Coverage from the Institute for Value-Based Medicine® session with Astera Cancer Care in Edison, New Jersey, held November 3, 2022.
As new cancer therapies or indications seem to arrive every week, the world of community oncology has felt the ground shift. Community oncology still delivers 80% of cancer care,1 but keeping pace with innovation means no one can stand still, said Edward J. Licitra, MD, PhD, CEO of Astera Cancer Care, as he opened the November 3, 2022, session of the Institute for Value-Based Medicine® in partnership with The American Journal of Managed Care®.
“Many people look at a cancer care or an oncology practice, and they see a practice,” Licitra said. “We really have rethought that. We are a practice, but we like to see ourselves as a platform.”
By platform, Licitra means building an infrastructure to offer patients the same cutting-edge care as an academic center, but with greater convenience—and for payers, at a lower cost. In early 2021, Licitra and Bruno Fang, MD, Astera’s president and director of clinical research, along with 35 other medical and radiation oncologists in Central New Jersey, left another multistate practice to form Astera and aligned with OneOncology, a network of 15 practices based in Nashville, Tennessee, that offers technology support, clinical pathways, and a clinical trial consortium.2
“Once we have the platform, which we have now, we want to use the platform to do innovative clinical care,” Licitra said. “And the next thing that you have to do is innovate when it comes to contracting.”
The 2 go “hand in hand,” he said, because as clinical innovation continues, there is an ongoing need to optimize how to pay for care. That means working with payers on unique structures that keep a practice viable while limiting the resources spent on time-consuming tasks, such as prior authorization.
As Licitra and other speakers later discussed, Astera and Horizon Blue Cross Blue Shield of New Jersey have pursued groundbreaking episode of care payment models that may now extend to treatments such as chimeric antigen receptor (CAR) T-cell therapy. These are programs, Licitra said, “that I don't think anybody else in the country has developed.” (See Sidebar).
Clinical Trials in the Community
The IVBM event took place in Edison, New Jersey, a town named for the state’s most famous inventor, one who set in motion the region’s tradition of basic science that is now seen in the presence of global pharmaceutical giants and emerging biotechs. Proximity yields partnerships: Astera, based nearby in East Brunswick, was the lone community oncology practice to take part in a clinical trial for Bristol Myers Squibb’s CAR T-cell therapy, lisocabtagene maraleucel; Licitra was a co-author on a recent article in The Lancet Oncology.3 Astera’s practice locations are not far from academic centers, whose relationship with community oncology has shifted, as Fang explained.
The changing landscape in science, in business models, and in patient needs demands that patients have an option to take part in clinical trials at the community practice level, he said.
Just a day earlier, Fang said he had been at a dinner where a director of a National Cancer Institute-Designated Cancer Center suggested that if Astera had patients eligible for phase 1 trial, “you can send the patients to us.”
Fang replied, “We have phase 1 trials.”
Twenty years ago, drug development was dominated by academic centers; Fang said it was all but impossible for a community oncologist to break into a collaborative research group. Over time, as partnerships with industry increased, there was more effort to “democratize” trials, which required collaboration with community oncologists for patient referrals. In return, he said, academic centers sent patients who needed standard of care back to the community.
But more recently, collaboration has soured, as academic centers have bought up practices, employing oncologists to treat the standard of care patients. “The academic centers, which used to be our partners, have become our competitors,” Fang said.
Meanwhile, the number and diversity of trials have exploded, and Fang and Licitra see the added layers of bureaucracy in academic centers as adding time and cost to a process that community practices can run more efficiently. Pharmaceutical companies should weigh these factors as they seek research partners, Fang said. Community practices such as Astera have responded by increasing in scale and adding the personnel to handle research; Fang noted that Astera is part of OneOncology’s OneR network and has 45 trials running currently.
“Why should you work with us?” he asked. The main advantage, he said, is time: An academic center may take a year to start a trial that Astera can launch in 2 months. Companies investing “billions of dollars” should not have to wait more than a year to start a trial.
Community practices can also promote diversity in trials, he said. Just navigating the parking lot at a large academic center is time-consuming and a deterrent for some patients. So trials at academic centers tend to get patients who are younger, healthier, and not representative of the population, Fang said.
For payers, Fang said, working with community oncology practices that offer clinical trials maximizes benefits: Patients receive access to cutting-edge science and therapies and diagnostics at reduced cost, and close monitoring of toxicities. A study by Tennessee Oncology, another OneOncology practice, found that when patients in an Oncology Care Model (OCM) were taking part in a clinical trial, the cost based on 6-month episodes of care was 18% lower than the average cost of a 6-month episode outside of a trial.4
Approaches to Maintenance After MM Treatment
The abundance new therapies and combinations has significantly increased the average life span for patients newly diagnosed with multiple myeloma (MM) over the past 20 years, but it has also raised an important question: Is it ever safe to stop maintenance therapy?
M. Hossein Kazemi, MD, a medical oncologist and hematologist at Astera, addressed this question in a discussion on the use of minimal residual disease (MRD) testing, which can find whether cancer cells remain in the bone marrow after treatment. The testing can both confirm remission and detect an early return of cancer, and Kazemi discussed an important trial studying how novel therapeutic regimens combined with MRD testing could lead to new protocols. This could free certain MM patients from indefinite maintenance therapy, with important implications for payers and for quality of life.
The phase 2 MASTER trial (NCT03224507), reported in 2021, combined daratumumab, carfilzomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma, then used minimal residual disease testing by next-generation sequencing (NGS) to decide the use and duration of the therapeutic combination post-autologous hematopoietic cell transplantation (AHCT).
“Instead of the conventional myeloma treatment paradigm—induction, transplant,maintenance until progression—they gave intensive treatment upfront. They gave 4 cycles at induction, then they checked the marker,” Kazemi explained. Patients then went to AHCT; then minimal residual disease was checked. Those with 2 consecutive negative residual disease tests went to observation; others had another 4 cycles. If residual disease negativity was not achieved, these patients went to lenalidomide maintenance.5 So far, 2-year progression-free survival results are 91% or higher for those who achieved minimal residual disease negative results early.
While more data are needed, Kazemi said, “we might be approaching a new paradigm” for management after initial treatment. It appears if minimal residual disease negativity is achieved early, a patient will “probably do very well long term.”
So, do these patients need maintenance therapy to avoid progression? “That’s the subject of several ongoing trials,” he said. By contrast, the patients who do not achieve minimal residual disease negative status may need more intensive therapy.
Managing Risk in the Era of Value-Based Care
Astera’s foray into value-based care programs meant moving away from a traditional fee-for-service environment, and that meant taking on risk. Whether the practice pursued episodes of care or Medicare’s Oncology Care Model (OCM), transitioning to upside only (1-side) and then to 2-sided risk demanded a change of mindset and financial modeling beyond most practices’ traditional scope of responsibility. For Astera and like-minded practices, the idea of improving patient care was not the issue. However, assuming risk was new territory.
“It really comes down to who’s going to ultimately take the risk for the health of the patients. That’s what value-based care is all about,” said presenter Brian S. Kern, JD, who is of counsel for the law firm Frier Levitt and a veteran of the medical malpractice and professional liability insurance sectors.
In 2018, Kern saw that CMS’ commitment to value-based models meant physicians needed help evaluating risk and finding properly priced stop-loss insurance and founded Deep Risk Management. Both OCM and the proposed Enhancing Oncology Model (EOM) have created a need for oncologists to find risk-sharing solutions if they want to participate in the next phase of practice transformation.
As Kern noted, the finances of the EOM appear more daunting than those of the OCM, which paid $160 per patient per month to deliver enhanced services. The EOM, set to start July 1, 2023, will pay $70 per patient per month for those services, with an extra $30 if the patient is Medicaid-eligible. But that’s not the most important part, Kern explained. “The big thing is, even though it’s not a tremendous amount of risk, you have to take risk right off the bat at 2%,” with an upside possibility of 6%. The EOM offers a second tier of higher risk, higher reward.
Pursuing a value-based care relationship without a good payer relationship is difficult, Kern said, because making it work requires data sharing and cooperation with a partner who understands the data structure. But taking on risk can be worth it. “I really believe the more risk we take, the more control you have over the continuum of care,” he said.
While the concepts Kern was presenting—using insurance to smooth out the good years and the bad years—are not new, they are still relatively recent in oncology, and for that reason gathering good data and using good analytics will be extremely important. But Kern was very clear about what his firm would and would not do.
“We believe value-based care is all about the ability to control risk; that’s how we approach this industry.” But once the results of data analytics are available, he said, “I’m not going to call in and say ‘Hey, you should change your practice patterns based on some of my research.’ ”
Once the data are available, it will be up to physician leaders to recommend changes at the practice level. Data will help physicians stratify patients based on risk levels, to prevent incidents most likely to result in hospitalization or added expense. “We do believe that variation can be controlled,” Kern said.
Data can also be used to determine whether certain therapies are costing practices money, to measure the impact of certain billing codes for patient comorbidities, and to see whether some situations are best managed with in-home care. Deep Risk Management built dashboards to make it easier to present these data to clients. “We wanted this to be a collaborative process,” he said. “So we had to build out a lot of capabilities that didn’t otherwise exist.”
Kern is clear on the role of risk management in value-based care. “We’re not interested in being a data analytics company. We’re not interested in being a care coordinator,” he said.
“But we’re very interested in understanding all the levers at play, to make sure these programs are successful.”
Assessing Social Determinants of Health
Achieving equity in cancer care outcomes starts with assessing social determinants of health (SDOH), said Ellen A. Ronnen, MD, who is Astera’s chief medical officer. As the American Society of Clinical Oncology (ASCO) and other groups address health equity on a global scale, Ronnen said much can be done at the community level. However, she said, “you can’t talk about knowing your patients without talking about assessments.”
Practical tools for SDOH assessment cannot be burdensome or time-consuming, and they must be understandable and actionable, she said. For Astera, Ronnen said, the areas of importance to promote equity are triage, social work, palliative care, and navigation, and assessments help in each one. Strategies that help broader groups of patients are also useful, such as transportation services, interpretation services, translation services, and financial advocacy. Ronnen identified the National Comprehensive Cancer Network’s Distress Thermometer as a good assessment tool, and the practice also uses depression screening, the Patient Health Questionnaire-9. By early November, Astera had helped 157 patients.
Some physicians have asked Ronnen why interpretation services are preferred over using family members. “The reason is, if you have an objective interpreter, a professional interpreter, they are not allowed to editorialize or to change the point that you’re saying; they can’t alter it at all. And so, it’s much more valuable for the patient,” she said. Translation services, meanwhile, provide the ability to translate documents into the language of a patient’s choice, from informed consent to education materials, to information on office locations.
Interpreter and translation services offer a vivid example of how overcoming language barriers—or failing to do so—can make a difference in a patient’s ability to access care. When patients lack interpreters, Ronnen said, research shows they fail to access care due to feelings of inadequacy about their ability to engage with the health care system.
The NCCN Distress Thermometer “can identify potential obstacles,” whether they are financial, or insurance barriers, or transportation issues, Ronnen said, allowing the practice to connect patients to a service or provide a referral to an outside agency. She shared data presented at the 2022 ASCO Quality Care Symposium, in which assessments were used to identify patients who reached a “trigger score” for referral to the social work department. Individual psychotherapy and group therapy, in addition to being beneficial to patients, are billable services, Ronnen said.
“There was uncredible uptake. Patients are very interested in using these services,” she said.
But addressing SDOH also comes down to asking the right questions. Arranging transportation might go beyond setting up a ride, to making sure a patient can get down a flight of stairs, for example. A patient advisory board can identify barriers to poor trial enrollment and gaps in quality of care.
“And I would say educate, educate, educate staff on equity-related content, because we all have so much to learn,” Ronnen said.
1. Wallis C. A wave of new cancer treatments challenges community oncologists to keep up. Scientific American. Better Local Cancer Care. 2022;326(25): doi:10.1038/scientificamerican0422-25
2. Premier Central New Jersey group of oncology care providers forms Astera Cancer Care, joins OneOncology. News release. PRNewswire. February 1, 2021. Accessed November 25, 2022. https://prn.to/3i9eVJT
3. Sehgal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022;23(8):1066-1077
4. Young G, Bilbrey LE, Arrowsmith E, et al. Impact of clinical trial enrollment on episode costs in the Oncology Care Model (OCM). J Clin Oncol. 2022;39(15_suppl):abstr 6513.
5. Costa LJ, Chhabra S, Medvedova E, et al. Daratumumab, carfilzomib, lenalidomide, and dexamethasone with minimal residual disease response-adapted therapy in newly diagnosed multiple myeloma. J Clin Oncol. 2022;40(25):2901-2912.