Overview

This document addresses the use of Aliqopa (copanlisib) injection. Aliqopa is a phosphatidylinositol-3-kinase (PI3K) inhibitor administered intravenously for the treatment of follicular lymphoma. The FDA approved indication for Aliqopa is for relapsed follicular lymphoma in those who have received at least two prior systemic therapies. The National Comprehensive Cancer Network (NCCN) provides additional recommendations with a category 2A level of evidence for the use of Aliqopa in marginal zone lymphoma (MZL). The three types of marginal zone lymphomas include extranodal MZLs, nodal MZL, and splenic MZL. The Phase II open-label, single-arm CHRONOS-1 Trial (Panayiotidis 2021) included a subset of individuals with MZL (n=23) who had received at least 2 prior lines of therapy. Aliqopa treatment resulted in an overall response rate of 70%.

Definitions and Measures

• Complete Response or Complete Remission (CR): The disappearance of all signs of cancer as a result of treatment; also called complete remission; does not indicate the cancer has been cured.
• Disease Progression: Cancer that continues to grow or spread.
• Follicular Lymphoma: A type of B-cell non-Hodgkin lymphoma, a cancer of the immune system that is usually indolent (slow-growing). The tumor cells grow as groups to form nodules. There are several subtypes of follicular lymphoma.
• Partial response (PR): A decrease in the size of a tumor, or in the amount of cancer in the body, resulting from treatment; also called partial remission.
• Refractory Disease: Illness or disease that does not respond to treatment.
• Relapse or recurrence: After a period of improvement, during which time a disease (for example, cancer) could not be detected, the return of signs and symptoms of illness or disease. For cancer, it may come back to the same place as the original (primary) tumor or to another place in the body.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Aliqopa (copanlisib)

Requests for Aliqopa (copanlisib) may be approved if the following criteria are met:

1. Individual has a diagnosis of one of the following:
   • A. Follicular lymphoma; OR
   • B. Splenic marginal zone lymphoma (NCCN 2A); OR
   • C. Nodal marginal zone lymphoma (NCCN 2A); OR
   • D. Extranodal marginal zone lymphoma of the stomach or of nongastric sites (NCCN 2A); OR
2. Disease is relapsed, refractory, or progressive; AND
3. Individual is using as third line of therapy or greater (Label/NCCN 2A); AND
4. Individual has not had previous treatment with another PI3-kinase inhibitor (e.g., idelasib (Zydelig)).

Requests for Aliqopa (copanlisib) may not be approved for the following:

1. Individual is requesting for any other indication, including but not limited to when the criteria above have not been met; OR
2. Repeat treatment after the development of disease progression or unacceptable toxicity.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

J9057
Injection, copanlisib, 1 mg [Aliqopa] [Note: code effective 01/01/2019; NOC codes J3590 or J9999 until 12/31/2018]

ICD-10 Diagnosis

C82.00-C82.99
Follicular lymphoma
C83.00-C83.09
Small cell B-cell lymphoma

Document History

Revised: 11/18/2022