OneOncology’s Platform Approach to Deliver CAR T Therapies in Community Practices

Innovation in healthcare delivery is critically important. Oncology practices and physician leaders should strive to ensure the delivery of the right therapy to the right patient at the right time, while also controlling the escalating cost of care for the most novel life-saving therapies. To achieve the most desired results at the dawn of the precision medicine era, it is vital that they continue to move patient care forward through three pillars of an innovation platform: drug discovery, care delivery models and value-based contracting.

As part of our comprehensive platform-based approach to care delivery, OneOncology practices are collaborating across the country to drive the future of cancer through these innovation pillars. This community-based platform approach has allowed OneOncology practices to excel. We utilize biomarker and genomic testing and deliver cutting-edge therapies and clinical trials, including immunotherapies and CAR T cells, to catalyze broader access to care for patients with cancer while also advancing scientific discovery.

Revolutionizing Clinical Trials to Improve Drug Discovery

The explosion of scientific discovery continues unabated, giving cancer patients more precise therapies than ever before. Since 2019, the US Food and Drug Administration has approved 151 new drugs, 70 of which have indications related to oncology. And in just the first half of 2020, the FDA approved 21 precision oncology drugs.

As new cancer treatments have become more precise—with advancements in understanding the genetic makeup of tumor cells—innovative clinical trials have also become more essential. This innovation plays to the strengths and nimbleness of community oncology and, specifically, OneOncology’s platform approach.

While the traditional path of a clinical trial rigidly follows a prospective protocol, during which patients receive a predetermined therapy for a fixed period, newer clinical trials are built with an adaptive design. This design gives researchers greater flexibility, as protocol modifications can be made while the trial progresses. Moreover, basket and umbrella trials have emerged to better match patient populations with a targetable genomic alteration to a specific investigational agent.

Community oncology practice investigators are an integral part of the clinical trial tapestry, alongside their academic centers and hospital colleagues in the U.S. and other nations. The practices on the OneOncology platform are a leading force in the clinical trial ecosystem, with many participating in multi-site programs from phase 1 to phase 3.

Data released last month at the American Society of Clinical Oncology’s (ASCO) annual meeting tells the story. Thirty-one abstracts were presented at ASCO that included research by an investigator from a practice affiliated with OneOncology. Collectively, the research evidences the advancement of a platform-based approach to cancer care. A research abstract presented demonstrates that biomarker testing, which has advanced from single-gene to next-generation sequencing, is the standard of care at community oncology practices. The physician uptake of biomarker testing at OneOncology practices was even higher than at community practices overall. This research, built on a previous OneOncology study, says the increased rate of biomarker testing is possibly “related to their network-wide strategy recommending NGS testing at diagnosis of advanced disease.”

Several abstracts published at ASCO revealed trial data for novel immunotherapies, including CAR T Cells. This data, coming from community practices and other trial sites, shows immense promise for using cellular therapies to treat different cancers in lung, colorectal cancer, prostate and lymphoma, among others.

As just one example, Astera Cancer Care physicians were the only community-based oncology authors whose data were presented from the PILOT study demonstrating that a CAR-T product, lisocabtagene maraleucel or liso-cel, is effective as second-line treatment for adults who experience a relapsed large B-cell lymphoma and who are not candidates for stem cell transplantation.

Liso-cel is marketed as having “inpatient or outpatient administration options” and is well-suited for community-based administration due to its favorable safety profile. There are very few infusion reactions, and the incidence of toxicities typically don’t start for several days. Moreover, if the patient is in close proximity to their oncologist and is closely monitored, toxicity issues can be followed, and then patients and family don't need to sit in a hospital waiting for something to happen; especially when the “something” occurs less than 30% of the time in most patients.

Care Delivery for CAR T
Even with the excitement surrounding CAR T, challenges exist. Overall, CAR T-cell therapies can cause severe side effects. One of the most frequent and serious side effects is cytokine release syndrome (CRS). T cells release cytokines, chemical messengers that help stimulate and direct the immune response. In CRS cases, the infused T cells flood the bloodstream with cytokines and cause serious side effects, including dangerously high fevers and precipitous drops in blood pressure. In some cases, severe CRS can be fatal. But these side effects can be very effectively treated, and an overwhelming majority of patients do well clinically.

Ironically though, CRS demonstrates that the CAR T-cell therapy is effective—since its presence demonstrates that T cells are at work in the body. Patients with the most extensive amount of cancer in their bodies are generally more likely to experience severe CRS from CAR T cells. And while it’s extremely dangerous if uncontrolled, in most patients, mild forms of CRS are managed with standard supportive therapies, including steroids.

Although these side effects can be quite serious, they should not preclude the development of outpatient care delivery models for CAR T cells. In fact, newer generations of CAR T cells have been rationally designed to improve efficacy and reduce toxicity. Through a platform-based care delivery approach, CAR T patients can be effectively managed in the outpatient setting. This will allow for a more broadly available care delivery model for not only CAR T cells but all cellular therapies that are currently being developed. This includes Natural Killer Cells, Tumor infiltrating Lymphocytes and other Bispecific antibodies, which engage T Cells and tumor cells.

And then there is the cost. A recent study of real-world data found that the total cost of care for CAR T-cell therapy averages more than $700,000 and can exceed $1 million in some cases.

If every patient who is a CAR T candidate must visit a large academic center to receive this type of therapy, the price will remain astronomical, and access barriers will persist as CAR T cells gain approval for more indications or are used in earlier-stage disease.

To fulfill the promise of community-based CAR T infusions to reduce costs while addressing the severe side effects, practices must organize cancer care delivery to overcome barriers. This means practice buy-in to create policies, establish treatment teams, develop communication frameworks, build the right hospital partnerships and establish a multidisciplinary commitment to making CAR T work in the community.

In this way, community cancer centers are addressing not only the immediate challenges of managing a CAR T program but also the long-term health delivery problems that end up needlessly driving up costs for patients and employers.

To do CAR T in a community-based setting, it requires more effort to assemble your teams and to educate the people that you want to be on your team. If you have a partner hospital and a staff that is committed to success, practices can provide CAR T on an outpatient basis, and both patients and the healthcare delivery system will benefit significantly by enhanced access at a lower cost.

Value-based Contracting
Astera Cancer Care has proven that community care delivery of CAR T cells is possible. Astera is now working with payers to create novel reimbursement models for comprehensive CAR T-cell delivery, through an episode of care payment structure that covers 6 months of comprehensive care—from patient identification, through preparation and infusion and up to 90 days post CAR T infusion.

Episode-based payment models align well with CAR T-cell treatments, and OneOncology practices will be at the forefront of the development of these payment arrangements. We believe that by creating a comprehensive CAR T therapy program at community practices, we can foster broader access to emerging therapies while establishing an economically viable reimbursement model for payers and self-funded employers.

Conclusion
From a rural town with one stop light to the most bustling city, every patient deserves the same access to world-class cancer care. It’s a matter of health equity. By addressing therapeutic discovery, how care is delivered and incentives for assuming risk in payment, community-based oncologists are innovating to improve access to contemporary care and health equity. But change is never easy nor fast enough. That’s why the platform approach taken by OneOncology allows for innovation and iteration: to improve our processes and systems while providing optimal care for our patients. It’s through this platform approach where we’ll create the most progress for our patients.