CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-0832

Yartemlea (narsoplimab-wuug) for transplant-associated thrombotic microangiopathy

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This policy governs prior authorization, dosing, renewal, and billing requirements for intravenous Yartemlea (narsoplimab-wuug) used to treat transplant-associated thrombotic microangiopathy after hematopoietic stem cell transplantation for eligible Security Health Plan members.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyYartemlea (narsoplimab-wuug) for transplant-associated thrombotic microangiopathy

Policy CodePolicy SHP-0832

Change TypeRevised

Effective DateJuly 1, 2026

Last ReviewFeb 3, 2026

Next Review DateN/A

Key ActionSubmit clinical documentation with every prior authorization request; prior authorization is required for Yartemlea.

SourceLink

POLICY UPDATE CHANGES

The billing code is updated to HCPCS J1289 for narsoplimab-wuug, effective July 1, 2026, and HCPCS J3590 is discontinued for this drug on that date.

6 monthsInitial prior authorization validity

12 monthsRenewal prior authorization validity

370 units twice weeklyMaximum dose limit

Age 2+

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CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-0832

Yartemlea (narsoplimab-wuug) for transplant-associated thrombotic microangiopathy

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Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyYartemlea (narsoplimab-wuug) for transplant-associated thrombotic microangiopathy

Policy CodePolicy SHP-0832

Change TypeRevised

Effective DateJuly 1, 2026

Last ReviewFeb 3, 2026

Next Review DateN/A

Key ActionSubmit clinical documentation with every prior authorization request; prior authorization is required for Yartemlea.

SourceLink

POLICY UPDATE CHANGES

The billing code is updated to HCPCS J1289 for narsoplimab-wuug, effective July 1, 2026, and HCPCS J3590 is discontinued for this drug on that date.

6 monthsInitial prior authorization validity

12 monthsRenewal prior authorization validity

370 units twice weeklyMaximum dose limit

Age 2+

2Covered diagnosis codes

J1289Effective billing code

Coverage Criteria

Initial approval criteria

Covered when prior authorization, supporting clinical documentation, all universal criteria, and all TA-TMA indication-specific criteria are met.

Prior authorization and documentation: Prior authorization is approved and supporting clinical documentation related to medical necessity is submitted, including medical records, chart notes, laboratory results, and confirmatory diagnostics; documentation should support the diagnosis, applicable step therapy, and clinical markers when applicable.

Submit documentation through the prior authorization web portal or by fax.

Universal criteria: The member is at least 2 years of age, does not have an active infection including a clinically important localized infection, does not have a positive direct Coombs test, and does not have Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS).Age ≥2 years

If active infection is present, the member should be monitored closely for worsening infection during therapy and treated promptly; initial approval requires absence of active infection.

TA-TMA indication criteria

Confirmed TA-TMA findings: Platelet count is less than 150,000/µL; there is evidence of microangiopathic hemolysis, shown by schistocytes, serum LDH greater than the upper limit of normal and/or haptoglobin less than the lower limit of normal; and there is renal dysfunction, defined as doubling of serum creatinine from pretransplant.Platelets <150,000/µL; creatinine doubled from pretransplant
All three diagnostic findings are required.

Renewal criteria

Renewal is available when all continuing requirements are met and either the documented response pathway or the inadequate-response dose-escalation pathway is satisfied.

Continuing requirements: The member continues to meet the universal and other relevant indication-specific initial criteria and has no unacceptable toxicity from narsoplimab.

Examples of unacceptable toxicity include serious and/or life-threatening infections.

ONE of the following renewal pathways

Documented response pathway
- Applicable platelet response threshold
  - Baseline platelet count ≤20,000/µL: Platelet count increases by at least 3-fold, the postbaseline platelet count is greater than 30,000/µL, and no platelet transfusion was received within 2 days before the platelet count assessment.≥3-fold increase; postbaseline count >30,000/µL; no platelet transfusion within prior 2 days

Initial approval is excluded when the member has an active infection, including a clinically important localized infection; a positive direct Coombs test; or Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS). If an active infection is present, the member should be monitored closely for worsening infection during narsoplimab therapy and treated promptly.

Billing and Diagnosis Coding

Current HCPCS CodeHCPCSCovered

J1289

Injection, narsoplimab-wuug, 1 mg; 1 billable unit = 1 mg

Discontinued HCPCS CodeHCPCS

J3590

Unclassified biologics (discontinue use on 07/01/2026)

NDCNDCCovered

62225-0300-xx

Yartemlea 370 mg/2 mL (185 mg/mL) single-dose vial in a carton

Covered Diagnosis CodesICD-10Covered

M31.10	Thrombotic microangiopathy, unspecified
M31.11	Hematopoietic stem cell transplantation-associated thrombotic microangiopathy [HSCT-TMA]

Maximum dose and billing-unit limits

Maximum per dose370 billable units

Administration frequencyTwice weekly

Maximum over seven days740 billable units every 7 days

Minimum member age

Minimum ageAt least 2 years of age

Applies toInitial approval

Criterion type

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization and Authorization Duration

Prior authorization is required for Yartemlea® (narsoplimab-wuug). Initial authorization is valid for 6 months (180 days), and renewal authorization may be granted every 12 months (365 days) thereafter.

Documentation Required

Required Clinical Documentation

Submit supporting clinical documentation with every authorization request so medical necessity can be evaluated. Documentation should support the diagnosis, applicable step therapy, and clinical markers, including genetic or mutational testing when applicable.

Provide medical records, chart notes, laboratory results, and confirmatory diagnostics related to the medical-necessity criteria.
Upload records directly through the prior-authorization web portal or submit them by fax.

Clinical Background

Transplant-associated thrombotic microangiopathy (TA-TMA) is a serious complication that can occur after hematopoietic stem cell transplantation. It involves microangiopathic hemolysis, thrombocytopenia, and organ dysfunction, particularly renal dysfunction. This policy addresses narsoplimab treatment for members with confirmed TA-TMA who meet the specified clinical and laboratory requirements; continued treatment requires evidence of clinical or laboratory response or documented inadequate response supporting increased dosing frequency.

Policy Definitions

Definition of transplant-associated thrombotic microangiopathy

Clinical settingOccurs after hematopoietic stem cell transplantation (HSCT)

Platelet findingPlatelet count less than 150,000/µL

Required associated findingsMicroangiopathic hemolysis and renal dysfunction, defined as doubling of serum creatinine from pretransplant

Definition of microangiopathic hemolysis

Platelet countBelow 150,000/µL

Blood-smear findingSchistocytes are present

Laboratory markers

Initial Narsoplimab Therapy

Initial narsoplimab therapy

Initial narsoplimab therapy is covered when all of the following are met.

Authorization and documentation: Prior authorization is obtained and supporting clinical documentation is submitted with the request, including medical records, chart notes, laboratory results, confirmatory diagnostics, and documentation supporting the diagnosis and clinical markers when applicable.

Documentation must be submitted through the prior authorization web portal or by fax.

Universal eligibility and safety: The member is at least 2 years old, does not have an active infection, does not have a positive direct Coombs test, and does not have Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS).Age ≥2 years

Confirmed TA-TMA after HSCT

Narsoplimab Continuation Therapy

Narsoplimab continuation therapy

Continuation therapy is covered when all continuing requirements are met and either documented response or justified dosing escalation is present.

Continuing requirements: The member continues to meet the universal and relevant indication-specific criteria for initial therapy and has no unacceptable toxicity from narsoplimab.

Serious or life-threatening infections are examples of unacceptable toxicity.

ONE of the following continuation pathways

Documented clinical and laboratory response
- Applicable platelet response threshold
  - Baseline platelet count ≤20,000/µL: Platelet count increases by at least 3-fold, the postbaseline platelet count is greater than 30,000/µL, and no platelet transfusion was received within 2 days before assessment.

Dose and Quantity Limits

Yartemlea quantity limit and maximum billable units per seven days

DrugYartemlea (narsoplimab-wuug)

Quantity limit370 billable units twice weekly

Maximum billable units740 billable units every 7 days

Billing unitOne HCPCS billable unit equals 1 mg

Administration Setting

Billing Rule

Administer by intravenous infusion

Administer Yartemlea in an infusion center as an intravenous infusion over 30 minutes. If there is inadequate improvement in TA-TMA signs and symptoms, dosing frequency may be increased to twice weekly.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyYartemlea (narsoplimab-wuug) for transplant-associated thrombotic microangiopathy

Policy CodePolicy SHP-0832

Change TypeRevised

Effective DateJuly 1, 2026

Last ReviewFeb 3, 2026

Next Review DateN/A

Key ActionSubmit clinical documentation with every prior authorization request; prior authorization is required for Yartemlea.

SourceLink

On This Page

Baseline platelet count >20,000/µL: Platelet count increases by at least 50%, the platelet count is greater than 75,000/µL, and no platelet transfusion was received within 2 days before the platelet count assessment.≥50% increase; platelet count >75,000/µL; no platelet transfusion within prior 2 days

Inadequate-response dose-escalation pathway: The member has had inadequate improvement in TA-TMA signs and symptoms and requires an escalation in dosing frequency to twice weekly to maximize effectiveness.Escalation to twice weekly

Universal eligibility requirement

Platelet-count threshold for TA-TMA diagnosis

Platelet thresholdLess than 150,000/µL

Diagnostic roleRequired finding for confirmed TA-TMA

Additional requirementsMust be present with microangiopathic hemolysis and renal dysfunction

Renal-dysfunction criterion for TA-TMA diagnosis

Renal-dysfunction criterionDoubling of serum creatinine from pretransplant

Diagnostic roleRequired finding for confirmed TA-TMA

Additional requirementsMust be present with thrombocytopenia and microangiopathic hemolysis

Hemolysis-marker criteria for TA-TMA diagnosis

Peripheral blood findingPresence of schistocytes

LDH criterionSerum LDH greater than the upper limit of normal (ULN)

Haptoglobin criterionHaptoglobin less than the lower limit of normal (LLN); LDH and/or haptoglobin criterion applies

LDH response threshold

LDH response thresholdLess than 1.5 times the upper limit of normal (ULN)

Renewal roleRequired response-to-therapy marker for renewal

Response requirementRequired together with improvement in platelet count

Platelet response when baseline platelet count is 20,000/µL or lower

Platelet increaseAt least a 3-fold increase in platelet count

Postbaseline countGreater than 30,000/µL

Transfusion requirementNo platelet transfusions within 2 days before the platelet count assessment

Platelet response when baseline platelet count is above 20,000/µL

Platelet increaseAt least a 50% increase in platelet count

Response countPlatelet count greater than 75,000/µL

Transfusion requirementNo platelet transfusions within 2 days before the platelet count assessment

Documentation Required

TA-TMA Diagnosis and Response Evidence

For TA-TMA requests, submit evidence establishing the diagnosis and, for renewal, evidence of clinical response and TMA-marker improvement. The records must support the applicable transplant history, laboratory findings, organ response, transfusion status, and platelet-response thresholds.

Document that the member is post-hematopoietic stem cell transplant (HSCT).
Document all required TA-TMA findings: platelet count <150,000/µL; microangiopathic hemolysis, such as schistocytes, LDH > ULN, and/or haptoglobin < LLN; and renal dysfunction, such as serum creatinine doubling from pretransplant.
For renewal response, document LDH <1.5× ULN and platelet improvement. If baseline platelets are ≤20,000/µL, show a ≥3-fold increase, postbaseline platelets >30,000/µL, and no platelet transfusion within the preceding 2 days. If baseline platelets are >20,000/µL, show a ≥50% increase, platelets >75,000/µL, and no platelet transfusion within the preceding 2 days.
Document improvement in at least one organ system or independence from red-blood-cell and/or platelet transfusions, as applicable.

Denial Risk

Denial Risk: Missing Medical-Necessity Documentation

Failure to submit the medical records and other supporting documentation may result in denial because the plan cannot establish medical necessity under the policy guidelines.

Denial Risk

Denial Conditions: Initial Eligibility

Authorization may be denied when the member does not meet the universal criteria or the TA-TMA indication-specific criteria.

Member must be at least 2 years of age.
Universal criteria require no active infection, no positive direct Coombs test, and no Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS). If an active infection is present, the member must be monitored closely for worsening infection and treated promptly.
TA-TMA criteria require the member to be post-HSCT and to have all required findings: platelet count <150,000/µL, evidence of microangiopathic hemolysis, and renal dysfunction.

Denial Risk

Denial Conditions: Renewal Criteria

Renewal may be denied when the member no longer meets the universal or indication-specific criteria, has unacceptable toxicity, or does not satisfy the required clinical-response criteria. Renewal may also be denied when the requested dosing-frequency escalation is not supported by inadequate improvement in TA-TMA signs and symptoms.

Unacceptable toxicity includes serious and/or life-threatening infections.
The member must show improvement in at least one organ system or independence from red-blood-cell and/or platelet transfusions.
Response requires both LDH <1.5× ULN and the applicable platelet-response threshold, including the required no-transfusion interval.
For baseline platelets ≤20,000/µL: a ≥3-fold increase, postbaseline platelets >30,000/µL, and no platelet transfusion within 2 days before assessment are required.
For baseline platelets >20,000/µL: a ≥50% increase, platelets >75,000/µL, and no platelet transfusion within 2 days before assessment are required.
If there is inadequate improvement in TA-TMA signs and symptoms, the member must require escalation to twice-weekly dosing to maximize effectiveness.

LDH is above the upper limit of normal and/or haptoglobin is below the lower limit of normal

Definition of response to therapy for renewal

LDH responseLDH less than 1.5 times the upper limit of normal

Platelet responseImprovement in platelet count meeting the applicable baseline-dependent response threshold

Clinical responseImprovement in at least one organ system or independence from red blood cell and/or platelet transfusions

Required diagnostic findings:

Platelet count is less than 150,000/µL; evidence of microangiopathic hemolysis is present, including schistocytes, LDH greater than the upper limit of normal and/or haptoglobin less than the lower limit of normal; and renal dysfunction is present, defined as doubling of serum creatinine from pretransplant.

Platelets <150,000/µL; creatinine doubled from pretransplant

All TA-TMA diagnostic components are required.

≥3-fold increase; postbaseline count >30,000/µL; no platelet transfusion within prior 2 days

Baseline platelet count >20,000/µL: Platelet count increases by at least 50%, the platelet count is greater than 75,000/µL, and no platelet transfusion was received within 2 days before assessment.≥50% increase; platelet count >75,000/µL; no platelet transfusion within prior 2 days