BlueCross BlueShield of Tennessee Medical Policy Manual

Durvalumab (Imfinzi®)

NDC CODE(S)

00310-4500-XX IMFINZI 50MG/ML Solution (ASTRAZENECA)

00310-4611-XX IMFINZI 500MG/10ML Solution (ASTRAZENECA)

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL CRITERIA

Universal Criteria

Non-Small Cell Lung Cancer (NSCLC)

Small Cell Lung Cancer (SCLC)

RENEWAL CRITERIA

Continuation Maintenance Therapy for SCLC

INDICATION

DOSE

NSCLC

Weight ≥30 kg:

Administer 10 mg/kg intravenously every 14 days OR 1,500 mg intravenously every 28 days, until disease progression or unacceptable toxicity (or a maximum of 12 months of therapy)

 

Weight <30 kg:

Administer 10 mg/kg intravenously every 14 days, until disease progression or unacceptable toxicity (or a maximum of 12 months of therapy)

SCLC

Weight ≥30 kg:

Administer 1,500 mg intravenously in combination with chemotherapy on day 1 of every 21 day cycle x 4 cycles, followed by a maintenance dose of 1,500 mg as a single agent on day 1 of every 28 day cycle thereafter, until disease progression or unacceptable toxicity

 

Weight <30 kg:

Administer 20 mg/kg intravenously in combination with chemotherapy on day 1 of every 21 day cycle x 4 cycles, followed by a maintenance dose of 10 mg/kg as a single agent on day 1 of every 14 day cycle thereafter, until disease progression or unacceptable toxicity

Dosing should be calculated using actual body weight and not flat dosing (as applicable) based on the following:

• Patient weight > 30 kg and <75 kg: Use 20 mg/kg dosing

 

Note: This information is not meant to replace clinical decision making when initiating or modifying medication therapy and should only be used as a guide. Patient-specific variables should be taken into account.

LENGTH OF AUTHORIZATION

DOSING LIMITS

Max Units (per dose and over time) [HCPCS Unit]:

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).).

SOURCES

1.     Imfinzi [package insert]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; February 2021. Accessed March 2021.

2.     Massard C, Gordon MS, Sharma S, et al. Safety and Efficacy of Durvalumab (MEDI4736), an Anti-Programmed Cell Death Ligand-1 Immune Checkpoint Inhibitor, in Patients With Advanced Urothelial Bladder Cancer. J Clin Oncol. 2016 Sep 10;34(26):3119-25.

3.     Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) durvalumab. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2021.

4.     Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Sep 8.

5.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Non-Small Cell Lung Cancer. Version 2.2021. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2021.

6.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 6.2020. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2021.

7.     Gupta S, Sonpavde G, Grivas P, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2019 Mar 1;37(7_suppl):451.

8.     Paz-Ares L, Dvorkin M, Chen Y, et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.

9.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Small Cell Lung Cancer. Version 1.2021. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2021.

10.  Powles T, O'Donnell PH, Massard C, et al. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Openlabel Study. JAMA Oncol. 2017 Sep 14;3(9):e172411. doi: 10.1001/jamaoncol.2017.2411. Epub 2017 Sep 14.

11.  Goldman JW, Dvorkin M, Chen Y, et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8.

12.  Lexi-Comp Online. (2021, February). AHFS DI. Durvalumab. Retrieved March 23, 2021 from Lexi-Comp Online with AHFS.

13.  MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2021, February). Durvalumab. Retrieved March 23, 2021 from MICROMEDEX Healthcare Series.

ORIGINAL EFFECTIVE DATE:  6/1/2017

MOST RECENT REVIEW DATE:    7/31/2021

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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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