In Value-Based Oncology Care, Who Decides When Less Is More?

As a concept, everyone believes that a patient should be at the center of care, supported by shared decision-making. Patients and their clinicians review the best available evidence, review the options, look at costs and benefits, and together decide how to proceed.¹ In reality, in a shift from fee for service to bundled health care payments that are now expanding to include oncology services, how will those processes play out in the years to come, given the inherent existential nature of issues raised by having advanced cancer, even as treatments continue to advance for some metastatic disease? And will difficult, emotional conversations about when to move from curative cancer therapy goals to palliative therapy or even hospice care become even more fraught when the specter of capitated fees is lingering in the background?

With drug costs for cancer now surpassing any other disease state, could physicians be incentivized to discontinue futile care—and who defines futile care?

No one knows yet how this will play out, but these topics and more were voiced in a wide-ranging presentation and discussion this spring during an Institute for Value-Based Medicine® session on oncology value-based care in Scottsdale, Arizona, held by The American Journal of Managed Care® in partnership with Banner|Aetna.

The cochairs of the event were Michael Choti, MD, MBA, division chief of surgery at Banner MD Anderson Cancer Center, and Robert Groves, MD, executive vice president and chief medical officer at Banner | Aetna. They were joined by Lalan Wilfong, MD, senior vice president, payer and care transformation at The US Oncology Network; Despina Kotis, PharmD, FASHP, chief pharmacy executive and vice dean of clinical affairs, University of California San Francisco (UCSF) Health/UCSF School of Pharmacy; Ryan W. Huey, MD, assistant professor, Department of Gastrointestinal Medical Oncology, Institute for Cancer Care Innovation at The University of Texas MD Anderson Cancer Center; and Ed Clarke, MD, vice president and chief medical officer, Insurance Division and Banner Health Networks at Banner Health.

Groves opened the evening with an overview of the challenging landscape, as well as a few reasons why he thought there may yet be a cause for optimism.

“I don’t think there are many people in the country [who] haven’t been impacted emotionally in some way by the pandemic, even if it’s only a sense of increased vulnerability, increased chaos, or less control of what happens in our lives. And I think we underestimate that impact,” he said.

Burnout, for example, was bad before the pandemic, but is now worse. Meanwhile, “the complexity of practicing medicine has sucked a lot of the joy out of the relationship,” between patients and physicians, as patients are dealing with their illness as well as fraying under higher levels of medical debt and increasingly unaffordable drug costs—assuming they come in for care at all.

On the other hand, he sees some reasons for optimism, citing new advances in artificial intelligence as well as the promise of precision medicine in oncology.

Groves is also not unhappy with payment reform. The Enhancing Oncology Model (EOM), the next oncology payment reform model from CMS, is “not perfect, but what I love is that they focus on getting back to the things that make us happy, helping people coordinate their care, navigate their care, supporting them, giving them access to communicate with their care team 24/7. How radically different is that from navigating that maze yourself?” he asked.

The need for payment reform in oncology is acute, Wilfong pointed out, as he laid out the backdrop against which this change is happening.

Alongside rapidly increasing health care costs, the incidence of cancer is growing with an aging population.

According to the National Cancer Institute, by 2040, the number of cancer survivors is projected to grow to 26 million.² And those survivors will also be older; although currently 67% of survivors are aged 65 or older, that percentage is expected to increase to 74%.

Cancer has surpassed all other disease states for having the highest costs for payers, both commercial and government, Wilfong said. He pointed to a recent survey from the Business Group on Health, in which employers cited the disease as an overriding concern, which was not the case less than a decade ago, he said.³

“Now every single employer meeting that I go to is all about cancer care, because it is now the most expensive disease that employers treat,” he said. That means employers are trying different measures to control cancer care costs.

After prior authorization (PA), site-of-care management is the second most common method used by businesses, which insist that infusions take place in community-based settings, where they are up to 10 times less expensive than hospital-based infusions.

In addition, oncology care providers are taking on more of the risk of managing their patients, a practice that is already common for primary care providers.

Typical value-based care agreements might include pay for performance; capitation; gold carding, which is when a provider is freed from PA requirements as a result of demonstrating the use of evidence-based medicine; and deploying clinical pathways. Value-based care models include an oncology medical home total cost of care; case rates for chemotherapy and radiation, using prospective fixed payments; and others, such as employing a clinically integrated pharmacy.

These payment reform efforts are not something to be ignored. Physicians will need to understand them to remain financially viable, Wilfong said.

And although providers must be comfortable with the latest developments in value-based payment reform in order to stay afloat, their patients have to worry whether the financial fallout of a cancer diagnosis might ultimately play a role in their death. “These are sort of the cold, hard facts and things that we don’t like to think about. But these are things that really matter to our patients,” said Huey, as he expanded on the topic of financial toxicity in oncology. He noted a 2016 study whose results were published in the Journal of Clinical Oncology showing that “severe financial distress requiring bankruptcy protection after cancer diagnosis appears to be a risk factor for mortality,” according to the paper.⁴

The effect was most pronounced for patients with breast, lung, colorectal, or prostate cancer, whose mortality rates after filing for bankruptcy were significantly higher than those of patients with the same cancers who did not seek bankruptcy protection.

Huey was not involved in that research, but he was first author on a paper examining the impact of financial toxicity in his own center’s patients, with respect to their participation in clinical trials.⁵ The study surveyed 213 patients enrolled in early-phase clinical trials. For nearly half these patients, monthly out-of-pocket costs associated with clinical trial participation were at least $1000. Perhaps not surprisingly, worse financial toxicity was linked with income under $60,000 as well as living farther away from the hospital. Patients of more diverse racial and ethnic backgrounds had higher rates of unanticipated medical costs. Having unaffordable out-of-pocket costs for transportation, lodging, food, or time off work keeps patients out of clinical trials.

In addition to having the audience consider the impact of financial toxicity, Huey encouraged them to think about the need to measure the right things.

“Quality is really health outcomes that matter the most to patients. And cost is really the cost over the full cycle of care,” he said, adding, “Are we really looking at the health outcomes that matter most to patients? Or are we really kind of stuck in some process metrics?”

High-value care is typically thought of as being aligned with clinical guidelines, for example, but he challenged the audience to think about whether “the guidelines [are] the ceiling or are they in fact the floor.”

Huey turned to the example of rectal cancer, his specialty, where guidelines call for surgery as a first-line approach. Emerging treatment options, such as avoiding surgery for some patients, are not yet in the guidelines, but other options, such as chemotherapy or chemotherapy and radiation, can improve health outcomes and reduce morbidity.

“Our guidelines sometimes can’t keep up,” he said.

This is where shared decision-making comes in, and along with that, Huey said any equations looking at value must also consider patient-reported outcomes (PROs) and the full cycle of care costs. PROs, tracked in real time, assess symptom burden and how patients feel along the care continuum, not merely on the day they walk in to see their oncologist.

“The day that you get chemotherapy is the day that you’re feeling your best, because you haven’t [received] the chemo[therapy] yet,”
he noted.

It would be preferable, Huey continued, to know how patients are doing in between their chemotherapy days. Findings from a study published in 2017 by Basch et al showed that integrating electronic PROs can assess symptoms in a way that makes them more apparent to the oncologist and even improves survival.⁶

In addition, Huey noted, patient care in cancer is also affected by state and federal policy, and he drew attention to the impact of Medicaid expansion. In general, states that have expanded Medicaid have seen cancer diagnosed at earlier stages. Moreover, Medicaid reduced the disparities in access to timely treatment for advanced cancers between Black and White patients, Huey said.

“What I want to show is that when we think about quality and cost, there’s a lot more nuance there as well [in] that we can really expand our thinking about value,” he said.

Choti, a surgeon who specializes in 2 challenging gastrointestinal cancers—hepatobiliary and pancreatic—raised a delicate point: When it comes to shared decision-making in value-based care, as payment structures are changing, the inclination of some oncologists and some patients may be to keep treating and treating to maintain hope, even if there is no evidence that therapy will work.

“How do you think those conversations are going to change as the payment structure may change?” Choti asked.

“I think it…becomes paramount in oncology to have conversations about what matters most to patients early on, so that later on in the disease course we have an understanding of what those goals are, we have an understanding of what those patient preferences are, and then we can pretty clearly talk about…what the tradeoffs [are] here. Ultimately, this is a conversation about tradeoffs.”

The cost conundrum of advanced therapies that keep patients alive—or are curative—is going to worsen, and health systems should be aware of the cost differences that are incurred depending on the site of care. Kotis noted that in 2017, one of the first chimeric antigen (CAR) T-cell therapies, axicabtagene ciloleucel, had a wholesale acquisition (WAC) price of about $508,000 when it was approved for acute lymphocytic leukemia, according to market data he presented at the meeting.

Now WAC prices for gene therapies, such as betibeglogene autotemcel (Zynteglo) for inherited beta thalassemia and etranacogene dezaparvovec (Hemgenix) for hemophilia B, range from $2.8 million to $3.5 million.

As another example, Kotis cited the expanding pipeline of CAR T-cell therapies for relapsed and/or refractory multiple myeloma (RRMM) including BCMA B-cell maturation agents. The latest RRMM therapies are generally covered only at the highest tier level and require PA and step therapy, although some allow coverage under medical exceptions.

What are payers and employer groups asking Banner|Aetna about in regard to oncology care? In a panel discussion following the presentations, Clarke said the organizations he has talked to want to know more about all the care that wraps around oncology care, not just the technicalities of cancer care itself.

No one is asking, “Hey, Ed, what are your 5-year survivability rates for your oncologist?” he noted.

Instead, Clarke explained, the focus is on members having difficulty accessing care, or issues with PA, or patients going to the emergency department because they could not reach the oncologist or had problems with medication refills. Payers also want more data on race, ethnicity, religion, and other patient characteristics that are not typically captured in claims data, he said.

References

1. Elwyn G, Frosch D, Thomson R, et al. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012;27(10):1361-1367. doi:1007/s11606-012-2077-6
2. American Cancer Society. Cancer treatment & survivorship: facts & figures 2022-2024. Accessed April 24, 2023. https://bit.ly/44XhKlu
3. 2023 large employers’ health care strategy and plan design survey. Business Group on Health. August 23, 2022. Accessed April 24, 2023. https://www.businessgrouphealth.org/%20resources/2023-large-employers-health-care-strategy-survey-intro.
4. Ramsey SD, Bansal A, Fedorenko CR, et al. Financial insolvency as a risk factor for early mortality among patients with cancer. J Clin Oncol. 2016;34(9):980-986. doi:10.1200/JCO.2015.64.6620
5. Huey RW, George GC, Phillips P, et al. Patient-reported out-of-pocket costs and financial toxicity during early-phase oncology clinical trials. Oncologist. 2021;26(7):588-596. doi:10.1002/onco.13767
6. Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA. 2017;318(2):197-198. doi:10.1001/jama.2017.7156