise of addressing these issues.

April 2018

From the Editor in Chief: A Game of Risk

Medical World News: Managed Care Updates

Conference Coverage: Association of Community Cancer Centers

Conference Coverage: ASCO Genitourinary Cancers Symposium

Oncology Practice Transformation Helps Deliver Patient-Centered Cancer Care in a Community Oncology Practice

Oncology Nurse Navigators: Putting the Value in Value-Based Payment Models

Value-Based Contracting: Creating the Terms of Engagement Around High-Cost Cancer Therapies

The Risk Conundrum in Healthcare