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HealthPartners

Coverage criteria policies

Chimeric antigen receptor/genetically engineered T-cell receptor (CAR-T) therapy

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for CAR-T therapy.

Coverage

  • CAR-T therapy is generally covered subject to the indications listed below and per your plan documents. Please see specific coverage criteria for the requested FDA- approved therapy below.
  • CAR-T therapy must be completed at a treatment center that has been certified to administer the specific type of therapy being requested. Please refer to your plan documents for information regarding any provider network limitations that may impact coverage.
  • All requests for CAR-T therapy will be reviewed by a Medical Director for determination that medical necessity criteria have been met.

Indications that are covered

Treatment with Kymriah (tisagenlecleucel) cellular immunotherapy is eligible for coverage when all of the following criteria are met:
  1. The requested cellular therapy will be administered at a certified treatment center
  2. The member is less than or equal to 25 years of age and has one of the following:
    1. B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse;
    2. Any bone marrow relapse after allogeneic stem cell transplant or member is ineligible for allogenic stem cell transplant. The member must be greater than 6 months from the stem cell transplant at the time of infusion if applicable;
    3. Refractory B-cell ALL as defined by not achieving a complete remission after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a complete remission after 1 cycle of standard chemotherapy for relapsed leukemia;
    4. Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse and has failed to respond to two tyrosine kinase inhibitors (TKI’s);
    5. Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse.
  3. The member is an adult with large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and lymphoma arising from follicular lymphoma that has relapsed or is refractory after two or more lines of systemic therapy. Relapsed or refractory is defined as the following:
    1. Progressive disease as best response to most recent therapy regimen
    2. Stable disease as best response to most recent therapy with duration no longer than 6 months from last dose
    3. Disease progression or relapse less than or equal to 12 months after autologous stem cell transplant (must have biopsy proven recurrence)
    4. If salvage chemotherapy is given post autologous stem cell transplant, the member must have had no response to or relapsed after the last line of therapy.
  4. The member has not previously been treated with CAR-T cell therapy
  5. Documentation indicates that the member has been screened for HBV, HCV and HIV before collection of cells for manufacturing of Kymriah (tisagenlecleucel) therapy. Results must indicate the absence of active or latent hepatitis B, active hepatitis C, and active HIV.
  6. Documentation indicates that the member does not have any of the following:
    1. History of malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease.
    2. Unresolved, serious adverse reactions from preceding chemotherapies (including pulmonary toxicity, cardiac toxicity or hypotension).
    3. High pre-infusion tumor burden (greater than 50% blasts in the bone marrow)
    4. Uncontrolled or accelerating tumor burden following lymphodepleting chemotherapy
    5. Active infection and/or inflammatory processes
    6. Active central nervous system malignant metastasis
    7. Active graft versus host disease

Indications that are not covered

  1. All uses of Kymriah (tisagenlecleucel) other than those described above, including but not limited to treatment of primary central nervous system lymphoma, are considered investigational.
  2. Repeat administration of Kymriah ((tisagenlecleucel) is considered investigational as there is insufficient evidence to establish the safety and efficacy of more than one treatment or its effect on healthcare outcomes.
Treatment with Yescarta (axicabtagene ciloleucel) cellular immunotherapy is eligible for coverage when all of the following criteria are met
  1. The requested cellular therapy will be administered at a certified treatment center
  2. The member is 18 years of age or older
  3. The member has been diagnosed with one of the following large B-cell subtypes of Non-Hodgkin lymphoma (NHL):
    1. Diffuse large B-Cell lymphoma (DLBCL) not otherwise specified
    2. Primary mediastinal large B-cell lymphoma
    3. High grade B-cell lymphoma
    4. DLBCL arising from follicular lymphoma (transformed follicular lymphoma)
  4. Documentation indicates chemotherapy-refractive disease or relapse as defined by one or more of the following:
    1. Progressive disease as best response to most recent therapy regimen
    2. Stable disease as best response to most recent therapy with duration no longer than 6 months from last dose
    3. Disease progression or relapse less than or equal to 12 months after autologous stem cell transplant (must have biopsy proven recurrence)
    4. If salvage chemotherapy is given post autologous stem cell transplant, the member must have had no response to or relapsed after the last line of therapy
  5. The member has not previously been treated with CAR-T cell therapy.
  6. Documentation indicates that the member has been screened for HBV, HCV and HIV before collection of cells for manufacturing of Yescarta (axicabtagene ciloleucel) therapy. Results must indicate the absence of HIV infection. History of hepatitis B or hepatitis C is permitted if the viral load is undetectable per polymerase chain reaction and/or nucleic acid testing.
  7. Documentation indicates that the member does not have any of the following:
    1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
    2. History of allogeneic stem cell transplantation
    3. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment
    4. Detectable cerebrospinal fluid malignant cells, or brain metastases, or history of central nervous system (CNS) lymphoma, cerebrospinal fluid malignant cells or brain metastases.
    5. History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
Indications that are not covered for Yescarta (axicabtagene ciloleucel) therapy
  1. All uses of Yescarta (axicabtagene ciloleucel) other than those described above, including but not limited to treatment of primary central nervous system lymphomas, are considered investigational.
  2. Repeat administration of Yescarta (axicabtagene ciloleucel) is considered investigational as there is insufficient evidence to establish the safety and efficacy of more than one treatment or its effect on healthcare outcomes.
  3. Administration of Yescarta (axicabtagene ciloleucel) to members less than 18 years of age is considered investigational as the safety and efficacy of this therapy have not been established in the pediatric population.

Definitions

Acute Lymphoblastic (or Lymphocytic) Leukemia (ALL) is a cancer of the blood and bone marrow (the spongy tissue inside bones where blood cells are made. Lymphocytes, a type of white blood cell responsible for the body’s immune response are primarily affected. The disease progresses rapidly and the bone marrow produces too many immature lymphocytes. These abnormal cells are unable to function properly and they can build up and crowd out other types of cells within the bone marrow. This action prevents the production of red blood cells which carry oxygen, other types of helpful white blood cells, and platelets which are needed for clotting.

Allogeneic stem cell transplant is one in which a person receives blood-forming stem cells from a genetically similar, but not identical donor.

Autologous stem cell transplant is one in which blood-forming stem cells are removed, stored and later given back to the same person.

B-cell acute lymphoblastic leukemia (also known as precursor B-Lymphoblastic or B-cell acute lymphocytic leukemia) is the most common type of acute lymphoblastic leukemia (ALL).

Chimeric antigen receptor (CAR) T cells and genetically engineered T-cell receptor (TCR) T cells are personalized, genetically modified, cell based immunotherapy used primarily to treat cancers of the blood.

Complete remission or response refers to the disappearance of all signs of cancer as a result of treatment. It does not indicate the cancer has been cured.

Induction chemotherapy aims to reduce the total body leukemia cell population to below the cytotoxically detectable level of 5 percent blasts (immature blood cells). The remaining burden of leukemia cells (minimal residual disease) will lead to relapse if no further therapy further therapy is administered. Reducing the level of residual ALL in the bone marrow at the end of induction to <0.01 percent as measured by flow cytometry, has been shown to predict for better long term outcomes.

Non-Hodgkin lymphoma (NHL) describes a large group of cancers of the lymphocytes (white blood cells) which are part of the body’s immune system. Diffuse large B-cell lymphoma is an aggressive form of NHL.

Partial remission or response refers to a decrease in the size of a tumor, or in the amount of cancer in the body, resulting from treatment.

Refractory disease is defined as those patient who fail to obtain a complete remission with induction chemotherapy; failure to eradicate all detectable leukemia cells (less than 5% blasts) from the bone marrow and blood with subsequent restoration of normal blood cell formation and development.

Relapsed disease describes the reappearance of leukemia cells in the bone marrow or peripheral blood after a complete remission was achieved.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The following codes are associated with administration of CAR-T therapy
HCPCS

Codes

Description

Q2040

Tisagenlecleucel, up to 250 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per infusion

Q2041

Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion

NDC

Codes

Description

00078-0846-19

Kymriah (Tisagenlecleucel) suspension

71287-0119-02

Yescarta Infusion Bag

CPT

Codes

Description

96365

Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour- When used to describe administration of CAR-T therapy

96366

Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure)- When used to describe administration of CAR-T therapy

96409

Chemotherapy administration; intravenous, push technique, single or initial substance/drug- When used to describe administration of CAR-T therapy

96411

Chemotherapy administration; intravenous, push technique, each additional substance/drug- When used to describe administration of CAR-T therapy

96413

Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug- When used to describe administration of CAR-T therapy

96415

Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to code for primary procedure)- When used to describe administration of CAR-T therapy

38241

Hematopoietic progenitor cell (HPC); autologous transplantation

38999

Unlisted procedure, hemic or lymphatic system- When used to describe administration of CAR-T therapy

XW033C3

Introduction of engineered autologous Chimeric Antigen Receptor T-cell Immunotherapy into peripheral vein, percutaneous approach, new technology group 3

XW043C3

Introduction of engineered autologous Chimeric Antigen Receptor T-cell Immunotherapy into central vein, percutaneous approach, new technology group 3

Applicable ICD-10- CM Diagnosis Codes

Codes

Description

C91.00

Acute lymphoblastic leukemia not having achieved remission

C91.02

Acute lymphoblastic leukemia, in relapse

C82.0- C82.99

Follicular lymphoma

C83.30-C83.39

Diffuse large B-cell lymphoma

C85.20-C85.29

Mediastinal (thymic) large B-cell lymphoma

Z51.11

Encounter for antineoplastic chemotherapy

Z51.12

Encounter for antineoplastic immunotherapy

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Freedman, A. Clinical manifestations, pathological features, and diagnostis of precursor B cell acute lymphiblastic leukemia/lymphoma. In: UpToDate, Lister, A. (Ed), UpToDate, Waltham, MA. (1/15/2018).
  2. Freedman, A. Treatment of relapsed or refractory diffuse large B cell lymphoma. In: UpToDate, Negrin, R. (Ed), UpToDate, Waltham, MA. (Accessed on 8/6/2018).
  3. Gaballa, S. Cancer immunotherapy with Chimeric Antigen Receptor (CAR) T- Cells. Besa, E. (Ed). Medscape. Accessed 10/9/2017 from https://emedicine.medscape.com/article/2500108-overview
  4. Hayes, Inc. Hayes Medical Technology Directory Report. Adoptive Immunotherapy Using Genetically Modified Lymphocytes for Lymphoproliferative Disorders and Hematological Malignancies. Lansdale, PA: Hayes, Inc.; Sept, 2017.
  5. Hayes, Inc. Hayes Prognosis Overview. Kymriah(Tisagenlecleucel). Lansdale, PA: Hayes, Inc.; February, 2018
  6. Hayes, Inc. Hayes Prognosis Overview. Yescarta (Axicabtagene Ciloleucel). Lansdale, PA: Hayes, Inc.; Dec, 2017.
  7. Hayes, Inc. Hayes Prognosis Overview. Kymriah (tisagenlecleucel) for Diffuse Large B-Cell Lymphoma. Lansdale, PA: Hayes, Inc. May, 2018.
  8. Horton, T. and Steuber, C. Overview of the treatment of acute lymphoblastic leukemia on children and adolescents. In: UpToDate, Park, J. (Ed), UpToDate, Waltham, MA. (Accessed on 10/25/2017).
  9. Kite Pharma. Highlights of prescribing information- YESCARTA™ (axicabtagene ciloleucel) suspension for intravenous infusion. Retrieved from https://www.yescarta.com/
  10. Kochenderfer, J. N., Dudley, M. E., Kassim, S. H., Somerville, R. P., Carpenter, R. O., Stetler-Stevenson, M., ... & Raffeld, M. (2014). Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma and Indolent B-Cell Malignancies Can Be Effectively Treated With Autologous T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor.
  11. Larson, R. Treatment of relapsed or refractory acute lymphoblastic leukemia in adults. In: UpToDate, Lowenberg, B. (Ed), UpToDate, Waltham, MA. (Accessed on 10/25/2017).
  12. Lee. D., Kochenderfer, J., Stetler-Stevenson, M., Cui, Y., Delbrook, C. Feldman, S. …& Mackall, C. (2015). T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. The Lancet; vol 385; Feb, 2015.
  13. Locke, F. L., Neelapu, S. S., Bartlett, N. L., Siddiqi, T., Chavez, J. C., Hosing, C. M. ... & Jiang, Y. (2017). Phase 1 results of ZUMA-1: a multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Molecular Therapy, 25(1), 285-295.
  14. Maude, S. L., Frey, N., Shaw, P. A., Aplenc, R., Barrett, D. M., Bunin, N. J. ... & Mahnke, Y. D. (2014). Chimeric antigen receptor T cells for sustained remissions in leukemia. New England Journal of Medicine, 371(16), 1507-1517.
  15. Maude, S. L., Laetsch, T. W., Buechner, J., Rives, S., Boyer, M., Bittencourt, H. ... & Qayed, M. (2018). Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. The New England journal of medicine, 378(5), 439.
  16. National CancerIinstitute (2017) CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers. Retrieved from https://www.cancer.gov/about-cancer/treatment/research/car-t-cells
  17. National Comprehensive Cancer Network (2017). NCCN Practice Guidelines in Oncology- Acute Lymphoblastic Leukemia. Version 3.2017. Retrieved from https://www.nccn.org/professionals/physician_gls/default.aspx
  18. National Comprehensive Cancer Network (2018). NCCN Practice Guidelines in Oncology- Diffuse Large B-Cell Lymphoma. Version 4.2018. Retrieved from https://www.nccn.org/professionals/physician_gls/pdf/b-cell_blocks.pdf
  19. Neelapu, S. S., Locke, F. L., Bartlett, N. L., Lekakis, L. J., Miklos, D. B., Jacobson, C. A., ... & Timmerman, J. M. (2017). Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. New England Journal of Medicine, 377(26), 2531-2544
  20. Novartis Pharmaceuticals Corporation. Highlights of prescribing information- KYMRIAH™ (tisagenlecleucel) suspension for intravenous infusion. Retrieved from https://www.hcp.novartis.com/products/kymriah/acute-lymphoblastic-leukemia-children/
  21. Roberts, Z. J., Better, M., Bot, A., Roberts, M. R., & Ribas, A. (2017). Axicabtagene ciloleucel, a first-in-class CAR T cell therapy for aggressive NHL. Leukemia & Lymphoma. Oct 23:1-12. (Epub ahead of print).
  22. Schuster, S. J., Svoboda, J., Chong, E. A., Nasta, S. D., Mato, A. R., Anak, Ö., ... & Wasik, M. (2017). Chimeric antigen receptor T cells in refractory B-cell lymphomas. New England Journal of Medicine, 377(26), 2545-2554.
  23. Terwilliger, T and Abdul-Hay, M. (2017) Acute lymphoblastic leukemia: a comprehensive review and 2017 update. Blood Cancer Journal 7(6), e577.

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Policy activity

  • 02/13/2018 - Date of origin
  • 08/08/2018 - Effective date
Revision date
  • 08/08/2018

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