Neighborhood Health Plan RI Adcetris Coverage Update

Coverage Criteria for Adcetris (brentuximab vedotin)

inv-01: CD30-positive T-Cell Lymphomas

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

CD30-positive T-cell lymphoma indications: 1) First-line therapy as a single agent or as a component of brentuximab vedotin plus chemotherapy (e.g., CHP: cyclophosphamide, doxorubicin, prednisone).

Applies to CD30-positive T-cell lymphomas including anaplastic large cell lymphoma.

CD30-positive T-cell lymphoma indications: 2) Second-line or subsequent therapy as a single agent for relapsed or refractory disease.

Applies to CD30-positive T-cell lymphomas including anaplastic large cell lymphoma.

inv-02: Classical Hodgkin Lymphoma

Covered for classical Hodgkin lymphoma when ALL conditions below are met (distinct covered scenarios):

Hodgkin lymphoma covered scenarios: A) Primary treatment: brentuximab vedotin in combination with AVD (doxorubicin, vinblastine, dacarbazine) for stage III–IV classical Hodgkin lymphoma.

Stage III–IV disease required for this primary treatment scenario.

Hodgkin lymphoma covered scenarios: B) Subsequent lines: single-agent brentuximab vedotin for later lines of therapy provided the member has not previously received brentuximab vedotin.

Applies when brentuximab vedotin was not used previously.

Hodgkin lymphoma covered scenarios: C) Consolidation: brentuximab vedotin following hematopoietic stem cell transplant (HSCT) for members who have not received prior brentuximab vedotin.

Consolidation use limited to those without prior brentuximab exposure.

Pediatric high-risk scenario: Brentuximab vedotin in combination with AVEPC (doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide) is covered for previously untreated high‑risk classical Hodgkin lymphoma in patients ≥2 years of age (high risk defined as Ann Arbor Stage IIB with bulk, IIIB, IVA, or IVB).

Age ≥2 years and previously untreated high‑risk disease required.

inv-03: Large B-Cell Lymphoma (LBCL)

Covered for specific LBCL population when ALL of the following are met:

LBCL relapsed/refractory criteria: Adcetris (brentuximab vedotin) in combination with lenalidomide (Revlimid) and rituximab (or rituximab biosimilar) is covered for adult members 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 who are ineligible for autologous HSCT or CAR T‑cell therapy.

Requires ≥2 prior lines of systemic therapy and documented ineligibility for auto‑HSCT and CAR T‑cell therapy.

Regimen	Indication / Notes	Coverage Status
Brentuximab vedotin as single agent or with chemotherapy (e.g., CHP)
CD30-positive T‑cell lymphomas: first‑line as single agent or as component of brentuximab vedotin + chemotherapy (eg, CHP); OR second‑line or subsequent single‑agent use for relapsed/refractory disease (includes anaplastic large cell lymphoma and other CD30+ T‑cell lymphomas)
Covered

Regimen	Indication / Notes	Coverage Status
Brentuximab vedotin in combination with AVD
Classical Hodgkin lymphoma: primary treatment in combination with AVD (doxorubicin, vinblastine, dacarbazine) for stage III–IV disease
Covered

Regimen	Indication / Notes	Coverage Status
Brentuximab vedotin in combination with AVEPC
High‑risk pediatric classical Hodgkin lymphoma (≥2 years, previously untreated): AVEPC = doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide; high risk defined as Ann Arbor Stage IIB with bulk, IIIB, IVA, or IVB
Covered

Regimen	Indication / Notes	Coverage Status
Brentuximab vedotin + lenalidomide + rituximab
Adult members with relapsed or refractory large B‑cell lymphoma (including DLBCL NOS, DLBCL from indolent lymphoma, or high‑grade B‑cell lymphoma) after ≥2 lines of systemic therapy who are ineligible for autologous HSCT or CAR T‑cell therapy
Covered

Regimen	Indication / Notes	Coverage Status
Brentuximab vedotin + nivolumab (Adcetris + Opdivo)
Combination for relapsed/refractory Hodgkin lymphoma — not supported by policy due to lack of Level 1 evidence showing superiority over single‑agent options or Evolent‑recommended alternatives
Not supported

Exclusions for Adcetris (brentuximab vedotin) requests include: disease progression while actively receiving Adcetris; dosing that exceeds the single-dose limits of 180 mg (1.8 mg/kg/dose) or 120 mg (1.2 mg/kg/dose); and treatment duration beyond specified maximums — specifically, exceeding 5 doses when used as part of AVEPC in pediatrics, exceeding 6 months / 12 doses when used as part of AAVD for first-line Hodgkin disease, exceeding 16 cycles for refractory/relapsed disease or consolidation after HSCT, or exceeding 8 doses for previously untreated CD30-positive T‑cell lymphoma.

Use of Adcetris for investigational or off‑label indications is considered not medically necessary when the requested indication or regimen lacks adequate supporting evidence. Determinations of adequacy reference CMS‑recognized compendia, peer‑reviewed literature, and whether the published studies appropriately represent the patient population and regimen, demonstrate clinically meaningful outcomes (for example, ASCO‑recommended effect sizes such as Hazard Ratio < 0.80 or survival benefit thresholds), and are of suitable study design. Case reports, meeting abstracts without full articles, or insufficiently representative or poorly designed studies generally do not provide adequate evidence to support coverage.

Coding and Dosing Limits

HCPCS CodesHCPCS

J9042

Injection, brentuximab vedotin, 1 mg

Single-dose limits — Adcetris (brentuximab vedotin)

Single-dose limit (adult weight-based)180 mg (1.8 mg/kg per dose)

Alternate single-dose limit (lower dosing scenario)120 mg (1.2 mg/kg per dose)

Coding referenceHCPCS code J9042 applies per mg for brentuximab vedotin (see coding section)

Maximum duration and cycle limits

Pediatric AVEPC (high‑risk, ≥2 years)Maximum of 5 doses when used as part of AVEPC regimen in pediatric patients

First‑line AAVD for Hodgkin lymphoma (stage III–IV)Up to 6 months (12 doses) when used in combination with AVD for first‑line treatment

Provider Actions, Requirements, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required through Evolent for Adcetris (brentuximab vedotin). Continuation requests are exempt from prior authorization only if the member has not experienced disease progression on Adcetris, 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.

Prior authorization required through Evolent for Adcetris.
Continuation request exemption conditions: member without disease progression on Adcetris; used within last year with ≤30-day lapse; no additional medications added.

Documentation Required

Supporting Documentation Required

Use must be supported by one or more of the following: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards per the Medicare Benefit Policy Manual Chapter 15.

Line of Therapy Applicability

inv-16: first-line | second-line | salvage

Line of therapy specifics: CD30‑positive T‑cell lymphomas: first‑line as single agent or with chemotherapy, or second‑line/subsequent single‑agent for relapsed/refractory disease; Hodgkin lymphoma: first‑line in combination with AVD for stage III–IV, or subsequent lines as single agent if not previously used, or consolidation post‑HSCT if brentuximab vedotin was not previously given; LBCL: use in combination with lenalidomide and rituximab after ≥2 prior systemic therapies for patients ineligible for auto‑HSCT or CAR T.

This node indicates the applicable line(s) of therapy for each covered indication.

Biomarker and Eligibility Requirements

CD30 — Biomarker requirement

Biomarker requirementTumor must be CD30‑positive to qualify for brentuximab vedotin per covered indications

Applicable cancersCD30 required for classical Hodgkin lymphoma and CD30‑positive T‑cell lymphomas (including anaplastic large cell lymphoma)

Documentation expectationCD30 expression should be established in clinical record or pathology report to support coverage

Definitions and Terms

CD30‑positive — definition

Definition of CD30‑positiveTumors expressing CD30 antigen, including classical Hodgkin lymphoma and certain T‑cell lymphomas, eligible for brentuximab vedotin

Includes classical Hodgkin lymphomaClassical Hodgkin lymphoma that is CD30‑positive is an indicated disease group

Includes certain T‑cell lymphomasCD30‑positive T‑cell lymphomas such as anaplastic large cell lymphoma are included

Consolidation after HSCT — definition

Definition: Consolidation after HSCTUse of brentuximab vedotin following hematopoietic stem cell transplant in members who have not previously received brentuximab vedotin

Eligibility contextCovered as post‑transplant consolidation in classical Hodgkin lymphoma when no prior brentuximab vedotin was given before HSCT

Background

Brentuximab vedotin (Adcetris) is an anti‑CD30 antibody‑drug conjugate indicated for use in CD30‑expressing lymphomas. Within this policy, Adcetris is described for multiple lymphoma settings including classical Hodgkin lymphoma, CD30‑positive T‑cell lymphomas (such as anaplastic large cell lymphoma), and selected large B‑cell lymphomas in defined clinical scenarios. Policy coverage references FDA labeling, randomized trials (for example ECHELON‑1 and ECHELON‑2 where applicable), and accepted compendia and guidelines to define appropriate, evidence‑based uses.

Revision History

2025-03operationalLatest

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

2024-12operational

Added Evolent disclaimer language and a coding information section including HCPCS code J9042.

OpenPayer

Adcetris (brentuximab vedotin) coverage