Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-136-004
Topic: Brentuximab Vedotin (Adcetris®)
Section: Injections
Effective Date: April 30, 2018
Issue Date: April 30, 2018
Last Reviewed: April 2018

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.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

The following indications may be considered medically necessary for receiving brentuximab vedotin (Adcetris®) intravenous therapy:

 

Classical Hodgkin Lymphoma

·         Previously untreated stage III or IV in combination with chemotherapy; or

·         Therapy in individuals after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in individuals who are not ASCT candidates; or

·         Treatment in individuals at high risk of relapse or progression as post-auto-HSCT consolidation; or

·         Maintenance therapy following high-dose therapy (HDT) and autologous stem cell rescue (ASCR) for relapsed or refractory disease individuals 18 years or older with high risk of relapse (if Deauville one (1)- three (3) prior to transplant or Deauville 4 prior to transplant); or

·         Therapy as a single agent in selected individuals as second-line therapy prior to HDT/ASCR to minimize the use of more intensive chemotherapy; or

·         Second line or subsequent systemic therapy for relapsed or refractory disease as a single agent or component of:

o    DHAP (dexamethasone, cisplatin, high-dose cytarabine); or

o    ESHAP (etoposide, methylprednisolone, high-dose cytarabine, cisplatin); or

o    Gemcitabine, bendamustine, vinorelbine; or

o    GVD (gemcitabine, vinorelbine, liposomal doxorubicin); or

o    ICE (ifosfamide, carboplatin, etoposide); or

o    IGEV (ifosfamide, gemcitabine, vinorelbine)

·         As palliative therapy as a single agent for relapsed or refractory disease in older adults (age greater than 60)

 

Adult T-Cell Leukemia/Lymphoma

·         Preferred therapy as a single agent for CD30 positive acute disease or lymphoma as:

o    Second line therapy for nonresponders to first-line therapy; or

o    Subsequent therapy after high dose therapy/autologous stem cell rescue (HDT/ASCR)

 

AIDS-Related B-Cell Lymphoma

·         Second-line or subsequent therapy for relapse of CD30 positive AIDS-related diffuse large B-cell for individuals who have failed high-dose therapy with autologous stem cell rescue or at least two (2) prior multi-agent chemotherapy regimens. Can be used for lymphoma, primary effusion lymphoma, and HHV8-positive diffuse large B-cell lymphoma, not otherwise specified (NOS) in non-candidates for high-dose therapy

 

Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL)

·         Adjuvant systemic therapy as a single agent for localized disease to capsule/implant/breast following incomplete excision or partial capsulectomy with residual disease or for extended disease (stage II-IV)

 

Diffuse Large B-Cell Lymphoma

·         Second-line or subsequent therapy for histologic transformation to CD30 positive diffuse large B cell lymphoma in individuals who have received previous chemoimmunotherapy for indolent or transformed disease; or

·         Treatment of histologic transformation of marginal zone lymphoma to CD30 positive diffuse large B cell lymphoma in individuals who have received previous chemoimmunotherapy for indolent or transformed disease; or

·         Second-line or subsequent therapy for CD30 positive relapsed or refractory disease in noncandidates for high-dose therapy; or

·         Second-line or subsequent therapy for CD30 positive relapsed or refractory primary cutaneous diffuse large B-cell lymphoma, leg type in non-candidates for high-dose therapy

 

Mycosis Fungoides (MF)/Sezary Syndrome (SS)

·         As first-line therapy with or without skin-directed therapy for:

o    Stage IA-IIA MF with blood B1 involvement; or

o    Stage IB-IIA MF with histologic evidence of folliculotropic or large-cell transformed MF for limited or generalized tumor lesions; or

o    Stage IIB MF with limited or generalized tumor lesions; or

o    Stage III MF with blood B1 involvement; or

o    Stave IV SS; or

o    Stage IV non-Sezary or visceral disease; or

·         As treatment in relapsed, refractory, or persistent disease for:

o    Stage IA MF with blood B1 involvement; or

o    Stage IA MF for limited or generalized tumor lesions; or

o    Stage IB-IIA MF; or

o    Stage IIB MF relapsed with T3 disease for limited or generalized tumor lesions; or

o    Stage IIB MF with limited tumor lesions; or

o    Stage III MF with blood B1 involvement; or

o    Stage IV SS; or

o    Stage IV non-Sezary or visceral disease; or

o    CD30 positive MF

 

Peripheral T-Cell Lymphoma

·         As second-line or subsequent therapy for relapsed or refractory systemic anaplastic large cell lymphoma CD30 positive peripheral T-cell lymphoma or CD30 positive angioimmunoblastic T-cell lymphoma

 

Primary Cutaneous CD30 Positive T-Cell Lymphoproliferative Disorders

·         As a single-agent therapy for primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions or cutaneous ALCL with regional nodes (excludes systemic ALCL) as

o    Primary treatment; or

o    Therapy for relapsed or refractory disease, or

·         As a single-agent for symptomatic lymphomatoid papulosis (LyP) or LyP with extensive lesions if refractory to all primary treatment options

Post-Transplant Lymphoproliferative Disorders (PTLD)

·         Second-line and subsequent therapy for individuals with partial response, persistent, or progressive disease after receiving chemoimmunotherapy as first-line treatment for CD30 positive monomorphic PTLD B-cell type

The use of brentuximab vedotin (Adcetris) is considered experimental/investigational and therefore non-covered for any other indications. Scientific evidence does not support the use for all other indications.

 

Procedure Codes
J9042


NOTE: Dosage recommendations per the FDA label.



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of brentuximab vedotin (Adcetris) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

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U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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