Coverage Policies

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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 01/01/2021 Title: Kymriah (tisagenlecleucel)
Revision Date: Document: BI666:00
CPT Code(s): Q2042
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Kymriah requires prior authorization.

2)    Kymriah is used to treat B-cell Precursor Acute Lymphoblastic Leukemia and Diffuse Large B-cell Lymphoma.


Medical Statement

Initial Approval Criteria:

A.   B-cell Precursor Acute Lymphoblastic Leukemia (second relapse or refractory)

1.    The member is age 25 years or younger.

2.    Medication is prescribed by an oncologist or in consultation with an oncologist.

3.    The member has a diagnosis of B-cell acute lymphoblastic leukemia with confirmed CD-19 tumor expression.

4.    The member does not have an active infection or inflammatory disorder.

5.    The member does not have primary central nervous system lymphoma.

6.    The Eastern Cooperative Oncology Group performance status is 0 to 3.

7.    The member has not received prior CAR-T therapy.

8.    The health-care facility has enrolled in the Kymriah® Risk Evaluation and Mitigation Strategies and training has been given to the provider on

the management of cytokine release syndrome and neurological toxicities.

 

Approval duration: Only 1 dose per lifetime will be provided on this drug regardless of Provider.

 

B.   Diffuse Large B-cell Lymphoma (relapsed or refractory)

1.    The member is 18 years or older.

2.    Medication is prescribed by an oncologist or in consultation with an oncologist.

3.    The member has a diagnosis of diagnosis of relapsed or refractory large B-cell lymphoma (such as diffuse large B-cell lymphoma, high grade B-cell lymphoma, diffuse large B-cell lymphoma arising from follicular lymphoma).

4.    The member must have relapsed or refractory disease as progression after two or more lines of systemic therapy (which may or may not include therapy supported by autologous stem cell transplant). The member must have received adequate prior therapy including, at a minimum, the following:

a.    An anthracycline-containing chemotherapy regimen

b.    For CD20+ disease, an anti-CD20 monoclonal antibody

c.    For members with transformed follicular lymphoma, prior chemotherapy refractory disease after transformation to DLBCL

5.    The member has an Eastern Cooperative Oncology Group performance status of 0 or 1.

6.    The member does not have primary central nervous system lymphoma.

7.    The member does not have an active infection or inflammatory disorder.

8.    The member has not received prior CAR-T therapy.

9.    The health-care facility has enrolled in the Kymriah® Risk Evaluation and Mitigation Strategies and training has been given to the provider on the management of cytokine release syndrome and neurological toxicities.

Approval duration: Only 1 dose per lifetime will be provided on this drug regardless of Provider.

 

Codes Used In This BI:

 

1)    Q2042


Reference

Kymriah (tisagenlecleucel) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2018.

 

For information regarding the Eastern Cooperative Oncology Group performance status please see: http://ecog-acrin.org/resources/ecog-performance-status.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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