vp-0301 - vp-0301 - Medical Policies
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
- 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
- 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:
|
- 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:
|
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
- Imfinzi [package insert]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; November 2020. Accessed November 2020.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 |