Oncology Rounds

Catching up with CAR-T: How centers are building out capabilities and struggling to get reimbursed

by Deirdre Saulet

When FDA approved two CAR-T cell therapies last year, it caused a groundswell of excitement across the country—but many questions remain around implementation and reimbursement. Keep reading to learn how one leading cancer center has reorganized its services to improve care for immunotherapy patients and how barriers to CAR-T reimbursement are raising concerns about access.

ICYMI: Our take on the CAR-T cell therapy FDA approvals

Moffitt builds Immune Cell Therapy service

In a recent OBR article, Dr. Frederik Locke, head of the Moffitt Cancer Center of the Immune Cell Therapy service (ICE-T), explained how CAR-T cell therapy drove reorganization away from simply being tumor-site specific. Traditionally, leukemia and lung cancer patients receiving immunotherapy would be treated and managed by their respective tumor-site teams. Now, patients on immunotherapies receive care from the specialized ICE-T team.

To build out this expertise, Moffitt added:

  • 5 new faculty to help manage new patients (estimated at 175 patients each year);
  • 2 scientists to drive new therapy development;
  • 1 new apheresis unit to collect patients' cells; and
  • 6 beds in their outpatient facility.

Moffitt is also planning to build a new inpatient/outpatient wing for cellular therapy.

Medicare reimbursement not even close to covering costs of CAR-T therapy

In addition to the above investments, Moffitt has a whole team of financial specialists working on reimbursement for CAR-T cell therapy. The list price of Yescarta (Kite's therapy for diffuse large B-cell lymphoma) is $373,000 for the product alone—and this does not include the cost of labor, additional supplies, and extended hospital stays needed to manage the severe side effects of the drug.

Unfortunately, because CMS was under the mistaken impression that all centers could perform the procedure in the outpatient setting, it did not create MS-DRGs specific for CAR-T cell therapy. Instead, on the inpatient side, CAR-T is mapped to several lymphoma DRGs, the highest of which is reimbursed around $17,000. Early adopters know that this amount would not even cover the cost of one critical supportive care drug administered to patients during their hospital stay.

Understandably, this has raised concerns around access for Medicare patients. To address this, the American Society for Blood and Marrow Transplantation has submitted two requests:

  1. That the CMS Innovation Center (CMMI) immediately use its authority to establish separate payment for the CAR-T biological product (which providers would receive in addition to the current MS-DRG payment) for FY2018; and
  2. That CMS create new MS-DRGs for CAR-T therapy for FY2019.

Private payer reimbursement is a better story—but requires a lot of time and energy

Thus far, private payers are paying separately for the cellular product and then negotiating a case rate based on the autologous stem cell transplant rate or agreeing to a percentage of charges. Since this is based on single case agreements, it has been extremely time-consuming and burdensome on both sides.

Novartis taking on risk for its new therapy

In August of 2017, Novartis secured FDA approval for Kymriah, a CAR-T cell therapy to treat pediatric and young adult patients with B-cell precursor acute lymphoblastic leukemia. It then set the price of the product at $475,000, which added to the ongoing debate around skyrocketing drug costs in the U.S.

Interestingly, Novartis and the centers authorized to provide Kymriah are entering into outcomes-based agreements. In these agreements, which were supposed to start at the beginning of 2018, Novartis only sends the bill for the cell product if the patient is responding at 30 days.

Cancer centers need to be prepared for new, expensive therapies

At the end of 2017, there were over 2,000 immunotherapies in development—ranging from cellular therapies to cancer vaccines to checkpoint inhibitors. This means that cancer program leaders can no longer afford to wait to establish an infrastructure to deal with the evolving landscape of immunotherapy. Critical elements include:

  • Proactive evaluation of drugs in the pipeline and processes to manage those coming on the market;
  • Education and support for patients, including comprehensive side effect management and robust financial navigation;
  • Education and support for oncologists. (One-third of Trending Now in Cancer Care respondents said that their oncologists felt "very uncomfortable" managing immunotherapy-related side effects); and
  • Ongoing analysis of drug costs, revenues, and revenue cycle performance, including rate of denials.

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