ModifiedCentenePolicy N/A

Clinical Policy: Tafasitamab-cxix (Monjuvi)

Defines medical necessity and coverage criteria for tafasitamab-cxix (Monjuvi) for treatment of specified B-cell lymphomas for Centene-affiliated health plans, affecting providers prescribing this agent for commercial, HIM and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyTafasitamab-cxix (Monjuvi) coverage criteria

Policy CodePolicy N/A

Change TypeMaterial revisions and additions (diagnoses and exclusions)

Effective DateDec 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, oncologist/hematologist involvement, prior therapies, transplant/CAR‑T intent, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

Added NCCN-supported off-label uses for certain B-cell lymphomas and moved additional off-label indications under B-cell lymphomas; revised header from DLBCL to B-cell Lymphoma.

Removed follicular lymphoma (grade 1-2) from additional NCCN recommended off-label uses as not currently supported by the NCCN compendium.

Added relapsed or refractory marginal zone lymphoma (MZL) to diagnoses for which coverage is not authorized due to lack of efficacy in the inMIND trial.

12 mg/kgmaximum approved dose listed

12 monthsapproval duration

J9349HCPCS code referenced

12 cycles

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Coverage Criteria for Tafasitamab-cxix (Monjuvi)

Initial Therapy

Covered when ALL of the following are met

Diagnosis: Member has one of the covered B-cell lymphomas: relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low-grade lymphoma; relapsed or refractory follicular lymphoma (FL); histologic transformation of indolent lymphomas to DLBCL (off-label); high-grade B-cell lymphoma (HGBL) (off-label); monomorphic post-transplant lymphoproliferative disorder (off-label); or HIV-related B-cell lymphoma (off-label).

See Appendix D for DLBCL subtypes.

Prescriber: Prescribed by or in consultation with an oncologist or hematologist.

Prior therapy / candidacy: For requests other than FL and histologic transformation: one of the following: relapsed disease < 12 months in non-candidates for CAR T-cell therapy (includes lack of access to CAR T-cell therapy); OR relapsed disease > 12 months after completion of first-line therapy if no intention to proceed to transplant.

For histologic transformation of indolent lymphomas to DLBCL: member has no intention to proceed to transplant.

Regimen and duration: For FL: tafasitamab-cxix (Monjuvi) must be used in combination with lenalidomide and rituximab for a maximum of 12 cycles. For DLBCL and other B-cell lymphomas: tafasitamab-cxix used in combination with lenalidomide for a maximum of 12 cycles and then may continue as monotherapy until progression or unacceptable toxicity.maximum 12 cycles combination

Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy

Continued therapy covered when

Continuation conditions: Member is currently receiving tafasitamab-cxix via the Centene benefit and has previously met initial approval criteria, OR member is enrolled in applicable continuity of care regulations; and member is responding positively to therapy.

Approval duration: 12 months.

Ongoing regimen limits: For FL: combination with lenalidomide and rituximab limited to a maximum of 12 cycles. For DLBCL and other B-cell lymphomas: combination with lenalidomide limited to a maximum of 12 cycles, after which tafasitamab-cxix may be continued as monotherapy.maximum 12 cycles combination

Requests for dose increases must not exceed 12 mg/kg unless supported by practice guidelines or peer-reviewed literature with documentation.

Coverage updates and exclusions

Policy updates reflect NCCN compendium-supported indications and exclusions

NCCN-supported off-label additions: Added NCCN-supported category 2A off-label indications including HIV-related B-cell lymphomas, high-grade B-cell lymphomas (HGBL), post-transplant lymphoproliferative disorders, and histologic transformation to DLBCL.

These additions were incorporated into the B-cell lymphoma section per 4Q updates.

Removed indications: Follicular lymphoma (grade 1-2) removed from additional NCCN recommended off-label uses as not currently supported by the NCCN compendium.

4Q2024 update.

Non-covered population: Relapsed or refractory marginal zone lymphoma (MZL) is added to diagnoses for which coverage is not authorized due to lack of efficacy observed in the inMIND trial.

Added RT4, 07.07.25; use for relapsed/refractory MZL is not authorized per policy.

Relapsed or refractory marginal zone lymphoma (MZL) has been evaluated in the randomized inMIND trial and demonstrated no evidence of improvement in investigator-assessed progression-free survival when tafasitamab-cxix (Monjuvi) was added to lenalidomide and rituximab. Per the product Prescribing Information and the policy Appendix E, Monjuvi is not recommended for treatment of relapsed or refractory MZL outside of controlled clinical trials due to lack of demonstrated efficacy in that population.

Requests for tafasitamab-cxix (Monjuvi) for the indication of relapsed or refractory marginal zone lymphoma (MZL) are not authorized under this policy; MZL has been added to the list of diagnoses/indications for which coverage is not authorized because efficacy was not shown in the inMIND trial.

Use of tafasitamab-cxix (Monjuvi) for relapsed or refractory MZL is not authorized by this policy. The Prescribing Information notes Monjuvi is not indicated for MZL and the clinical trial evidence (inMIND) did not demonstrate benefit in this subgroup; therefore coverage for this indication is not granted.

The rationale for not authorizing Monjuvi in relapsed or refractory MZL is based on trial data summarized in Appendix E: a randomized cohort of 106 MZL patients in the inMIND study showed no progression-free survival advantage for the Monjuvi arm, and the Prescribing Information explicitly states Monjuvi is not recommended for MZL outside controlled trials. For these reasons the policy designates relapsed or refractory MZL as a non-covered indication.

Regimens and Dosing

Regimen	Dose / Schedule	Combination limits	Coverage status
Tafasitamab-cxix (Monjuvi) with lenalidomide for DLBCL	Tafasitamab 12 mg/kg IV per prescribing information: Cycle 1 — Days 1, 4, 8, 15, 22 of 28-day cycle; Cycles 2–3 — Days 1, 8, 15, 22 of 28-day cycle; Cycle 4+ — Days 1 and 15 of 28-day cycle	Administer with lenalidomide for a maximum of 12 combination cycles; after up to 12 cycles, continue tafasitamab as monotherapy until disease progression or unacceptable toxicity	Covered
Tafasitamab-cxix (Monjuvi) with lenalidomide and rituximab for follicular lymphoma (FL)	Tafasitamab 12 mg/kg IV per prescribing information: Cycles 1–3 — Days 1, 8, 15, 22 of 28-day cycle; Cycles 4–12 — Days 1 and 15 of 28-day cycle	Administer with lenalidomide (Cycles 1–12) and rituximab (Cycles 1–5); combination limited to a maximum of 12 cycles	Covered

Off-label indication	Supporting requirements	Prior authorization	Coverage status
High-grade B‑cell lymphoma (HGBL); histologic transformation to DLBCL; monomorphic post‑transplant lymphoproliferative disorder; HIV‑related B‑cell lymphoma	Use supported when prescribed by or in consultation with an oncologist or hematologist and dosing is supported by FDA approval, NCCN recommendations, or peer‑reviewed literature (prescriber must submit supporting evidence)	Prior authorization may be required; requests must include documentation of diagnosis, prescriber specialty, prior therapies, and intent regarding transplant/CAR‑T candidacy	covered_with_criteria

Regimen	Dosing	Cycle limit / notes	Coverage status
Tafasitamab-cxix plus lenalidomide (combination therapy)	Tafasitamab 12 mg/kg IV per prescribing information (see DLBCL/FL dosing schedules) administered in combination with lenalidomide	Combination with lenalidomide limited to a maximum of 12 cycles per prescribing information	Covered

Line of Therapy Specifications

second-line

Line: Used in relapsed or refractory settings as second-line therapy when the diagnosis and prior-line timing meet policy criteria (e.g., DLBCL patients not eligible for ASCT; relapsed disease timing < or > 12 months influences eligibility and transplant intent considerations).

Prescribed regimen must align with FDA or NCCN recommendations and prior authorization requirements.

second-line

Combination with lenalidomide: When used in combination with lenalidomide, therapy is limited to a maximum of 12 cycles per the prescribing information; documentation of cycle count and regimen required for continuation.12 cycles

Document qualifier per PI; HCPCS code J9349 referenced for tafasitamab-cxix.

Codes, Dosing Limits, and Coding Notes

Codes referencedmixed

N/A	No explicit CPT/HCPCS/ICD-10/NDC codes provided in this portion of the document

Referenced HCPCS CodesHCPCS

J9349

Injection, tafasitamab-cxix, 1 mg

inv-10: Maximum dose — 12 mg/kg per dosing schedule

Maximum dose12 mg/kg per dosing schedule (maximum dose specified in Dosage and Administration for DLBCL and FL)

RouteIntravenous infusion per prescribing schedule

Dose timingCycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle; Cycles 2–3: Days 1, 8, 15 and 22; Cycle 4 onward: Days 1 and 15 of each 28-day cycle (DLBCL schedule)

FL schedule noteFL cycles 1–3: Days 1, 8, 15 and 22; Cycles 4–12: Days 1 and 15 of each 28-day cycle

inv-11: Maximum cycles with lenalidomide — maximum of 12 cycles

Combination duration limitWhen used in combination with lenalidomide, a maximum of 12 cycles per the prescribing information

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Monjuvi (tafasitamab-cxix). Providers must obtain prior authorization before initiation and for dose increases as specified in the clinical criteria. Include the member's diagnosis, oncology involvement or treating oncologist's information, prior therapies and timeline (including CAR‑T candidacy/access), and intent regarding transplant when applicable.

HCPCS: J9349 (Injection, tafasitamab‑cxix) — reference current professional coding guidance prior to claim submission.
Prior authorization required for initiation and for dose increases beyond standard regimen.

Denial Risk

Not Authorized Indication

Requests for Monjuvi for relapsed or refractory marginal zone lymphoma (MZL) are not authorized.

Not authorized indication: relapsed or refractory MZL.

Background

Tafasitamab-cxix (Monjuvi) is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for certain relapsed or refractory B‑cell lymphomas. Dosing per the Prescribing Information uses an IV dose of 12 mg/kg with specified cycle schedules for initiation and maintenance; the product is supplied in single‑dose vials and the dosing schedule and administration details are provided in the manufacturer’s Prescribing Information.

Definitions and Terminology

inv-21: ASCT — autologous stem cell transplant definition/term

TermAutologous stem cell transplant (ASCT)

DefinitionASCT = autologous stem cell transplant as listed in Appendix A (abbreviation key)

ContextASCT referenced in eligibility criteria for DLBCL where transplant candidacy affects treatment pathway

inv-22: HGBL — high-grade B-cell lymphoma definition/term

TermHGBL

DefinitionHigh-grade B-cell lymphoma (HGBL) as listed in Appendix A (abbreviation key)

Use in policy