Centene bendamustine Coverage & Prior Auth Update

Coverage and Medical Necessity Criteria

Initial Therapy - CLL/SLL

Covered when ALL of the following are met

CLL/SLL Initial Approval: 1. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

2. Prescription is by, or in consultation with, an oncologist or hematologist.

3. Prescribed in combination with an anti‑CD20 agent (rituximab) or obinutuzumab (Gazyva).

4. Patient age > 18 years.

5. Dose does not exceed 100 mg/m2 on Days 1 and 2 of a 28‑day cycle, up to 6 cycles.CLL/SLL: <= 100 mg/m2 Days 1 & 2 of 28‑day cycle; up to 6 cycles

6. Prescribed regimen is FDA‑approved for the indication or is a regimen recommended by NCCN. For relevant off‑label uses, prescriber must submit supporting evidence from guidelines or peer‑reviewed literature.

Prescriber must submit supporting evidence for off‑label uses.

Initial Therapy - Non-Hodgkin B-cell Lymphomas

Covered when ALL of the following are met

Indolent and other B‑cell NHL Initial Approval: 1. Diagnosis of an indolent B‑cell non‑Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab‑containing regimen, or one of the specified B‑cell histologies listed below.

2. Eligible histologies include: classic follicular lymphoma; splenic marginal zone lymphoma (MZL); nodal MZL; gastric MALT lymphoma; nongastric MALT lymphoma; diffuse large B‑cell lymphoma (DLBCL) when there is no intention to proceed to transplant and as subsequent therapy; mantle cell lymphoma; HIV‑related B‑cell lymphoma as subsequent therapy; monomorphic post‑transplant lymphoproliferative disorder (PTLD) B‑cell type as subsequent therapy; and high‑grade B‑cell lymphomas with no intention to proceed to transplant (subsequent therapy).

3. Prescription is by, or in consultation with, an oncologist or hematologist.

4. For classic follicular lymphoma and MZL: prescribed in combination with rituximab or obinutuzumab (Gazyva).

NCCN Recommended Off-Label Uses

Covered when ALL of the following are met

NCCN‑Recommended Off‑Label Uses: 1. Diagnosis corresponds to one of the NCCN‑listed off‑label uses (examples include: relapsed/refractory pediatric Hodgkin lymphoma as re‑induction or subsequent therapy; relapsed/refractory multiple myeloma after ≥3 prior therapies; hematopoietic cell transplantation conditioning for NHL without CNS disease or for HL; mycosis fungoides/Sezary syndrome; specified T‑cell lymphomas including HSTCL, ATLL, PTCL subtypes and others; systemic light chain amyloidosis relapsed/refractory; Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma).

2. Prescription is by, or in consultation with, an oncologist or hematologist.

3. When indicated, specific combination regimens required by the indication are used (e.g., transplant conditioning with etoposide/cytarabine/melphalan; MF/SS with Adcentris; T‑cell lymphomas as single agent or with Adcentris; SLCA with dexamethasone; Waldenstrom's as single agent or with rituximab).

4. Age ≥ 18 years unless the diagnosis is a pediatric indication explicitly listed by NCCN (e.g., pediatric HL).

Continuation Therapy

Covered when ALL of the following are met

Continued Therapy: 1. Member is currently receiving bendamustine via the Centene benefit and documentation supports active receipt of Belrapzo, Bendeka, Treanda, Vivimusta, or bendamustine for a covered indication for at least 30 days.

2. Member is responding positively to therapy (clinical documentation required).

3. The new or continued dose does not exceed established limits for the diagnosis (e.g., CLL/SLL: 100 mg/m2 Days 1 and 2 of a 28‑day cycle up to 6 cycles; indolent B‑cell NHL: 120 mg/m2 Days 1 and 2 of a 21‑day cycle up to 8 cycles).see dose limits

4. If a dose increase is requested, the increased dose is supported by practice guidelines or peer‑reviewed literature and the prescriber submits supporting evidence.

Policy-level criteria and revisions

Policy updates and indication clarifications per NCCN (summarized):

Commercial approval duration: Revised commercial approval duration to 6 months or to the member's renewal date per NCCN guidance for NHL indications.duration

applies to commercial lines of business

Product applicability: Policy applies to generic bendamustine and the named brand products including Belrapzo, Bendeka, Treanda, and Vivimusta (Vivimusta added as a new dosage form).product list

Vivimusta added as new dosage form

Combination‑use requirements: Added or revised requirements for combination use with other agents (e.g., rituximab, obinutuzumab/Gazyva, polatuzumab vedotin/Polivy, etoposide/cytarabine/melphalan for transplant conditioning, Adcentris) across CLL, follicular lymphoma, MZL, indolent NHL, DLBCL, HIV‑related B‑cell lymphoma, PTLD, and high‑grade B‑cell lymphomas per NCCN categories.

Non‑FDA approved indications for bendamustine are not authorized under this policy unless they are specifically addressed in this policy or the prescriber submits sufficient documentation demonstrating efficacy and safety consistent with the referenced off‑label use policies. For commercial members refer to CP.CPA.09, for Health Insurance Marketplace members refer to HIM.PA.154, and for Medicaid members refer to CP.PMN.53 (or other applicable evidence of coverage documents) when requesting coverage for an off‑label use.

Bendamustine is contraindicated in patients with a prior hypersensitivity reaction to bendamustine. Certain formulations list additional formulation‑specific excipient hypersensitivities as contraindications: for Treanda the contraindication is prior hypersensitivity to bendamustine; for Belrapzo and Bendeka include prior hypersensitivity to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol; and for Vivimusta include prior hypersensitivity to bendamustine, polyethylene glycol 400, dehydrated alcohol, or monothioglycerol.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage directives related to bendamustine for Medicaid members.

Uses of bendamustine that are not listed in this policy and that lack sufficient supporting evidence per the referenced off‑label use policies are considered not authorized (not medically necessary). Providers requesting coverage for such uses must submit clinical documentation (e.g., office notes, laboratory results, peer‑reviewed literature or guideline support) showing the requested use meets applicable evidentiary standards referenced in the off‑label policies.

Primary cutaneous lymphomas were reviewed and subsequently removed as a supported indication based on the NCCN guideline revisions; therefore bendamustine use for primary cutaneous lymphomas is no longer supported by this policy. The clinical rationale and coding/approval updates reflecting this change are documented in the policy revision history and coding implications.

Claims Coding and Dose Limits

HCPCS Codes referencedHCPCS

J9033	Injection, bendamustine hydrochloride; 1 mg.
J9034	Injection, bendamustine HCL (Bendeka) 1 mg.
J9036	Injection, bendamustine hydrochloride (belrapzo/bendamustine) 1 mg.
J9056	Injection, bendamustine hydrochloride (vivimusta) 1 mg.

Dose limits — CLL/SLL and Indolent B-cell NHL

CLL/SLL per-cycle dose limitDoes not exceed 100 mg/m2 on Days 1 and 2 of a 28-day cycle (up to 6 cycles)

Indolent B-cell NHL per-cycle dose limitDoes not exceed 120 mg/m2 on Days 1 and 2 of a 21-day cycle (up to 8 cycles)

Minimum age for these indicationsAge > 18 years required for covered use

Maximum cycles per indication

Maximum cycles — CLL/SLLUp to 6 cycles for CLL/SLL when dosing per policy (100 mg/m2 Days 1 and 2 of a 28-day cycle)

Maximum cycles — Indolent B-cell NHLUp to 8 cycles for indolent B-cell NHL when dosing per policy (120 mg/m2 Days 1 and 2 of a 21-day cycle)

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Belrapzo, Bendeka, Treanda, Vivimusta, and bendamustine (generic and brand products). Providers must submit clinical documentation (e.g., office chart notes, lab results, prior therapy records) supporting that the member meets all approval criteria. Failure to provide sufficient documentation or evidence supporting off‑label uses per applicable off‑label policies may result in denial.

Prior authorization required for branded and generic bendamustine products
Submit supporting clinical documentation at time of PA request (office notes, labs, prior therapy)
Insufficient documentation or unsupported off‑label use may lead to denial

Documentation Required

Approval Duration and Regimen Requirements

Approval durations vary by line of business: Medicaid/HIM — 6 months; Commercial — 6 months or to the member’s renewal date, whichever is longer. Prescribed regimens must be FDA‑approved or recommended by NCCN. If the drug’s label has changed recently and is not yet reflected in this policy, follow the applicable formulary/non‑formulary exception policies referenced in the policy header.

Approved Regimens and Combinations

Regimen	Indication / Notes	Coverage Status
Bendamustine + rituximab
Indication: Chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) when prescribed by or in consultation with an oncologist or hematologist; must be prescribed in combination with rituximab; Age > 18 years; dose does not exceed 100 mg/m2 on Days 1 and 2 of a 28-day cycle, up to 6 cycles; regimen must be FDA‑approved or NCCN‑recommended (off‑label uses require supporting evidence).

Regimen	Indication / Notes	Coverage Status
Bendamustine + rituximab or obinutuzumab (Gazyva)
Indication: Indolent B-cell non-Hodgkin lymphoma progressed during or within 6 months of rituximab-containing therapy; for classic follicular lymphoma and MZL prescribe in combination with rituximab or obinutuzumab; Age > 18 years; dose does not exceed 120 mg/m2 on Days 1 and 2 of a 21-day cycle, up to 8 cycles; regimen must be FDA‑approved or NCCN‑recommended.
Bendamustine with Polivy (polatuzumab vedotin) ± rituximab

Regimen	Indication / Notes	Coverage Status
Bendamustine + etoposide + cytarabine + melphalan
Indication: Hematopoietic cell transplantation conditioning for non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL); prescribed in combination as part of transplantation conditioning per NCCN; Age ≥ 18 years unless pediatric transplant indication specified; prescriber must submit supporting evidence when off‑label.

Regimen	Indication / Notes	Coverage Status
Bendamustine (single agent)
Indication: T-cell lymphomas (including specified PTCL subtypes); may be prescribed as single agent for NCCN‑recommended uses; prescribed by or in consultation with an oncologist or hematologist; Age ≥ 18 years unless pediatric diagnosis applies; off‑label uses require supporting evidence.
Bendamustine + Adcentris (brentuximab vedotin)

Regimen	Typical Context / Example Use	Coverage Status
R-CHOP (rituximab + cyclophosphamide, doxorubicin, vincristine, prednisone)
Common primary regimen for various B-cell lymphomas; listed as a therapeutic alternative in Appendix B (NCCN examples).
EPOCH (+ rituximab)

Key Terms and Abbreviations

Bendamustine — product names and indication summary

Generic and brand namesBendamustine is marketed as Belrapzo, Bendeka, Treanda, and Vivimusta

Drug classAlkylating agent (bendamustine hydrochloride)

High-level indicationsFDA‑approved for chronic lymphocytic leukemia (CLL) and indolent B‑cell non‑Hodgkin lymphoma that progressed during or within 6 months of rituximab‑containing therapy

National Comprehensive Cancer Network (NCCN)

NCCN abbreviationNCCN = National Comprehensive Cancer Network

RoleReferenced throughout the policy as the guideline source for recommended regimens and off‑label uses

Clinical Background

Bendamustine hydrochloride is an alkylating agent marketed in multiple formulations (for example, Belrapzo, Bendeka, Treanda, and Vivimusta) and is used in hematologic malignancies. FDA‑approved indications include chronic lymphocytic leukemia (CLL) and certain indolent B‑cell non‑Hodgkin lymphomas, and the policy also references multiple NCCN‑recommended uses and combination regimens (e.g., combinations with rituximab, obinutuzumab, transplant conditioning regimens, and selected T‑cell lymphoma regimens) that may be covered when policy criteria are met.

Therapy Line Placement

mixed — Line of therapy related criteria (top-level node)

Line of therapy mapping: Policy addresses first‑line (where NCCN indicates initial palliative intent), subsequent therapy, and re‑induction contexts. Specific line (first vs subsequent) is identified per diagnosis in the criteria (for example: CLL initial use; indolent B‑cell NHL use as subsequent therapy after progression on a rituximab‑containing regimen).

mixed — Line of therapy related criterion (top-level node)

Initial vs subsequent therapy notes: Policy revisions clarify line‑of‑therapy requirements: added relapsed/refractory requirements for HL, MM, and SLCA; added subsequent therapy requirement to MM and PTCL; revised high‑grade B‑cell lymphoma to require no intention to proceed to transplant when used as subsequent therapy; some uses specified as initial therapy per updated NCCN guidance.line_of_therapy

see full policy for line‑specific decision logic

Policy Changes and Revision Timeline

2022-12-28product_addition

Added Vivimusta as a new dosage form of bendamustine and removed reference to a formulary exception policy for Belrapzo and Bendeka (operational template updates).

2023-05-24coding_update

Added HCPCS code(s) including J9056 (and other added codes listed in the document) to the policy's coding list.

2023-08-23criteria_revision

OpenPayer

Bendamustine (Belrapzo, Bendeka, Treanda, Vivimusta)

Coverage and Medical Necessity Criteria

Claims Coding and Dose Limits

Prior Authorization, Documentation, and Billing Guidance

Approved Regimens and Combinations

Key Terms and Abbreviations

Clinical Background

Therapy Line Placement

Policy Changes and Revision Timeline