Cellular Therapy: The next crossroad in cancer care

Allina Health Cancer Institute, with more than ten locations in both Minnesota and Wisconsin, has comprehensive cancer center status and is considering the many technology factors to be able to provide cutting edge cellular therapy in its future design.Cellular therapy has been a mainstay for the treatment of blood cancers for the past 50 years with autologous and allogeneic stem cell transplant. A new category of cellular immunotherapy (e.g., CAR-T therapy) is rapidly shifting the care paradigm by harnessing the immune system to fight cancer through extraction, re-engineering, and reinfusion of a patient’s T-cells. The five, current, FDA-approved CAR-T products on the market have demonstrated tremendous impact on survival, and in some cases have proved curative. Dozens more CAR-T agents are in advanced stages of clinical trials, as are a host of other immune effector class agents. As these powerful new therapies come to market, cancer programs, such as Allina Health Cancer Institute (AHCI), are racing to develop the infrastructure and competencies to safely deliver next-generation cancer care.

Allina Health has embarked on a strategic growth initiative for AHCI, guided by a clear and compelling vision to build an integrated and innovative model of cancer care. With that, hematology and immunology intersect in treating diseases such as lymphoma, leukemia, and myeloma which has historically been a component of a Blood and Marrow Transplant (BMT) Program. However, an extension of BMT is also providing CAR-T therapy. In fact, all certified CAR-T programs also have stem cell transplant programs, driven by the complexity of the treatment and the shared/complementary assets between CAR-T and stem cell transplant. Many in the industry predict that new hospital and physician practice entrants may go directly to CAR-T therapy, bypassing traditional stem cell transplant, and that the mix of academic versus community providers will continue to shift as large community health systems deploy their scale and resources toward offering CAR-T therapy.

It was just in 2017, when CAR-T was approved by the FDA as a cancer immunotherapy treatment. Often referred to as a “living drug,” it is an innovative type of immunotherapy. CAR-T therapy involves the extraction of T cells (a specific form of immune cells) from a patient’s blood. These cells are then genetically engineered to express modified or chimeric antigen receptors on their cell surface. The engineered CAR-T cells are then grown in a laboratory until they number in the billions before being infused back into the patient. Once in the patient, the chimeric receptors on the T cells detect and attach to the patient’s cancer cells. Once attached, the T cells signal the immune system to destroy those specific cancer cells. CAR-T cell therapy holds tremendous promise, particularly for hematologic cancers (e.g., leukemia, lymphoma), where current CAR-T cell clinical research and regulatory approval efforts are largely directed.

Initial CAR-T cell clinical trials have reported high response rates in hematologic cancer patients who had relapsed following initial chemotherapy or bone marrow transplant (BMT). These highly promising results have bred excitement in the scientific and medical oncology communities, accompanied by discussions of whether the continued development and use of CAR-T cell therapy may impact or replace existing hematologic cancer therapies such as BMT and even chemotherapy in some patients.

Despite its clinical innovation, CAR-T therapy has unique economic challenges that influence financial feasibility for our clients. These challenges include extensive infrastructure and training, fluid Medicare and commercial reimbursement dynamics, and a cost profile—including the average $375,000 CAR-T product expense (CMS Medicare Rate 2021) that leaves little margin for error when business planning for cellular immunotherapy. For these reasons, it is critical that a hospital evaluate CAR-T with a contemporary understanding of things like Centers for Medicare and Medicaid Services reimbursement, invoice-based commercial payment dynamics, FACT accreditation, requirements of inpatient versus outpatient CAR-T infusion, and a lens on the broader trajectory of CAR-T patient eligibility. With significant payor reform impacting oncology reimbursement, including value-based and population health initiatives, the need for patient informatics and cost of care are imperatives in addressing the cost conundrum associated with cellular therapy. In addition, cellular therapy will also parallel the use of artificial intelligence (AI) healthcare, from screening to clinical trial and decision making. With the shift to value-based and population health initiatives, the need for total cost of care will be an informatics requirement to navigate the cost and resource considerations of cellular therapy.

Despite its technology, operational and financial complexities, immune cell therapy has rapidly shifted from early market to mainstream market interest among larger cancer centers. As the technology proliferates, it will be imperative that both academic and large community cancer centers understand the treatment and its specific applications in their local environment and create plans for CAR-T program implementation. In coming years, immune cell therapy will migrate from a program differentiator to a requirement for provision of contemporary cancer care.