HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-180-004
Topic:
Chimeric Antigen Receptor T-Cell Therapy
Section:
Injections
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
September 2018
Annual Review:
June 2018
 
 

Chimeric antigen receptor T-cell (CAR-T) therapy is a cellular therapy that uses genetic engineering to alter a patient’s own T-cells to produce unique receptors on their cell surface that recognize a specific protein.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Tisagenlecleucel (Kymriah®) may be considered medically necessary for the treatment of refractory* or second or later relapsed** B-cell precursor acute lymphoblastic leukemia (ALL) in individuals up to and including 25 years of age when all of the following criteria are met:

  • Documentation of CD19 tumor expression demonstration in bone marrow or peripheral blood;  and
  • No uncontrolled bacterial, viral or fungal infection; and
  • No presence of grade 2-4 acute or extensive chronic graft-versus-host disease (GVHD); and
  • No active central nervous system involvement by malignancy; and
  • No prior anti-CD19/anti-CD3 therapy (bispecific T-cell engager, such as blinatumumab), or any other anti-CD19 therapy (such as inotuzumab ozogamycin) in the four (4) weeks preceding the apheresis collection; and  
  • No prior gene therapy; and
  • Karnofsky/Lansky score greater than or equal to 50; and
  • No live vaccination within two (2) weeks prior to initiation of lymphodepleting chemotherapy; and
  • Apheresis product received and accepted by manufacturing site.

Tisagenlecleucel (Kymriah) may be considered medically necessary for the treatment of Philadelphia chromosome-positive ALL in individuals up to and including 25 years of age when all of the following criteria are met:

  • Failed two (2) lines of tyrosine kinase inhibitor (TKI); and
  • Documentation of CD19 tumor expression demonstration in bone marrow or peripheral blood;  and
  • No uncontrolled bacterial, viral or fungal infection; and
  • No presence of grade 2-4 acute or extensive chronic GVHD; and
  • No active central nervous system involvement by malignancy; and
  • No prior anti-CD19/anti-CD3 therapy (bispecific T-cell engager, such as blinatumumab), or any other anti-CD19 therapy (such as inotuzumab ozogamycin) in the four (4) weeks preceding the apheresis collection; and  
  • No prior gene therapy; and
  • Karnofsky/Lansky score greater than or equal to 50; and
  • No live vaccination within two (2) weeks prior to initiation of lymphodepleting chemotherapy; and 
  • Apheresis product received and accepted by manufacturing site.

Tisagenlecleucel (Kymriah) may be considered medically necessary for the treatment of adult individuals 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; when all of the following criteria are met:

  • Greater than or equal to 18 years of age; and
  • Greater than or equal to two (2) lines of chemotherapy, including rituximab and anthracycline, or relapsed following autologous hematopoietic stem cell transplantation (HSCT); and
  • No active central nervous system malignancy; and
  • No prior allogeneic HSCT; and
  • ECOG performance status greater than or equal to two (2); and
  • Creatinine clearance greater than or equal to 60; and
  • Alanine aminotransferase less than or equal to five (5) times the upper limit of normal; and
  • Cardiac ejection fraction greater than or equal to 45%; and
  • Absolute lymphocyte count greater than or equal to 300/μL; and
  • No prior gene therapy; and
  • Apheresis product received and accepted by manufacturing site.

Tisagenlecleucel (Kymriah) is considered experimental/investigational and therefore non-covered for any other indications than those listed above. There is insufficient evidence regarding its effectiveness and safety for any other indications.

* Refractory is defined by not achieving an initial complete remission after two (2) cycles of a standard chemotherapy regimen (primary refractory). Subjects who were refractory to subsequent chemotherapy regimens after an initial remission are considered chemorefractory.

**Relapse is defined by greater than 5% lymphoblasts and second or subsequent bone marrow (BM) relapse, or any BM relapse after allogeneic (stem cell transplant) SCT and must be greater than or equal to six (6) months from SCT at the time of tisagenlecleucel infusion.

Because of the risk of cytokine release syndrome (CRS) and neurological toxicities, Kymriah is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS. The required components of the KYMRIAH REMS are:

  • Healthcare facilities that dispense and administer Kymriah 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 administration within two hours after Kymriah infusion, if needed for treatment of CRS.
  • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer tisagenlecleucel (Kymriah) are trained about the management of CRS and neurological toxicity.

Q2040

 

 

 

 

 

 




Axicabtagene ciloleucel (Yescarta®) may be considered medically necessary for individuals 18 years of age or older when ALL the following criteria are met:

  • Individual has a diagnosis of ANY ONE of the following aggressive forms of NHL:
    • Diffuse large B-cell lymphoma (DLBCL), not otherwise specified; or
    • High-grade B-cell lymphoma; or
    • Double hit lymphoma; or
    • Primary mediastinal large B-cell lymphoma (PMBCL); or
    • Transformed follicular lymphoma (t-FL); or
    • Monomorphic post-transplant B-lymphoproliferative disorder (B-PTLD); and
  • Individual has relapsed and/or refractory disease after 2 or more lines of therapy; or
  • Individual has t-FL and fails to achieve complete remission with one line of chemoimmunotherapy incorporating anthracycline or anthracenedione, at a minimum; or
  • Individual has monomorphic B-PTLD which has progressed after reduction or withdrawal of immunosuppression and has failed to achieve complete remission with salvage chemoimmunotherapy or relapses after achieving complete remission; and
  • No active central nervous system involvement by malignancy; and
  • No prior anti-CD19/anti-CD3 therapy (bispecific T-cell engager, such as blinatumumab), or any other anti-CD19 therapy (such as inotuzumab ozogamycin) in the four (4) weeks preceding the apheresis collection; and 
  • No prior cellular gene therapy; and
  • ECOG scale of performance status less than or equal to one (1); and
  • No live vaccination within two weeks prior to initiation of lymphodepleting chemotherapy; and
  • Apheresis product received and accepted by manufacturing site.

Axicabtagene ciloleucel (Yescarta) is considered experimental/investigational and therefore non-covered for any other indication than those listed above. There is insufficient evidence regarding its effectiveness and safety for any other indications.


Because of the risk of CRS and neurological toxicities, axicabtagene ciloleucel (Yescarta) is available only through a restricted program under a REMS called the YESCARTA REMS. The required components of the YESCARTA REMS are:

  • Healthcare facilities that dispense and administer axicabtagene ciloleucel (Yescarta) 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 individual for administration within two hours after axicabtagene ciloleucel (Yescarta) infusion, if needed for treatment of CRS.
  • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administeraAxicabtagene ciloleucel (Yescarta) are trained about the management of CRS and neurological toxicities. 

Q2041

 

 

 

 

 

 




NOTE: Dosage recommendations per FDA label. 

C9399

 

 

 

 

 

 




Related Policies

Refer to medical policy I-31 Tocilizumab (Actemra) for additional information

Refer to medical policy S-11 Pheresis Therapy for additional information.


Covered Diagnosis Codes for Q2040

C83.30

C83.31

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C85.20

C85.21

C85.22

C85.23

C85.24

C85.25

C85.26

C85.27

C85.28

C85.29

C91.00

C91.02

 

 

 

 

 

 

 

Covered Diagnosis Codes for Q2041

B20

C83.30

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C85.80

C85.81

C85.82

C85.83

C85.84

C85.85

C85.86

C85.87

C85.88

C85.89

 



Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Treatment with tisagenlecleucel (Kymriah) and Axicabtagene ciloleucel (Yescarta) are typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require moni is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



Links






This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.