Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Bevacizumab (Avastin®) and related biosimilars

Policy #:08.00.66k

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Bevacizumab (Avastin®) and related biosimilars (e.g., bevacizumab-awwb [Mvasi]) are considered medically necessary and, therefore, covered when the dosing and frequency requirements listed in Attachment A and the following indications are met:

BREAST CARCINOMA, INVASIVE
In combination with paclitaxel for recurrent or metastatic disease that meets any of the following criteria:
  • Human epidermal growth factor receptor 2 (HER2)--negative with symptomatic visceral disease or visceral crisis
  • HER2-negative and either hormone receptor--negative or hormone receptor--positive and endocrine therapy refractory

CENTRAL NERVOUS SYSTEM TUMORS
  • In individuals who have glioblastoma with progressive disease following prior therapy, as a single agent.
  • Treatment as a single-agent for disease progression of adult intracranial and spinal ependymoma (excludes subependymoma)
  • Treatment of recurrent disease or salvage therapy as a single agent or in combination with irinotecan, carmustine, lomustine, or temozolomide for anaplastic glioma or glioblastoma

CERVICAL CARCINOMA
  • In combination with paclitaxel and cisplatin or paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix
  • First-line treatment for local/regional recurrence or distant metastases in combination with paclitaxel and cisplatin, paclitaxel and carboplatin, or paclitaxel and topotecan

COLON OR RECTAL CARCINOMA: ADENOCARCINOMA
Colorectal
  • In individuals who have metastatic carcinoma of the colon or rectum, as first- or second-line treatment, in combination with intravenous 5-fluorouracil--based chemotherapy (e.g., IFL [irinotecan, fluorouracil, leucovorin] or FOLFOX4 [fluorouracil, leucovorin, oxaliplatin])
  • In individuals who have metastatic carcinoma of the colon or rectum, as a second-line treatment in patients who have progressed on a first-line bevacizumab (or related biosimilar) regimen, in combination with fluoropyrimidine-, irinotecan-, or fluoropyrimidine-oxaliplatin--based chemotherapy
  • For colon or rectal carcinoma as National Comprehensive Cancer Network's (NCCN) preferred anti-angiogenic therapy for individuals with unresectable metachronous metastases and previously received adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months:
    • In combination with irinotecan
    • In combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen
  • For colon or rectal carcinoma as subsequent therapy after first progression of unresectable advanced or metastatic disease in combination with:
    • FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen for disease previously treated with irinotecan-based therapy without oxaliplatin
    • FOLFOX, CapeOX, or irinotecan and oxaliplatin for individuals previously treated with fluoropyrimidine therapy without irinotecan or oxaliplatin
    • As the NCCN-preferred anti-angiogenic agent in combination with irinotecan or with FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen in individuals previously treated with one of the following regimens:
      • fluoropyrimidine therapy without irinotecan or oxaliplatin
      • oxaliplatin-based therapy without irinotecan

Colon
  • For colon carcinoma, as initial treatment for unresectable synchronous liver and/or lung metastases in combination with one of the following regimens:
    • FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen
    • FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen
    • FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin and irinotecan) regimen
    • CapeOX (capecitabine and oxaliplatin) regimen
  • For colon carcinoma, in combination with capecitabine, FOLFOX, FOLFIRI, CapeOX (capecitabine and oxaliplatin), FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan), or fluorouracil/leucovorin for any of the following indications:
    • as primary treatment for locally unresectable or medically inoperable disease
    • for unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy
    • as primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for patients with imminent or existing obstruction
    • for unresectable synchronous metastases of other sites
    • as primary treatment for unresectable metachronous metastases in patients who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months
    • for unresectable metachronous metastases that remain unresectable after primary treatment

Rectal
  • For rectal carcinoma in combination with any of the following regimens as (1) primary therapy for unresectable synchronous metastases or for medically inoperable disease or (2) primary therapy for T3, N0, M0; any T, N1-2, M0; or T4 and/or locally unresectable or medically inoperable disease with no metastases following neoadjuvant treatment if resection is contraindicated or (3) systemic therapy for unresectable metachronous metastases that remain unresectable after primary treatment or (4) systemic therapy following primary treatment with chemoradiation or local therapy for symptomatic unresectable synchronous metastases or medically inoperable disease or (5) primary treatment for unresectable metachronous metastases in individuals who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, when used with:
    • fluorouracil/leucovorin
    • capecitabine
    • FOLFOX
    • FOLFIRI
    • CapeOX (capecitabine and oxaliplatin)
    • FOLFOXIRI

KIDNEY CARCINOMA
  • In individuals who have metastatic renal cell carcinoma (mRCC) in combination with interferon alpha
  • In individuals with relapsed or stage IV kidney cancer with predominant clear cell histology in combination with interferon alfa-2b as first-line therapy
  • In individuals with relapsed or stage IV kidney cancer with non-clear cell histology as a single agent

MALIGNANT PLEURAL MESOTHELIOMA
In combination with cisplatin and pemetrexed followed by single-agent maintenance bevacizumab as treatment of one of the following:
  • unresectable clinical stage I-III disease and tumors of epithelial histology
  • clinical stage IV disease, tumors of sarcomatoid or mixed histology, or medically inoperable tumors in patients with performance status (PS) 0-2

NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC): ADENOCARCINOMA AND LARGE CELL CARCINOMA
  • In individuals who have unresectable, locally advanced, recurrent, or metastatic NSCLC, as first-line treatment in combination with paclitaxel (Taxol®) and carboplatin (Paraplatin®)
  • In individuals who have NSCLC in combination with carboplatin and paclitaxel or pemetrexed, or in combination with cisplatin and pemetrexed for recurrence or metastasis in individuals with performance status 0 to 1, tumors of nonsquamous cell histology, and no history of recent hemoptysis (excluding locoregional recurrence [with the exception of mediastinal lymph node recurrence with prior radiation therapy] with no evidence of disseminated disease) for one of the following regimens:
    • first-line therapy for EGFR, ALK, ROS1, and PD-L1 negative or unknown
    • subsequent therapy for sensitizing EGFR mutation-positive tumors and prior erlotinib, afatinib, gefitinib, or osimertinib therapy
    • subsequent therapy for ALK rearrangement-positive tumors and prior crizotinib, ceritinib, or alectinib therapy
    • subsequent therapy for ROS1 rearrangement-positive tumors and prior crizotinib therapy
    • subsequent therapy for PD-L1 expression-positive (≥50%) and EGFR, ALK, and ROS1 negative tumors and prior pembrolizumab therapy
  • As single-agent or in combination with pemetrexed (if previously used with a first-line pemetrexed/platinum chemotherapy regimen) when given as continuation maintenance therapy for recurrence or metastasis if given first line with chemotherapy in individuals with performance status 0 to 2 tumors of nonsquamous cell histology, and no history of recent hemoptysis who achieve tumor response or stable disease following first-line chemotherapy

OVARIAN CANCER
  • In individuals who have persistent or recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, in individuals who have not previously received bevacizumab, for one of the following indications:
    • as NCCN-preferred therapy if platinum-sensitive, in combination with carboplatin and gemcitabine, followed by bevacizumab (Avastin®) or related biosimilar as a single agent.
    • if platinum-sensitive, in combination with carboplatin and paclitaxel, followed by bevacizumab (Avastin®) or related biosimilar as a single agent.
    • as NCCN-preferred therapy if platinum-resistant, in combination with liposomal doxorubicin, weekly paclitaxel, or topotecan
    • as NCCN-preferred preferred therapy as a single agent
  • In individuals who have malignant sex cord-stromal tumors (stage II-IV) as therapy for clinical relapse, as a single agent

SOFT TISSUE SARCOMA
  • In individuals with angiosarcoma as a single agent
  • In individuals with solitary fibrous tumor or hemangiopericytoma in combination with temozolomide

UTERINE CANCER/ ENDOMETRIAL CANCER
  • As a single agent for disease that has progressed on prior cytotoxic chemotherapy

VASCULAR DISEASES OF THE EYE
Bevacizumab (Avastin®) and related biosimilars for intravitreal injection are considered medically necessary and, therefore, covered when performed by an ophthalmologist for vascular diseases of the eye that are FDA-approved or that meet the requirements as an accepted-off-label use, as defined in the Company’s medical policy for Off-label Coverage for Prescription Drugs and Biologics. Examples of vascular diseases of the eye include, but are not limited to, the following:
  • Choroidal neovascularization due to angioid streaks, central serous chorioretinopathy, choroidal rupture or trauma, idiopathic choroidal neovascularization, multifocal choroiditis, pathologic myopia, and presumed ocular histoplasmosis syndrome, uveitis
  • Diabetic macular edema
  • Diabetic retinopathy
  • Macular edema following retinal vein occlusion (RVO)
  • Neovascular (wet) age-related macular degeneration (AMD)
  • Neovascular glaucoma

EXPERIMENTAL/INVESTIGATIONAL

All other uses of bevacizumab (Avastin®) and related biosimilars (e.g., bevacizumab-awwb [Mvasi]) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics.

PRECERTIFICATION OR PREAPPROVAL REQUIREMENTS

Bevacizumab (Avastin®) and related biosimilars (e.g., bevacizumab-awwb [Mvasi]) require precertification or preapproval every six months, regardless of place of service, with the exception of the following:
  • INTRAVITREAL INJECTION: Precertification or preapproval for intravitreal injection of bevacizumab (Avastin®) and related biosimilars for vascular ophthalmologic conditions that are FDA-approved or that meet the requirements as an accepted-off-label use, as defined in the Company’s medical policy for Off-label Coverage for Prescription Drugs and Biologics, is not required when performed by an ophthalmologist. Individual product requirements must be verified.

DOSING AND FREQUENCY REQUIREMENTS

Refer to Attachment A for dosing and frequency requirements for bevacizumab (Avastin®) and related biosimilars (e.g., bevacizumab-awwb [Mvasi]).

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this Policy to ensure consistency with the most recently published recommendations for the use of bevacizumab (Avastin®) and related biosimilars. Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of bevacizumab (Avastin®) and related biosimilars outside of the Dosing and Frequency Requirements listed in this Policy. For a list of Company-recognized pharmacology compendia, view our policy on off-label coverage for prescription drugs and biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the precertification process. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for bevacizumab (Avastin®) and related biosimilars.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

When coverage of bevacizumab (Avastin®) and related biosimilars is requested outside of the Dosing and Frequency Guidelines listed in this Policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.

BILLING REQUIREMENTS

If there is no specific HCPCS code available for the drug administered, then the drug must be reported with the most appropriate unlisted code along with the corresponding National Drug Code (NDC).
Guidelines

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The ECOG has developed the ECOG Performance Status; it was originally published in 1982 in the American Journal of Clinical Oncology*. ECOG states, "These scales and criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. They are included here for health care professionals to access."
ECOG Performance Status
Grade
ECOG
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2
Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3
Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
4
Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
5
Dead
*Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, bevacizumab (Avastin®) and related biosimilars are covered under the medical benefits of the Company’s products when the medical necessity criteria, dosing and frequency requirements, and the precertification/preapproval requirements listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The initial approval for the use of bevacizumab (Avastin®) was granted by the FDA on February 26, 2004. Supplemental approvals have since been issued. The safety, effectiveness and pharmacokinetic profile of bevacizumab (Avastin®) in the pediatric population have not been established.

Bevacizumab-awwb (Mvasi) was approved by the FDA on September 14, 2017 for metastatic colorectal cancer, non-squamous cell lung cancer, glioblastoma, metastatic renal carcinoma, and cervical cancer. The safety, effectiveness and pharmacokinetic profile of bevacizumab-awwb (Mvasi) in the pediatric population have not been established.

Description

Bevacizumab (Avastin®) and related biosimilars (e.g., bevacizumab-awwb [Mvasi]) are recombinant humanized monoclonal IgG1 antibodies that work by binding to and inhibiting the action of vascular endothelial growth factor (VEGF). VEGF is a substance that binds to certain cells to stimulate new blood vessel formation (angiogenesis). When VEGF is bound to bevacizumab (Avastin®) and related biosimilars, it cannot stimulate the formation and growth of new blood vessels. Bevacizumab (Avastin®) and related biosimilars are thought to enhance the effects of chemotherapy.

The US Food and Drug Administration (FDA) has granted approval for the use of bevacizumab (Avastin®) and related biosimilars (e.g., bevacizumab-awwb [Mvasi]) for the following indications:
  • In individuals who have metastatic carcinoma of the colon or rectum, as first- or second-line treatment, in combination with intravenous 5-fluorouracil--based chemotherapy
  • In individuals who have metastatic carcinoma of the colon or rectum, as a second-line treatment in patients who have progressed on a first-line bevacizumab (Avastin®) regimen, in combination with fluoropyrimidine-, irinotecan-, or fluoropyrimidine-oxaliplatin--based chemotherapy
  • In individuals who have unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer, as first-line treatment in combination with paclitaxel (Taxol®) and carboplatin (Paraplatin®)
  • In individuals who have glioblastoma with progressive disease following prior therapy, as a single agent
    • The FDA labeling states that the effectiveness of bevacizumab (Avastin®) in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease-related symptoms or increased survival with bevacizumab (Avastin®).
  • In individuals who have metastatic renal cell carcinoma, in combination with interferon alfa
  • In individuals who have persistent, recurrent, or metastatic carcinoma of the cervix, in combination with paclitaxel and cisplatin or paclitaxel and topotecan
  • *In individuals who have platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan.
  • *In individuals who have platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer when given either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by bevacizumab (Avastin®) as a single agent.

*Note: These indications are not FDA-approved for biosimilars (e.g., bevacizumab-awwb [Mvasi]).

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

In 2008, the FDA gave accelerated approval for the treatment of metastatic breast cancer. However in 2011, the FDA withdrew this indication, since further studies showed only a small delay in tumor growth compared to earlier trials, no increase in overall survival, and an increase in the incidence of serious adverse events. Considering all information from these studies, the FDA concluded that the risks of this drug outweighed its benefits in the treatment of patients with metastatic breast cancer. Although this indication was withdrawn from the FDA, drug compendia still support the use of bevacizumab (Avastin®) for the treatment of metastatic breast cancer.
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National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Non-small cell lung cancer. v.6.2017. [NCCN Web site]. 06/07/2017. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf. Accessed June 19, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Ovarian cancer, including fallopian tube cancer and primary peritoneal cancer. v.1.2017. [NCCN Web site]. 05/16/2017. Available at: https://www.nccn.org/professionals/physician_gls/pdf/ovarian_blocks.pdf . Accessed June 19, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Rectal cancer. v.3.2017. [NCCN Web site]. 03/13/2017. Available at: https://www.nccn.org/professionals/physician_gls/pdf/rectal_blocks.pdf . Accessed June 16, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Soft Tissue Sarcoma. v.2.2017. [NCCN Web site]. 06/06/2017. Available at: https://www.nccn.org/professionals/physician_gls/pdf/sarcoma_blocks.pdf . Accessed June 19, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Uterine Neoplasms. v.1.2017. [NCCN Web site]. 04/07/2017. Available at: https://www.nccn.org/professionals/physician_gls/pdf/uterine_blocks.pdf . Accessed June 19, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium™.Bevacizumab (Avastin®). 2017. [NCCN Web site]. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed June 15, 2017.

National Eye Institute (NEI), part of the National Institutes of Health (NIH). Facts about diabetic eye disease. [NEI Web site]. 09/2015. Available at: https://www.nei.nih.gov/health/diabetic/retinopathy . Accessed June 30, 2017.

Nicholson BP, Schachat AP. A review of clinical trials of anti-VEGF agents for diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol. 2010;248(7):915-30.

Novitas Solutions, Inc. Local Coverage Article for Billing and Coding Information Regarding Uses, Including Off-Label Uses, of Anti-Vascular Endothelial Growth Factor (anti-VEGF), for The Treatment of Ophthalmological Diseases (A53121). [Novitas-Solutions Web site]. Original: 05/14/09. (Revised: 07/11/2016). Available at:
https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53121&ver=7&Keyword=bevacizumab&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=SAD%7cEd&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&bc=IAAAACAAAAAAAA%3d%3d& . Accessed June 23, 2017.

Pai SA, Shetty R, Vijayan PB, et al. Clinical, anatomic, and electrophysiologic evaluation following intravitreal bevacizumab for macular edema in retinal vein occlusion. Am J Ophthalmol. 2007;143(4):601-606.

Parodi MB, Iacono P, Kontadakis DS, et al. Bevacizumab vs photodynamic therapy for choroidal neovascularization in multifocal choroiditis. Arch Ophthalmol. 2010;128(9):1100-3.

Parodi MB, Iacono P, Papayannis A, et al. Intravitreal bevacizumab for extrafoveal choroidal neovascularization secondary to pathologic myopia. Retina. 2013;33(3):593-7.

Pope WB, Lai A, Nghiemphu P, et al. MRI in patients with high-grade gliomas treated with bevacizumab and chemotherapy. Neurology. 2006;66(8):1258-1260.

Rajagopal R, Shah GK, Blinder KJ, et al. Bevacizumab Versus Ranibizumab in the Treatment of Macular Edema Due to Retinal Vein Occlusion: 6-Month Results of the CRAVE Study. Ophthalmic Surg Lasers Imaging Retina. 2015;46(8):844-50.

Rajendram R, Fraser-Bell S, Kaines A, et al. A 2-year prospective randomized controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema: 24-month data: report 3. Arch Ophthalmol. 2012;130(8):972-9.

Salah Uddin ABM, Jarmi T. Neurologic Manifestations of Glioblastoma multiforme. [eMedicine Web site]. 11/09/15. Available at: http://emedicine.medscape.com/article/1156220-overview . Accessed June 30, 2017.

Sawada O, Ohji M. Retinal Vein Occlusion. Dev Ophthalmol. 2016;55:147-53.

Soheilian M, Garfami KH, Ramezani A, et al. Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina. 2012;32(2):314-21.

Soheilian M, Ramezani A, Obudi A, et al. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology. 2009;116(6):1142-50.

Solomon SD, Chew E, Duh EJ, et al. Diabetic retinopathy: a position statement by the American Diabetes Association. Diabetic Care. 2017;40:412-418.

Solomon SD, Lindsley K, Vedula SS, et al. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014;8:CD005139.

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Tufail A, Patel PJ, Egan C, et al; ABC Trial Investigators. Bevacizumab for neovascular age related macular degeneration (ABC Trial): multicentre randomised double masked study. BMJ. 2010;340:c2459.

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US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Mvasi(bevacizumab-awwb). Package insert. [FDA Web site]. 09/14/17. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed September 15, 2017.

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Virgili G, Parravano M, Menchini F, Brunetti M. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for diabetic macular oedema. Cochrane Database Syst Rev. 2012;12:CD007419.

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Wakabayashi T, Oshima Y, Sakaguchi H, et al. Intravitreal bevacizumab to treat iris neovascularization and neovascular glaucoma secondary to ischemic retinal diseases in 41 consecutive cases. Ophthalmology. 2008;115(9):1571-80, 1580.e1-3.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C18.0 Malignant neoplasm of cecum

C18.1 Malignant neoplasm of appendix

C18.2 Malignant neoplasm of ascending colon

C18.3 Malignant neoplasm of hepatic flexure

C18.4 Malignant neoplasm of transverse colon

C18.5 Malignant neoplasm of splenic flexure

C18.6 Malignant neoplasm of descending colon

C18.7 Malignant neoplasm of sigmoid colon

C18.8 Malignant neoplasm of overlapping sites of colon

C18.9 Malignant neoplasm of colon, unspecified

C19 Malignant neoplasm of rectosigmoid junction

C20 Malignant neoplasm of rectum

C21.8 Malignant neoplasm of overlapping sites of rectum, anus and anal canal

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

C45.0 Mesothelioma of pleura

C48.0 Malignant neoplasm of retroperitoneum

C48.1 Malignant neoplasm of specified parts of peritoneum

C48.2 Malignant neoplasm of peritoneum, unspecified

C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C49.0 Malignant neoplasm of connective and soft tissue of head, face and neck

C49.10 Malignant neoplasm of connective and soft tissue of unspecified upper limb, including shoulder

C49.11 Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder

C49.12 Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder

C49.20 Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip

C49.21 Malignant neoplasm of connective and soft tissue of right lower limb, including hip

C49.22 Malignant neoplasm of connective and soft tissue of left lower limb, including hip

C49.3 Malignant neoplasm of connective and soft tissue of thorax

C49.4 Malignant neoplasm of connective and soft tissue of abdomen

C49.5 Malignant neoplasm of connective and soft tissue of pelvis

C49.6 Malignant neoplasm of connective and soft tissue of trunk, unspecified

C49.8 Malignant neoplasm of overlapping sites of connective and soft tissue

C49.9 Malignant neoplasm of connective and soft tissue, unspecified

C50.011 Malignant neoplasm of nipple and areola, right female breast

C50.012 Malignant neoplasm of nipple and areola, left female breast

C50.019 Malignant neoplasm of nipple and areola, unspecified female breast

C50.021 Malignant neoplasm of nipple and areola, right male breast

C50.022 Malignant neoplasm of nipple and areola, left male breast

C50.029 Malignant neoplasm of nipple and areola, unspecified male breast

C50.111 Malignant neoplasm of central portion of right female breast

C50.112 Malignant neoplasm of central portion of left female breast

C50.119 Malignant neoplasm of central portion of unspecified female breast

C50.121 Malignant neoplasm of central portion of right male breast

C50.122 Malignant neoplasm of central portion of left male breast

C50.129 Malignant neoplasm of central portion of unspecified male breast

C50.211 Malignant neoplasm of upper-inner quadrant of right female breast

C50.212 Malignant neoplasm of upper-inner quadrant of left female breast

C50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast

C50.221 Malignant neoplasm of upper-inner quadrant of right male breast

C50.222 Malignant neoplasm of upper-inner quadrant of left male breast

C50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311 Malignant neoplasm of lower-inner quadrant of right female breast

C50.312 Malignant neoplasm of lower-inner quadrant of left female breast

C50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321 Malignant neoplasm of lower-inner quadrant of right male breast

C50.322 Malignant neoplasm of lower-inner quadrant of left male breast

C50.329 Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411 Malignant neoplasm of upper-outer quadrant of right female breast

C50.412 Malignant neoplasm of upper-outer quadrant of left female breast

C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421 Malignant neoplasm of upper-outer quadrant of right male breast

C50.422 Malignant neoplasm of upper-outer quadrant of left male breast

C50.429 Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511 Malignant neoplasm of lower-outer quadrant of right female breast

C50.512 Malignant neoplasm of lower-outer quadrant of left female breast

C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521 Malignant neoplasm of lower-outer quadrant of right male breast

C50.522 Malignant neoplasm of lower-outer quadrant of left male breast

C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611 Malignant neoplasm of axillary tail of right female breast

C50.612 Malignant neoplasm of axillary tail of left female breast

C50.619 Malignant neoplasm of axillary tail of unspecified female breast

C50.621 Malignant neoplasm of axillary tail of right male breast

C50.622 Malignant neoplasm of axillary tail of left male breast

C50.629 Malignant neoplasm of axillary tail of unspecified male breast

C50.811 Malignant neoplasm of overlapping sites of right female breast

C50.812 Malignant neoplasm of overlapping sites of left female breast

C50.819 Malignant neoplasm of overlapping sites of unspecified female breast

C50.821 Malignant neoplasm of overlapping sites of right male breast

C50.822 Malignant neoplasm of overlapping sites of left male breast

C50.829 Malignant neoplasm of overlapping sites of unspecified male breast

C50.911 Malignant neoplasm of unspecified site of right female breast

C50.912 Malignant neoplasm of unspecified site of left female breast

C50.919 Malignant neoplasm of unspecified site of unspecified female breast

C50.921 Malignant neoplasm of unspecified site of right male breast

C50.922 Malignant neoplasm of unspecified site of left male breast

C50.929 Malignant neoplasm of unspecified site of unspecified male breast

C53.0 Malignant neoplasm of endocervix

C53.1 Malignant neoplasm of exocervix

C53.8 Malignant neoplasm of overlapping sites of cervix uteri

C53.9 Malignant neoplasm of cervix uteri, 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

C56.1 Malignant neoplasm of right ovary

C56.2 Malignant neoplasm of left ovary

C56.9 Malignant neoplasm of unspecified ovary

C57.00 Malignant neoplasm of unspecified fallopian tube

C57.01 Malignant neoplasm of right fallopian tube

C57.02 Malignant neoplasm of left fallopian tube

C57.10 Malignant neoplasm of unspecified broad ligament

C57.11 Malignant neoplasm of right broad ligament

C57.12 Malignant neoplasm of left broad ligament

C57.20 Malignant neoplasm of unspecified round ligament

C57.21 Malignant neoplasm of right round ligament

C57.22 Malignant neoplasm of left round ligament

C57.3 Malignant neoplasm of parametrium

C57.4 Malignant neoplasm of uterine adnexa, unspecified

C57.8 Malignant neoplasm of overlapping sites of female genital organs

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

C71.0 Malignant neoplasm of cerebrum, except lobes and ventricles

C71.1 Malignant neoplasm of frontal lobe

C71.2 Malignant neoplasm of temporal lobe

C71.3 Malignant neoplasm of parietal lobe

C71.4 Malignant neoplasm of occipital lobe

C71.5 Malignant neoplasm of cerebral ventricle

C71.6 Malignant neoplasm of cerebellum

C71.7 Malignant neoplasm of brain stem

C71.8 Malignant neoplasm of overlapping sites of brain

C71.9 Malignant neoplasm of brain, unspecified

C78.00 Secondary malignant neoplasm of unspecified lung

C78.01 Secondary malignant neoplasm of right lung

C78.02 Secondary malignant neoplasm of left lung

C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum

C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct


REPORT THE MOST APPROPRIATE CODE THAT REPRESENTS VASCULAR DISEASES OF THE EYE.



HCPCS Level II Code Number(s)


C9257 Injection, bevacizumab, 0.25 mg

J9035 Injection, bevacizumab, 10 mg

Q5107 Injection, bevacizumab-awwb, biosimilar, (mvasi), 10 mg



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Bevacizumab (Avastin®) and related biosimilars
Description: Dosing and Frequency Requirements




Policy History

Revisions from 08.00.66k:
01/01/2019This policy has been identified for the HCPCS code update, effective 01/01/2019.

The following HCPCS code has been added to this policy:
Q5107 Injection, bevacizumab-awwb, biosimilar, (mvasi), 10 mg

The following HCPCS code has been removed from this policy:
J3590 Unclassified biologics


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 01/02/2019
Version Reissued Date: N/A

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