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.

On the outpatient side, effective April 1, 2018, CMS capped Medicare beneficiaries' copayments for Kymriah and Yescarta at $1,340. CMS also set the hospital reimbursement rate at about $400,000 for Yescarta and $500,000 for Kymriah in the outpatient setting.

However, CAR T-cell therapies are typically administered in the inpatient setting. 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. Currently, 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.

The 2019 Medicare Inpatient Prospective Payment System proposed rule, which takes effect on October 1, 2018, proposes assigning ICD-10-PCS procedure codes XW033C3 and XW043C3 for CAR T-cell therapies to an existing code (MS-DRG 016), but they are also considering the idea of creating a new code.

Understandably, this has raised concerns around access for Medicare patients. CMS has also put plans in motion to provide additional reimbursement guidance over the next year by opening a National Coverage Analysis for CAR T-cell therapies. The National Coverage Analysis aims to develop a consistent national coverage policy for Medicare beneficiaries by May of 2019; a proposed decision is expected by February 16, 2019. To accomplish this analysis, the evidence on CAR T-cell therapies will be reviewed on August 22, 2018, during a Medicare Evidence Development and Coverage Advisory Committee meeting.

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.

CMS pulls plug on outcomes-based payment for Kymriah

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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 United States. At first, 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 would only send the bill for the cell product if the patient is responding at 30 days.

However, as reported by Politico in early July 2018, CMS administrators quietly suspended the arrangement.

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.