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Asset Publisher
Bavencio® (avelumab)
Policy Number: VP-0295
Intravenous
Last Review Date: 07/02/2024
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, 03/2024, 07/2024
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. |
- Length of Authorization
Coverage will be provided for 6 months and may be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
- Bavencio 200 mg/10 mL single-dose vial: 4 vials per 14 days
- Max Units (per dose and over time) [HCPCS Unit]:
- 80 billable units (800 mg) every 14 days (all indications)
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
|
- 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, retifanlimab, tislelizumab, toripalimab, 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 primary locally advanced disease ‡; AND
- Both curative surgery and curative radiation therapy are not feasible; OR
- Patient has had disease progression on neoadjuvant nivolumab therapy; OR
- Patient has primary locally advanced disease ‡; AND
- Patient has metastatic disease †; OR
- Patient has recurrent locally advanced or recurrent regional disease; AND
- Both curative surgery and curative radiation therapy are not feasible
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 treated with curative intent ‡
- Metastatic or local bladder cancer recurrence post cystectomy treated with curative intent ‡
- 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
- Patient has one of the following diagnoses:
- 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: 6,17,20
|
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)
- Patient has intermediate placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT); AND
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
- 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, severe immune-mediated adverse reactions (e.g., pneumonitis, hepatotoxicity/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:
|
- 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:
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. |
- 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
- References
- Bavencio [package insert]. Rockland, MA; EMD Serono, Inc; March 2024. Accessed May 2024.
- 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.
- 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.
- Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) avelumab. National Comprehensive Cancer Network, 2024. 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 May 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Merkel Cell Carcinoma. Version 1.2024. National Comprehensive Cancer Network, 2024. 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 May 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 4.2024. National Comprehensive Cancer Network, 2024. 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 May 2024.
- 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.
- 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.
- 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.
- 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.
- 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
- Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Gestational Trophoblastic Neoplasia. Version 1.2024. National Comprehensive Cancer Network, 2024. 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 May 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Kidney Cancer. Version 4.2024. National Comprehensive Cancer Network, 2024. 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 June 2024.
- 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.
- 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.
- Bellmunt, J. (2024). Treatment of metastatic urothelial cancer of the bladder and urinary tract. In Lerner SP, Shah S (Eds.), UptoDate. Last updated April 11, 2024. Accessed May 28, 2024. 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.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Uterine Neoplasms. Version 2.2024. National Comprehensive Cancer Network, 2024. 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 May 2024.
- 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.
- 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.
- 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)
The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied 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 |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
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 |