Last Review Date: 04/06/2021

Date of Origin: 05/30/2017

Dates Reviewed: 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 12/2020, 03/2021, 04/2021

I. Length of Authorization ^1,10

• Non-Small Cell Lung Cancer: Coverage will be provided for six months and may be renewed up to a maximum of 12 months of therapy.
• Small Cell Lung Cancer: Coverage will be provided for six months and may be renewed.

II. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Imfinzi 120 mg single-dose vial: 2 vials per 14 days
• Imfinzi 500 mg single-dose vial: 2 vials per 14 days

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

• NSCLC: 112 billable units (1120 mg) every 14 days
• SCLC (first-line therapy): 150 billable units (1500 mg) every 21 days
• SCLC (maintenance therapy): 150 billable units (1500 mg) every 28 days

III. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria

• Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, cemiplimab, etc.) unless otherwise specified; AND

Non-Small Cell Lung Cancer (NSCLC) † ^1,3-5

• Used as a single agent; AND
• Used as consolidation therapy; AND
• Patient has unresectable stage II-III disease; AND
• Disease did not progress after 2 or more cycles of definitive chemoradiation; AND
• Patient has a performance status (PS) of 0-1

Small Cell Lung Cancer (SCLC) † Ф ^3,8,9

• Patient has extensive stage disease (ES-SCLC); AND
  • Used as first-line therapy in combination with etoposide and either carboplatin or cisplatin; OR
  • Used as single-agent maintenance therapy after initial therapy with etoposide and either carboplatin or cisplatin

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria ^1,3-6,8-10

Coverage can be renewed based upon the following criteria:

• Patient continues to meet universal and other indication-specific relevant criteria identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion reactions, immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, skin reactions, etc.), etc.; AND

NSCLC

• Patient has not exceeded a maximum of twelve (12) months of therapy

Continuation Maintenance Therapy for SCLC

• Refer to Section III for criteria

V. Dosage/Administration ^1,8,9

VI. Billing Code/Availability Information

HCPCS Code:

• J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg

NDC:

• Imfinzi 120 mg/2.4 mL single-dose vial: 00310-4500-xx
• Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx

VII. References

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 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.
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 Open-label 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.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):  N/A