CAR-T Cell Cancer Drug Coverage
A look into how CMS may assess emerging drug therapies
The number of new cancer diagnoses is estimated to continue to grow each year, reaching 1.9 million newly diagnosed in 2020 (CDC). At the same time, new innovations in cancer care continue to come online, including immunotherapy drugs, which may help increase survivorship rates as well. Chimeric Antigen Receptor T-cell, or CAR-T, is one of those new drug therapies.
CAR-T is an immunotherapy where a receptor, called a CAR, is produced on the surface of the T-cell. Those CARs are used to target a protein, called an antigen, on the cancer cell itself (CMS proposed CAR-T decision memo). In this way, the drug boosts the body’s ability to specifically target cancer cells. In 2017, the Federal Drug Administration (FDA) approved the first two CAR-T cell drugs—KMRYIAH® (Novartis) and YESCARTA® (Kite, A Gilead Company). Cost estimates for these types of therapies have ranged from hundreds of thousands of dollars to over a million.
In its final 2019 Inpatient Prospective Payment System Rule (IPPS), the Centers for Medicare & Medicaid Services (CMS) assigned CAR-T-cell therapies to Medicare Severity-Diagnosis Related Group (MS-DRG) code 016. The base MS-DRG 016 payment is $36,000. In the final 2019 IPPS rule CMS also approved KYMRIAH® and YESCARTA® for new technology add-on payments, but noted the maximum for those add-on payments is $186,500. CMS also then opened a national coverage determination (NCD) analysis on CAR T-cell therapy for Medicare beneficiaries. That NCD was requested by UnitedHealthcare due to the newness and potential cost of this drug therapy.
On February 15, 2019, CMS released its proposed national coverage determination for CAR-T therapies as “coverage with evidence development” (CED). While CMS is proposing to cover these CAR-T therapies, the CED puts into place a different paradigm governing that coverage. CMS chose to use the CED because CAR-T cell therapies are new and there is limited clinical evidence to assess the drug broadly across patient populations.
CED Requirements for CAR-T
As described in the proposed NCD, a CED is where “Medicare covers items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data. In making coverage decisions involving CED, CMS decides after a formal review of the medical literature to cover an item or service only in the context of an approved clinical study or when additional clinical data are collected to assess the appropriateness of an item or service for use with a particular beneficiary.”
Under the CED proposal, CAR-T therapies can be provided only in hospitals that have an acceptable Cellular Therapy Program. For example, the program must have a designated area for patients, must have certain staff – such as a Clinical Program Director, a Quality Manager and a minimum of one physician experienced in cellular therapy – and have a variety of required protocols and procedures. Both the patient and the hospital have to be enrolled in an approved clinical trial or registry. The hospital will be required to monitor and track the progress of the patient for two years. Only FDA-approved indications are covered, which at this point are those individuals with relapsed or refractory cancer and are not currently experiencing any comorbidity that would otherwise preclude patient benefit.
More details on the study requirements itself are still needed, and HI2 will be watching for those. In the end, CAR-T cell therapy will be a case study to watch on how our health care system responds to new, innovative drug therapies that hold the potential for better health outcomes but at a significant price.
Jennifer Boese is the Director of Health Care Policy at CLA. She is a highly successful public policy, legislative, advocacy and political affairs leader, including working in both the state and federal government as well as the private sector. She brings over 20 years of government relations and public policy knowledge with her to CLA. Well over half of her career has been spent dedicated to health care policy and the health care industry, affording her a deep understanding of the health care market and environment, health care organizations and health care stakeholders. Her role at CLA is to provide thought leadership, policy analysis and strategic insights to health care providers across the continuum related to the industry's ongoing transformation towards value. A key focus of that work is on market innovations and emerging payment models. Her goal is to help CLA clients navigate and thrive in an increasingly dynamic health care environment.
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