CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Adcetris (brentuximab vedotin) — Coverage Criteria

Defines accepted indications, limits, contraindications, and coding for Adcetris (brentuximab vedotin) for members of Neighborhood Health Plan of Rhode Island; applies to providers submitting medication requests to Evolent for authorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdcetris (brentuximab vedotin) — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded codingadministrative conversion

Effective DateN/A

Next Review DateN/A

Key ActionSupport medication requests with FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

Added coding information section with HCPCS code J9042 for brentuximab vedotin.

Converted to new Evolent guideline template and replaced prior UM ONC_1203 Adcetris guideline.

J9042HCPCS code for brentuximab vedotin (1 mg)

16Maximum cycles (refractory/relapsed or consolidation)

12First-line AAVD maximum doses

Commercial/Exchange/MedicaidLines of business

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CD-30 Positive T-Cell Lymphomas

Covered when ANY of the following are met for CD30-positive T-cell lymphomas:

CD30+ T-cell lymphoma indications: First-line therapy as a single agent or as a component of brentuximab vedotin plus chemotherapy (e.g., CHP: cyclophosphamide, doxorubicin, prednisone).

Includes anaplastic large cell lymphoma and other CD30-positive T‑cell lymphomas.

Relapsed/refractory single-agent use: Second-line or subsequent therapy as a single agent for relapsed or refractory disease.

Classical Hodgkin Lymphoma

Covered when ANY of the following are met for classical Hodgkin lymphoma:

Stage III–IV primary therapy: Primary treatment in combination with AVD (doxorubicin, vinblastine, dacarbazine) for stage III–IV disease.

Subsequent-line single agent: Use as a single agent for subsequent lines of therapy if brentuximab vedotin has not been previously given.

Post‑transplant consolidation: Consolidation therapy after hematopoietic stem cell transplant (HSCT) in members who have not received prior brentuximab vedotin.

Pediatric high‑risk disease: Use in combination with AVEPC (doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide) for members ≥2 years with previously untreated high‑risk classical Hodgkin lymphoma (Ann Arbor Stage IIB with bulk, IIIB, IVA, IVB).

Unsupported combination: Combination of brentuximab vedotin + nivolumab (Opdivo) for relapsed/refractory Hodgkin lymphoma is not supported by Evolent due to lack of Level 1 evidence.

This position is based on absence of randomized clinical trial or meta-analysis evidence demonstrating superior outcomes versus single‑agent approaches or recommended alternatives.

Large B-Cell Lymphoma (LBCL)

Covered when ALL of the following are met for relapsed/refractory Large B‑Cell Lymphoma (LBCL):

LBCL combination indication: Adult member with relapsed or refractory large B‑cell lymphoma (including DLBCL NOS, DLBCL arising from indolent lymphoma, or high‑grade B‑cell lymphoma) after two or more lines of systemic therapy; AND member is ineligible for autologous HSCT or CAR T‑cell therapy; AND planned use is in combination with lenalidomide (Revlimid) and rituximab or a rituximab biosimilar.after two or more prior lines

References ECHELON‑3 evidence as supporting trial per policy.

Regimen	Indication	Coverage
Brentuximab vedotin as single agent or in combination with CHP (cyclophosphamide, doxorubicin, prednisone)
CD30-positive T-cell lymphomas (including anaplastic large cell lymphoma); first-line as single agent or component of brentuximab + chemotherapy, or second-line/subsequent single-agent for relapsed/refractory disease
Covered when criteria met per policy

Regimen	Indication	Coverage
Brentuximab vedotin in combination with AVD (doxorubicin, vinblastine, dacarbazine)
Primary treatment for classical Hodgkin lymphoma, stage III–IV, CD30-positive
Covered when criteria met per policy

Regimen	Indication	Coverage
Brentuximab vedotin in combination with AVEPC (doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide)
Previously untreated high‑risk classical Hodgkin lymphoma in members ≥2 years of age (Ann Arbor Stage IIB with bulk, IIIB, IVA, IVB), CD30‑positive
Covered when criteria met per policy

Regimen	Indication	Coverage
Brentuximab vedotin combined with lenalidomide (Revlimid) and rituximab or rituximab biosimilar
Adult members with relapsed or refractory large B‑cell lymphoma (including DLBCL NOS, DLBCL arising from indolent lymphoma, or HGBL) after ≥2 lines of systemic therapy who are ineligible for auto‑HSCT or CAR‑T
Covered when ALL policy criteria are met

Regimen	Indication	Coverage
Combination of brentuximab vedotin + nivolumab (Opdivo)
Relapsed/refractory classical Hodgkin lymphoma
Not covered — combination not supported by Evolent due to lack of Level 1 evidence

Requests for Adcetris (brentuximab vedotin) for indications that are investigational or off‑label will be excluded when the available evidence is insufficient to support the proposed use. Sufficient evidence is defined by concordance with FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature. Policy review evaluates whether the published data adequately represent the patient population and cancer characteristics, whether the regimen tested matches the requested chemotherapy/biologic/targeted or immunotherapy regimen, and whether study outcomes are clinically meaningful.

Specifically, evidence will be considered inadequate when outcomes are not clinically meaningful per ASCO standards (for example, hazard ratios ≥ 0.80 or survival benefits below recommended thresholds), when study design is inappropriate to answer the question, or when support relies solely on abstracts, case reports, or other uncontrolled anecdotal reports. Use must therefore be supported by full peer‑reviewed publications, accepted compendia, or robust trial data to be approvable.

Concomitant administration of Adcetris with bleomycin is expressly excluded due to the risk of pulmonary toxicity. This concomitant use is listed as a contraindication in the policy and may trigger denial of the request.

When evaluating requests, reviewers should confirm that bleomycin is not part of the planned regimen; if bleomycin is present, the request should be denied per the contraindication for combined use with Adcetris.

Requests will be denied for members who demonstrate disease progression while on Adcetris. Dosing that exceeds the policy’s single‑dose limits — 180 mg (1.8 mg/kg/dose) or 120 mg (1.2 mg/kg/dose) — will not be approved. Reviewers must check the dose requested against these single‑dose thresholds.

Duration limits are indication‑specific and must be observed: examples include a maximum of 5 doses when used as part of AVEPC in pediatrics, up to 6 months (12 doses) for AAVD first‑line Hodgkin treatment, up to 16 cycles for refractory/relapsed disease or consolidation after HSCT, and up to 8 doses for previously untreated CD30+ T‑cell lymphoma. Requests exceeding these maximum durations are considered not approvable.

Regimens and Indications Covered

Regimen	Indication	Coverage
Brentuximab vedotin as single agent or in combination with chemotherapy such as CHP (cyclophosphamide, doxorubicin, prednisone)
CD30‑positive T‑cell lymphomas, including anaplastic large cell lymphoma; first‑line as single agent or component of brentuximab + chemotherapy, or second‑line/subsequent single‑agent for relapsed/refractory disease
Covered when criteria met per policy

Regimen	Indication	Coverage
Brentuximab vedotin in combination with AVD (doxorubicin, vinblastine, dacarbazine)
Classical Hodgkin lymphoma, stage III–IV, CD30‑positive — primary treatment
Covered when criteria met per policy

Regimen	Indication	Coverage
Brentuximab vedotin in combination with AVEPC (doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide)
Pediatric members ≥2 years with previously untreated high‑risk classical Hodgkin lymphoma (Ann Arbor Stage IIB with bulk, IIIB, IVA, IVB), CD30‑positive
Covered when criteria met per policy

Regimen	Indication	Coverage
Brentuximab vedotin combined with lenalidomide (Revlimid) and rituximab or rituximab biosimilar
Adult members with relapsed/refractory large B‑cell lymphoma after ≥2 lines of systemic therapy who are ineligible for autologous HSCT or CAR‑T
Covered when ALL policy criteria are met

Regimen	Indication	Coverage
Combination of brentuximab vedotin + nivolumab (Opdivo)
Relapsed/refractory classical Hodgkin lymphoma
Not supported / Not covered by Evolent (lack of Level 1 evidence)

Provider Requirements and Actionable Rules

Documentation Required

Supporting documentation required

The use of Adcetris (brentuximab vedotin) must be supported by one or more of the following: FDA-approved product labeling; CMS-recognized compendia; National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines; or peer-reviewed literature that meets the standards in the CMS Medicare Benefit Policy Manual, Chapter 15.

FDA labeling
CMS-approved compendia
NCCN/ASCO clinical guidelines
Acceptable peer-reviewed literature meeting CMS Medicare Benefit Manual Chapter 15 requirements

Prior Authorization

Continuation request requirements

Continuation (renewal) requests may be exempt from full policy review when ALL of the following are true: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

No disease progression on the requested medication
Used within the last year with ≤30-day lapse in active authorization
No additional medications added to the continuation request

Denial Risk

Unsupported combination — Adcetris + nivolumab

The combination of Adcetris (brentuximab vedotin) with nivolumab (Opdivo) for relapsed/refractory classical Hodgkin lymphoma is not supported by Evolent due to lack of Level 1 evidence showing superiority over single-agent therapy or other recommended regimens.

Adcetris + nivolumab not supported for relapsed/refractory Hodgkin lymphoma

Denial Risk

Denial triggers

Denial/exclusion may be triggered when any of the following apply: disease progression while on Adcetris; dosing exceeding single-dose limits (180 mg / 1.8 mg/kg or 120 mg / 1.2 mg/kg); treatment durations exceeding published limits (e.g., pediatric AVEPC: >5 doses; AAVD first-line Hodgkin: >12 doses/6-month cycles; refractory/relapsed/consolidation after HSCT: >16 cycles; previously untreated CD30+ T‑cell lymphoma: >8 doses); investigational or off-label uses lacking sufficient evidence or not supported by CMS compendia or acceptable peer-reviewed literature.

Disease progression while on Adcetris
Single dose exceeds 180 mg (1.8 mg/kg) or 120 mg (1.2 mg/kg)
Exceeds maximum duration limits (see policy for indication-specific limits)
Investigational or off-label use without sufficient evidence or CMS/peer-reviewed support

Denial Risk

Contraindication — bleomycin

Concomitant use of Adcetris with bleomycin is a contraindication due to risk of pulmonary toxicity and may lead to denial of the request.

Concomitant use with bleomycin

Lines of Therapy and Biomarker Requirements

Mixed

Top-level line-of-therapy rules for covered uses:

Line‑of‑therapy overview: First‑line use is permitted for CD30‑positive T‑cell lymphomas and for classical Hodgkin lymphoma stage III–IV when used with the specified frontline regimens; single‑agent or subsequent‑line use is permitted for relapsed/refractory disease where specifically stated; the LBCL indication is restricted to adults after two or more prior systemic therapies and when ineligible for auto‑HSCT or CAR‑T.

Specific line requirements differ by diagnosis as detailed in the individual indication criteria above.

Continuation/renewal guidance: Continuation (renewal) requests may be exempt from full policy review if there is no disease progression, prior continuous use within the last year without a lapse greater than 30 days, and no addition of new medications to the regimen.

See authorization requirements for documentation expectations.

CD30 biomarker requirement

Biomarker requirementCD30 positivity is required for use of brentuximab vedotin in CD30‑positive T‑cell lymphomas and classical Hodgkin lymphoma indications.

Applications requiring CD30First‑line or subsequent single‑agent use or combination regimens for CD30‑positive T‑cell lymphomas (e.g., CHP) and primary treatment/consolidation in classical Hodgkin lymphoma.

Pediatric high‑risk HodgkinUse with AVEPC in previously untreated high‑risk classical Hodgkin lymphoma (>=2 years) requires CD30‑positive disease.

CD-30 Positive T-Cell Lymphomas — definition

DefinitionCD‑30 Positive T‑Cell Lymphomas: T‑cell lymphomas (including anaplastic large cell lymphoma) that express CD30 antigen.

Covered usesFirst‑line therapy as single agent or as component of brentuximab vedotin plus chemotherapy (e.g., CHP), or second‑line/subsequent single‑agent therapy for relapsed/refractory disease.

Examples includedIncludes anaplastic large cell lymphoma and other CD30‑positive T‑cell lymphoma subtypes listed in policy.

Classical Hodgkin Lymphoma — definition and related regimens

DefinitionClassical Hodgkin Lymphoma: CD30‑positive classical Hodgkin lymphoma as defined in policy for treatment considerations.

First‑line regimenAdcetris in combination with AVD (doxorubicin, vinblastine, dacarbazine) for stage III‑IV disease.

Consolidation after HSCTAdcetris may be used as consolidation therapy post‑hematopoietic stem cell transplant in members who have not previously received brentuximab vedotin.

OpenPayer

Adcetris (brentuximab vedotin) — Coverage Criteria

Coverage Criteria for Adcetris (brentuximab vedotin)

Regimens and Indications Covered

Coding and Dosage Limits

Provider Requirements and Actionable Rules

Lines of Therapy and Biomarker Requirements

Background and Drug Information