Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Brentuximab Vedotin (Adcetris®)

Policy #:08.01.13d



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. 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.

MEDICALLY NECESSARY

Brentuximab vedotin (Adcetris®) is considered medically necessary and, therefore, covered when used for any of the following indications:

B-CELL LYMPHOMAS
Histologic Transformation of Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

  • For the treatment of individuals who have received multiple lines of chemoimmunotherapy for indolent or transformed disease


Diffuse Large B-Cell Lymphoma, High-Grade B-Cell Lymphomas
  • For the treatment of individuals who are non-candidates for transplant as a second-line or subsequent therapy for partial response, no response, relapsed, progressive, refractory CD30+ disease, or refractory CD30+ primary cutaneous diffuse large B-cell lymphoma, leg type
B-Cell Lymphomas Post-Transplant Lymphoproliferative Disorders (PTLD)
  • For the treatment of individuals with partial response or persistent or progressive disease after receiving chemoimmunotherapy as a second-line and subsequent therapy
  • For treatment of individuals with CD30+ monomorphic PTLD (B-cell type) as first-line therapy
AIDS-Related B-Cell Lymphomas
  • For the treatment of individuals who are non-candidates for transplant as a second-line or subsequent therapy for relapse of CD30+ AIDS-related diffuse large B-cell lymphoma, primary effusion lymphoma, and HHV8-positive diffuse large B-cell lymphoma, not otherwise specified (NOS)
Follicular Lymphoma (Grades 1-2)
  • For the treatment of individuals with histologic transformation to CD30+ diffuse large B-cell lymphoma who have received multiple lines of chemoimmunotherapy for indolent or transformed disease

CLASSICAL HODGKIN LYMPHOMA
For individuals 18 years or older via any of the following therapeutic approaches:
  • As a maintenance therapy following high-dose therapy and autologous stem cell rescue (HDT/ASCR) for relapsed or refractory disease for individuals with a high risk* of relapse if Deauville 1- 4 prior to transplant
      *NOTE: Individuals with two or more of the following risk factors are considered high risk: remission duration less than 1 year; extranodal involvement; PET+ response at time of transplant; B-cell lymphoma symptoms; and/or >1 salvage/subsequent therapy regimen
  • As second-line or subsequent systemic therapy (if not previously used) for relapsed or refractory disease:
    • As a single agent
    • In combination with bendamustine
  • As palliative therapy as a single agent for relapsed or refractory disease
  • As primary treatment in combination with AVD (doxorubicin, vinblastine, dacarbazine) for stage III--IV disease in individuals with no known neuropathy, International Prognostic Score (IPS) of 4 or more, or if bleomycin is contraindicated

For individuals older than 60 years of age with either of the following therapeutic approaches:
  • As primary treatment in combination with dacarbazine for stage I--II unfavorable or stage III--IV disease
  • As a single agent part of a palliative therapy for relapsed or refractory disease

Previously Untreated Stage III or IV Classical Hodgkin Lymphoma
  • For the treatment of adult individuals in combination with AVD (doxorubicin, vinblastine, dacarbazine)

Classical Hodgkin Lymphoma Consolidation
  • For the treatment of adult individuals with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation

Relapsed Classical Hodgkin Lymphoma
  • For the treatment of adult individuals with classical Hodgkin lymphoma after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in individuals who are not auto-HSCT candidates
    Previously Untreated Systemic Anaplastic Large Cell Lymphoma (sALCL) or Other CD30-Expressing Peripheral T-Cell Lymphomas (PTCL), in Combination with Chemotherapy
    • For the treatment of adult individuals with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone

    Relapsed Systemic Anaplastic Large Cell Lymphoma (sALCL)
    • For the treatment of adult individuals with sALCL after failure of at least one prior multi-agent chemotherapy regimen

    Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) or CD30-Expressing Mycosis Fungoides (MF)
    • For the treatment of adult individuals with pcALCL or CD30-expressing MF who have received prior systemic therapy

    PRIMARY CUTANEOUS LYMPHOMAS
    Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders
    • For the treatment of primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions, or cutaneous ALCL with regional nodes (excludes systemic ALCL) as a single agent for:
      • Primary treatment (NCCN preferred)
      • Relapsed/refractory disease
    • For the treatment of cutaneous anaplastic large cell lymphoma (ALCL) with regional nodes (excludes systemic ALCL):
      • As a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone) for:
        • Primary treatment (NCCN preferred)
        • Relapsed/refractory disease
    • Therapy for lymphomatoid papulosis (LyP) with extensive lesions as a single agent for relapsed/refractory disease following clinical trial, observation, retreatment with primary treatment, or treatment with alternative regimen not used for primary treatment

    Mycosis Fungoides (MF)/Sezary Syndrome (SS)
    • NCCN-preferred systemic therapy as treatment for one of the following:
      • Stage IA mycosis fungoides (MF) with B1 blood involvement that is refractory to multiple previous therapies, with or without skin-directed therapy
      • Stage IB-IIA MF relapsed or persistent with a higher disease burden (e.g., predominantly plaque disease), with or without skin-directed therapy
      • Stage IIB MF relapsed or persistent with limited tumor lesions, with or without local radiation therapy
      • Stage IIB MF with limited tumor lesions refractory to multiple previous therapies, with or without skin-directed therapy
      • Stage IIB MF relapsed or persistent with generalized tumor lesions, with or without skin-directed therapy
      • Stage IIB MF with generalized tumor lesions refractory to multiple previous therapies
      • Stage III MF relapsed or persistent, with or without skin-directed therapy
      • Stage III MF that is refractory to multiple previous therapies
      • Stage IV SS relapsed or persistent
      • Stage IV non Sezary or visceral disease (solid organ) relapsed or persistent, with or without radiation therapy for local control
      • Large cell transformation (LCT) with limited cutaneous lesions that is refractory to multiple previous therapies
      • Relapsed or persistent LCT with generalized cutaneous or extracutaneous lesions, with or without skin-directed therapy
    • Systemic therapy as primary treatment for one of the following:
      • Stage IB-IIA MF with a higher disease burden (e.g., predominantly plaque disease) and B1 blood involvement, with or without skin-directed therapy
      • Stage IIB MF with generalized tumor lesions, with or without skin-directed therapy (preferred)
      • Stage III MF, with or without skin-directed therapy
      • Stage IV Sezary syndrome, with or without skin-directed therapy
      • Stage IV non-Sezary or visceral disease (solid organ), with or without radiation therapy for local control (preferred)
      • Large cell transformation (LCT) with generalized cutaneous or extracutaneous lesions, with or without skin-directed therapy (NCCN preferred)
    • NCCN preferred systemic therapy as primary treatment for one of the following:
      • Stage IB-IIA MF with a higher disease burden (e.g., predominantly plaque disease), with or without skin-directed therapy
      • Stage IIB MF with limited tumor lesions, with or without local radiation therapy
      • Stage IIB MF with generalized tumor lesions, with or without skin-directed therapy
      • Stage III MF, with or without skin-directed therapy
      • Stage IV SS

    T-CELL LYMPHOMAS
    Hepatosplenic Gamma-Delta T-Cell Lymphoma
    • As a single agent for CD30+ refractory disease after 2 primary treatment regimens (NCCN preferred second-line and subsequent therapy)
    • As a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone) for CD30+ cases (NCCN preferred primary treatment or as an alternate induction regimen if not used in primary treatment)

    Extranodal NK/T-Cell Lymphoma, Nasal Type
    • As a single agent for CD30+ relapsed/refractory disease following additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used (NCCN preferred therapy)

    Peripheral T-Cell Lymphomas
    • As first-line therapy as a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone) regimen (NCCN preferred therapy) for any of the following:
      • CD30+ stage I--IV peripheral T-cell lymphoma not otherwise specified
      • ALK-negative anaplastic large cell lymphoma
      • Angioimmunoblastic T-cell lymphoma
      • Enteropathy-associated T-cell lymphoma
      • Monomorphic epitheliotropic intestinal T-cell lymphoma
      • Nodal peripheral T-cell lymphoma with TFH phenotype
      • Follicular T-cell lymphoma
      • Stage III, IV ALK-positive anaplastic large cell lymphoma
      • Stage I - III ALK-positive anaplastic large cell lymphoma (for six cycles+/- Involved-site radiation therapy [ISRT])
    • As second-line and subsequent therapy (NCCN preferred) as a single agent for:
      • Relapsed/refractory anaplastic large cell lymphoma
      • CD30+ peripheral T-cell lymphoma
      • CD30+ angioimmunoblastic T-cell lymphoma

    Adult T-Cell Leukemia/Lymphoma
    • As a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone) regimen for CD30+ individuals:
      • As chemotherapy in nonresponders to first-line therapy for chronic/smoldering subtype
      • As first-line therapy for acute subtype
      • As continued treatment in responders to first-line therapy for acute subtype
      • First-line therapy for lymphoma subtype
      • Continued treatment in responders to first-line therapy for lymphoma subtype
    • As a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes (for CD30 expressing cases) (NCCN preferred second-line or subsequent therapy)

    T-Cell Lymphomas --- Breast Implant--Associated Anaplastic Large Cell Lymphoma (ALCL)
    • As adjuvant systemic therapy for localized disease to capsule/implant/breast following incomplete excision or partial capsulectomy with residual disease if node positive or radiation therapy is not feasible, or consider for extended disease (stage II - IV)
      • As a single agent
      • As a component of brentuximab vedotin + CHP (cyclophosphamide, doxorubicin, prednisone)

    EXPERIMENTAL/INVESTIGATIONAL

    All other uses for brentuximab vedotin (Adcetris®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

    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.
    Guidelines

    BLACK BOX WARNINGS

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

    BENEFIT APPLICATION

    Subject to the terms and conditions of the applicable benefit contract, brentuximab vedotin (Adcetris®) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

    US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

    Brentuximab vedotin (Adcetris®) was approved by the FDA on August 19, 2011, for the treatment of individuals with the following indications:
    • Individuals with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplant
    • Individuals with classical Hodgkin lymphoma who are not candidates for autologous hematopoietic stem cell transplant and after failure of two prior multi-agent chemotherapy treatments
    • Individuals with classical Hodgkin lymphoma at high risk of relapse or progression as post auto- hematopoietic stem cell transplantation consolidation
    • Individuals with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen

    PET 5-POINT SCALE (DEAUVILLE CRITERIA)

    The Deauville scale is a 5-point scoring system recommended internationally for staging and assessment of treatment response in Hodgkin lymphoma and certain types of non-Hodgkin lymphoma. Fluro-deoxy-glucose (FDG) is a radioactive compound used for imaging. The metabolism of FDG in the body can be seen on PET scans. Since cancer cells are more metabolically active and use more glucose, these cells light up on scans as abnormal activity. The Deauville scale is based on visual interpretation of FDG uptake. Reference organs are the mediastinum and liver.

    Score
    PET/CT scan result
    1
    No uptake
    2
    Uptake mediastinum
    3
    Uptake > mediastinum but liver
    4
    Uptake moderately higher than liver
    5
    Uptake markedly higher than liver and/or new lesions

    Complete metabolic response: scores 1-3 with absence of FDG-avid bone marrow lesions

    Partial response: Deauville score 4-5, provided that uptake is decreased compared to baseline and absence of structural progression development

    Stable disease (no metabolic response): Deauville score 4-5 without significant change in FDG uptake from baseline

    Progressive disease: Deauville score 4-5 with increasing intensity compared to baseline or any interim scan or new FDG-avid focus consistent with malignant lymphoma.

    INTERNATIONAL PROGNOSTIC SCORE (IPS) IN HODGKIN LYMPHOMA

    Points
    Criteria
    1
    Serum Albumin <4 g/dL
    1
    Hemoglobin <10.5 g/dL
    1
    Male Sex
    1
    Stage IV Disease by Ann Arbor Classification
    1
    Age ≥45 Years
    1
    White Cell Count ≥15,000/mm3
    1
    Lymphocyte Count <600/mm3 or <8% of White Cell Count

Description

    Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma, Hodgkin lymphoma and non-Hodgkin lymphoma; both express CD30.

    CLASSICAL HODGKIN LYMPHOMA

    Classical Hodgkin lymphoma is a type of Hodgkin lymphoma characterized by an abnormal type of B lymphocytes called Reed Sternberg cells. It accounts for 90 to 95 percent of Hodgkin lymphoma. Brentuximab vedotin (Adcetris®) was approved by the Food and Drug Administration (FDA) on August 19, 2011 for the treatment of individuals with Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (HSCT) or after failure of at least two prior multi-agent chemotherapy treatments in individuals who are not candidates for autologous HSCT.

    On August 17, 2015, the FDA-approved label was updated to allow brentuximab vedotin (Adcetris®) for the treatment of individuals with classical Hodgkin lymphoma after failure of autologous HSCT or after failure of at least two prior multi-agent chemotherapy treatments in individuals who are not candidates for autologous HSCT.

    Brentuximab vedotin (Adcetris®) is an antibody-drug conjugate designed to target tumor cells expressing CD30, a tumor necrosis factor (TNF) receptor. The antibody-drug conjugate binds with the CD30, and a small-molecule chemotherapeutic agent (monomethyl auristatin [MMAE]) is released. The MMAE causes cell cycle arrest and cell death.

    FDA approval for brentuximab vedotin (Adcetris®) was supported by a multi-center phase two trial involving 102 study participants with classical Hodgkin lymphoma who had received a median of five prior therapies, including autologous stem cell transplant. These participants received the recommended dose and schedule of brentuximab vedotin (Adcetris®), which is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks for a maximum of 16 cycles. Results showed that 73 percent experienced complete or partial response rate after treatment.

    On August 17, 2015 brentuximab vedotin (Adcetris®) was approved for the treatment of individuals with classical Hodgkin lymphoma at high risk of relapse or progression as post auto-hematopoietic stem cell transplantation consolidation, treatment given after the cancer has disappeared following the initial therapy. The efficacy of brentuximab vedotin (Adcetris®) in this population was studied in a randomized, double-blind, placebo-controlled clinical trial of 329 individuals. The brentuximab vedotin (Adcetris®) group received 1.8 mg/kg intravenously over 30 minutes every 3 weeks for up to 16 cycles. The primary endpoint was progression-free survival determined by an independent review facility. High risk of relapse or progression was defined by status following first-line therapy: refractory, relapse within 12 months, or relapse at 12 months or later with extranodal disease. The brentuximab vedotin (Adcetris®) group had a statistically significant improvement in progression-free survival than the placebo group (42.9 median months vs. 24.1 median months).

    On March 20, 2018, brentuximab vedotin (Adcetris®) was approved for the treatment of individuals with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. The approval for adult individuals with previously untreated stage III or IV classical Hodgkin lymphoma was based on a clinical trial comparing brentuximab vedotin Adcetris® plus chemotherapy, AVD regimen (Adriamycin [doxorubicin], vinblastine and dacarbazine) to a chemotherapy-only regimen common for classical Hodgkin lymphoma treatment (AVD plus bleomycin, also known as ABVD). The trial measured modified progression-free survival (mPFS), which considers the length of time it took for the disease to progress, death to occur, or new therapy to be initiated in individuals who did not achieve a complete response. In the trial of 1,334 individuals, after individuals received an average of six 28-day cycles of treatment, those treated with brentuximab vedotin Adcetris® plus AVD were 23 percent less likely to experience progression, death, or initiation of new therapy compared with those receiving ABVD. There were 117 individuals (18 percent) on the brentuximab vedotin Adcetris® plus AVD arm who experienced disease progression, death, or began new therapy compared to 146 (22 percent) individuals on the ABVD arm.

    SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA

    Anaplastic large cell lymphoma is a rare form of indolent (slow growing) non-Hodgkin lymphoma. It accounts for 1 in 50 cases of non-Hodgkin lymphoma and is more common in children and men. This cancer often affects the lymph nodes, skin, liver, lungs, and bone marrow. This disease can be systemic (occurring throughout the body) or cutaneous (occurring in or on the skin).

    Systemic anaplastic large cell lymphoma is a type of T-cell non-Hodgkin lymphoma that expresses the CD30 antigen. It occurs in both nodal and extranodal locations. Conventional first-line combination chemotherapy regimens used to treat systemic anaplastic large cell lymphoma often result in long-term remissions and sometimes cures; however, there are limited therapeutic options for individuals with relapsed or refractory disease. First-line chemotherapy regimen includes CHOP (cyclophosphamide, hydroxydoxorubicin [doxorubicin], oncovin [Vincristine], prednisone).

    Brentuximab vedotin (Adcetris®) was also approved by the FDA on August 19, 2011, for treatment of individuals with systemic anaplastic large cell lymphoma, a type of non-Hodgkin lymphoma, after failing at least one prior multi-agent chemotherapy regimen. The FDA approval of brentuximab vedotin (Adcetris®) for systemic anaplastic large cell lymphoma was based on a phase two, open-label, single-arm, multi-center trial involving 58 individuals who experienced a relapse of systemic anaplastic large cell lymphoma after receiving a median of two prior therapies. Eighty-six percent of study participants experienced a complete or partial response rate after treatment with brentuximab vedotin (Adcetris®).

    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.
    References


    American Hospital Formulary Service (AHFS). Drug Information. 2017. Brentuximab vedotin. [LexiDrugs website]. 02/22/2019. Available at: http://online.lexi.com/lco/action/home[via subscription only]. Accessed October 15, 2019.

    Elsevier Gold Standard’s Clinical Pharmacology Compendium. Brentuximab vedotin. [Clinical Pharmacology website]. 11/26/2018. Available at: http://www.clinicalpharmacology-ip.com/default.aspx. [via subscription only]. Accessed October 15, 2019.

    Lexi-Drugs Compendium. Brentuximab vedotin (Adcetris®). 10/14/2019. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/3509801 [via subscription only]. Accessed October 15, 2019.

    Lymphoma Research Foundation [website]. Anaplastic Large Cell Lymphoma. Revised 11/2018. Available at: http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6300143. Accessed October 15, 2019.

    Lymphoma Research Foundation [website]. Hodgkin Lymphoma. 03/2018. Available at: http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6300137. Accessed October 15, 2019.

    Lymphoma Research Foundation [website]. Non-Hodgkin Lymphoma. 03/2018. Available at: http://www.lymphoma.org/site/apps/s/content.asp?c=bkLTKaOQLmK8E&b=6298135&ct=8763927. Accessed October 15, 2019.

    Micromedex® Healthcare Series [Internet database]. Brentuximab vedotin. Greenwood Village, CO: Thomson Micromedex. 07/23/2019. Available at:
    http://www.micromedexsolutions.com/micromedex2/librarian. Accessed October 15, 2019.

    National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Hodgkin Lymphomas. V2.2019. [NCCN Web site]. 07/15/2019. Available at: http://www.nccn.org/professionals/physician_gls/pdf/hodgkins.pdf [via subscription only]. Accessed October 15, 2019.

    National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - T-Cell Lymphomas. V2.2019. [NCCN Web site]. 12/17/2018. Available at: http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf [via subscription only]. Accessed October 15, 2019.

    National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Primary Cutaneous Lymphomas. V2.2019. [NCCN Web site]. 12/17/2018. Available at: http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf [via subscription only]. Accessed October 15, 2019.

    National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - B-Cell Lymphomas. V5.2019. [NCCN Web site]. 09/23/2019. Available at: http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf [via subscription only]. Accessed October 15, 2019.

    National Comprehensive Cancer Network (NCCN). NCCN Drugs and Biologics Compendium. Brentuximab vedotin. [NCCN Web site]. Available at:
    http://www.nccn.org/index.asp [via subscription only]. Accessed October 15, 2019.

    Pro B, Advani R, Brice P, et al. Brentuximab vedotin (SGN-35) in patients with relapsed or refractorysystemic anaplastic large-cell lymphoma: Results of a phase II study. J Clin Oncol. 2012;30:2190-2196.

    US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs @FDA. Prescribing Information. Adecetris® (brentuximab vedotin).[FDA website]. 10/15/2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf. Accessed October 15, 2019.


    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)

See Attachment A


HCPCS Level II Code Number(s)

J9042 Injection, brentuximab vedotin, 1 mg




Revenue Code Number(s)

N/A



Coding and Billing Requirements


Cross References

Attachment A: Brentuximab Vedotin (Adcetris®)
Description: ICD CODES AND NARRATIVES




Policy History

    Revisions from 08.01.13d
    12/30/2019This version of the policy will become effective 12/30/2019.
    This policy has been updated to communicate the coverage criteria for Brentuximab vedotin (Adcetris®) in accordance with the US Food and Drug Administration (FDA) prescribing information and the National Comprehensive Cancer Network (NCCN) Compendia. Revisions have been made to all conditions:
    • Classical Hodgkin lymphoma
    • B-Cell lymphomas
    • Peripheral T-cell lymphoma
    • Mycosis fungoides/Sezary syndrome
    • Anaplastic large cell lymphoma
    • Adult T-cell leukemia/lymphoma

    08.01.13c
    11/01/2017This version of the policy will become effective 11/01/2017.

    This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling and NCCN compendia.

    Policy criteria was updated to include new recommendations from NCCN:
    • Criteria was updated for Classical Hodgkin Lymphoma
    • Criteria was updated for peripheral T-cell lymphoma
    • Criteria was updated for Mycosis Fungoides/Sezary Syndrome
    • Criteria was updated for Anaplastic Large Cell Lymphoma
    • Adult T-cell Leukemia/Lymphoma was added as a new indication

    Added description of Deauville criteria.
    Version Effective Date: 12/30/2019
    Version Issued Date: 12/30/2019
    Version Reissued Date: N/A



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