vp-0301
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Imfinzi™ (durvalumab) (Intravenous)

Policy Number: VP-0301

Last Review Date: 12/01/2020

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

I. Length of Authorization 

  • Bladder Cancer/Urothelial Carcinoma and 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]:
  • Bladder Cancer/Urothelial Carcinoma and NSCLC: 150 billable units (1500 mg) every 28 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 

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; AND
  • 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

Urothelial Carcinoma (Bladder Cancer) † 

  • Used as a single agent; AND
  • Used as subsequent therapy after previous platinum treatment*; AND
  • Patient has a diagnosis of one of the following:
    • Locally advanced or metastatic urothelial carcinoma; OR
    • Local bladder cancer recurrence or persistent disease in a preserved bladder; OR
    • Local or metastatic bladder cancer recurrence post-cystectomy; OR
    • Metastatic upper genitourinary (GU) tract tumors; OR
    • Metastatic urothelial carcinoma of the prostate; OR
    • Recurrent or metastatic primary carcinoma of the urethra; AND
    • Patient does not have recurrence of stage T3-4 disease or palpable inguinal lymph nodes

* Note:

  • If platinum treatment occurred greater than 12 months ago, the patient should be re-treated with platinum-based therapy if the patient is still platinum eligible (see below for cisplatin- or carboplatin-ineligible comorbidities).
  • Cisplatin-ineligible comorbidities may include the following:  GFR < 60 mL/min, PS ≥ 2, hearing loss of ≥ 25 decibels (dB) at two contiguous frequencies, or grades ≥ 2 peripheral neuropathy. Carboplatin may be substituted for cisplatin particularly in those patients with a GFR <60 mL/min or a PS of 2.
  • Carboplatin-ineligible comorbidities may include the following: GFR < 30 mL/min, PS ≥ 3, grade ≥ 3 peripheral neuropathy, or NYHA class ≥ 3, etc.

Non-Small Cell Lung Cancer (NSCLC) † 

  • Used as a single agent; AND
  • Used as consolidation therapy; AND
  • Patient has unresectable stage 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 

  • 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 

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. 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, aseptic meningitis, hemolytic anemia, immune thrombocytopenic purpura, myocarditis, myositis, and ocular inflammatory toxicity, including uveitis and keratitis etc.), serious infection, etc.; AND

Urothelial Carcinoma (Bladder Cancer) 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 

Indication

Dose

Bladder Cancer/Urothelial Carcinoma and 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 cycle thereafter, 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

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; November 2020. Accessed November 2020.
  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, 2020. 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 October 2020.
  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 8.2020. National Comprehensive Cancer Network, 2020. 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 October 2020.
  6. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 6.2020. National Comprehensive Cancer Network, 2020. 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 October 2020.
  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, 2020. 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 October 2020.
  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.
  1. Palmetto GBA. Local Coverage Article (LCA): Billing and Coding: Chemotherapy (A56141). Centers for Medicare & Medicaid Services, Inc. Updated on 05/26/2020 with effective date 04/30/2020. Accessed October 2020.

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

C61

Malignant neoplasm of prostate

C65.1

Malignant neoplasm of right renal pelvis

C65.2

Malignant neoplasm of left renal pelvis

C65.9

Malignant neoplasm of unspecified renal pelvis

C66.1

Malignant neoplasm of right ureter

C66.2

Malignant neoplasm of left ureter

C66.9

Malignant neoplasm of unspecified ureter

C67.0

Malignant neoplasm of trigone of bladder

C67.1

Malignant neoplasm of dome of bladder

C67.2

Malignant neoplasm of lateral wall of bladder

C67.3

Malignant neoplasm of anterior wall of bladder

C67.4

Malignant neoplasm of posterior wall of bladder

C67.5

Malignant neoplasm of bladder neck

C67.6

Malignant neoplasm of ureteric orifice

C67.7

Malignant neoplasm of urachus

C67.8

Malignant neoplasm of overlapping sites of bladder

C67.9

Malignant neoplasm of bladder, unspecified

C68.0

Malignant neoplasm of urethra

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

D09.0

Carcinoma in situ of bladder

Z85.51

Personal history of malignant neoplasm of bladder

Z85.59

Personal history of malignant neoplasm of other urinary tract organ

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):  

Jurisdiction(s): J&M

NCD/LCD/Article Document (s): A56141

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56141&bc=gAAAAAAAAAAA

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