CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Yartemlea (narsoplimab-wuug) Coverage for TA-TMA

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This policy governs prior authorization, dosing, initial coverage, renewal, and billing requirements for intravenous Yartemlea (narsoplimab-wuug) used to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) for Medicaid, Commercial, and Medicare members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyYartemlea (narsoplimab-wuug) Coverage for TA-TMA

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2026

Last ReviewAug 17, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming post-HSCT TA-TMA, required laboratory findings, renal dysfunction, weight-based dosing, and specialist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2 yearsMinimum member age

8 dosesInitial authorization

8 dosesRenewal authorization

370 mgMaximum weekly dose

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CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Yartemlea (narsoplimab-wuug) Coverage for TA-TMA

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Sign up for all Neighborhood Health Plan of Rhode Island policy alerts

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Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyYartemlea (narsoplimab-wuug) Coverage for TA-TMA

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2026

Last ReviewAug 17, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming post-HSCT TA-TMA, required laboratory findings, renal dysfunction, weight-based dosing, and specialist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2 yearsMinimum member age

8 dosesInitial authorization

8 dosesRenewal authorization

370 mgMaximum weekly dose

Phase 2 TMA response

Coverage Criteria

Initial Therapy

Covered when all applicable criteria are met.

Initial therapy

Age requirement
- Member is at least 2 years of age.
Universal criteria
- Member does not have an active infection, including a clinically important localized infection.
- Documentation shows that the member does not have a positive direct Coombs test.
- Documentation shows that the member does not have Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS).
TA-TMA diagnosis and treatment requirements
- Yartemlea is prescribed by or in consultation with a hematologist or transplant specialist.
- Member is post-hematopoietic stem cell transplant (HSCT).
- Confirmed TA-TMA diagnosis
  - Platelet count is less than 150,000/µL.<150,000/µL
  - Evidence of microangiopathic hemolysis
    At least one finding
    Schistocytes are present.

Continuation/Renewal Therapy

Renewal is covered when all renewal criteria are met.

Continuation/renewal therapy

Member continues to meet the universal and other relevant indication-specific initial criteria.
There is no unacceptable toxicity from Yartemlea.
Examples of unacceptable toxicity include serious and/or life-threatening infections.
Positive response to therapy
- Platelet levels have improved.
- LDH and/or haptoglobin have normalized.
- Renal function has improved and/or the need for dialysis has decreased.

Coverage is excluded when the member has an active infection, including a clinically important localized infection.

Coverage is excluded when documentation shows a positive direct Coombs test.

Coverage is excluded for Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS).

Coverage is excluded when Yartemlea is used in combination with another complement inhibitor, including eculizumab or ravulizumab.

Coding and Clinical Parameters

Covered HCPCS CodesHCPCSCovered

J1289

Injection, narsoplimab-wuug, 1 mg

Covered NDCsNDCCovered

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]

Minimum age

Minimum ageAt least 2 years of age

Coverage populationAdults and pediatric members

RequirementThe member must meet the minimum age requirement for initial coverage

Platelet count

Platelet countLess than 150,000/µL

Clinical significanceSupports a confirmed diagnosis of TA-TMA

Documentation

Authorization and Provider Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required. Initial coverage is approved for 8 doses, and renewal may be approved for an additional 8 doses.

Initial: 8 doses—eight weeks when dosed once weekly or four weeks when dosed twice weekly.
Renewal: an additional 8 doses.

Documentation Required

Specialist Involvement Required

Yartemlea must be prescribed by, or administered in consultation with, a hematologist or transplant specialist.

Documentation Required

Document TA-TMA Diagnosis

Clinical Background

Yartemlea (narsoplimab-wuug) is a MASP-2 inhibitor indicated for adults and pediatric patients at least 2 years of age with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). TA-TMA is a serious complication of hematopoietic stem cell transplantation involving endothelial injury, thrombocytopenia, hemolytic anemia, and organ dysfunction.

Definitions

Transplant-associated thrombotic microangiopathy (TA-TMA)

DefinitionA thrombotic microangiopathy occurring after hematopoietic stem cell transplantation

Supporting findingThrombocytopenia, including a platelet count less than 150,000/µL

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

Microangiopathic hemolysis

SchistocytesPresence of schistocytes

Serum LDHGreater than the upper limit of normal (ULN)

Haptoglobin

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyYartemlea (narsoplimab-wuug) Coverage for TA-TMA

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2026

Last ReviewAug 17, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation confirming post-HSCT TA-TMA, required laboratory findings, renal dysfunction, weight-based dosing, and specialist involvement.

SourceLink

On This Page

Serum lactate dehydrogenase (LDH) is greater than the upper limit of normal.> upper limit of normal

Haptoglobin is less than the lower limit of normal.< lower limit of normal

Renal dysfunction is present, defined as doubling of serum creatinine from pretransplant.Doubling of serum creatinine from pretransplant

Weight-based dose

Documented weight is at least 50 kg and the dose is 370 mg once weekly.≥50 kg: 370 mg once weekly
Documented weight is less than 50 kg and the dose is 4 mg/kg once weekly.<50 kg: 4 mg/kg once weekly

Yartemlea will not be used in combination with another complement inhibitor, including eculizumab or ravulizumab.

Member has not received treatment with Yartemlea for more than 16 weeks.Not greater than 16 weeks

Include the platelet count in the TA-TMA diagnostic documentation

Serum LDH

Serum LDHGreater than the upper limit of normal (ULN)

Clinical significanceEvidence of microangiopathic hemolysis

Diagnostic roleSupports a confirmed diagnosis of TA-TMA

Haptoglobin

HaptoglobinLess than the lower limit of normal (LLN)

Clinical significanceEvidence of microangiopathic hemolysis

Diagnostic roleSupports a confirmed diagnosis of TA-TMA

Renal dysfunction

Renal dysfunctionDoubling of serum creatinine from pretransplant

Clinical significanceSupports a confirmed diagnosis of TA-TMA

DocumentationInclude the change in serum creatinine in the TA-TMA diagnostic documentation

Weight-based dose

Weight at least 50 kg370 mg once weekly by intravenous infusion

Weight below 50 kg4 mg/kg once weekly by intravenous infusion

AdministrationInfuse over 30 minutes; frequency may increase to twice weekly if TA-TMA signs and symptoms do not improve adequately

Maximum treatment duration

Maximum durationNo more than 16 weeks of treatment

Renewal requirementThe member must not have received Yartemlea for greater than 16 weeks

Coverage impactTreatment extending beyond 16 weeks may result in renewal denial

Document that the member is post-hematopoietic stem cell transplant (HSCT) and has confirmed transplant-associated thrombotic microangiopathy (TA-TMA).

Platelet count less than 150,000/µL.
Evidence of microangiopathic hemolysis, such as schistocytes, serum LDH above the ULN, and/or haptoglobin below the LLN.
Renal dysfunction, such as doubling of serum creatinine from pretransplant.

Documentation Required

Universal Clinical Documentation

For every request, document that the member does not have the applicable universal exclusions or risks requiring denial.

No active infection, including clinically important localized infection.
No positive direct Coombs test.
No Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS).

Documentation Required

Prescriber and Weight Documentation

Document the member’s weight, the requested Yartemlea dose, and the prescribing specialist.

For documented weight ≥50 kg: 370 mg once weekly.
For documented weight <50 kg: 4 mg/kg once weekly.

Documentation Required

Renewal Documentation

Renewal requests must demonstrate continued eligibility and clinical benefit without unacceptable toxicity, and must remain within the allowed treatment duration.

Member continues to meet universal and indication-specific criteria.
No unacceptable toxicity, including serious and/or life-threatening infections.
Documented positive response, shown by improved platelet levels, normalization of LDH and/or haptoglobin, improved renal function, and/or reduced need for dialysis.
Total Yartemlea treatment must not exceed 16 weeks.

Denial Risk

Universal Exclusion Risks

Coverage may be denied when any universal exclusion is present or when required documentation is missing.

Active infection, including a clinically important localized infection.
Positive direct Coombs test.
STEC-HUS.

Denial Risk

TA-TMA and Dosing Requirements

Coverage may be denied if the member does not have confirmed post-HSCT TA-TMA or if the required diagnostic and dosing criteria are not met.

Required findings include platelet count <150,000/µL, evidence of microangiopathic hemolysis, and renal dysfunction.
The dose must not exceed 370 mg once weekly for documented weight ≥50 kg or 4 mg/kg once weekly for documented weight <50 kg.

Denial Risk

Renewal Denial Risks

Renewal may be denied for unacceptable toxicity, lack of documented positive response, or treatment beyond the maximum permitted duration.

Unacceptable toxicity, including serious and/or life-threatening infections.
No documented positive response to therapy.
Treatment with Yartemlea for more than 16 weeks.

Less than the lower limit of normal (LLN)