Brentuximab Vedotin (Adcetris®)

BlueCross BlueShield of Tennessee Medical Policy Manual

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

I. INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

A. FDA-Approved Indications

1. Classical Hodgkin Lymphoma (cHL)

i. Treatment of cHL after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates

ii. Treatment of cHL at high risk of relapse or progression as post-auto-HSCT consolidation

iii. Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine

iv. Treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide

2. Systemic anaplastic large cell lymphoma (sALCL)

i. Treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen

ii. Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone

3. Treatment of primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) in patients who have received prior systemic therapy

B. Compendial Uses

1. cHL stage I-II unfavorable

2. CD30+ B-Cell Lymphomas

i. Monomorphic post-transplant lymphoproliferative disorders (B-cell type)

ii. Monomorphic post-transplant lymphoproliferative disorders (T-cell type)

iii. Diffuse large B-cell lymphoma

iv. HIV Related B-cell lymphomas (CD30+ HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma, and human herpesvirus-8 (HHV8)-positive diffuse large B-cell lymphoma)

v. High-grade B-Cell lymphomas

vi. Primary mediastinal large B-cell lymphoma

3. CD30+ Primary Cutaneous Lymphomas

i. Mycosis Fungoides (MF)/Sezary Syndrome (SS)

ii. Lymphomatoid papulosis (LyP)

iii. Cutaneous anaplastic large cell lymphoma

4. CD30+ T-Cell Lymphomas

i. Hepatosplenic T-cell lymphoma

ii. Adult T-cell leukemia/lymphoma

iii. Breast implant-associated anaplastic large cell lymphoma (ALCL)

iv. Peripheral T-cell lymphoma (PTCL)

v. Extranodal NK/T-cell Lymphoma

vi. Angioimmunoblastic T-cell lymphoma

All other indications are considered experimental/investigational and not medically necessary.

II. DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

Testing or analysis confirming CD30 expression on the surface of the cell (initial requests).

III. CRITERIA FOR INITIAL APPROVAL

A. Classical Hodgkin lymphoma (cHL)

Authorization of 12 months may be granted for treatment of CD30+ cHL when any of the following are met:

1. The requested drug will be used as a single agent, or

2. The requested drug will be used in combination with doxorubicin, vinblastine, and dacarbazine, or

3. The requested drug will be used in combination with bendamustine for subsequent therapy, or

4. The requested drug will be used in combination with dacarbazine, or

5. The requested drug will be used in combination with nivolumab for subsequent therapy, or

6. The requested drug will be used in combination with gemcitabine for subsequent therapy, or

7. The requested drug will be used in combination with ifosfamide, carboplatin and etoposide for subsequent therapy, or

8. The requested drug will be used in combination with etoposide, prednisone and doxorubicin, or

9. The requested drug will be used in combination with cyclophosphamide, prednisone, and dacarbazine for subsequent therapy, or

10. The requested drug will be used in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide

B. B-Cell Lymphomas

Authorization of 12 months may be granted for treatment of CD30+ B-cell lymphomas with any of the following subtypes:

1. Monomorphic post-transplant lymphoproliferative disorders (B-cell type) when both of the following are met:

i. The requested drug will be used for subsequent therapy, and

ii. The member is not a candidate for transplant.

2. Monomorphic post-transplant lymphoproliferative disorders (T-cell type) when the requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone.

3. Diffuse large B-cell lymphoma when all of the following are met:

i. T he requested drug will be used as subsequent therapy, and

ii. The member is not a candidate for transplant.

4. HIV-Related B-cell lymphomas (HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma, and human herpesvirus-8 (HHV8)-positive diffuse large B-cell lymphoma) when both of the following are met:

i. The requested drug will be used for subsequent therapy, and

ii. The member is not a candidate for transplant.

5. Pediatric primary mediastinal large B-cell lymphoma when both of the following are met:

i. The requested drug will be used for relapsed or refractory disease, and

ii. The requested drug will be used in combination with nivolumab or pembrolizumab

6. High-grade B-cell lymphomas when both of the following are met:

i. The requested drug will be used for subsequent therapy, and

ii. The member is not a candidate for transplant.

C. Primary Cutaneous Lymphomas

Authorization of 12 months may be granted for treatment of CD30+ primary cutaneous lymphomas with any of the following subtypes:

1. Mycosis fungoides (MF)/Sezary syndrome (SS)

2. Lymphomatoid papulosis (LyP) when both of the following are met:

i. The requested drug will be used as a single agent, and

ii. The disease is relapsed or refractory.

3. Cutaneous anaplastic large cell lymphoma when either of the following are met:

i. The requested drug will be used as a single agent, or

ii. The requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone (CHP).

D. T-Cell Lymphomas

Authorization of 12 months may be granted for treatment of CD30+ T-cell lymphomas with any of the following subtypes:

1. Hepatosplenic T-cell lymphoma when either of the following are met:

i. The requested drug will be used as a single agent after two or more primary treatment regimens, or

ii. The requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone.

2. Adult T-cell leukemia/lymphoma when either of the following are met:

i. The requested drug will be used as a single agent for subsequent therapy, or

ii. The requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone.

3. Breast implant associated anaplastic large cell lymphoma (ALCL) when either of the following are met:

i. The requested drug will be used as a single agent, or

ii. The requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone.

4. Peripheral T-cell lymphoma (PTCL) [including the following subtypes: anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, enteropathy associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, nodal peripheral T-cell lymphoma with TFH phenotype, or follicular T-cell lymphoma] when either of the following are met:

i. The requested drug will be used a single agent for subsequent or palliative therapy, or

ii. The requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone.

5. Extranodal NK/T-cell lymphoma when all of the following are met:

i. The requested drug will be used as a single agent, and

ii. The member has relapsed or refractory disease, and

iii. The member has had an inadequate response or contraindication to asparaginase-based therapy (e.g., pegaspargase).

6. Systemic anaplastic large cell lymphoma when either of the following are met:

i. The requested drug will be used as a single agent, or

ii. The requested drug will be used in combination with cyclophosphamide, doxorubicin, and prednisone (CHP).

IV. CONTINUATION OF THERAPY

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen

MEDICATION QUANTITY LIMITS

Drug Name

Diagnosis

Maximum Dosing Regimen

Adcetris (Brentuximab vedotin)

Classical Hodgkin Lymphoma

Route of Administration: Intravenous

≥18 Years

1.2mg/kg (up to a maximum of 120 mg) every 2 weeks

1.8mg/kg (up to a maximum of 180 mg) every 3 weeks

1.5mg/kg (up to a maximum of 150 mg) on day 1 and 8 of a 21 day cycle for 2 cycles

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

1. Adcetris [package insert]. Bothell, WA: Seagen, Inc; November 2022.

ORIGINAL EFFECTIVE DATE: 9/6/2011

MOST RECENT REVIEW DATE: 4/30/2024

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information