With 475 cell and gene therapy companies in North America representing a business enterprise with approximately $20 billion, new immunotherapies are moving rapidly from the laboratory to the clinic. As chimeric antigen receptor (CAR) T-cell therapy makes its way from the academic to the community setting, however, appropriate resources and infrastructure are required to ensure the safe and effective management of patients.
At ASCO 2019, Carlos R. Bachier, MD, Director, Cellular Therapy Research, Sarah Cannon, Nashville, TN, discussed the components needed for the successful management of CAR T-cell therapy, issues surrounding regulatory oversight, and the financial considerations that may impede the delivery of these agents.
“It’s possible that these agents will be less toxic in the future, or that we may be able to identify patients who are at high risk of toxicities,” said Dr Bachier. “In the meantime, however, because we’re still learning how to properly administer these agents, it’s important that centers have the appropriate resources and infrastructure. We also need to work to improve reimbursement models so that financial barriers don’t prevent widespread use of these highly effective therapies.”
Of the 88 centers in the United States that are licensed to administer tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta), Dr Bachier reported 17 (19%) are nonacademic, community-based programs. The move to the community setting, however, remains a challenge.
The successful management of immune effector cells involves the development of an organizational structure, staff training and education, operational capabilities, compliance with regulatory agencies—including the FDA and the Foundation for the Accreditation of Cellular Therapy (FACT)—and the development of a specialized budget.
According to Dr Bachier, key personnel need to be trained in the management of these patients, including nurse coordinators, a financial team, and physicians, and facilities are needed to support cell therapy and apheresis. In addition, providers need to be aware of serious toxicities in the acute setting and beyond.
“When these patients go back to the community, it’s important that we keep good communications with referring oncologists, because some of these patients can have low counts for a significant period of time,” he explained. “They can be hypogammaglobulinemic and therefore at risk of infections.”
Data reporting to registries and regulatory oversight of programs administering these therapies are also necessary, said Dr Bachier. FACT accreditation is now a requirement by insurance companies for Center of Excellence designation, and more than 90% of hematopoietic-cell transplant programs are FACT accredited, he said.
“Credentials matter for providing these CAR T-cell therapies, and that goes for both manufacturers and for payers,” Dr Bachier added. “They also both require that expertise is demonstrated in the management of these patients.”
Reimbursement by Public and Private Payers
Additional financial considerations are associated with the use of CAR T-cell therapy. With commercial payers, similar to transplantation, hospitals and healthcare administrations are reimbursed based on case rates or on single-case agreements, and the same applies for management in the outpatient setting. With Medicare, however, reimbursement is a bit more complicated.
The 3 components that make up the current payment landscape include:
- Diagnosis-related groups
- New technology add-on payments, which are paid when expensive treatments are received and cover up to 50% of the drug cost (up to $186,000)
- Outlier payments, which depend on how much the hospital charges for treatment or for the procurement of CAR T-cell therapies.
Patients can also receive treatment in the outpatient hospital based on Q codes (temporary codes assigned by the Centers for Medicare & Medicaid Services), but if they are admitted to a hospital within 72 hours, they are at risk for reverting to an inpatient status.
Despite these reimbursement options, Dr Bachier emphasized that the current reimbursement model does not cover all of the costs associated with the management of patients receiving CAR T-cell therapy.
“From the standpoint of a hospital or a healthcare administration, the reality is that we are in a relatively tough spot,” he said. “While these therapies are very effective, we don’t have the means under the current model to cover even the cost of the product.”
“There have been visits to the Hill to determine if we can provide a reimbursement model that can truly allow these treatments to be given in the community effectively, without breaking the banks of healthcare organizations,” Dr Bachier emphasized. “However, a lot of work still needs to be done.”