CurrentMass General Brigham Health PlanPolicy N/A

Monjuvi (tafasitamab-cxix) — coverage criteria for relapsed/refractory DLBCL

Policy governs prior authorization and coverage criteria for Monjuvi (tafasitamab-cxix) in combination with lenalidomide for adult members with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant; applies to Mass General Brigham Health Plan pharmacy/medical benefits as specified.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMonjuvi (tafasitamab-cxix) for relapsed/refractory DLBCL

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization and supply documentation confirming relapsed/refractory DLBCL, ASCT ineligibility, CD19 positivity, and planned combination with lenalidomide for up to 12 cycles.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsapproval duration

up to 12 cyclescombination duration

CD19+biomarker

Not eligibleASCT eligibility

Coverage Criteria for Monjuvi (tafasitamab-cxix)

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inv-01: Initial authorization criteria

Covered when ALL of the following are met:

Primary diagnosis: Member has a diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low-grade lymphoma

Supported by the medication indication.

Transplant eligibility: Member is not eligible for an autologous stem cell transplant (ASCT)

ASCT ineligibility required for coverage.

Combination therapy duration: Requested medication will be used in combination with lenalidomide for up to a maximum of 12 cycles<= 12 cycles

Maximum duration of combination therapy specified.

Biomarker requirement: B-cells must be CD19-positive as confirmed by testing or analysis

CD19 positivity confirmation required.

inv-02: Reauthorization / Continuation therapy

Continuation/Reauthorization criteria:

Toxicity and progression: Provider documents no evidence of unacceptable toxicity or disease progression while on the current regimen

Required documentation for reauthorization.

Use after 12 cycles: If the member has completed 12 cycles, the requested drug will be used as monotherapy

Permits continuation as monotherapy after combination period if no progression/toxicity.

Approval duration: Initial approvals and reauthorizations will be for 12 months12 months

Policy limitation on authorization period.

Authorization will not be reviewed for members obtaining the product as samples or through the manufacturer's patient assistance programs. Providers should note that requests for coverage or prior authorization are only considered when the member's access to the medication is not via sample supply or manufacturer assistance.

Regimen	Indication / Limitations	Coverage status
Monjuvi (tafasitamab-cxix) in combination with lenalidomide for up to 12 cycles; may continue Monjuvi as monotherapy after 12 cycles if no unacceptable toxicity or disease progression	Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low-grade lymphoma; member must be ineligible for autologous stem cell transplant; B-cells must be CD19-positive as confirmed by testing; combination therapy limited to a maximum of 12 cycles; continuation as monotherapy allowed after 12 cycles if no unacceptable toxicity or disease progression	Covered

inv-11: Line of therapy

Indication: Relapsed or refractory DLBCL in adults not eligible for ASCT

Indication for use in combination with lenalidomide as specified in policy.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Monjuvi (tafasitamab-cxix). Requests for members who are new to the plan but currently receiving Monjuvi may be reviewed. Contact the appropriate plan phone/fax for prior authorization.

Affected benefit: Pharmacy Benefit (Specialty)
Prior authorization contact: All Plans Phone: 877-519-1908; Fax: 855-540-3693

Step Therapy

Step Therapy Not Applicable

Step therapy is not applicable for this specialty-limited medication per the specialty limitations listing.

Step therapy: N/A

Documentation Required

Documentation Requirements

Provider must supply documentation confirming the diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, that the member is ineligible for autologous stem cell transplant (ASCT), plan for use in combination with lenalidomide (up to 12 cycles) or as monotherapy for continuation, and confirmation that B-cells are CD19-positive.

Documented diagnosis: relapsed or refractory DLBCL (including DLBCL arising from low grade lymphoma)
Documentation of ineligibility for autologous stem cell transplant (ASCT)
Planned regimen: combination with lenalidomide for up to 12 cycles (initial) and criteria for continuation/monotherapy
Laboratory confirmation: CD19-positive B-cells

Denial Risk

Denial-Risk Conditions

Requests that do not document the required diagnosis, ineligibility for ASCT, planned lenalidomide combination (or appropriate continuation plan), or CD19-positive status may be denied.

Missing documentation of relapsed/refractory DLBCL diagnosis
No documentation of ineligibility for autologous stem cell transplant (ASCT)
No treatment plan showing combination with lenalidomide for up to 12 cycles or appropriate continuation/monotherapy plan
No documentation confirming CD19-positive B-cells

Key Definitions

Diffuse large B-cell lymphoma (DLBCL) definition

TermDiffuse large B-cell lymphoma (DLBCL)

DescriptionA type of B-cell non-Hodgkin lymphoma that may arise from low-grade lymphoma and can be relapsed or refractory.

Indication contextMonjuvi (tafasitamab-cxix) in combination with lenalidomide is indicated for adults with relapsed or refractory DLBCL (including DLBCL arising from low-grade lymphoma) who are not eligible for autologous stem cell transplant (ASCT).

CD19-positive — definition and testing requirement

DefinitionCD19-positive: B-cells with confirmed CD19 expression as required for therapy selection.

Testing requirementCD19 positivity must be confirmed by testing or analysis prior to use of Monjuvi in combination with lenalidomide.

PurposeEnsures target antigen presence for tafasitamab-cxix activity.

Background

B-cell lymphomas are clonal tumors of mature and immature B cells and constitute the majority of non-Hodgkin lymphomas. Diffuse large B-cell lymphoma (DLBCL) is a common aggressive B-cell non-Hodgkin lymphoma that can arise de novo or from transformation of a low-grade lymphoma and may present as relapsed or refractory disease requiring additional therapy.

Monjuvi (tafasitamab-cxix) in combination with lenalidomide is indicated for adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). Treatment with Monjuvi requires confirmation that B-cells are CD19-positive, and the combination with lenalidomide is authorized for up to 12 cycles, after which Monjuvi may be continued as monotherapy if there is no unacceptable toxicity or disease progression.

OpenPayer

Monjuvi (tafasitamab-cxix) — coverage criteria for relapsed/refractory DLBCL

Coverage Criteria for Monjuvi (tafasitamab-cxix)

Provider Actions and Authorization Requirements

Key Definitions

Biomarker Requirements

Background