Copanlisib (Aliqopa)

Policy ID: I-191-004

Section: Injections

Effective Date: December 01, 2019

Revised Date: September 03, 2020

Revision Effective Date: October 01, 2020

Last Reviewed: September 21, 2020

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.

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 in adults for the following indications:

Food and Drug Administration (FDA) Indications

For the treatment of individuals with relapsed FL who have received at least two (2) prior systemic therapies; or

National Comprehensive Cancer Network (NCCN) Recommendations

For ANY of the following indications after two (2) prior therapies:

As a subsequent therapy for relapsed/refractory disease for ANY of the following:
- FL (grade 1-2); or
- Gastric mucosa associated lymphoid tissue (MALT) lymphoma; or
- Non-gastric MALT lymphoma ; or
As a subsequent therapy as a single agent for relapsed/refractory disease for ANY of the following:
- Nodal marginal zone lymphoma; or
- Splenic marginal zone lymphoma.

The use of copanlisib (Aliqopa) for any other indication will be considered experimental/investigational and therefore non-covered as published peer reviewed literature does not support its efficacy or safety for any other indication.

Procedure Codes

J9057

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
C83.01	C83.02	C83.03	C83.04	C83.05	C83.06	C83.07
C83.08	C83.09	C83.80	C83.81	C83.82	C83.83	C83.84
C83.85	C83.86	C83.87	C83.88	C83.89	C85.80	C85.81
C85.82	C85.83	C85.84	C85.85	C85.86	C85.87	C85.88
C85.89	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 Changed to pre-certification drug effective 8/1/20. No clinical content change

Internal Medical Policy Committee 9-21-2020 Updated NCCN recommendations

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.

Section: Injections

Effective Date: December 01, 2019

Revised Date: November 26, 2019

Revision Effective Date: August 01, 2020

Last Reviewed: July 22, 2020

Archived Date: September 30, 2020

Description

Criteria

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

Copanlisib (Aliqopa) may be considered medically necessary in adults for the following indications:

Food and Drug Administration (FDA) Indications

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

National Comprehensive Cancer Network (NCCN) Indications

For ANY of the following indications after two (2) prior therapies:

As a subsequent therapy for relapsed/refractory disease for ANY of the following:
- Follicular lymphoma (grade 1-2); or
- Gastric mucosa associated lymphoid tissue (MALT) lymphoma; or
- Non-gastric MALT lymphoma ; or
- Nodal marginal zone lymphoma; or
- Splenic marginal zone lymphoma; or
As a second-line therapy for relapsed/refractory follicular lymphoma (grade 1-2).

Procedure Codes

J9057

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

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
C83.01	C83.02	C83.03	C83.04	C83.05	C83.06	C83.07
C83.08	C83.09	C83.80	C83.81	C83.82	C83.83	C83.84
C83.85	C83.86	C83.87	C83.88	C83.89	C85.80	C85.81
C85.82	C85.83	C85.84	C85.85	C85.86	C85.87	C85.88
C85.89	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 changing to pre-certification 8/1/20. No clinical content change

Links

References (PDF)

Disclaimer

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