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National Coverage Analysis (NCA) Tracking Sheet for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

CAR T-cell therapy is a precision cancer treatment wherein each treatment dose is individually manufactured for the patient using their own T-cells, a type of white blood cell known as a lymphocyte. CAR T-cell therapy is a rapidly emerging adoptive cell transfer immunotherapy for select patients with relapsed or refractory cancers. Treatment protocols vary, but may be summarized in five steps:

  1. lymphocyte harvesting from the patient with cancer;
  2. creation of cancer-targeting lymphocytes in vitro using various immune modulators;
  3. selection of lymphocytes with reactivity to cancer antigens using enzyme-linked immuno-assay;
  4. depletion of the patient's remaining lymphocytes using immunosuppressive agents;
  5. transfusion of the cancer-targeting lymphocytes back into the patient with cancer-this transfusion represents one treatment.

In 2017, the Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah®) and axicabtagene ciloleucel (Yescarta®) CAR T-cell therapies for the treatment of certain relapsed or refractory leukemias and lymphomas. The two FDA-approved therapies include boxed warnings (calling attention to serious and life-threatening risks) and safety monitoring through an FDA Risk Evaluation and Mitigation Strategy (REMS). To date, few Medicare patients have been studied and follow up has been limited. The majority of patients who received CAR T-cell therapy also experienced adverse events including cytokine release syndrome and neurologic effects. Initial studies were also confined to the inpatient hospital setting.

On August 22, 2018, we are convening a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting to review the available evidence on this topic.

Drugs and Biologicals
Inpatient Hospital Services
Requestor Name(s)Efrem Castillo, MD, Medicare & Retirement Chief Medical Officer, UnitedHealthcare
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated05/16/2018
Expected NCA Completion Date05/17/2019
Public Comment Period05/16/2018 - 06/15/2018
Proposed Decision Memo Released02/15/2019
Proposed Decision Memo Public Comment Period02/15/2019 - 03/17/2019 
Decision Memo Released08/07/2019
Comments for this NCAView Public Comments
Lead Analyst(s)
  • Katherine B. Szarama, PhD
Lead Medical Officer(s)
  • Lori A. Paserchia, MD

May 16, 2018

CMS initiates this national coverage analysis for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

February 15, 2019

May 17, 2019

CMS will not be issuing a final National Coverage Determination on CAR T-cell therapy for cancer today, but a decision is forthcoming

August 7, 2019

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