00310-4500-XX Imfinzi 120 MG/2.4ML SOLN (ASTRAZENECA)
00310-4611-XX Imfinzi 500 MG/10ML SOLN (ASTRAZENECA)
Durvalumab is a human immunoglobulin G1 kappa monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 and CD80 (B7.1) molecules. This PD-L1 blocking antibody binds to receptors on both tumor cells and tumor-associated immune cells in the tumor microenvironment, releasing the inhibition of immune responses without inducing antibody dependent cell-mediated cytotoxicity (ADCC). PD-L1 blockade leads to increased T-cell activation and decreased tumor size.
Durvalumab is considered medically necessary for the treatment of the following if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Non-small Cell Lung Cancer (NSCLC)
Urothelial carcinoma /Bladder Cancer
Durvalumab for the treatment of other conditions/diseases is considered investigational.
Durvalumab is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Used as a single agent
Individual has not received previous therapy with a programmed death ligand (PD-1/PD-L1) -directed therapy (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, etc.) unless otherwise specified
Diagnosis of ANY ONE of the following:
Non-small Cell Lung Cancer (NSCLC) if ALL of the following:
Used as consolidation therapy
Disease is unresectable stage III without progression after 2 or more cycles definitive chemoradiation
Individual has performance status 0-1
Urothelial Carcinoma/Bladder Cancer if ALL of the following:
Used as subsequent therapy following platinum-containing chemotherapy
Disease is NOT recurrent stage T3-4 or with palpable inguinal lymph nodes
Disease is ANY ONE of the following:
Locally advanced or metastatic Urothelial Carcinoma
Metastatic Upper Genitourinary Tract Tumors
Metastatic Urothelial Carcinoma of the Prostate
Recurrent or metastatic Primary Carcinoma of the Urethra
*If platinum treatment occurred greater than 12 months ago, the individual should be re-treated with platinum-based therapy. Individuals with comorbidities (e.g., hearing loss, neuropathy, poor PS, renal insufficiency, etc.) may not be eligible for cisplatin. Carboplatin may be substituted for cisplatin particularly in those individuals with a GFR <60 mL/min or a PS of 2.
Durvalumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet the initial approval criteria
Individual shows tumor response with stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the agent, e.g., severe infusion reactions, immune-mediated adverse reactions, including, but not limited to, pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, skin, etc.
For NSCLC, individual has not exceeded a maximum of twelve (12) months of therapy
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|All indications||10 mg/kg intravenously every 14 days|
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months and may be renewedNSCLC can be authorized up to a maximum of 12 months of therapy
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
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).
Lexi-Comp Online. (2019, Friday). AHFS DI. Durvalumab. Retrieved April 29, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, April). Durvalumab. Retrieved April 26, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Durvalumab. Retrieved April 26, 2019 from National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2018, July). NCCN Clinical Practice Guidelines in Oncology®. Bladder Cancer, version 5.2018. Retrieved October 16, 2018 from National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, February). Center for Drug Evaluation and Research. Imfinzi®(durvalumab) injection, for intravenous use. Retrieved April 26, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/1/2017
MOST RECENT REVIEW DATE: 6/11/2019
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 10 mg