Peach State Health Plan Brentuximab Coverage Update

Coverage Criteria for Brentuximab vedotin (Adcetris)

Initial Approval — Classical Hodgkin Lymphoma in Adults

Covered when ALL of the following are met

cHL adult initial: 1. Diagnosis of classical Hodgkin lymphoma (cHL); 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age ≥ 18 years; 4. If previously untreated disease, prescribed in one of the following: a) in combination with AVD (doxorubicin, vinblastine, dacarbazine) — if vinblastine is unavailable due to shortage, may be prescribed with CHP (cyclophosphamide, doxorubicin, prednisone) instead; b) for age > 60 years OR member unfit for intensive therapy: in combination with dacarbazine or nivolumab; c) for age 18-60 years: as a component of BrECADD (brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone) with granulocyte colony-stimulating factor; 5. If relapsed or refractory disease, prescribed in one of the following: a) as a single agent; b) in combination with bendamustine; c) in combination with ICE (ifosfamide, carboplatin, etoposide); d) in combination with nivolumab; e) following high-dose therapy and autologous stem cell rescue; 6. Request meets one of the following: a) Dose does not exceed one of the following: i) Previously untreated Stage III or IV cHL: 1.2 mg/kg up to 120 mg IV every 2 weeks for a maximum of 12 doses; ii) cHL consolidation: 1.8 mg/kg up to 180 mg IV every 3 weeks for a maximum of 16 cycles; iii) Relapsed cHL: 1.8 mg/kg up to 180 mg IV every 3 weeks; OR b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).see node text

Prescribed regimen must be FDA-approved or recommended by NCCN

Initial Approval — Classical Hodgkin Lymphoma in Pediatric and Adolescent Patients

Covered when ALL of the following are met

cHL pediatric: 1. Diagnosis of classical Hodgkin lymphoma (cHL); 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age between 2 and 21 years; 4. One of the following: a) If previously untreated: prescribed as a component of one of: i) Bv-AVE-PC (brentuximab vedotin, doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide); ii) AEPA (brentuximab vedotin, etoposide, prednisone, doxorubicin); iii) Stage III-IV disease only: Bv-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine); iv) Stage III-IV disease only: BrECADD (brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone); b) If following AEPA: prescribed as a component of CAPDAC (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine); c) For relapsed or refractory disease: prescribed in combination with involved-site radiation therapy (ISRT), bendamustine, nivolumab, or gemcitabine, or following high-dose therapy and autologous stem cell rescue for high-risk disease (progressive, refractory, or relapse within 1 year of diagnosis); 5. If request is for stage I-II disease, member has risk factors (see Appendix D); 6. Request meets one of the following: a) Dose does not exceed 1.8 mg/kg up to 180 mg IV every 3 weeks for a maximum of 5 doses; OR b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).1.8 mg/kg up to 180 mg q3w max 5 doses

Prescribed regimen must be FDA-approved or recommended by NCCN

Initial Approval — T-Cell Lymphomas

Covered when ALL of the following are met

T-cell lymphomas: 1. Diagnosis of one of the following T-cell lymphoma entities: a) PTCL — including sALCL and PTCL subtypes (angioimmunoblastic T-cell lymphoma; enteropathy-associated T-cell lymphoma; monomorphic epitheliotropic intestinal T-cell lymphoma; nodal PTCL with TFH phenotype; follicular T-cell lymphoma); b) Breast implant-associated ALCL (off-label); c) Adult T-cell leukemia/lymphoma (off-label); d) Relapsed or refractory extranodal NK/T-cell lymphoma (off-label); e) Hepatosplenic T-cell lymphoma (off-label); 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age ≥ 18 years; 4. For all requests except ALCL: disease is CD30-positive; 5. Prescribed as one of: a) single agent; b) in combination with CHP (cyclophosphamide, doxorubicin, prednisone); c) for PTCL only: in combination with CHEP (cyclophosphamide, doxorubicin, etoposide, prednisone); d) for PTCL, breast implant-associated ALCL, or hepatosplenic T-cell lymphoma only: in combination with bendamustine for relapsed/refractory disease; 6. Request meets one of the following: a) Previously untreated sALCL or other CD30-positive PTCL: dose does not exceed 1.8 mg/kg up to 180 mg IV every 3 weeks with each cycle of chemotherapy for 6 to 8 doses; b) Relapsed sALCL: dose does not exceed 1.8 mg/kg up to 180 mg IV every 3 weeks; OR c) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).1.8 mg/kg up to 180 mg q3w

Prescribed regimen must be FDA-approved or recommended by NCCN

Initial Approval — Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders

Covered when ALL of the following are met

primary cutaneous CD30+ disorders: 1. Diagnosis of one of: a) primary cutaneous anaplastic large cell lymphoma (pcALCL); b) cutaneous ALCL with multifocal lesions or lymph node positive (off-label); c) lymphomatoid papulosis — as subsequent therapy for relapsed/refractory disease (off-label); 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age ≥ 18 years; 4. Disease is CD30-positive; 5. Request meets one of the following: a) Relapsed pcALCL: dose does not exceed 1.8 mg/kg up to 180 mg IV every 3 weeks for a maximum of 16 cycles; OR b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).1.8 mg/kg up to 180 mg q3w max 16 cycles

Prescribed regimen must be FDA-approved or recommended by NCCN

Initial Approval — Mycosis Fungoides / Sezary Syndrome

Covered when ALL of the following are met

MF/Sezary: 1. Diagnosis of Mycosis Fungoides (MF) or Sezary syndrome (off-label); 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age ≥ 18 years; 4. Prescribed as a single agent or in combination with skin-directed therapy; 5. Request meets one of the following: a) Relapsed CD30-positive MF: dose does not exceed 1.8 mg/kg up to 180 mg IV every 3 weeks for a maximum of 16 cycles; OR b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).1.8 mg/kg up to 180 mg q3w max 16 cycles

Prescribed regimen must be FDA-approved or recommended by NCCN

Initial Approval — B-Cell Lymphomas

Covered when ALL of the following are met

B-cell lymphomas: 1. Diagnosis of one of: a) large B-cell lymphoma (LBCL); b) diffuse large B-cell lymphoma (DLBCL), including histologic transformation of indolent lymphomas to DLBCL; c) high-grade B-cell lymphoma (HGBL); d) HIV-related B-cell lymphoma (off-label); e) monomorphic post-transplant lymphoproliferative disorder (PTLD), B-cell type (off-label); 2. Prescribed by or in consultation with an oncologist or hematologist; 3. One of the following: a) Age ≥ 18 years and prescribed in one of: i) in combination with lenalidomide and rituximab; ii) in combination with rituximab (off-label); iii) in combination with nivolumab (off-label); iv) as a single agent (off-label); OR b) Age < 18 years (off-label) and both: i) disease is primary mediastinal LBCL; ii) prescribed in combination with nivolumab or pembrolizumab; 4. Disease is relapsed or refractory; 5. Adcetris is prescribed as subsequent therapy; 6. Member is not a candidate for allogeneic or autologous stem cell transplant or CAR T-cell therapy; 7. Request meets one of the following: a) LBCL: dose does not exceed 1.2 mg/kg up to 120 mg IV every 3 weeks; OR b) Dose is within the FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).LBCL: 1.2 mg/kg up to 120 mg q3w

Prescribed regimen must be FDA-approved or recommended by NCCN

Continued Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continued therapy requirements: 1. Member is currently receiving Adcetris via the Centene benefit OR documentation supports current receipt of Adcetris for a covered indication with at least 30 days of therapy; 2. Member is responding positively to therapy; 3. If request is for a dose increase, one of the following applies: a) New dose does not exceed indication-specific maxima (examples listed under dosing limits); OR b) New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN

Dosing by indication (selected examples)

Dosing regimens and maximums (examples extracted exactly as listed):

Previously untreated Stage III or IV cHL in adults: 1.2 mg/kg IV up to 120 mg every 2 weeks until max 12 dosesmax 120 mg; max 12 doses

Administer in combination with chemotherapy

Previously untreated high-risk pediatric/adolescent cHL: 1.8 mg/kg IV up to 180 mg every 3 weeks with chemotherapy for max 5 dosesmax 180 mg; max 5 doses

Pediatric risk factors defined in Appendix D

cHL consolidation in adults: 1.8 mg/kg IV up to 180 mg every 3 weeks initiated within 4-6 weeks post-autoHSCT for up to 16 cyclesmax 180 mg; max 16 cycles

Updated coverage criteria highlights

Coverage updated per NCCN with specific regimen and population adjustments

BrECADD adult component eligibility: Member age within revised limit (e.g., age 18-60 for certain BrECADD uses) AND member meets regimen-specific criteria (previous Deauville score 4-5 option removed) OR member is unfit for intensive therapy allowing use with dacarbazine or nivolumab.age 18-60

Age and fitness criteria revised 3Q 2026

Alternative regimen options: Use with CHP allowed as alternative to AVD when vinblastine is unavailable; option to combine with nivolumab for older patients; for pediatric cHL, BrECADD and Bv-AVD allowed for stage III-IV disease.stage III-IV for pediatric regimens

Added per NCCN review

DLBCL coverage expansion: DLBCL coverage includes histologic transformation of indolent lymphomas; CD30-positive requirement removed for DLBCL indication.

If the requested use is not addressed in Section III (Diagnoses/Indications for which coverage is NOT authorized) and the policy does not reflect a recent label change within the last 6 months, providers should follow the plan's referral guidance. For drugs on the formulary or preferred drug list, refer to the no-coverage-criteria policy for the applicable line of business (e.g., CP.CPA.190 for commercial, HIM.PA.33 for ICHRA, CP.PMN.255 for Medicaid). For drugs not on the formulary/PDL, refer to the non‑formulary policy for the applicable line of business (e.g., CP.CPA.190, HIM.PA.103, CP.PMN.16). If neither of those pathways applies, refer the request to the applicable off‑label use policy for the member's line of business.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (CP.CPA.09 for commercial, HIM.PA.154 for ICHRA, CP.PMN.53 for Medicaid). Requests for such uses should include supporting evidence per those off‑label policies to be considered for coverage.

Concomitant administration of brentuximab vedotin with bleomycin is contraindicated because of the risk of pulmonary toxicity. Do not authorize combined use of these agents.

Per the 3Q 2026 annual review and NCCN updates, the prior policy criterion that required a Deauville score of 4–5 for use of brentuximab vedotin as a component of BrECADD has been removed. The BrECADD component eligibility is now governed by the revised age and regimen/fitness criteria rather than a Deauville 4–5 requirement.

Uses that are not FDA‑approved and are not specifically covered by this policy may be considered not medically necessary if adequate supporting evidence required by the applicable off‑label use policy is not provided.

Requests for brentuximab vedotin that fall outside the policy's revised age limits or the regimen/combination criteria (for example, BrECADD age limits revised to 18–60 years for certain uses) may be considered not medically necessary per plan guidelines when they do not meet the updated eligibility criteria.

Regimens and Combination Uses

Indication	Allowed Regimens / Combinations	Notes (age, line, dosing limits)
Classical Hodgkin lymphoma (Adults)	- In combination with AVD (doxorubicin, vinblastine, dacarbazine) - CHP (cyclophosphamide, doxorubicin, prednisone) if vinblastine unavailable - As component of BrECADD (brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone) with G-CSF - Single-agent for relapsed/refractory disease - With bendamustine; with ICE (ifosfamide, carboplatin, etoposide); with nivolumab; following high-dose therapy and autologous stem cell rescue	Age ≥18; previously untreated: use with AVD/CHP or BrECADD (age 18–60 for BrECADD per revisions) or with dacarbazine/nivolumab if >60 or unfit for intensive therapy; dosing limits include 1.2 mg/kg up to 120 mg q2w (previously untreated Stage III/IV, max 12 doses) or 1.8 mg/kg up to 180 mg q3w for consolidation/relapsed cHL (see dosing criteria)
Classical Hodgkin lymphoma (Pediatric/Adolescent)	- Bv-AVE-PC (brentuximab vedotin, doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide) - AEPA (brentuximab vedotin, etoposide, prednisone, doxorubicin) - Bv-AVD (Stage III–IV only) - BrECADD (Stage III–IV only) - CAPDAC (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine) following AEPA; for relapsed disease: ISRT, bendamustine, nivolumab, or gemcitabine; post-high-dose therapy/autologous stem cell rescue for high-risk disease	Age 2–21 years; Stage III–IV pediatric regimens specified; dose limit 1.8 mg/kg up to 180 mg q3w for max 5 doses (unless supported by guidelines)
T‑cell lymphomas (including sALCL, PTCL subtypes)	- Single agent - In combination with CHP - For PTCL: combination with CHEP - For relapsed/refractory PTCL, breast implant-associated ALCL, or hepatosplenic T-cell lymphoma: with bendamustine (per pathway)	Age ≥18; for all requests except ALCL disease must be CD30-positive; dosing examples: 1.8 mg/kg up to 180 mg q3w for previously untreated sALCL or CD30-positive PTCL (with chemo, 6–8 doses) or relapsed sALCL: 1.8 mg/kg up to 180 mg q3w
Primary cutaneous CD30+ T‑cell lymphoproliferative disorders	- Single agent for relapsed pcALCL or lymphomatoid papulosis as subsequent therapy	Age ≥18; disease must be CD30-positive; dose up to 1.8 mg/kg up to 180 mg q3w (max 16 cycles) for relapsed pcALCL
Mycosis Fungoides / Sezary syndrome	- Single agent or in combination with skin-directed therapy (previously listed combinations revised) - (Previously included bendamustine combination but options were revised)	Age ≥18; relapsed CD30-positive MF: up to 1.8 mg/kg up to 180 mg q3w (max 16 cycles); combination use criteria per policy
B‑cell lymphomas (LBCL, DLBCL including transformed disease, HGBL, select off-label B-cell indications)	- In combination with lenalidomide and rituximab - In combination with rituximab (off-label) - In combination with nivolumab (off-label) - Single-agent (off-label)	Generally age ≥18 for adult pathways; disease must be relapsed or refractory and Adcetris prescribed as subsequent therapy; member may need to be not a candidate for transplant or CAR T-cell therapy for certain LBCL pathways; LBCL dosing example: ≤1.2 mg/kg up to 120 mg q3w

Regimen / Combination	Indications	Policy Notes
Adcetris + AVD (Bv-AVD)	Previously untreated classical Hodgkin lymphoma (adult and pediatric Stage III–IV per pediatric criteria)	If vinblastine unavailable in adults, CHP may be used as alternative; pediatric Stage III–IV use specified in pediatric criteria
Adcetris + BrECADD (component use)	Classical Hodgkin lymphoma (adult component use; pediatric Stage III–IV per pediatric criteria)	Adult BrECADD component: age-limited (revised to 18–60 for certain uses); required use with G-CSF when specified; Deauville 4–5 option removed in latest revision
Adcetris + CHP	Classical Hodgkin lymphoma when vinblastine is unavailable; T‑cell lymphomas in combination with CHP	CHP allowed as alternative to AVD for cHL adults if vinblastine unavailable; used in PTCL per regimen criteria
Adcetris + nivolumab	cHL (age >60 or unfit for intensive therapy), select B‑cell lymphoma off-label pathways	NCCN-specified combination option for older/unfit cHL patients; listed as off-label option for B-cell lymphomas in coding implications
Adcetris + bendamustine	Relapsed/refractory cHL; PTCL relapsed settings (per pathway)	Added pathway for combination use with bendamustine for PTCL and certain off-label T-cell indications per NCCN review
Adcetris + rituximab ± lenalidomide	Relapsed or refractory LBCL (adult) in combination with lenalidomide and rituximab; off-label B-cell pathways may include rituximab combinations	Policy includes specific LBCL pathway requiring disease to be relapsed/refractory and member may not be candidate for CAR T-cell therapy; dosing and approval criteria apply

Regimen	Indication	Special Eligibility / Sequencing Notes
Adcetris + lenalidomide + rituximab	Relapsed or refractory large B‑cell lymphoma (LBCL) in adults	Policy specifies LBCL must be relapsed/refractory and Adcetris prescribed as subsequent therapy; member may need to be not a candidate for allogeneic/autologous stem cell transplant or CAR T-cell therapy per criteria; dose does not exceed 1.2 mg/kg up to 120 mg q3w
Adcetris per FDA‑approved LBCL indication (single agent or as specified)	Relapsed or refractory LBCL (adult)	RT4 added new FDA-approved indication for relapsed/refractory LBCL with added criterion that disease is relapsed/refractory and member may not be candidate for CAR T-cell therapy; dosing and prior authorization requirements apply

Regimen / Component	Applicable Indications	Policy Details / Limits
BrECADD (component use of brentuximab vedotin)	Classical Hodgkin lymphoma (adult and pediatric as specified)	Adult BrECADD component: age-limited (revised to 18–60 for certain uses); Deauville 4–5 option removed in 3Q2026 update; required to use with granulocyte colony-stimulating factor when specified; pediatric BrECADD allowed for Stage III–IV disease
Bv-AVD (brentuximab vedotin with doxorubicin, vinblastine, dacarbazine)	Pediatric classical Hodgkin lymphoma (Stage III–IV) and adult previously untreated cHL pathways	Pediatric Stage III–IV allowed per pediatric criteria; adult use typically as part of previously untreated regimens where specified
CHP as alternative to AVD	Classical Hodgkin lymphoma adults when vinblastine is unavailable; T‑cell lymphomas in combination with CHP	Added per NCCN review as option when vinblastine shortage exists; policy notes CHP may substitute for AVD
Adcetris combined with nivolumab or dacarbazine for patients unfit for intensive therapy	cHL in adults >60 years or those unfit for intensive therapy	Policy added option to use with nivolumab or dacarbazine for members unfit for intensive therapy; dosing and eligibility per cHL criteria
CHEP for PTCL	Peripheral T‑cell lymphoma (PTCL) where CHEP is indicated	CHEP combination added as an option for PTCL per 3Q2026 NCCN updates; use subject to T‑cell lymphoma criteria including CD30 status when required

Coding and Dosage Information

Referenced HCPCSHCPCS

J9042

Injection, brentuximab vedotin, 1 mg.

Administrative/coding notesmixed

ICHRA

line of business added

Dose caps

Typical adult IV single-dose cap1.2 mg/kg up to 120 mg (commonly used for previously untreated Stage III/IV cHL every 2 weeks)

Typical adult consolidation/relapse cap1.8 mg/kg up to 180 mg (used for cHL consolidation and many relapsed adult indications every 3 weeks)

Typical pediatric/adolescent cap1.8 mg/kg up to 180 mg (pediatric high‑risk cHL: every 3 weeks, max 5 doses)

Maximum dosing limits by indication

Previously untreated Stage III/IV adult cHL1.2 mg/kg IV up to 120 mg every 2 weeks (maximum 12 doses)

cHL consolidation in adults (post-autoHSCT)1.8 mg/kg IV up to 180 mg every 3 weeks (maximum 16 cycles)

Provider Requirements and Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. Submit documentation demonstrating the member meets the indication-specific criteria, including prescriber specialty, age, dosing, and regimen requirements.

Prior authorization must include evidence that the prescribed regimen is FDA‑approved or recommended by NCCN where specified.
Prescriber must be an oncologist or hematologist or be in consultation with one.

Prior Authorization

Prior authorization and approval durations

Prior authorization is required. Initial approval durations vary by line of business: Medicaid/HIM/ICHRA = 12 months; Commercial = 6 months or to the member's renewal date, whichever is longer.

Prior Authorization

Line-of-Therapy Specific Criteria

first-line | subsequent

line_of_therapy_examples: Policy specifies previously untreated regimens for frontline therapy and defines relapsed/refractory or subsequent therapy scenarios (e.g., post-auto-HSCT consolidation, relapsed after multiple regimens, subsequent therapy for LBCL when not candidate for transplant or CAR T).

first-line

Previously untreated cHL or PTCL regimens: Use in combination with chemotherapy for previously untreated Stage III/IV cHL (examples: Bv-AVD, BrECADD per NCCN allowances) and in combination with CHP for sALCL/PTCL when specified.

second-line

Relapsed/refractory indications: Relapsed cHL, relapsed sALCL, relapsed pcALCL, relapsed CD30-positive MF, relapsed or refractory LBCL (new FDA indication) — dosing and combination options vary by indication; some B-cell lymphoma uses include requirement that member is not a candidate for CAR T-cell therapy.

Biomarker and Diagnostic Requirements

CD30 — Biomarker requirements

CD30 requirement — T‑cell lymphomasFor all T‑cell lymphoma requests except ALCL, disease must be CD30‑positive

CD30 requirement — Primary cutaneous disordersPrimary cutaneous CD30+ disorders (pcALCL, cutaneous ALCL multifocal/ node positive, lymphomatoid papulosis as subsequent therapy) must be CD30‑positive

CD30 requirement — Mycosis FungoidesRelapsed CD30‑positive MF: disease must be CD30‑positive for the relapsed MF indication

CD30 — Additional CD30 requirement references

CD30 exceptions and related notesDLBCL indication clarified to include histologic transformation of indolent lymphomas and the DLBCL pathway no longer requires disease to be CD30‑positive

Documentation expectation

Definitions and Abbreviations

Brentuximab vedotin (Adcetris)

Drug class/descriptionBrentuximab vedotin (Adcetris) is a CD30‑directed antibody–drug conjugate linked to a microtubule inhibitor

Trade nameAdcetris

Mechanism overviewTargets CD30 on malignant cells to deliver a cytotoxic microtubule‑disrupting agent

cHL — Abbreviation (Appendix A)

AbbreviationcHL = classical Hodgkin lymphoma

Reference locationAbbreviation listed in Appendix A of the policy

Use in criteria

Background

Brentuximab vedotin (Adcetris) is a CD30‑directed antibody–drug conjugate combining a monoclonal antibody targeting CD30 with a microtubule‑disrupting agent. It is indicated for multiple CD30‑expressing lymphomas and is used either as monotherapy or in combination regimens depending on the disease type, patient age, and treatment setting; regimen‑ and indication‑specific dosing limits and prescriber requirements are specified in the policy.

Brentuximab Vedotin (Adcetris)

Sign up for Peach State Health Plan Policy CP.PHAR.303 alerts

Brentuximab Vedotin (Adcetris)

Sign up for Peach State Health Plan Policy CP.PHAR.303 alerts

Coverage Criteria for Brentuximab vedotin (Adcetris)

Regimens and Combination Uses

Coding and Dosage Information

Provider Requirements and Authorization

Line-of-Therapy Specific Criteria

Biomarker and Diagnostic Requirements

Definitions and Abbreviations

Background