50419-0385-XX Aliqopa 60 MG SOLR (BAYER HEALTHCARE PHARMA)
Copanlisib is a kinase inhibitor for intravenous infusion and exhibits inhibitory activity predominantly against phosphatidylinositol-3-kinase PI3K-α and PI3K-δ isoforms expressed in malignant B cells. Copanlisib has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines.
Copanlisib for the treatment of follicular lymphoma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Copanlisib for the treatment of other conditions/diseases is considered investigational.
Copanlisib is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Has a diagnosis of relapsed, refractory or progressive follicular lymphoma
Is to be used as a single agent
Has received at least two prior systemic therapies, which included rituximab and an alkylating agent
Copanlisib is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Disease response as indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the agent (e.g., Grade 3 or greater infections, uncontrolled hyperglycemia, uncontrolled hypertension, non-infectious pneumonitis, severe cutaneous reactions, ANC < 0.5 x 103 cells/mm3)
DOSAGE & ADMINISTRATION
60 mg as a 1-hour intravenous infusion on Days 1, 8 and 15 of a 28-day treatment cycle
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months and may be renewed.
Refer to DOSAGE LIMITS below
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Lexicomp Online. (2018). AHFS DI. Fluocinolone. Retrieved December 7, 2018 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, November). Copanlisib. Retrieved December 7, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Omacetaxine. Retrieved December 7, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2017, September). Center for Drug Evaluation and Research. Aliqopa® (copanlisib). Retrieved December 7, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 11/24/2017
MOST RECENT REVIEW DATE: 4/2/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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Maximum billable units per dose and over time by indication as a Medical Benefit