Pending Policies - Prescription Drugs


Copanlisib (Aliqopa)

Number:RX501.097

Effective Date:07-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Medical policies are a set of written guidelines that support current standards of practice. They are based on current peer-reviewed scientific literature. A requested therapy must be proven effective for the relevant diagnosis or procedure. For drug therapy, the proposed dose, frequency and duration of therapy must be consistent with recommendations in at least one authoritative source. This medical policy is supported by FDA-approved labeling and nationally recognized authoritative references. These references include, but are not limited to: MCG care guidelines, DrugDex (IIb level of evidence or higher), NCCN Guidelines (IIb level of evidence or higher), NCCN Compendia (IIb level of evidence or higher), professional society guidelines, and CMS coverage policy.

When the requested chemotherapeutic agent is being utilized in a regimen in combination with other chemotherapeutic agents, the entire regimen (including dose, frequency, and duration) must be consistent with recommendations in at least one authoritative source including, but not limited to, FDA labeling and nationally recognized compendia or clinical Guidelines such as National Comprehensive Cancer Network (NCCN) and CMS coverage policy. HCSC may require a provider to submit documentation from nationally recognized compendia, clinical Guidelines, or active Phase III clinical trials supporting the requested regimen.

Copanlisib (Aliqopa™) may be considered medically necessary for the treatment of adult patients as a second-line or subsequent therapy with relapsed or progressive follicular lymphoma (FL) that is refractory to at least 2 prior systemic therapies.

Copanlisib (Aliqopa™) is considered experimental, investigational and/or unproven for all other indications.

NOTE: Safety and effectiveness have not been established in pediatric patients.

Description:

Non-Hodgkin lymphoma (NHL) is a form of cancer that develops in the lymph system, in B lymphocytes, T lymphocytes or natural killer cells. Most types of NHL develop from B-cells. Follicular lymphoma (FL), a non-Hodgkin lymphoma, is usually an indolent (slow growing) lymphoma that originates from B lymphocytes. Although indolent NHL may be responsive to different forms of treatment, relapse is generally seen in advanced stages. Some cases of FL can change to an aggressive type of NHL. Symptoms of adult non-Hodgkin lymphoma may include fever, night sweats, weight loss, fatigue and swelling in the lymph nodes.

The Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute estimated 72,240 new cases of NHL for 2017; and approximately 20,140 patients with NHL will die from the disease in 2017. NHL is most frequently diagnosed among people aged 65-74. (1)

Copanlisib (Aliqopa™) is a kinase inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. Copanlisib (Aliqopa™) has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B-cell lines. Copanlisib inhibits several key cell-signaling pathways, including B-cell receptor (BCR) signaling, CXCR12 mediated chemotaxis of malignant B-cells, and NFκB signaling in lymphoma cell lines. (2)

Copanlisib (Aliqopa™) is administered as a 1-hour intravenous infusion on days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (three weeks on and one week off). The treatment is continued until disease progression or unacceptable toxicity. (2)

Serious side effects include: infections, including fatal infections, hyperglycemia, hypertension, non-infectious pneumonitis, neutropenia, severe cutaneous reactions, and embryo-fetal toxicity. (2)

Regulatory Status

Copanlisib (Aliqopa™) (Bayer HealthCare Pharmaceuticals, Inc.) received an accelerated approval from the U.S. Food and Drug Administration in September 2017. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (2) Aliqopa™ is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies (2). Aliqopa™ also received Orphan Drug designation.

Rationale:

The policy originated in 2018 and is based on the U.S. Food and Drug Administration (FDA) approved labeling for copanlisib (Aliqopa™).

The FDA’s accelerated approval of Aliqopa™ was based on a single-arm, multicenter, phase 2 clinical trial (NCT01660451), CHRONOS-1. (2) Aliqopa™ was evaluated in a total of 142 patients; 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. Patients must have received rituximab and an alkylating agent. In the CHRONOS-1 trial, 36% of the patients received three prior lines of therapy. One hundred thirty patients received fixed dose 60 mg Aliqopa and 12 patients received 0.8 mg/kg equivalent Aliqopa administered as a 1-hour intravenous infusion on days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (three weeks on and one week off). Treatment continued until disease progression or unacceptable toxicity. Efficacy results from CHRONOS-1 trial included an overall response rate of 59%, complete response rate of 14% and a partial response rate of 44% with a median duration of response of 12.2 months.

National Comprehensive Cancer Network

The National Comprehensive Cancer Network Drugs and Biologics Compendium recommends copanlisib for follicular lymphoma (grade 1-2) as second-line or subsequent therapy for refractory or progressive disease that is refractory to at least 2 prior therapies. Category of Evidence: 2A. (3)

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

None

HCPCS Codes

C9030, J9057, J9999

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. SEER Cancer Stat Facts: Non-Hodgkin Lymphoma. National Cancer Institute. Bethesda, MD. Available at <http://seer.cancer.gov> (accessed January 5, 2018).

2. FDA - Highlights of Prescribing Information (FDA-Approved Label) for Aliqopa™ (copanlisib). Food and Drug Administration. (September 2017). Available at <http://www.accessdata.fda.gov> (accessed January 3, 2018).

3. NCCN Drugs and Biologics Compendium. Copanlisib (Aliqopa™) National Comprehensive Cancer Network. Available at <http://www.nccn.org> (accessed January 3, 2018).

4. National Comprehensive Cancer Network Clinical Practice guidelines in Oncology (NCCN Guidelines®) B-cell Lymphomas Version 7.2017 (December 5, 2017) Available at <http://www.nccn.org> (accessed January 3, 2018).

5. Adult Non-Hodgkin Lymphoma Treatment (PDQ®) Health Professional Version-National Cancer Institute. Available at <https://www.cancer.gov> (accessed January 5, 2018)

6. Adult Non-Hodgkin Lymphoma Treatment (PDQ®) Patient Version-National Cancer Institute. Available at <https://www.cancer.gov> (accessed January 5, 2018).

7. FDA News Release FDA approves new treatment for adults with relapsed follicular lymphoma, September 14, 2017. Available at <https://www.fda.gov> (accessed January 3, 2018).

Policy History:

Date Reason
7/1/2018 New medical document. Copanlisib (Aliqopa™) may be considered medically necessary for the treatment of adult patients as a second-line or subsequent therapy with relapsed or progressive follicular lymphoma (FL) that is refractory to at least 2 prior systemic therapies. Copanlisib (Aliqopa™) is considered experimental, investigational and/or unproven for all other indications.
Back to Top