Asset Publisher

vp-0295

print Print Back Back

Bavencio® (avelumab)

Policy Number: VP-0295

 

Intravenous

 

Last Review Date: 12/07/2023

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, 09/2021, 12/2021, 03/2022, 06/2022, 09/2022, 12/2022, 03/2023, 06/2023, 09/2023, 12/2023

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.

  1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Bavencio 200 mg/10 mL single-dose vial: 4 vials per 14 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 80 billable units (800 mg) every 14 days (all indications)
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; AND
  • Patient is at least 18 years of age, unless otherwise indicated; AND

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, nivolumab/relatlimab-rmbw, retifanlimab, etc.), unless otherwise specified Δ; AND

Merkel Cell Carcinoma (MCC) ‡ Ф 1,2,4,5

  • Patient is at least 12 years of age; AND
  • Used as single-agent therapy; AND
  • Patient has metastatic disease

Urothelial Carcinoma (Bladder Cancer) † 1,4,6,8,16

  • Used as single-agent therapy; AND
    • Patient has one of the following diagnoses:
      • Locally advanced or metastatic urothelial carcinoma
      • Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder
      • Metastatic or local bladder cancer recurrence post cystectomy
      • Metastatic upper genitourinary (GU) tract tumors
      • Metastatic urothelial carcinoma of the prostate
      • Recurrent or metastatic primary carcinoma of the urethra (excluding recurrence of stage T3-4 disease or palpable inguinal lymph nodes); AND
  • Used for disease that progressed during or following platinum-containing chemotherapy*; OR
  • Used as second-line treatment after chemotherapy other than a platinum; OR
    • Used as first-line maintenance treatment; AND
      • Patient has locally advanced or metastatic urothelial carcinoma (inclusive of bladder, upper GU tract, urethra, and/or prostate cancer); AND
      • Patient has not progressed with first-line platinum-containing chemotherapy

* Note: 6,7,17,20

  • If patient was progression free for > 12 months after platinum therapy, consider re-treatment with platinum-based therapy if the patient is still platinum eligible (see below for cisplatin- or platinum-ineligible comorbidities).
  • Cisplatin-ineligible comorbidities may include the following: CrCl < 60 mL/min, ECOG PS ≥ 2 or KPS <70 % hearing loss of ≥ 25 decibels (dB) at two contiguous frequencies, grade ≥ 2 peripheral neuropathy, or NYHA Heart Failure class ≥ 3. Carboplatin may be substituted for cisplatin particularly in those patients with a CrCl < 60 mL/min or an ECOG PS of 2.
  • Platinum-ineligible comorbidities may include the following: CrCl < 30 mL/min, ECOG PS ≥ 3, grade ≥ 2 peripheral neuropathy, or NYHA Heart Failure class > 3, etc.

Renal Cell Carcinoma (RCC) 1,4,9,14

  • Used in combination with axitinib; AND
  • Used as first-line therapy; AND
  • Used for the treatment of advanced, relapsed, or stage IV disease and clear cell histology

Gestational Trophoblastic Neoplasia ‡ 4,13,15

  • 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; OR
    • Patient has high-risk disease (i.e., prognostic score ≥ 7 or FIGO stage IV disease)

Endometrial Carcinoma (Uterine Neoplasms) ‡ 4,18

  • Used as single-agent therapy; AND
  • Patient has recurrent disease; AND
  • Used as subsequent therapy for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors

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

  1. Renewal Criteria Δ  1

Coverage may 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 or life-threatening infusion-related reactions, hepatotoxicity, severe immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, dermatitis/dermatologic adverse reactions, etc.), major adverse cardiovascular events (MACE) when used in combination with axitinib, complications of allogeneic hematopoietic stem cell transplantation (HSCT), etc.

 

Δ Notes:

  • Patients whose tumors, upon re-biopsy, demonstrate a change in actionable mutation (e.g., MSS initial biopsy; MSI-H subsequent biopsy) may be eligible to re-initiate PD-directed therapy and will be evaluated on a case-by-case basis.
  1. Dosage/Administration 1,13,18

Indication

Dose

All Indications

Administer 800 mg intravenously every 14 days, 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 is ≤ 66 kg:

  • Use 600 mg (10mg/kg) 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.

  1. 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
  1. References
  1. Bavencio [package insert]. Rockland, MA; EMD Serono, Inc; September 2023. Accessed October 2023.
  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, 2023. 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 2023.
  5. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Merkel Cell Carcinoma. Version 1.2023. National Comprehensive Cancer Network, 2023. 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 2023.
  6. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 3.2023. National Comprehensive Cancer Network, 2023. 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 2023.
  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 (2022). Intravenous Cancer Drug Waste Issue Brief. Retrieved from: https://www.hoparx.org/documents/65/HOPA_Drug_Waste_Issue_Brief_-_Updated_01.19.22_FINAL.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 1.2024. National Comprehensive Cancer Network, 2023. 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 2023.
  5. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Kidney Cancer. Version 1.2024. National Comprehensive Cancer Network, 2023. 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 2023.
  6. You B, Bolze PA, Lotz JP, et al. Avelumab in Patients With Gestational Trophoblastic Tumors With Resistance to Single-Agent Chemotherapy: Cohort A of the TROPHIMMUN Phase II Trial. J Clin Oncol. 2020 Sep 20;38(27):3129-3137. Doi: 10.1200/JCO.20.00803. Epub 2020 Jul 27.
  7. Powles T, Park SH, Voog E, et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020 Sep 24;383(13):1218-1230. Doi: 10.1056/NEJMoa2002788. Epub 2020 Sep 18. PMID: 32945632.
  8. Bellmunt, J. (2023). Treatment of metastatic urothelial cancer of the bladder and urinary tract. In Lerner SP, Shah S (Eds.), UptoDate. Last updated October 26, 2023. Accessed October 30, 2023. Available from https://www.uptodate.com/contents/treatment-of-metastatic-urothelial-cancer-of-the-bladder-and-urinary-tract?search=cisplatin%20ineligible&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1.
  9. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Uterine Neoplasms. Version 1.2024. National Comprehensive Cancer Network, 2023. 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 2023.
  10. Galsky MD, Balar AV, Black PC, et al. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer. Journal for ImmunoTherapy of Cancer 2021;9:e002552. doi: 10.1136/jitc-2021-002552.
  11. Gupta S, Bellmunt J, Plimack ER, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2022 June 1;40(16_suppl):4577.
  12. You B, Bolze PA, Lotz JP, et al. Avelumab in patients with gestational trophoblastic tumors with resistance to polychemotherapy: Cohort B of the TROPHIMMUN phase 2 trial. Gynecol Oncol. 2023 Jan;168:62-67. doi: 10.1016/j.ygyno.2022.11.005.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

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

C54.0

Malignant neoplasm of isthmus uteri

C54.1

Malignant neoplasm of endometrium

C54.2

Malignant neoplasm of myometrium

C54.3

Malignant neoplasm of fundus uteri

C54.8

Malignant neoplasm of overlapping sites of corpus uteri

C54.9

Malignant neoplasm of corpus uteri, unspecified

C55

Malignant neoplasm of uterus, part unspecified

C58

Malignant neoplasm of placenta

C61

Malignant neoplasm of prostate

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

O01.9

Hydatidiform mole, unspecified

Z85.42

Personal history of malignant neoplasm of other parts of uterus

Z85.51

Personal history of malignant neoplasm of bladder

Z85.59

Personal history of malignant neoplasm of other urinary tract organ

Z85.821

Personal history of Merkel cell carcinoma

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: https://www.cms.gov/medicare-coverage-database/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

 

 

 

 

 

 

BAVENCIO® (avelumab) Prior Auth Criteria
Proprietary Information. Restricted Access – Do not disseminate or copy without approval.
©2023, Magellan Rx Management

White MRx.PNG