Adcetris (brentuximab) utilization and coverage criteria
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Defines prior authorization, coverage criteria, dosing limits, and approved indications for Adcetris (brentuximab) for UCare plans; applies to providers prescribing or administering the drug.
Hodgkin lymphoma dosing frequency was revised from no more frequently than once every 2 weeks to no more frequently than once weekly.
B-Cell lymphoma condition moved from 'Other Uses with Supportive Evidence' to the 'FDA Approved Indications' section and examples were revised to remove 'CD30+' from listed B-cell lymphomas; histological transformation to DLBCL was added and age ≥18 requirement was removed.
T-Cell lymphoma examples updated: added CD30+ hepatosplenic and CD30+ extranodal NK/T-cell lymphoma to examples previously; later edits removed some items and added specific anaplastic large cell lymphoma and breast implant–associated ALCL options.
Recommended Authorization and FDA‑Approved Indications
Initial FDA-Approved Indications
Coverage of Adcetris is recommended when the following indication-specific criteria are met:
Coverage of Adcetris (brentuximab) is limited to the situations specifically listed in the Recommended Authorization Criteria. Requests that do not meet those listed criteria are not recommended for approval. The policy criteria will be updated as new published data become available.
Prior Authorization, Documentation, and Prescriber Requirements
Prior Authorization Required
Prior Authorization is recommended. Approval is recommended for requests that meet the criteria and dosing in this policy; approvals may be granted for up to 1 year when criteria and dosing are met. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician (Medical Director or Pharmacist). Automation: None.
- Approvals up to 1 year when criteria and dosing met
- Doses outside policy dosing considered case-by-case by clinician
Prescriber and Dosing Documentation
For B‑cell lymphoma and other oncologic indications, Adcetris must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist). Documentation must include the prescribing clinician specialty and any justification for dosing deviations; requests lacking prescriber specialty or dosing rationale may be denied.
- Prescribed by or in consultation with an oncologist (required)
- Document prescriber specialty and rationale for any dosing deviations
Prior Therapy Requirement
For B‑cell lymphoma, approval requires that the patient has tried at least one prior therapy before authorization is granted.
- Prior therapy: at least one prior therapy attempted (B‑cell lymphoma)
Denial Trigger
Requests that do not meet the Recommended Authorization Criteria (including indication-specific requirements, prior therapy, prescriber consultation, and dosing limits) are not recommended for approval.
- Nonconforming requests (not meeting criteria or dosing) — not recommended for approval
Drug Background and Indication Context
Adcetris (brentuximab) is a CD30-directed antibody–drug conjugate used systemically for approved indications in Hodgkin lymphoma, selected T‑cell and primary cutaneous lymphomas, and certain B‑cell lymphoma settings. National Comprehensive Cancer Network (NCCN) guidance addresses its use across B‑cell, Hodgkin, and T‑cell lymphoma indications, including specific combination regimens and subsequent‑line therapy.
Key Terms and Drug Identity
Allowed Lines of Therapy
first-line | second-line | subsequent
Biomarker / Test Requirements
Allowed Combination Regimens
| Regimen / Setting | Details / Examples | Coverage status |
|---|---|---|
| Hodgkin lymphoma — first-line (previously untreated Stage III or IV) | ||
| Brentuximab in combination with doxorubicin, vinblastine, and dacarbazine (AVD). | ||
| Covered with criteria | ||
| Hodgkin lymphoma — post-autologous HSCT consolidation | ||
| Brentuximab as consolidation after autologous hematopoietic stem cell transplantation for patients at high risk of relapse or progression. | ||
| Covered with criteria | ||
| Hodgkin lymphoma — relapsed/refractory after HSCT or multiple prior regimens | ||
| Brentuximab for patients after failure of autologous HSCT or after failure of at least two prior multi-agent chemotherapy regimens (adult indications). | ||
| Covered with criteria | ||
| T-cell lymphoma — first-line in combination | ||
| Brentuximab in combination with cyclophosphamide, doxorubicin, and prednisone for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas. | ||
| Covered with criteria |
| Regimen / Setting | Details | Coverage status |
|---|---|---|
| Relapsed/refractory large B-cell lymphoma (adult), after two or more prior systemic therapies | ||
| Brentuximab in combination with lenalidomide and a rituximab product for patients who are not eligible for autologous HSCT or CAR-T-cell therapy. | ||
| Covered with criteria |
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