vp-0295
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Bavencio® (avelumab) (Intravenous)

Policy Number: VP-0295

Last Review Date: 06/01/2021

Date of Origin: 04/25/2017

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

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

Coverage will be provided for six months and may be renewed.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Bavencio 200 mg single-use vial: 4 vials per 14 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 80 billable units every 14 days (all indications)

III. Initial Approval Criteria1

  • Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; AND

Coverage is provided in the following conditions:

Universal Criteria

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

Merkel Cell Carcinoma (MCC) Ф 1,2,4,5

  • Patient is at least 12 years of age; AND
  • Used as a single agent; AND
  • Patient has metastatic or recurrent disseminated disease

Bladder Cancer/Urothelial Carcinoma 1,4,6,8

  • Patient is at least 18 years of age; AND
  • Used as a single agent; AND
  • Used as subsequent therapy after previous platinum* or other treatment; AND
  • Patient has a diagnosis of one of the following:
      • Locally advanced or metastatic urothelial carcinoma; OR
      • Local muscle invasive 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; OR
  • Used as first-line maintenance treatment; AND
    • Patient has locally advanced or metastatic urothelial carcinoma (inclusive of the bladder, upper GU, urethra, and/or prostate); AND
    • Patient has not progressed with first-line platinum-containing chemotherapy

* 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 grade ≥ 2 peripheral neuropathy, etc. 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.

Renal Cell Carcinoma 1,4,9

  • Patient is at least 18 years of age; AND
  • Used in combination with axitinib; AND
  • Used as first line therapy; AND
    • Used for the treatment of advanced disease; OR
    • Used for relapsed or metastatic disease with clear cell histology

Gestational Trophoblastic Neoplasia ‡ 4,13

  • Patient is at least 18 years of age; AND
  • Used as single-agent therapy for multiagent chemotherapy resistant disease; AND
    • Patient has intermediate placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT); AND
      • Patient has recurrent or progressive disease; AND
      • Patient was previously treated with a platinum/etoposide containing regimen; OR
    • Patient has methotrexate-resistant high-risk disease (i.e., Prognostic score ≥7 OR FIGO stage IV disease)

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

IV. Renewal Criteria1,2,8,9

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the 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, hepatotoxicity, immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, myocarditis, pancreatitis, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, systemic inflammatory response, etc.), major adverse cardiovascular events (MACE) when used in combination with axitinib, complications of allogeneic HSCT, etc.

V. Dosage/Administration1,2,8,9

Indication

Dose

All indications

800 mg via intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

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

Weight > 60 kg:

  • Standard dose 800 mg IV every 2 weeks 

Weight is ≤ 60kg:

  • Use 600 mg IV every 2 weeks

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:

  • J9023 – Injection, avelumab, 10 mg; 1 billable unit = 10 mg

NDC:

  • Bavencio 200 mg/10 mL single-dose vial: 44087-3535-xx

VII. References

  1. Bavencio [package insert]. New York, NY; EMD Serono, Inc; November 2020. Accessed April 2021
  2. Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385.
  3. Novakovic AM, Wilkins JJ, Dai H, et al. Changing body weight-based dosing to a flat dose for avelumab in metastatic Merkel cell and advanced urothelial carcinoma. Clin Pharmacol Ther. 2019 Sep 25.
  4. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) avelumab. 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 April 2021.
  5. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Merkel Cell Carcinoma. 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 April 2021.
  6. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 3.2021. 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 April 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. Patel MR, Ellerton J, Infante JR, et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol. 2018 Jan;19(1):51-64. doi: 10.1016/S1470-2045(17)30900-2. Epub 2017 Dec 5.
  9. Motzer RJ, Penkov K, Haanen J, et al. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103-1115. doi: 10.1056/NEJMoa1816047. Epub 2019 Feb 16.
  1. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
  2. Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf
  3. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
  4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Gestational Trophoblastic Neoplasia. 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 April 2021

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C21.0

Malignant neoplasm of anus, unspecified

C4A.0

Merkel cell carcinoma of lip

C4A.10

Merkel cell carcinoma of eyelid, including canthus

C4A.111

Merkel cell carcinoma of right upper eyelid, including canthus

C4A.112

Merkel cell carcinoma of right lower eyelid, including canthus

C4A.121

Merkel cell carcinoma of left upper eyelid, including canthus

C4A.122

Merkel cell carcinoma of left lower eyelid, including canthus

C4A.20

Merkel cell carcinoma of unspecified ear and external auricular canal

C4A.21

Merkel cell carcinoma of right ear and external auricular canal

C4A.22

Merkel cell carcinoma of left ear and external auricular canal

C4A.30

Merkel cell carcinoma of unspecified part of face

C4A.31

Merkel cell carcinoma of nose

C4A.39

Merkel cell carcinoma of other parts of face

C4A.4

Merkel cell carcinoma of scalp and neck

C4A.51

Merkel cell carcinoma of anal skin

C4A.52

Merkel cell carcinoma of skin of breast

C4A.59

Merkel cell carcinoma of other part of trunk

C4A.60

Merkel cell carcinoma of unspecified upper limb, including shoulder

C4A.61

Merkel cell carcinoma of right upper limb, including shoulder

C4A.62

Merkel cell carcinoma of left upper limb, including shoulder

C4A.70

Merkel cell carcinoma of unspecified lower limb, including hip

C4A.71

Merkel cell carcinoma of right lower limb, including hip

C4A.72

Merkel cell carcinoma of left lower limb, including hip

C4A.8

Merkel cell carcinoma of overlapping sites

C4A.9

Merkel cell carcinoma, unspecified

C58

Malignant neoplasm of placenta

C61

Malignant neoplasm of prostate

C63.2

Malignant neoplasm of scrotum

C64.1

Malignant neoplasm of right kidney, except renal pelvis

C64.2

Malignant neoplasm of left kidney, except renal pelvis

C64.9

Malignant neoplasm of unspecified kidney, except renal pelvis

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

C7B.1

Secondary Merkel cell carcinoma

D09.0

Carcinoma in situ of bladder

D39.2

Neoplasm of uncertain behavior of placenta

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): 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