Tafasitamab-cxix (Monjuvi) Form

Tafasitamab-cxix (Monjuvi®) is a CD19-directed cytolytic antibody. FDA Approved Indication(s) Monjuvi, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Monjuvi is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Diffuse Large B-Cell Lymphoma (must meet all):

1. Diagnosis of relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma (e.g., follicular lymphoma or nodal marginal zone lymphoma);

2. Prescribed by or in consultation with an oncologist or hematologist;

   3. Age ≥ 18 years;
   4. Prescribed after prior therapy (see Appendix B) in combination with Revlimid® (lenalidomide) for a maximum of 12 cycles and subsequently as monotherapy; Prior authorization may be required.
   5. Member is not eligible for ASCT;
   6. Request meets one of the following (a or b): a. Dose does not exceed 12 mg/kg as follows (i, ii, and iii): i. Cycle 1: Days 1, 4, 8, 15, and 22 of the 28-day cycle; ii. Cycles 2 and 3: Days 1, 8, 15, and 22 of each 28-day cycle; iii. Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle; b. 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
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   CLINICAL POLICY Tafasitamab-cxix Approval duration: 6 months B. Additional NCCN Recommended Uses (off-label) (must meet all):

3. Diagnosis of one of the following B-cell lymphoma subtypes (a, b, c, d, or e): a. HIV-related B-cell lymphomas; b. Follicular lymphoma (grade 1-2);
   c. High-grade B-cell lymphomas; d. Histologic transformation of lymphomas to DLBCL; e. Post-transplant lymphoproliferative disorders (monomorphic);
   2. Prescribed by or in consultation with an oncologist or hematologist;
   3. Age ≥ 18 years;
   4. Prescribed after prior therapy (see Appendix B) in combination with Revlimid® (lenalidomide) for a maximum of 12 cycles and subsequently as monotherapy; Prior authorization may be required.
4. For all subtypes except follicular lymphoma: Member is not eligible for ASCT;
   6. Dose is within 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).Prescribed regimen must be FDA-approved or recommended by NCCN. Approval duration: 6 months C. Other diagnoses/indications (must meet 1 or 2):
5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. All Indications in Section I (must meet all):

7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); Page 2 of 7

   CLINICAL POLICY Tafasitamab-cxix

8. Member is responding positively to therapy;
   3. Prescribed in combination with Revlimid (lenalidomide) for a maximum of 12 cycles and subsequently as monotherapy; Prior authorization may be required.
9. If request is for a dose increase, request meets one of the following (a or b): a. Dose does not exceed 12 mg/kg as follows (i, ii, and iii): i. Cycle 1: Days 1, 4, 8, 15, and 22 of the 28-day cycle; ii. Cycles 2 and 3: Days 1, 8, 15, and 22 of each 28-day cycle; iii. Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle; 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 Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
10. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

11. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ASCT: autologous stem cell transplant DLBCL: diffuse large B-cell lymphoma FDA: Food and Drug Administration NCCN: National Comprehensive Cancer Network Page 3 of 7

    CLINICAL POLICY Tafasitamab-cxix Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/
    Revlimid® (lenalidamide) Maximum Dose 25 mg/day 25 mg PO on Days 1 to 21 of each 28-day cycle for a maximum of 12 cycles with Monjuvi DLBCL and histologic transformation of lymphomas to DLBCL - Examples First-Line Treatment Regimens - Examples • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) Varies Varies • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) + rituximab Second-Line Treatment Regimens (non-candidates for transplant) - Examples • GemOx (gemcitabine, oxaliplatin) ± rituximab
    • polatuzumab vedotin ± bendamustine ± Varies Varies rituximab, • CEPP (cyclophosphamide, etoposide, prednisone, procarbazine) ± rituximab • CEOP (cyclophosphamide, etoposide, vincristine, prednisone) ± rituximab • dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) + rituximab • GDP (gemcitabine, dexamethasone, cisplatin) ± rituximab HIV-related B-cell lymphomas - Examples • R-EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin + rituximab)
    • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) Follicular lymphoma (grade 1-2) - Examples • CHOP + Gazyva® or rituximab • CVP (cyclophosphamide, vincristine, prednisone) + Gazyva® or rituximab
    • Revlimid® + rituximab High-grade B-cell lymphomas - Examples • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) Page 4 of 7 Varies Varies Varies Varies Varies Varies

    CLINICAL POLICY Tafasitamab-cxix Drug Name • DA-EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin + rituximab) Dosing Regimen Dose Limit/
    Maximum Dose rituximab Post-transplant lymphoproliferative disorders (monomorphic) - Examples • • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) Varies Varies Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
    Indication Dosing Regimen DLBCL Administer premedications prior to starting Monjuvi. 12 mg/kg as an IV infusion according to the following Maximum Dose 12 mg/kg/day per dosing schedule dosing schedule:
    • Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle. • Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle. • Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle. Administer Monjuvi in combination with lenalidomide for a maximum of 12 cycles and then continue Monjuvi as monotherapy until disease progression or unacceptable toxicity. See prescribing information for premedication and dosing modifications. VI. Product Availability
    Single-dose vial: 200 mg VII.