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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsQualChoice Yartemlea (narsoplimab) Coverage Update…
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    CurrentQualChoicePolicy CP.PHAR.527

    Narsoplimab‑wuug (Yartemlea) coverage for TA‑TMA

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    Criteria and authorization rules for coverage of Yartemlea (narsoplimab‑wuug) for treatment of hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA) for qualifying members across listed lines of business.

    Policy Summary
    PayerQualChoice
    PolicyNarsoplimab‑wuug (Yartemlea) coverage for TA‑TMA
    Policy CodePolicy CP.PHAR.527
    Change TypeClinical criteria and coding revisions
    Effective DateDec 24, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization with office notes and relevant labs demonstrating the member meets all initial or continued therapy criteria.
    SourceLink
    POLICY UPDATE CHANGES

    Updated clinical criteria to align with FDA labeling: clarified LDH above upper limit of normal, added presence of schistocytes as hemolysis example, platelet count threshold <150 x 10^9/L, and serum creatinine ≥2 times pre‑transplant baseline.

    Maximum duration of Yartemlea administration revised from 12 weeks to 16 weeks and added limit that member has not received Yartemlea for >16 weeks.

    Added concurrent prescribing exclusion to prohibit use with Soliris and its biosimilars (Bkemv/Epijkstra) and Ultomiris.

    Added HCPCS code J1289 (Injection, narsoplimab‑wuug, 1 mg) and removed nonspecific codes C9399 and J3590.

    Added ICHRA line of business.

    ≥2minimum approved patient age
    <150platelet threshold

    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.

    Cr ≥2x
    renal criterion
    16 wkmax course length
    J1289billing code added

    Coverage Criteria

    Initial Therapy — Covered when ALL of the following are met

    Covered when ALL of the following are met

    Initial Approval for TA‑TMA: 1. Diagnosis of hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA); 2. Prescribed by or in consultation with a hematologist or transplant specialist; 3. Age ≥ 2 years; 4. Member has signs of persistent TMA as evidenced by presence of all of the following for at least 2 weeks after modification or discontinuation of calcineurin inhibitor therapy: (a) Platelet count < 150 x 10^9/L; (b) Evidence of hemolysis (e.g., serum lactate dehydrogenase [LDH] above the upper limit of normal, presence of schistocytes); (c) Serum creatinine ≥ 2 times pre‑transplantation baseline or member requires dialysis; 5. Documentation that member does not have any of the following: (a) ADAMTS13 deficiency; (b) Shiga toxin E. coli related hemolytic uremic syndrome (STEC‑HUS); (c) atypical hemolytic uremic syndrome (aHUS); 6. Yartemlea is not prescribed concurrently with Soliris/Bkemv/Epijkstra (biosimilars) or Ultomiris; 7. Member has not received Yartemlea for > 16 weeks; 8. Dose does not exceed: (a) Weight ≥ 50 kg: 370 mg once weekly; (b) Weight < 50 kg: 4 mg/kg once weekly.

    Initial approval duration: 8 weeks

    Continuation Therapy — Continued therapy covered when ALL of the following are met

    Continued therapy covered when ALL of the following are met

    Continued Therapy for TA‑TMA: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; or (b) currently receiving medication and continuity of care regulations apply; 2. Member is responding positively to therapy as evidenced by improvement in any of the following: (a) improved measures of hemolysis (e.g., normalization of LDH, decrease/absence of schistocytes); (b) increased or stabilized platelet counts; (c) improved or stabilized serum creatinine or eGFR; (d) reduced need for dialysis; 3. Member has not received Yartemlea for > 16 weeks; 4. Yartemlea is not prescribed concurrently with Soliris/Bkemv/Epijkstra or Ultomiris; 5. If request is for a dose increase, new dose does not exceed: (a) Weight ≥ 50 kg: 370 mg twice weekly; (b) Weight < 50 kg: 4 mg/kg twice weekly.

    Approval duration up to 16 weeks total

    Other Indications — Not authorized when

    Not authorized when

    Non‑FDA indications: Use for non‑FDA approved indications not listed in this policy is not authorized unless sufficient documentation of efficacy and safety is provided per the off‑label use policies or applicable evidence of coverage documents (see CP.CPA.09, HIM.PA.154, CP.PMN.53 and line‑of‑business references).

    Refer to off‑label/no coverage/non‑formulary policies by line of business

    Coverage is not provided for non‑FDA approved indications unless the provider supplies sufficient clinical documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies or evidence of coverage documents. Refer to the off‑label policies CP.CPA.09 (Commercial), HIM.PA.154 (ICHRA/marketplace), and CP.PMN.53 (Medicaid) for requirements and acceptable supporting information.

    Requests that do not satisfy the policy’s specific diagnostic, laboratory, prescriber specialty, dosing, or duration criteria are considered not medically necessary. Examples include failure to document the diagnosis of hematopoietic stem cell TA‑TMA, absence of a hematologist or transplant specialist involvement, age < 2 years, lack of required TMA findings persisting for at least 2 weeks after modification/discontinuation of calcineurin inhibitors (platelet count < 150 x 10^9/L, evidence of hemolysis such as elevated LDH or schistocytes, or serum creatinine ≥ 2 times pre‑transplant baseline or dialysis dependency), requests exceeding dosing limits, therapy courses beyond the maximum allowed duration (member has received Yartemlea for > 16 weeks), or concurrent prescribing with excluded agents (Soliris/Bkemv/Epijkstra or Ultomiris). Such requests may be denied without adequate supporting documentation.

    Initial Therapy Dosing & Criteria

    Initial Therapy Dosing — Initial dosing and limits

    Initial dosing and limits

    Initial Dosing Criteria: Administer IV once weekly: (a) Weight ≥ 50 kg: 370 mg once weekly; (b) Weight < 50 kg: 4 mg/kg once weekly. Therapy limited to an initial approval duration of 8 weeks. Member must not have received Yartemlea for > 16 weeks at time of request.

    Continuation Therapy Criteria

    Continued Therapy — Criteria for continued coverage

    Criteria for continued coverage

    Continued Therapy Nodes: Member is responding positively to therapy (improvement in hemolysis measures such as normalization of LDH or decrease/absence of schistocytes, increased or stabilized platelet counts, improved or stabilized serum creatinine or eGFR, or reduced need for dialysis), has not received Yartemlea for > 16 weeks, therapy is not concurrent with excluded agents (Soliris/Bkemv/Epijkstra/Ultomiris); if dose increase requested, new dose does not exceed: weight ≥50 kg: 370 mg twice weekly; weight <50 kg: 4 mg/kg twice weekly.

    Approval duration up to 16 weeks total

    Coding and Billing

    Drug HCPCS CodesHCPCSCovered
    J1289Injection, narsoplimab‑wuug, 1 mg
    inv-07: Platelet count — < 150 x 10^9/L
    ThresholdPlatelet count < 150 x 10^9/L
    ContextRequired as part of persistent TMA signs for at least 2 weeks after modification or discontinuation of calcineurin inhibitor therapy
    Clinical roleOne of three concurrent laboratory criteria (with hemolysis and renal impairment) required for initial approval of Yartemlea for TA‑TMA
    inv-08: Serum creatinine — ≥ 2 times pre‑transplantation baseline
    ThresholdSerum creatinine ≥ 2 times pre‑transplantation baseline (or member requires dialysis)
    ContextRequired as part of persistent TMA signs for at least 2 weeks after modification or discontinuation of calcineurin inhibitor therapy

    Provider Actions & Authorization

    Prior Authorization

    Prior authorization required

    Prior authorization is required. Submit a prior authorization request that includes documentation supporting that all initial or continued therapy criteria are met, including relevant laboratory results and specialist consultation notes. HCPCS code J1289 should be used for narsoplimab‑wuug (1 mg) requests where applicable.

    • Include relevant labs (e.g., platelet count, serum creatinine, LDH) and specialist (hematologist or transplant) consultation notes.
    • Ensure dose and duration requested do not exceed policy limits (see dosing and maximum duration criteria).
    • Use HCPCS J1289 for billing the drug per coding implications.
    Step Therapy

    No formal step therapy specified

    This policy does not define a formal pharmacologic step therapy sequence. For uses or scenarios not listed in this policy, refer to the off‑label/non‑formulary/no‑coverage policies for the applicable line of business.

    Step Therapy

    StepDescription
    1No specific pharmacologic step therapy steps are defined in this policy; off‑label, non‑formulary, or recently changed‑label scenarios are referred to the appropriate line‑of‑business policies (see CP.CPA.190, HIM.PA.154, CP.PMN.53 and related non‑formulary/no‑coverage policies listed in the policy).

    Quantity Limits

    inv-20: Yartemlea (narsoplimab‑wuug) — 370 mg per dose or 4 mg/kg per dose depending on weight
    Dose options370 mg per dose (weight ≥ 50 kg) or 4 mg/kg per dose (weight < 50 kg)
    Route and frequencyAdminister as an IV infusion once weekly (may increase frequency to twice weekly if inadequate improvement)
    Maximum course guidanceMember must not have received Yartemlea for > 16 weeks; initial approval duration typically 8 weeks with continuation up to 16 weeks total

    Site of Care

    Note

    Administer as IV infusion (infusion center)

    Yartemlea is administered as an intravenous infusion and should be provided in an appropriate infusion setting.

    • Dosing per policy: ≥50 kg = 370 mg IV once weekly; <50 kg = 4 mg/kg IV once weekly.
    • Administration setting: infusion center (IV infusion).

    Background

    Narsoplimab‑wuug (Yartemlea) is a MASP‑2 inhibitor indicated in this policy for treatment of hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA) in patients aged 2 years and older. The policy aligns coverage criteria with pivotal trial definitions and FDA labeling by requiring persistent TMA signs after modification or discontinuation of calcineurin inhibitors, specific laboratory thresholds for thrombocytopenia (platelet count < 150 x 10^9/L), evidence of hemolysis (e.g., elevated LDH or presence of schistocytes), and renal impairment defined as serum creatinine ≥ 2 times pre‑transplantation baseline (or need for dialysis). Concurrent use with complement inhibitors such as eculizumab (Soliris) and its biosimilars (Bkemv/Epijkstra) or Ultomiris is restricted.

    Definitions

    inv-15: transplant‑associated thrombotic microangiopathy — TA‑TMA
    TermTransplant‑associated thrombotic microangiopathy (TA‑TMA)
    ScopeTA‑TMA following hematopoietic stem cell transplant — indication for Yartemlea per policy
    Diagnostic requirementDiagnosis required for initial approval; must be confirmed by hematologist or transplant specialist documentation
    inv-16: elevated LDH above upper limit of normal and/or presence of schistocytes — Hemolysis evidence
    DefinitionEvidence of hemolysis: elevated serum LDH above the upper limit of normal and/or presence of schistocytes
    Role in criteriaRequired as one of three laboratory indicators of persistent TMA for at least 2 weeks after calcineurin modification

    Biosimilars & Concurrent Prescribing

    Billing Rule

    Concurrent prescribing exclusion: Soliris and its biosimilars

    Biosimilars of eculizumab (Bkemv/Epijkstra) are included in the policy's concurrent prescribing exclusion with Soliris; Yartemlea must not be prescribed concurrently with Soliris or its biosimilars.

    • Concurrent use with Soliris, Bkemv/Epijkstra, or Ultomiris is prohibited per the policy's exclusion criteria.
    Policy Summary
    PayerQualChoice
    PolicyNarsoplimab‑wuug (Yartemlea) coverage for TA‑TMA
    Policy CodePolicy CP.PHAR.527
    Change TypeClinical criteria and coding revisions
    Effective DateDec 24, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization with office notes and relevant labs demonstrating the member meets all initial or continued therapy criteria.
    SourceLink
    On This Page
    Coverage CriteriaInitial Therapy Dosing & CriteriaContinuation Therapy CriteriaCoding and BillingProvider Actions & AuthorizationStep TherapyQuantity LimitsSite of CareBackgroundDefinitionsBiosimilars & Concurrent Prescribing
    Clinical roleOne of three concurrent laboratory criteria (with thrombocytopenia and hemolysis) required for initial approval of Yartemlea for TA‑TMA
    inv-09: Duration of persistent TMA signs after calcineurin modification — at least 2 weeks
    DurationPersistent TMA signs must be present for at least 2 weeks after modification or discontinuation of calcineurin inhibitor therapy
    Examples of calcineurin inhibitorsIncludes drugs such as cyclosporine and tacrolimus
    PurposeEnsures TMA is persistent despite modification of contributing immunosuppressive therapy before initiating Yartemlea
    • Refer to CP.CPA.09, HIM.PA.154, CP.PMN.53, or other line‑of‑business policies as directed in the policy for off‑label or unlisted uses.
    Documentation Required

    Required clinical documentation

    Provider must submit office chart notes, laboratory results, or other clinical information demonstrating that the member meets all approval criteria for TA‑TMA prior to authorization.

    • Documentation should show diagnosis of hematopoietic stem cell TA‑TMA, prescriber specialty (hematologist or transplant specialist), age ≥ 2 years, and evidence of persistent TMA signs after calcineurin inhibitor modification.
    • Include labs demonstrating platelet count, LDH and hemolysis evidence (e.g., schistocytes), and serum creatinine relative to pre‑transplant baseline or dialysis status.
    Denial Risk

    Insufficient documentation or unmet criteria may lead to denial

    Requests lacking documentation that the member meets all approval criteria may be denied. Missing evidence commonly includes the TA‑TMA diagnosis, prescriber specialty, age ≥ 2 years, persistence of TMA signs ≥ 2 weeks after calcineurin modification, absence of excluded diagnoses, non‑concurrent use with excluded agents, dose within limits, and therapy duration ≤ 16 weeks.

    • Absent or incomplete labs (platelet count, LDH/schistocyte documentation, serum creatinine) or lack of specialist consultation notes increases denial risk.
    • Concurrent prescribing with Soliris, its biosimilars (Bkemv/Epijkstra), or Ultomiris is a grounds for denial per policy exclusions.
    Continued therapy noteImprovement in hemolysis (e.g., normalization of LDH or decrease/absence of schistocytes) is used to judge response for continuation