vp-0301
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Imfinzi™ (durvalumab) (Intravenous)

Policy Number: VP-0301

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

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

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
  1. 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

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

Coverage is provided in the following conditions:

Patient does not have any of the following:

  • History of immunodeficiency; OR
  • History of severe autoimmune disease; OR
  • Require systemic immunosuppression; OR
  • Active immune-mediated disease; OR
  • Severe or life-threatening infection; OR
  • Untreated central nervous system (CNS) metastases.
  • 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

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.

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

ICD-10

ICD-10 Description

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C78.00

Secondary malignant neoplasm of unspecified lung

C78.01

Secondary malignant neoplasm of right lung

C78.02

Secondary malignant neoplasm of left lung

C79.31

Secondary malignant neoplasm of brain

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

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

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC