Coverage Policy Manual
Policy #: 2018003
Category: Pharmacy
Initiated: February 2018
Last Review: February 2019
  Copanlisib (Aliqopa)

Description:
Copanlisib is a phosphatidylinositol-3-kinase (PI3K) inhibitor, with activity predominantly against  certain isoforms of PI3K expressed in malignant B cells (specifically PI3K-α and PI3K-δ).  Copanlisib inhibits several cell-signaling pathways, induces tumor cell death, and inhibits proliferation of primary malignant B cells.
 
Copanlisib was FDA approved in 2017 for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
 
Coding
Effective January 01, 2019, there is a specific HCPCS code for Copanlisib.

Policy/
Coverage:
Effective February 2019.
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Copanlisib meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indication:
        • Adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
 
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Off-label
NCCN 1, 2A, and 2B recommendations in accordance with Coverage Policy #2000030.
 
DOSING
    • Dosing must be within FDA dosage guidelines of 60mg administered as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day treatment cycle.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Copanlisib does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for all other indications.
 
For members with contracts without primary coverage criteria, Copanlisib is considered investigational for all other indications. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective February 2018 to January 2019
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Copanlisib meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indication:
    • Adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
 
Dosing must be within FDA dosage guidelines of 60mg administered as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day treatment cycle.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Copanlisib does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for all other indications.
 
For members with contracts without primary coverage criteria, Copanlisib is considered investigational for all other indications. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
The safety and efficacy of copanlisib  in relapsed or refractory indolent lymphoma was investigated in one single-arm, multicenter Phase II study in which 142 patients were enrolled.  Of these, 104 had follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments.  In this study, 130 patients received a fixed dose of 60mg of copanlisib on days 1, 8, and 15 of a 28-day treatment cycle, and 12 patients received 0.8mg/kg on days 1, 8, and 15 of a 28-day treatment cycle.  Treatment continued until disease progression or unacceptable toxicity. The primary end point was objective response rate and secondary end points included duration of response, progression-free survival, and overall survival.  Of those with relapsed follicular lymphoma, the ORR was 59% (61 of 104 patients, 95% CI 49-68), with 14% achieving a complete response.  Median duration of response was 12.2 months.  The most common adverse reactions were transient hyperglycemia (all grades, 50%; grade 3 or 4, 41%), transient hypertension (all grades, 30%; grade 3, 24%), decreased neutrophil count (24%) and lung infection (15%).
 
2019 Update
A literature search conducted through January 2019 did not reveal any new information that would prompt a change in the coverage statement.

CPT/HCPCS:
J3490Unclassified drugs
J9057Injection, copanlisib, 1 mg
J9999Not otherwise classified, antineoplastic drugs

References: Copanlisib.(2017) Clinical Pharmacology [Internet]. Tampa (FL): Elsevier. c2017- [cited 2017 October 27]. Available from: http://www.clinicalpharmacology.com

Dreyling M, Santoro A, Mollica L, et al.(2017) Phosphatidylinositol 3-Kinase Inhibition by Copanlisib in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2017;:JCO2017754648.

National Comprehensive Cancer Network. Bone Cancer http://www.nccn.org/professionals/physician_gls/pdf/bone.pdf

U.S. Food and Drug Administration (FDA).(2017) Aliqopa. Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf. Last accessed Feb. 02, 2018.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2019 American Medical Association.