Related Medicare Advantage Medical/Pharmacy Coverage Policies

• ABECMA® (idecabtagene vicleucel) Humana Pharmacy Coverage Policy
• Breyanzi® (lisocabtagene maraleucel) Humana Pharmacy Coverage Policy
• CARVYKTI™ (ciltacabtagene autoleucel) Humana Pharmacy Coverage Policy
• Kymriah™ (tisagenlecleucel) Humana Pharmacy Coverage Policy
• Tecartus™ (brexucabtagene autoleucel) Humana Pharmacy Coverage Policy
• Yescarta™ (axicabtagene ciloleucel) Humana Pharmacy Coverage Policy

Related Documents
Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.

Chimeric Antigen Receptor (CAR) T-cell Therapy

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Description

Chimeric Antigen Receptor (CAR) T-cell therapy is a therapy that uses the body’s immune system, specifically the T cells, to fight cancer cells (immunotherapy). CAR T-cells have been genetically altered in order to improve the ability of the T-cells to fight cancer by creating a chimeric antigen receptor (CAR) that allows the T-cell to recognize an antigen on the surface of cancer cells.

Abecma® (idecabtagene vicleucel), a chimeric antigen receptor T cell therapy (CAR-T), is BCMA-directed for patients with multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Breyanzi® (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous T cell immunotherapy, which involves reprogramming a patient’s own T cells with a retroviral transduction to express a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells. Breyanzi® is indicated for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy.

Carvykti™ (ciltacabtagene autoleucel), a chimeric antigen receptor T cell therapy (CAR-T), is BCMA-directed for patients with multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Kymriah™ (tisagenlecleucel) is a CD19-directed genetically modified autologous T cell immunotherapy, which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells.

Kymriah™ is indicated for the treatment of (1) patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse and (2) adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma (3) Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Tecartus™ (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy, which involves reprogramming a patient’s own T cells with a retroviral transduction to express a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells. Tecartus™ is indicated for the treatment of 1) adult patients with relapsed or refractory mantle cell lymphoma (MCL); and 2) Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Yescarta™ (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy, which involves reprogramming a patient’s own T cells with a retroviral transduction to express a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells. Yescarta™ is indicated for the treatment of 1) adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy or large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma; and 2) adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

Please refer to the above CMS guidance for CAR T-cell therapy.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following:

• ABECMA® (idecabtagene vicleucel) Humana Pharmacy Coverage Policy
• Breyanzi® (lisocabtagene maraleucel) Humana Pharmacy Coverage Policy
• CARVYKTI™ (ciltacabtagene autoleucel) Humana Pharmacy Coverage Policy
• Kymriah™ (tisagenlecleucel) Humana Pharmacy Coverage Policy
• Tecartus™ (brexucabtagene autoleucel) Humana Pharmacy Coverage Policy
• Yescarta™ (axicabtagene ciloleucel) Humana Pharmacy Coverage Policy

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage