CurrentBlueCross BlueShield of TennesseePolicy ID_CHS_17002025_1026

Brentuximab Vedotin (Adcetris®) Coverage Criteria

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Coverage and prior authorization for intravenous brentuximab vedotin for specified CD30-expressing lymphomas and related hematologic malignancies when applicable indication, regimen, documentation, and continuation requirements are met.

Policy Summary

PayerBlueCross BlueShield of Tennessee

PolicyBrentuximab Vedotin (Adcetris®) Coverage Criteria

Policy CodePolicy ID_CHS_17002025_1026

Change TypeNo material change

Effective DateDecember 31, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with a covered indication, applicable disease and regimen criteria, and required documentation, including CD30 expression testing for initial requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsStandard authorization duration

CD30+Required tumor-cell expression

13Listed indication groupings

ExcludedOther indications

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CurrentBlueCross BlueShield of TennesseePolicy ID_CHS_17002025_1026

Brentuximab Vedotin (Adcetris®) Coverage Criteria

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Policy Summary

PayerBlueCross BlueShield of Tennessee

PolicyBrentuximab Vedotin (Adcetris®) Coverage Criteria

Policy CodePolicy ID_CHS_17002025_1026

Change TypeNo material change

Effective DateDecember 31, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with a covered indication, applicable disease and regimen criteria, and required documentation, including CD30 expression testing for initial requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsStandard authorization duration

CD30+Required tumor-cell expression

13Listed indication groupings

ExcludedOther indications

Coverage Criteria

Classical Hodgkin lymphoma

Authorization of 12 months may be granted for treatment of CD30+ classical Hodgkin lymphoma when ANY of the following are met:

Approved cHL regimens: The requested drug will be used as a single agent; in combination with doxorubicin, vinblastine, and dacarbazine (BV + AVD); in combination with bendamustine for re-induction or subsequent therapy; in combination with dacarbazine; in combination with nivolumab; in combination with gemcitabine for re-induction or subsequent therapy; in combination with ifosfamide, carboplatin, and etoposide (ICE) for subsequent therapy; in combination with etoposide, prednisone, and doxorubicin (AEPA); in combination with cyclophosphamide, prednisone, and dacarbazine (CAPDAC) for subsequent therapy; in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (Bv-AVE-PC); in combination with cyclophosphamide, doxorubicin, and prednisone (BV-CHP); or in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone (BrECADD).

The disease must be CD30+ classical Hodgkin lymphoma.

B-cell lymphomas

Authorization of 12 months may be granted for treatment of CD30+ B-cell lymphomas when the applicable subtype and regimen criteria are met:

B-cell lymphoma subtypes

Pediatric primary mediastinal large B-cell lymphoma: The disease is relapsed or refractory and the requested drug will be used in combination with nivolumab or pembrolizumab.
Both requirements must be met.

Primary cutaneous lymphomas

Authorization of 12 months may be granted for treatment of CD30+ primary cutaneous lymphomas when ANY of the following are met:

Primary cutaneous lymphoma subtypes

Lymphomatoid papulosis: The requested drug will be used as a single agent and the disease is relapsed or refractory.
Both requirements must be met.
Cutaneous anaplastic large cell lymphoma: The requested drug will be used as a single agent or in combination with cyclophosphamide, doxorubicin, and prednisone (CHP).
Either regimen is acceptable.

T-cell lymphomas

Authorization of 12 months may be granted for treatment of CD30+ T-cell lymphomas when the applicable subtype and regimen criteria are met:

T-cell lymphoma subtypes

Hepatosplenic T-cell lymphoma: The requested drug will be used as a single agent after two or more primary treatment regimens.2 or more primary treatment regimens
Adult T-cell leukemia/lymphoma: The requested drug will be used as a single agent for subsequent therapy or in combination with cyclophosphamide, doxorubicin, and prednisone.
Either regimen is acceptable.
Breast implant-associated anaplastic large cell lymphoma: The requested drug will be used as a single agent or in combination with cyclophosphamide, doxorubicin, and prednisone.
Either regimen is acceptable.

Continuation of therapy

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

Continuation therapy: The reauthorization is for an indication listed in the coverage criteria section and there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Both requirements must be met.

Qualifying off-label indication

Off-label use of an FDA-approved drug may be covered under Tennessee Code Annotated Section 56-7-2352 when at least one qualifying recognition source applies:

Qualifying recognition source

Standard reference compendium: The off-label use is recognized in a statutorily recognized standard reference compendium.
Published peer-reviewed medical literature: The off-label use is recognized in published peer-reviewed medical literature.

All indications other than the listed FDA-approved indications and compendial uses are considered experimental/investigational and are excluded from coverage.

Brentuximab vedotin is not medically necessary for unlisted indications. Coverage is limited to the FDA-approved and compendial uses identified in this policy.

Dosing and Quantity Limits

Brentuximab vedotin weight-based maximum dose

Dose option 11.8 mg/kg, up to a maximum of 180 mg

Dose option 21.5 mg/kg, up to a maximum of 150 mg

Dose option 31.2 mg/kg, up to a maximum of 120 mg

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial coverage requires a listed FDA-approved indication or a use recognized by a qualifying compendium, with all applicable approval criteria met.

Prior Authorization

12-Month Authorization

When the applicable coverage criteria are met, authorization may be granted for 12 months for the requested covered indication and regimen.

Documentation Required

CD30 Expression Testing

For initial requests, submit testing or analysis confirming CD30 expression on the surface of the cell.

Policy Background

Brentuximab vedotin is covered for selected CD30-expressing Hodgkin and non-Hodgkin lymphomas, including classical Hodgkin lymphoma, systemic and cutaneous anaplastic large cell lymphoma, selected B-cell lymphomas, and selected T-cell lymphomas. Coverage depends on the specific disease subtype, treatment history or relapse status, and required combination regimen when applicable.

Terminology

Classical Hodgkin lymphoma

AbbreviationcHL

Full termClassical Hodgkin lymphoma

Policy contextIncludes specified adult and pediatric classical Hodgkin lymphoma indications

Autologous hematopoietic stem cell transplantation

Abbreviationauto-HSCT

Full termAutologous hematopoietic stem cell transplantation

Policy contextReferenced in the cHL indication after failure of transplantation and in post-transplant consolidation

Therapy Sequence Requirements

Line of therapy

Coverage may apply according to the disease-specific line-of-therapy or disease-status requirement:

Line or disease-status requirements: The requested therapy is for previously untreated disease under a specified FDA-approved regimen; subsequent therapy; relapsed or refractory disease; re-induction; palliative therapy; or therapy after failure of specified prior regimens, as required for the applicable diagnosis.

The disease-specific criterion controls.

CD30 Expression

CD30 expression

Required findingCD30 expression on the surface of the cell

Initial-request documentationSubmit testing or analysis confirming CD30 expression on the surface of the cell

Quantitative thresholdNo quantitative threshold is stated

CD30

Required biomarker statusCD30+

Covered disease groupsClassical Hodgkin, B-cell, primary cutaneous, and T-cell lymphomas meeting the applicable criteria

Specified additional uses

Covered Indications and Regimens

Coverage	Indication	Covered regimen and requirements
Covered
Classical Hodgkin lymphoma (cHL)
Single agent; BV with doxorubicin, vinblastine, and dacarbazine (BV + AVD); bendamustine for re-induction or subsequent therapy; dacarbazine; nivolumab; gemcitabine for re-induction or subsequent therapy; ICE for subsequent therapy; AEPA; CAPDAC for subsequent therapy; Bv-AVE-PC; BV-CHP; or BrECADD. Requests must be for CD30+ cHL.

Coverage	Indication	Covered regimen and requirements
Covered
B-cell lymphomas
Post-transplant lymphoproliferative disorder, B-cell type; diffuse large B-cell lymphoma; HIV-related B-cell lymphoma; or high-grade B-cell lymphoma, as subsequent therapy. Pediatric primary mediastinal large B-cell lymphoma must be relapsed or refractory and treated in combination with nivolumab or pembrolizumab.

Coverage	Indication	Covered regimen and requirements
Covered
Primary cutaneous lymphomas
Mycosis fungoides/Sezary syndrome; lymphomatoid papulosis as a single agent for relapsed or refractory disease; or cutaneous anaplastic large cell lymphoma as a single agent or in combination with cyclophosphamide, doxorubicin, and prednisone (CHP). Requests must be for CD30+ disease.

Coverage	Indication	Covered regimen and requirements
Covered
T-cell lymphomas
Hepatosplenic T-cell lymphoma: single agent after two or more primary treatment regimens. Adult T-cell leukemia/lymphoma: single agent for subsequent therapy or with CHP. Breast implant-associated ALCL: single agent or with CHP. PTCL: single agent for subsequent or palliative therapy or with CHP. Extranodal NK/T-cell lymphoma: single agent for relapsed or refractory disease after inadequate response or with contraindication to asparaginase-based therapy.

Coverage	FDA-approved hematologic malignancy	Indication or regimen requirement
Covered
Classical Hodgkin lymphoma
Includes adult cHL after failure of auto-HSCT or at least two prior multi-agent chemotherapy regimens, post-auto-HSCT consolidation for patients at high risk of relapse or progression, previously untreated Stage III or IV disease with AVD, and previously untreated high-risk pediatric disease with Bv-AVE-PC.
Covered
Systemic anaplastic large cell lymphoma (sALCL)
Adult sALCL after failure of at least one prior multi-agent chemotherapy regimen, or previously untreated disease in combination with cyclophosphamide, doxorubicin, and prednisone.
Covered
CD30-expressing peripheral T-cell lymphoma (PTCL)
Previously untreated adult disease in combination with cyclophosphamide, doxorubicin, and prednisone.
Covered
Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides
Adult patients who have received prior systemic therapy.
Covered
Relapsed or refractory large B-cell lymphoma (LBCL)
Includes DLBCL NOS, DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy in patients not eligible for auto-HSCT or CAR T-cell therapy; used with lenalidomide and a rituximab product.

Coverage	Indication	Intravenous dosing regimen
Covered
B-cell lymphomas, including DLBCL, high-grade B-cell lymphomas, specified HIV-related B-cell lymphomas, monomorphic post-transplant lymphoproliferative disorder of B-cell type, and primary mediastinal large B-cell lymphoma
Adcetris 1.8 mg/kg, up to a maximum of 180 mg, every 3 weeks.

Coverage	Indication	Intravenous dosing regimen
Covered
CD30+ primary cutaneous lymphomas, including cutaneous anaplastic large cell lymphoma and lymphomatoid papulosis
Adcetris 1.8 mg/kg, up to a maximum of 180 mg, every 3 weeks.

Coverage	Indication	Intravenous dosing regimen
Covered
CD30+ mycosis fungoides and Sezary syndrome
Adcetris 1.8 mg/kg, up to a maximum of 180 mg, every 3 weeks.

Coverage	Patient group and indication	Intravenous dosing regimen
Covered
Classical Hodgkin lymphoma; patients 18 years and older
Adcetris 1.2 mg/kg, up to a maximum of 120 mg, every 2 weeks; or 1.5 mg/kg, up to a maximum of 150 mg, on days 1 and 8 of a 21-day cycle for 2 cycles; or 1.8 mg/kg, up to a maximum of 180 mg, every 3 weeks.

Coverage	Patient group and indication	Intravenous dosing regimen
Covered
Classical Hodgkin lymphoma; patients 2 to less than 18 years of age
Adcetris 1.2 mg/kg, up to a maximum of 120 mg, on days 1, 8, and 15 of a 28-day cycle for 2 cycles, followed by 1.2 mg/kg, up to a maximum of 120 mg, on days 1 and 8 of a 21-day cycle for 4 cycles.

Coverage	Indication	Intravenous dosing regimen
Covered
Specified T-cell lymphomas, including hepatosplenic T-cell lymphoma, adult T-cell leukemia/lymphoma, breast implant-associated ALCL, PTCL, sALCL, extranodal NK/T-cell lymphoma, and angioimmunoblastic T-cell lymphoma
Adcetris 1.8 mg/kg, up to a maximum of 180 mg, every 3 weeks.

Policy Summary

PayerBlueCross BlueShield of Tennessee

PolicyBrentuximab Vedotin (Adcetris®) Coverage Criteria

Policy CodePolicy ID_CHS_17002025_1026

Change TypeNo material change

Effective DateDecember 31, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with a covered indication, applicable disease and regimen criteria, and required documentation, including CD30 expression testing for initial requests.

SourceLink

On This Page

Peripheral T-cell lymphoma: The requested drug will be used as a single agent for subsequent or palliative therapy or in combination with cyclophosphamide, doxorubicin, and prednisone (CHP).

Includes 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, and follicular T-cell lymphoma.

Extranodal NK/T-cell lymphoma: The requested drug will be used as a single agent; the member has relapsed or refractory disease; and the member has had an inadequate response or contraindication to asparaginase-based therapy, such as pegaspargase.

All three requirements must be met.

Documentation Required

Support for Off-Label Use

For an off-label request, document the specific indication and provide support showing that the use is recognized in a statutorily recognized standard reference compendium or in published peer-reviewed medical literature.

Denial Risk

Unlisted Indication

Requests for indications outside the FDA-approved or qualifying compendial uses are considered experimental/investigational and not medically necessary.

Denial Risk

Missing CD30 Confirmation

Initial requests may be denied when testing or analysis confirming cell-surface CD30 expression is not submitted.

Denial Risk

Toxicity or Progression

Continuation requests require that the member is receiving treatment for an indication listed in the coverage criteria and has no evidence of unacceptable toxicity or disease progression on the current regimen.

Billing Rule

Exceeds Medication Quantity Limits

Dosing must remain within the specified weight-based and maximum-dose limits and administration schedule. Adcetris is administered intravenously.

B-cell lymphomas: 1.8 mg/kg, up to 180 mg, every 3 weeks.
CD30+ primary cutaneous lymphomas: 1.8 mg/kg, up to 180 mg, every 3 weeks.
CD30+ T-cell lymphomas: 1.8 mg/kg, up to 180 mg, every 3 weeks.
Classical Hodgkin lymphoma, adults (≥18 years): 1.2 mg/kg, up to 120 mg, every 2 weeks; or 1.5 mg/kg, up to 150 mg, on days 1 and 8 of a 21-day cycle for 2 cycles; or 1.8 mg/kg, up to 180 mg, every 3 weeks.
Classical Hodgkin lymphoma, ages ≥2 to <18 years: 1.2 mg/kg, up to 120 mg, on days 1, 8, and 15 of a 28-day cycle for 2 cycles, followed by 1.2 mg/kg, up to 120 mg, on days 1 and 8 of a 21-day cycle for 4 cycles.

Denial Risk

Unrecognized Off-Label Indication

Off-label use must be recognized by a qualifying standard reference compendium or supported by published peer-reviewed medical literature that meets the applicable statutory requirements.

Systemic anaplastic large cell lymphoma

AbbreviationsALCL

Full termSystemic anaplastic large cell lymphoma

Policy contextIncludes specified previously treated and previously untreated systemic anaplastic large cell lymphoma indications

Primary cutaneous anaplastic large cell lymphoma

AbbreviationpcALCL

Full termPrimary cutaneous anaplastic large cell lymphoma

Policy contextCovered as a CD30+ primary cutaneous lymphoma under the applicable single-agent or CHP criteria

Peripheral T-cell lymphoma

AbbreviationPTCL

Full termPeripheral T-cell lymphoma

Policy contextIncludes specified CD30-expressing PTCL subtypes and applicable single-agent or CHP regimens

Diffuse large B-cell lymphoma not otherwise specified

AbbreviationDLBCL NOS

Full termDiffuse large B-cell lymphoma not otherwise specified

Policy contextIncluded within relapsed or refractory large B-cell lymphoma and covered as subsequent therapy under the applicable criteria

CD30+ status is identified for primary cutaneous lymphomas and primary mediastinal large B-cell lymphoma in the medication quantity-limit criteria