Chimeric Antigen Receptor T-Cell (CAR-T) and Advanced Cellular/Immune Effector Cell Therapy

Drug and Biologic Coverage Policy

Effective Date ...... 5/15/2021 Next Review Date… ...... 5/1/2022 Coverage Policy Number ...... 1808

Table of Contents Related Coverage Resources

Coverage Policy ...... 1 Adoptive Immunotherapy - (0225) FDA Approved Indications ...... 3 Immunomodulators - (1805) Recommended Dosing ...... 4 General Background ...... 6 Coding/Billing Information ...... 7 References ...... 7

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

Coverage Policy

Chimeric Antigen Receptor T-Cell (CAR-T) and Advanced Cellular/Immune Effector Cell Therapy includes the following products: • Yescarta™ (axicabtagene ciloleucel) • Tecartus™ (brexucabtagene autoleucel) • Kymriah™ (tisagenlecleucel)

I. Axicabtagene ciloleucel (Yescarta) is considered medically necessary when ALL of the following criteria are met: A. Age 18 years of age and older B. ANY of the following: i. Diagnosis of any of the following large B-cell lymphoma subtypes: diffuse large B-cell lymphoma [DLBCL] not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, AIDS-related B-cell lymphoma, human herpes virus 8-positive DLBCL, and post-transplant lymphoproliferative disorders [B-cell type]); AND a. Disease is relapsed or refractory after two or more lines of systemic therapy ii. Diagnosis of DLBCL arising from follicular lymphoma; AND

Page 1 of 8 Coverage Policy Number: 1808 a. The individual has received prior treatment with two or more chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated iii. Diagnosis of DLBCL arising from nodal marginal zone lymphoma; AND a. The individual has received prior treatment with two or more chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated C. Individual is not being treated for primary central nervous system lymphoma D. No prior use of axicabtagene ciloleucel (Yescarta) or another CD19-directed CAR-T therapy

Authorization is for a single dose.

Axicabtagene ciloleucel (Yescarta) is considered not medically necessary for all other uses including the following: • Repeat administration of axicabtagene ciloleucel (Yescarta) • Acute lymphocytic leukemia • Burkitt lymphoma • Chronic lymphocytic leukemia • Mantle cell lymphoma • Small lymphocytic leukemia • Solid tumors • Splenic marginal zone lymphoma

II. Brexucabtagene autoleucel (Tecartus) is considered medically necessary when ALL of the following criteria are met: A. Individual is 18 years of age or older B. Diagnosis relapsed or refractory of Mantle Cell Lymphoma (MCL) C. Individual has previously received chemoimmunotherapy (for example, anthracycline- or bendamustine- based chemotherapy, anti-CD20 monoclonal antibody) AND a Bruton tyrosine kinase inhibitor D. Individual has received lymphodepleting (for example, cyclophosphamide and fludarabine) chemotherapy prior to Tecartus infusion E. Tecartus is prescribed by, or in consultation with, a hematologist or oncologist F. No prior use of another CD19-directed CAR-T therapy (for example, Kymriah or Yescarta)

Authorization is for a single dose.

Brexucabtagene autoleucel (Tecartus) is considered not medically necessary for all other uses.

III. Tisagenlecleucel (Kymriah) is considered medically necessary when ALL of the following criteria are met: A. EITHER of the following: 1) Treatment for an individual up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is ONE of the following: a. Disease is refractory, or in second or later relapse b. Minimal residual disease positive after consolidation therapy c. Philadelphia chromosome-positive and ONE of the following: i. Less than complete response ii. High-risk genetics iii. Tyrosine kinase inhibitor (TKI) intolerant or refractory (TKIs include: Sprycel® [dasatinib tablets], imatinib tablets, Iclusig® [ponatinib tablets], Tasigna® [nilotinib capsules], and Bosulif® [bosutinib tablets]) iv. Relapse post-hematopoietic stem cell transplantation 2) Treatment for an adult when ANY of the following criteria are met:

Page 2 of 8 Coverage Policy Number: 1808 a. Diagnosis of any of the following large B-cell lymphoma subtypes: diffuse large B- cell lymphoma [DLBCL] not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, AIDS-related B-cell lymphoma, human herpes virus 8-positive DLBCL, and post-transplant lymphoproliferative disorders [B- cell type]); AND i. Disease is relapsed or refractory after two or more lines of systemic therapy b. Diagnosis of DLBCL arising from follicular lymphoma; AND i. The individual has received prior treatment with two or more chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated c. Diagnosis of DLBCL arising from nodal marginal zone lymphoma; AND i. The individual has received prior treatment with two or more chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated B. Individual is not being treated for primary central nervous system lymphoma C. No prior use of axicabtagene ciloleucel (Yescarta) or another CD19-directed CAR-T therapy

Authorization is for a single dose.

Tisagenlecleucel (Kymriah) is considered not medically necessary for all other uses including the following: • Repeat administration of tisagenlecleucel (Kymriah) • Acute Myeloid Leukemia (AML) • Chronic lymphocytic leukemia • Hodgkin lymphoma • Mantle cell lymphoma • Plasma cell disorders • Solid tumors • T-cell leukemia/lymphoma

When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy.

Note: Receipt of sample product does not satisfy any criteria requirements for coverage.

FDA Approved Indications

FDA Approved Indication Axicabtagene ciloleucel (Yescarta) Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory 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. Limitation of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

REMS Program • Because of the risk of CRS and neurologic toxicities, Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS • The required components of the Yescarta REMS are: o Healthcare facilities that dispense and administer Yescarta must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate

Page 3 of 8 Coverage Policy Number: 1808 access to tocilizumab, and ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of CRS o Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer Yescarta are trained about the management of CRS and neurologic toxicities • Further information is available at www.YescartaREMS.com or 1-844-454-KITE (5483)

Brexucabtagene autoleucel (Tecartus) Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

REMS Program • Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program • The required components of the Yescarta and Tecartus REMS Program are: o Healthcare facilities that dispense and administer Tecartus must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of two doses of tocilizumab are available for each patient for infusion within two hours after Tecartus infusion, if needed for treatment of CRS o Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer Tecartus are trained in the management of CRS and neurologic toxicities • Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483)

Tisagenlecleucel (Kymriah) Kymriah is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: • Pediatric and Young Adult Relapsed or Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (ALL) Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

• Adult Relapsed or Refractory (r/r) Diffuse Large B-Cell Lymphoma (DLBCL) 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.

Limitation of Use: Kymriah is not indicated for treatment of patients with primary central nervous system lymphoma.

Recommended Dosing

FDA Recommended Dosing Axicabtagene ciloleucel (Yescarta) Dose Each single infusion bag of Yescarta contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL. The target dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.

Administration

Page 4 of 8 Coverage Policy Number: 1808 Yescarta is for autologous use only. The patient’s identity must match the patient identifiers on the Yescarta cassette and infusion bag. Do not infuse Yescarta if the information on the patient-specific label does not match the intended patient.

Preparing Patient for Yescarta Infusion Confirm availability of Yescarta prior to starting the lymphodepleting regimen.

Pre-treatment • Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously on the fifth, fourth, and third day before infusion of Yescarta.

Premedication • Administer acetaminophen 650 mg PO and diphenhydramine 12.5 mg intravenously or PO approximately 1 hour before Yescarta infusion. • Avoid prophylactic use of systemic corticosteroids, as it may interfere with the activity of Yescarta.

Brexucabtagene autoleucel (Tecartus) Dose Each single infusion bag of Tecartus contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL. The dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.

Administration Tecartus is for autologous use only. The patient’s identity must match the patient identifiers on the Tecartus cassette and infusion bag. Do not infuse Tecartus if the information on the patient-specific label does not match the intended patient.

Preparing Patient for Tecartus Infusion Confirm availability of Tecartus prior to starting the lymphodepleting chemotherapy regimen.

Pre-treatment Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously on each of the fifth, fourth, and third days before infusion of Tecartus.

Premedication • Premedicate with acetaminophen and diphenhydramine or another H1-antihistamine approximately 30 to 60 minutes prior to Tecartus infusion. • Avoid prophylactic use of systemic corticosteroids as it may interfere with the activity of Tecartus.

Tisagenlecleucel (Kymriah) Administer a lymphodepleting regimen if needed before infusion of Kymriah. Premedicate with acetaminophen and an H1-antihistamine. Confirm availability of tocilizumab prior to infusion.

Dosing of Kymriah is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. • Pediatric and Young Adult B-cell ALL (up to 25 years of age) o For patients 50 kg or less, administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight intravenously. 8 o For patients above 50 kg, administer 0.1 to 2.5 x 10 total CAR-positive viable T cells (non-weight based) intravenously. • Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma 8 o Administer 0.6 to 6.0 x 10 CAR-positive viable T cells intravenously.

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General Background

Pharmacology Axicabtagene ciloleucel and tisagenlecleucel are created from the individual’s own T cells, which are genetically engineered to target the CD19 antigen on B cells. Axicabtagene ciloleucel and tisagenlecleucel undergo rapid expansion (replication) upon intravenous (IV) administration.

Professional Societies/Organizations National Comprehensive Cancer Network (NCCN) guidelines for B-cell lymphoma (version 1.2020 – January 22, 2020) recommend Yescarta for the treatment of a variety of B-cell lymphomas in individuals with relapsed or refractory disease and after at least two chemotherapy regimens. Recommended indications include DLBCL which transformed from follicular lymphoma or nodal marginal zone lymphoma, DLBCL, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, AIDS-related B-cell lymphoma, human herpes virus 8 (HHV8)-positive DLBCL, and post-transplant lymphoproliferative disorders (category 2A). (NCCN, 2020b; NCCN, 2020c)

The National Comprehensive Cancer Network (NCCN) guidelines for B-cell lymphomas (version 3.2020 – August 4, 2020) recommend Tecartus for the subsequent treatment of relapsed or refractory mantle cell lymphoma, following treatment with chemoimmunotherapy and Bruton tyrosine kinase inhibitor therapy. (NCCN, 2020d; NCCN, 2020e)

National Comprehensive Cancer Network (NCCN) guidelines for ALL (version 1.2020 – January 15, 2020) address Kymriah. In Philadelphia chromosome-positive B-cell ALL, Kymriah is cited as a treatment option for individuals < 26 years of age and with refractory disease or ≥ two relapses and failure of two tyrosine kinase inhibitors (TKIs) [category 2A]. For Philadelphia chromosome-negative B-cell ALL, Kymriah is listed as a therapy option for individuals < 26 years of age and with refractory disease or ≥ two relapses (category 2A). (NCCN, 2020a; NCCN, 2020c)

The NCCN guidelines for Pediatric ALL (version 2.2020 – November 25, 2019) recommends Kymriah for the treatment of individuals with refractory or ≥ 2 relapses, TKI intolerant or refractory disease, or relapse post- hematopoietic stem cell transplantation (category 2A). Kymriah is also recommended for individuals who are minimal residual disease positive after consolidation therapy, and in Philadelphia chromosome-positive disease with less than complete response, or high-risk genetics. (NCCN, 2020c; NCCN, 2020d)

The NCCN guidelines for B-cell lymphomas (version 1.2020 – January 22, 2020) recommend Kymriah for the treatment of the following relapsed or refractory disease after at least two course of systemic therapy: DLBCL following transformation from follicular lymphoma or nodal marginal zone lymphoma, DLBCL, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, AIDS-related B-cell lymphoma, human herpes virus 8 (HHV8)-positive DLBCL, and post-transplant lymphoproliferative disorders (category 2A). (NCCN, 2020b; NCCN, 2020c)

The American Board of Internal Medicine’s (ABIM) Foundation Choosing Wisely® Initiative No recommendations are available for chimeric antigen receptor T-Cell (CAR-T) and advanced cellular/immune effector cell therapy.

Centers for Medicare & Medicaid Services - National Coverage Determinations (NCDs) There are no CMS National Coverage Determinations for chimeric antigen receptor T-Cell (CAR-T) and advanced cellular/immune effector cell therapy.

Off Label Uses AHFS Drug Information 2020 Edition does not support any off-label uses of either axicabtagene ciloleucel or tisagenlecleucel.

Page 6 of 8 Coverage Policy Number: 1808 Experimental, Investigational, Unproven Uses Axicabtagene ciloleucel has also been studied in a limited number of individuals for treating acute lymphocytic leukemia, chronic lymphocytic leukemia, mantle cell lymphoma, and small lymphocytic leukemia. (Brudno, 2016; Kochenderfer, 2010; Lee, 2015; Savoldo, 2011) At this time there is insufficient evidence to support use of axicabtagene ciloleucel in these conditions and NCCN does not provide recommendations for its use. There is also no data supporting the repeat administration of axicabtagene ciloleucel.

Tisagenlecleucel has also been studied in a limited number of individuals for treating chronic lymphocytic leukemia, multiple myeloma, and mantle cell lymphoma. (Fraietta, 2016; Garfall, 2015; Porter, 2011; Porter, 2015; Ruella, 2016) At this time there is insufficient evidence to support use of tisagenlecleucel in these conditions and NCCN does not provide recommendations for its use. There is also no data supporting the repeat administration of tisagenlecleucel.

Coding/Billing Information

Note: 1) This list of codes may not be all-inclusive. 2) Deleted codes and codes which are not effective at the time the service is rendered may not be eligible for reimbursement.

Considered Medically Necessary when criteria in the applicable policy statements listed above are met:

CPT®* Description Codes 0537T Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day 0538T Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (e.g., cryopreservation, storage) 0539T Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration 0540T Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous

HCPCS Description Codes C9073 Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose (Code deleted 03/31/2021) Q2041 Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 car positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose Q2042 Tisagenlecleucel, up to 600 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose Q2053 Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose

References

1. Brudno JN, Somerville RP, Shi V, et al. Allogeneic T cells that express an anti-CD19 chimeric antigen receptor induce remissions of B-cell malignancies that progress after allogeneic hematopoietic stem-cell transplantation without causing graft-versus-host disease. J Clin Oncol. 2016; 34 (10): 1112-1121. 2. Fraietta JA, Beckwith KA, Patel PR, et al. Ibrutinib enhances chimeric antigen receptor T-cell engraftment and efficacy in leukemia. Blood. 2016; 127 (9): 1117-1127.

Page 7 of 8 Coverage Policy Number: 1808 3. Garfall AL, Maus MV, Hwang WT, et al. Chimeric Antigen Receptor T Cells against CD19 for Multiple Myeloma. N Engl J Med. 2015; 373 (11): 1040-1047. 4. Kite Pharma. Yescarta (axicabtagene ciloleucel) [prescribing information]. Santa Monica, CA: Kite Pharma; May 2019. 5. Kochenderfer JN, Wilson WH, Janik JE, et al. Eradication of B-lineage cells and regression of lymphoma in a patient treated with autologous T cells genetically engineered to recognize CD19. Blood. 2010; 116 (20): 4099-4102. 6. Kymriah (tisagenlecleucel) Risk Evaluation and Mitigation Strategy (REMS) Novartis Pharmaceuticals Corporation website. http://www.kymriah-rems.com/. Published 2017. 7. Lee DW, Kochenderfer JN, Stetler-Stevenson M, et al. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015; 385 (9967): 517-528. 8. McEvoy GK, ed. 2020. AHFS Drug Information. Bethesda, MD: American Society of Health-System Pharmacists, Inc; 2020. 9. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Acute Lymphoblastic Leukemia Version 1.2020; [available with free subscription] https://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Updated January 15, 2020(a). Accessed April 17, 2020. 10. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®): B-Cell Lymphomas Version 1.2020; [available with free subscription] https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Updated January 22, 2020(b). Accessed April 17, 2020. 11. The NCCN B-Cell Lymphomas Clinical Practice Guidelines in Oncology (version 3.2020 – August 4, 2020). © 2020 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed on August 5, 2020(d). 12. National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. 2020(c); Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed April 17, 2020. 13. The NCCN Drugs and Biologics Compendium. © 2020 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed on August 5, 2020(e). Search term: brexucabtagene. 14. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Pediatric Acute Lymphoblastic Leukemia Version 2.2020; [available with free subscription] https://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Updated November 25, 2019(d). Accessed April 17, 2020. 15. Novartis Pharmaceutical Corporation. Kymriah (tisagenlecleucel) [prescribing information]. East Hanover, NJ: Novartis Pharmaceutical Corporation; May 2018. 16. Porter DL, Hwang WT, Frey NV, et al. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med. 2015; 7 (303): 303ra139. 17. Porter DL, Levine BL, Kalos M, Bagg A, June CH. Chimeric antigen receptor-modified T cells in chronic lymphoid leukemia. N Engl J Med. 2011; 365 (8): 725-733. 18. Ruella M, Kenderian SS, Shestova O, et al. The Addition of the BTK Inhibitor Ibrutinib to Anti-CD19 Chimeric Antigen Receptor T Cells (CART19) Improves Responses against Mantle Cell Lymphoma. Clin Cancer Res. 2016; 22 (11): 2684-2696. 19. Savoldo B, Ramos CA, Liu E, et al. CD28 costimulation improves expansion and persistence of chimeric antigen receptor-modified T cells in lymphoma patients. J Clin Invest. 2011; 121 (5): 1822-1826. 20. Yescarta REMS program live training. Kite Pharma website. https://www.Yescartarems.com/wp- content/uploads/Yescarta-rems-training-deck.pdf. Published 2017.

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