Copanlisib (Aliqopa) (ARCHIVED)

Policy ID: I-191-008

Section: Injections

Effective Date: February 01, 2019

Revised Date: September 10, 2024

Revision Effective Date: July 01, 2024

Last Reviewed: September 17, 2024

Applies To: Commercial and Medicaid Expansion

**This policy has been Archived effective November 01, 2024. Click the Archive tab above for more information.**

Policy ID: I-191-008

Section: Injections

Effective Date: February 01, 2019

Revised Date: September 10, 2024

Revision Effective Date: July 01, 2024

Last Reviewed: September 17, 2024

Archived Date: November 01, 2024

Applies To: Commercial and Medicaid Expansion

Description

Copanlisib (Aliqopa ^TM ) is a kinase inhibitor indicated for the treatment of adults with relapsed follicular lymphoma (FL) who have received at least two previous systemic therapies. It is an inhibitor of phosphatidylinositol-3-kinase (PI3K) against the two main forms of PI3K expressed in malignant B cells. It induces tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. It also inhibits several key cell-signaling pathways, including B-cell receptor (BCR) signaling, Chemokine Receptor 12 (CXCR12) mediated chemotaxis of malignant B cells and NFkB signaling in lymphoma cell lines.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

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

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Copanlisib (Aliqopa) may be considered medically necessary when the following criteria are met:

For the treatment of individuals 18 years of age or older with relapsed follicular lymphoma who have received at least two (2) prior systemic therapies; or

Compendia Sources

Copanlisib (Aliqopa) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of copanlisib (Aliqopa) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9057

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C82.00

C82.01

C82.02

C82.03

C82.04

C82.05

C82.06

C82.07

C82.08

C82.09

C82.10

C82.11

C82.12

C82.13

C82.14

C82.15

C82.16

C82.17

C82.18

C82.19

C82.20

C82.21

C82.22

C82.23

C82.24

C82.25

C82.26

C82.27

C82.28

C82.29

C82.30

C82.31

C82.32

C82.33

C82.34

C82.35

C82.36

C82.37

C82.38

C82.39

C82.40

C82.41

C82.42

C82.43

C82.44

C82.45

C82.46

C82.47

C82.48

C82.49

C82.50

C82.51

C82.52

C82.53

C82.54

C82.55

C82.56

C82.57

C82.58

C82.59

C82.60

C82.61

C82.62

C82.63

C82.64

C82.65

C82.66

C82.67

C82.68

C82.69

C82.80

C82.81

C82.82

C82.83

C82.84

C82.85

C82.86

C82.87

C82.88

C82.89

C82.90

C82.91

C82.92

C82.93

C82.94

C82.95

C82.96

C82.97

C82.98

C82.99

C83.00

C83.07

C83.08

C83.80

C83.81

C83.82

C83.83

C83.84

C83.87

C83.88

C83.89

C83.85

C83.86

C85.87

C88.4

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 Code update

Internal Medical Policy Committee 7-22-2020 - Effective August 01, 2020

Changed to pre-certification drug
No clinical content change

Internal Medical Policy Committee 9-21-2020

Updated NCCN recommendations

Internal Medical Policy Committee 9-21-2021 Annual Review-no change in criteria

Internal Medical Policy Committee 5-24-2022

Removed NCCN recommendations and
Added this statement 'Copanlisib (Aliqopa) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.',
Updated the experimental/investigational statement,
Updated dx codes

Internal Medical Policy Committee 5-23-2023 Annual review, no clinical content change

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 9-17-2024 Effective November 01, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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