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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsViva Health Plan Sarclisa Prior Auth | OpenPayer
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    CurrentViva Health PlanPolicy IC-0874

    Sarclisa Escena (isatuximab-irfc) Subcutaneous Therapy

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    This policy governs prior authorization, medical necessity, dosing, administration, and renewal requirements for Sarclisa Escena subcutaneous therapy in adults with multiple myeloma-related indications. It applies to providers requesting coverage under Viva Health Plan.

    Policy Summary
    PayerViva Health Plan
    PolicySarclisa Escena (isatuximab-irfc) Subcutaneous Therapy
    Policy CodePolicy IC-0874
    Change TypeNo material change
    Effective DateN/A
    Last ReviewAug 4, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and administer Sarclisa Escena subcutaneously by a healthcare professional.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsInitial authorization
    6 monthsRenewal interval
    1,400 mgInitial dose
    2,800 mgMaintenance dose
    18 years

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Minimum age
    SubcutaneousAdministration route

    Coverage Criteria

    Initial Therapy

    Covered when all universal and indication-specific criteria are met.

    General eligibility: Member is at least 18 years of age.>=18 years
    Universal criteria: Therapy will not be used concomitantly with intravenous isatuximab and will not be used in combination with other anti-CD38 therapies.

    Eligible disease and regimen

    • Previously treated relapsed or refractory disease: pomalidomide regimen: Used for previously treated multiple myeloma for relapsed or refractory disease, in combination with pomalidomide and dexamethasone after prior therapy with lenalidomide and a proteasome inhibitor such as bortezomib, carfilzomib, or ixazomib.
    • Previously treated relapsed or refractory disease: carfilzomib regimen: Used for previously treated multiple myeloma for relapsed or refractory disease, in combination with carfilzomib and dexamethasone after 1 to 3 prior lines of therapy.1 to 3 prior lines
    • Newly diagnosed disease: Used for newly diagnosed disease in a member not eligible for autologous stem cell transplant, in combination with bortezomib, lenalidomide, and dexamethasone.Not eligible for ASCT

    Continuation Therapy

    Covered for renewal when all continuation criteria are met.

    Continued eligibility: Member continues to meet the universal and other indication-specific relevant criteria identified in the initial approval section, including applicable concomitant therapy requirements, performance status, and other relevant criteria.

    Prerequisite therapy is not required to be repeated for renewal.

    Authorization duration: Duration of authorization has not been exceeded.6 months (180 days) per authorization period
    Disease response is demonstrated by stabilization of disease or decrease in size of tumor or tumor spread.Stable disease or decreased tumor/tumor spread
    Safety:

    Coverage excludes use of Sarclisa Escena concomitantly with intravenous isatuximab or in combination with other anti-CD38 therapies. The product is also excluded when administered intravenously.

    Sarclisa Escena must be administered subcutaneously by a healthcare professional, using the CirCLIQ™ On-Body Delivery System or a syringe and infusion set for manual administration.

    Coding and Quantity Limits

    HCPCS CodeHCPCS
    J9999Not otherwise classified, antineoplastic drugs
    HCPCS CodeHCPCS
    C9399Unclassified drugs or biologicals (Hospital Outpatient Use)
    NDC(s)NDC
    00024-0674-xxSarclisa Escena 1,400 mg/10 mL single-dose vial
    Covered Diagnosis CodesICD-10Covered
    C90.00Multiple myeloma not having achieved remission
    C90.02Multiple myeloma, in relapse
    C90.10Plasma cell leukemia not having achieved remission
    C90.12Plasma cell leukemia in relapse
    C90.20Extramedullary plasmacytoma not having achieved remission
    C90.22Extramedullary plasmacytoma in relapse
    C90.30Solitary plasmacytoma not having achieved remission
    C90.32Solitary plasmacytoma in relapse
    Z85.79Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues
    Initial Dosing Limit
    Initial dose1,400 mg
    FrequencyEvery 7 days
    Number of doses4 doses
    Maintenance Dosing Limit
    Maintenance dose2,800 mg
    FrequencyEvery 28 days
    Timing

    Authorization and Provider Requirements

    Prior Authorization

    Initial Prior Authorization

    Prior authorization is required. Initial authorization is valid for 6 months (180 days).

    • Member must be at least 18 years of age.
    • Approval requires satisfaction of the applicable universal and indication-specific criteria.
    Prior Authorization

    Renewal Prior Authorization

    Renewal prior authorization may be requested every 6 months (180 days). Authorization may continue only while renewal criteria are met and the applicable authorization duration has not been exceeded.

    • Member continues to meet applicable universal and indication-specific criteria, including concomitant therapy requirements and other relevant criteria identified for initial approval.
    • Disease response is demonstrated by stabilization of disease or a decrease in tumor size or tumor spread.
    • No unacceptable toxicity is present.

    Background

    Sarclisa Escena (isatuximab-irfc) is the subcutaneous formulation of an anti-CD38 therapy used in multiple myeloma treatment regimens. Coverage includes previously treated multiple myeloma with relapsed or refractory disease and newly diagnosed disease when the member is not eligible for autologous stem cell transplant.

    Treatment is administered in 28-day cycles and continues until disease progression or unacceptable toxicity. Depending on the regimen, Sarclisa Escena is administered subcutaneously with the CirCLIQ™ On-Body Delivery System or by manual administration using a syringe and infusion set.

    Definitions

    Definition
    TermRelapsed or refractory multiple myeloma
    DefinitionMultiple myeloma that has returned after prior treatment or has failed to respond to treatment
    Policy useApplies to previously treated multiple myeloma treatment pathways
    Definition
    AbbreviationASCT
    Full termAutologous stem cell transplant
    Policy useNewly diagnosed disease may qualify when the member is not eligible for autologous stem cell transplant

    Initial Therapy

    Initial Therapy

    Initial approval requires all age and universal requirements plus one covered multiple myeloma treatment pathway.

    Age and universal requirements: Member is at least 18 years of age; therapy will not be used concomitantly with intravenous isatuximab; and therapy will not be used in combination with other anti-CD38 therapies.>=18 years

    Covered treatment pathways

    • Relapsed/refractory pomalidomide regimen: Previously treated relapsed or refractory multiple myeloma treated in combination with pomalidomide and dexamethasone after prior therapy with lenalidomide and a proteasome inhibitor such as bortezomib, carfilzomib, or ixazomib.
    • Relapsed/refractory carfilzomib regimen: Previously treated relapsed or refractory multiple myeloma treated in combination with carfilzomib and dexamethasone after 1 to 3 prior lines of therapy.

    Continuation Therapy

    Renewal Therapy

    Renewal requires continued eligibility, a valid authorization period, disease response, and no unacceptable toxicity.

    Continued eligibility: Member continues to meet the universal and other indication-specific relevant criteria identified in the initial approval section, including applicable concomitant therapy requirements, performance status, and other relevant criteria.

    Prerequisite therapy is not required to be repeated for renewal.

    Authorization period: Duration of authorization has not been exceeded.No longer than 6 months (180 days) per authorization period
    Disease response: Disease has stabilized or the size of the tumor or tumor spread has decreased.Stable disease or decreased tumor/tumor spread

    Step Therapy Requirements

    StepRegimenRequired prior therapy
    1Pomalidomide and dexamethasone for previously treated relapsed or refractory multiple myelomaPrior therapy with lenalidomide and a proteasome inhibitor, such as bortezomib, carfilzomib, or ixazomib

    Quantity Limits

    Quantity Limits
    DrugSarclisa Escena (isatuximab-irfc)
    Initial dosing1,400 mg every 7 days for 4 doses
    Maintenance dosing2,800 mg every 28 days after the initial 4 doses

    Site of Care and Administration

    Billing Rule

    Administer in the office by a healthcare professional

    Administer Sarclisa Escena subcutaneously by a healthcare professional using the CirCLIQ On-Body Delivery System or a syringe and infusion set for manual administration.

    Note

    No separate infusion-center site is specified

    The policy specifies administration by a healthcare professional but does not identify a separate infusion-center or hospital-outpatient site-of-care requirement.

    Policy Summary
    PayerViva Health Plan
    PolicySarclisa Escena (isatuximab-irfc) Subcutaneous Therapy
    Policy CodePolicy IC-0874
    Change TypeNo material change
    Effective DateN/A
    Last ReviewAug 4, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization and administer Sarclisa Escena subcutaneously by a healthcare professional.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Quantity LimitsAuthorization and Provider RequirementsBackgroundDefinitionsInitial TherapyContinuation TherapyStep Therapy RequirementsQuantity LimitsSite of Care and Administration
    There is no unacceptable toxicity from the drug.

    Examples include hypersensitivity or other administration-related reactions, severe infections, neutropenia, and secondary primary malignancies.

    After the initial 4 doses
    Step Therapy

    Required Prior Therapy for Pomalidomide Regimen

    For the pomalidomide and dexamethasone regimen in previously treated relapsed or refractory multiple myeloma, documentation must show prior therapy with lenalidomide and a proteasome inhibitor.

    • Acceptable proteasome inhibitors include bortezomib, carfilzomib, ixazomib, or another applicable agent.
    Documentation Required

    Initial Clinical Documentation

    Submit clinical documentation supporting the requested indication and all applicable initial approval criteria.

    • Member is at least 18 years of age.
    • Disease is previously treated multiple myeloma with relapsed or refractory disease, or newly diagnosed disease in a member who is not eligible for autologous stem cell transplant (ASCT).
    • Document the requested combination regimen: pomalidomide and dexamethasone after prior lenalidomide and proteasome inhibitor therapy; carfilzomib and dexamethasone after 1 to 3 prior lines of therapy; or bortezomib, lenalidomide, and dexamethasone for newly diagnosed disease in an ASCT-ineligible member.
    • Document relevant treatment history, including prior lines of therapy and required prerequisite therapy.
    • Confirm therapy will not be used concomitantly with intravenous isatuximab or in combination with other anti-CD38 therapies.
    Documentation Required

    Renewal Documentation

    Renewal requests must include documentation that the member remains eligible for treatment and continues to meet the applicable criteria.

    • Continued satisfaction of universal and indication-specific criteria, including relevant concomitant therapy requirements and other criteria identified in the initial approval section.
    • Authorization duration has not been exceeded.
    • Disease response, defined as stabilization of disease or a decrease in tumor size or tumor spread.
    • Absence of unacceptable toxicity, including hypersensitivity or other administration-related reactions, severe infections, neutropenia, or secondary primary malignancies.
    Denial Risk

    Failure to Meet Initial Approval Criteria

    Initial approval will be denied when the requested therapy does not meet all applicable initial approval requirements.

    • Member is younger than 18 years of age.
    • Therapy will be used concomitantly with intravenous isatuximab.
    • Therapy will be used in combination with another anti-CD38 therapy.
    • The requested disease state, regimen, prior treatment history, number of prior lines, or ASCT eligibility does not meet the applicable indication-specific criteria.
    • The required route or administration requirements are not met.
    Denial Risk

    Failure to Meet Renewal Criteria

    Renewal will be denied when the member no longer meets the applicable continuation requirements or the authorization limit has been exceeded.

    • Authorization duration has been exceeded; renewal is otherwise limited to 6-month (180-day) intervals.
    • Required universal or indication-specific criteria are no longer met.
    • There is no documented disease stabilization or decrease in tumor size or tumor spread.
    • Unacceptable toxicity is present, including hypersensitivity or other administration-related reactions, severe infections, neutropenia, or secondary primary malignancies.
    Billing Rule

    Incorrect Route or Administration Setting

    Sarclisa Escena must be administered subcutaneously by a healthcare professional. It must not be administered intravenously.

    • Administration options include the CirCLIQ™ On-Body Delivery System (OBDS) or a syringe and infusion set for manual administration.
    • Intravenous administration is not permitted.
    Definition
    AbbreviationOBDS
    Full termCirCLIQ On-Body Delivery System
    Administration roleUsed to administer Sarclisa Escena subcutaneously by a healthcare professional
    1 to 3 prior lines
  1. Newly diagnosed regimen: Newly diagnosed disease in a member not eligible for autologous stem cell transplant, treated in combination with bortezomib, lenalidomide, and dexamethasone.Not eligible for ASCT
    2. No unacceptable toxicity: There is no unacceptable toxicity from the drug.

    Examples include hypersensitivity or other administration-related reactions, severe infections, neutropenia, and secondary primary malignancies.