CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Monjuvi (tafasitamab-cxix) for Diffuse Large B‑Cell Lymphoma (DLBCL) — Coverage Criteria

Defines indications, exclusion criteria, coding, and prior authorization expectations for use of Monjuvi (tafasitamab-cxix) in diffuse large B-cell lymphoma (DLBCL) for Neighborhood Health Plan of Rhode Island members and network providers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMonjuvi (tafasitamab-cxix) for Diffuse Large B‑Cell Lymphoma (DLBCL) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversion and content update

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document CD19 expression, prior therapy (1–3 regimens including anti‑CD20), transplant eligibility, and planned up to 12 cycles when requesting Monjuvi (J9349).

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaces prior UM ONC_1412 Monjuvi guideline; indication and exclusion sections were updated.

12 cyclesmaximum combination therapy duration with lenalidomide

J9349billing code

1-3prior regimens required

12 mg/kgsingle dose maximum

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial combination therapy (Monjuvi + lenalidomide)

Covered when ALL of the following are met

DLBCL combination indication: Patient has relapsed or refractory diffuse large B-cell lymphoma (including transformation from an indolent lymphoma)

CD19 expression on lymphoma cells confirmed by any standard test

required

Transplant status: Patient is not a candidate for stem cell transplant or has failed a prior stem cell transplant

Prior therapy: Patient has received 1-3 prior regimens including a chemoimmunotherapy regimen containing an anti-CD20-targeted therapy (eg, rituximab, obinutuzumab)1-3 prior regimens

Treatment plan: Planned use of tafasitamab-cxix (Monjuvi) in combination with lenalidomide for up to 12 cycles with further continuation as monotherapy as clinically appropriateup to 12 cycles combination

Monjuvi (tafasitamab-cxix) is not covered when it is being used on or after documented disease progression with the same regimen. Coverage also requires documented CD19 expression on lymphoma cells as confirmed by any standard test; absence of that documentation is an exclusion. Dosing that exceeds the single-dose limit of 12 mg/kg is excluded. When used in combination with lenalidomide, coverage for the combination is limited to a maximum of 12 cycles; treatment that exceeds this duration is excluded. Requests should note these limits and provide supporting documentation to avoid denial.

Monjuvi (tafasitamab-cxix) is considered investigational and not covered for off-label indications that lack sufficient evidence or are not generally accepted by the medical community. The policy defines insufficient evidence as, for example, inadequate representation of the patient population or regimen in the published evidence, outcomes that are not clinically meaningful, inappropriate experimental design for the question under study, reliance on uncontrolled case reports, or abstracts without full peer‑reviewed publication. Coverage for off-label uses requires support from CMS‑recognized compendia or acceptable peer‑reviewed literature.

Approved Regimens and Billing Units

Regimen	Indication / Patient population	Billing code (unit)	Combination duration limit
Tafasitamab-cxix (Monjuvi) + lenalidomide	Relapsed/refractory diffuse large B-cell lymphoma (including transformation from an indolent lymphoma) in patients who are not candidates for stem cell transplant or who have failed a prior transplant; CD19 expression on lymphoma cells must be confirmed; prior receipt of 1-3 regimens including an anti-CD20-containing chemoimmunotherapy	J9349 — Injection, tafasitamab-cxix, 2 mg	Up to 12 cycles when used in combination with lenalidomide (with further continuation as monotherapy per treatment plan)

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization required for Monjuvi (tafasitamab-cxix) (J9349). Coverage is limited to the DLBCL indication when all clinical criteria are met and supporting documentation is provided. Requests must include required clinical documentation to adjudicate medical necessity.

Prior authorization required for Monjuvi (tafasitamab-cxix) (HCPCS J9349).
Coverage limited to Relapsed/Refractory Diffuse Large B‑Cell Lymphoma (DLBCL) when all criteria are met.

Note

Continuation Exemption

Re‑authorization may be allowed without full re‑evaluation when the member has not experienced disease progression on Monjuvi, there has been no lapse greater than 30 days in active therapy within the past year, and no additional medications are being added to the regimen.

Continuation exemption applies if no disease progression on the requested medication.
No lapse > 30 days in active authorization within the last year.
No additional medications added to the continuation request.

Documentation Required

Required Documentation

Documentation must demonstrate CD19 expression on lymphoma cells, prior treatment history showing 1–3 prior regimens including an anti‑CD20 chemoimmunotherapy (e.g., rituximab, obinutuzumab), and that the patient is not a candidate for stem cell transplant or has failed prior transplant when applicable. If used in combination with lenalidomide, document intent for up to 12 cycles and plan for monotherapy continuation.

Confirmatory test documenting CD19 expression on lymphoma cells.
History of 1–3 prior regimens, including a chemoimmunotherapy regimen containing an anti‑CD20 agent.
Clinical rationale that the member is not a stem cell transplant candidate or has failed prior transplant.
Planned treatment duration: up to 12 cycles when used with lenalidomide, with subsequent monotherapy as indicated.

Denial Risk

Triggers for Denial

Denial may be issued when Monjuvi is requested after documented disease progression on the same regimen, when CD19 expression is not confirmed, when a single dose exceeds 12 mg/kg, when combination therapy with lenalidomide would exceed 12 cycles, or when the use is investigational/off‑label without sufficient supporting evidence.

Use on or after disease progression with the same regimen — denial trigger.
Lack of confirmed CD19 expression on lymphoma cells — denial trigger.
Single dose exceeding 12 mg/kg — denial trigger.
Treatment in combination with lenalidomide beyond 12 cycles — denial trigger.
Off‑label or investigational use not supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed evidence — denial trigger.

Key Definitions

Relapsed/refractory DLBCL — definition

DefinitionRelapsed/refractory diffuse large B-cell lymphoma (DLBCL), including transformation from an indolent lymphoma

Clinical contextPatients who are not candidates for stem cell transplant or who have failed a prior stem cell transplant

Prior therapy requirementReceipt of 1-3 prior regimens including a chemoimmunotherapy regimen containing an anti‑CD20-targeted therapy (e.g., rituximab, obinutuzumab)

CD19 expression — coverage requirement for Monjuvi

Biomarker requirementPresence of CD19 on lymphoma cells confirmed by any standard test

Coverage dependencyRequired for Monjuvi (tafasitamab-cxix) coverage in DLBCL

DocumentationMust be included in prior authorization supporting documentation

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMonjuvi (tafasitamab-cxix) for Diffuse Large B‑Cell Lymphoma (DLBCL) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversion and content update

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Monjuvi (tafasitamab-cxix) for Diffuse Large B‑Cell Lymphoma (DLBCL) — Coverage Criteria

Coverage Criteria for Monjuvi (tafasitamab-cxix)

Approved Regimens and Billing Units

Billing Codes and Dose Limits

Prior Authorization, Documentation, and Denial Triggers

Key Definitions

Permitted Line(s) of Therapy

Biomarker and Test Requirements

Clinical Background

Policy Revision History