ModifiedBluecross IdahoPolicy MP 5.01.677

Yartemlea (narsoplimab-wuug) for TA-TMA

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Medical policy governing coverage and authorization criteria for Yartemlea (narsoplimab-wuug) for treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in patients aged 2 years and older for Blue Cross of Idaho members.

Policy Summary

PayerBluecross Idaho

PolicyYartemlea (narsoplimab-wuug) for TA-TMA

Policy CodePolicy MP 5.01.677

Change TypeNew policy added

Effective DateSep 1, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

Key ActionSubmit prior authorization demonstrating patient is ≥2 years old, post-HSCT with confirmed TA-TMA and requested quantity ≤24 vials for 12 weeks.

SourceLink

POLICY UPDATE CHANGES

New policy added to Prescription Drug section specifying that intravenously administered Yartemlea (narsoplimab-wuug) may be considered medically necessary when specified criteria are met for TA-TMA.

2 yearsminimum patient age for treatment

24 vialstreatment limit

4 mg/kg or 370 mgdosing (weekly)

61%

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ModifiedBluecross IdahoPolicy MP 5.01.677

Yartemlea (narsoplimab-wuug) for TA-TMA

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Policy Summary

PayerBluecross Idaho

PolicyYartemlea (narsoplimab-wuug) for TA-TMA

Policy CodePolicy MP 5.01.677

Change TypeNew policy added

Effective DateSep 1, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

Key ActionSubmit prior authorization demonstrating patient is ≥2 years old, post-HSCT with confirmed TA-TMA and requested quantity ≤24 vials for 12 weeks.

SourceLink

POLICY UPDATE CHANGES

New policy added to Prescription Drug section specifying that intravenously administered Yartemlea (narsoplimab-wuug) may be considered medically necessary when specified criteria are met for TA-TMA.

2 yearsminimum patient age for treatment

24 vialstreatment limit

4 mg/kg or 370 mgdosing (weekly)

61%

TA-TMA response (study)

09/01/26Policy effective date

Coverage Criteria for Yartemlea (narsoplimab-wuug)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Treatment Criteria: I. The patient is 2 years of age or older; AND II. Documentation of diagnosis of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA); AND III. Documentation that the patient is post-hematopoietic stem cell transplant (HSCT); AND IV. Diagnosis confirmed by at least ONE of: A. Histological evidence of microangiopathy on biopsy of affected organ (e.g., kidney, intestines); OR B. Presence of at least FOUR diagnostic features: i. Anemia (failure to achieve transfusion independence, hemoglobin decline from baseline by at least 1 g/dL, or new transfusion dependence); OR ii. Thrombocytopenia (e.g., increased transfusion needs, refractoriness, ≥50% reduction from baseline after engraftment, or platelet count <150,000/μL); OR iii. Elevated lactate dehydrogenase (LDH); OR iv. Presence of schistocytes; OR v. Hypertension; OR vi. Elevated soluble complement 5b-9 (sC5b-9); OR vii. Renal dysfunction (e.g., proteinuria defined as rUPCR ≥ 1 mg/mg)); AND V. Alternative diagnoses (e.g., autoimmune/alloimmune hemolytic anemia, TTP, Shiga-toxin HUS, etc.) have been ruled out; AND VI. TA-TMA triggers (e.g., calcineurin inhibitor toxicity, GVHD, infections) have been evaluated and are being appropriately managed; AND VII. Prescriber is a specialist in the area of the patient's diagnosis (e.g., hematologist) or has consulted a specialist; AND VIII. Requested quantity does NOT exceed the maximum vials allowed for the duration of approval (Limits: 24 vials per 12 weeks).

Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Continuation Criteria: I. Coverage criteria for initiation previously met OR the patient would have met initial criteria at the time therapy was started; AND II. Documentation of positive clinical response while using the requested agent, demonstrated by BOTH: A. Improvement in TMA laboratory markers (e.g., improved platelet counts, reduction in LDH and sC5b-9, resolution of schistocytes); AND B. Improvement in organ function (e.g., reduced proteinuria, reduced transfusion requirements, improved blood pressure control, resolution of gastrointestinal manifestations); AND III. The patient has NOT experienced unacceptable toxicity or adverse events requiring discontinuation; AND IV. Prescriber is a specialist in the area of the patient's diagnosis (e.g., hematologist) or has consulted a specialist; AND V. Requested quantity does NOT exceed the maximum vials allowed for the duration of approval (Limits: 24 vials per 12 weeks).

Initial coverage stance — Covered when ALL of the following are met

Covered when ALL of the following are met

Medically necessary coverage statement: Intravenously administered Yartemlea (narsoplimab-wuug) may be considered medically necessary when specified criteria are met for individuals with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

Full criteria set appears elsewhere in the policy.

The drug has a known safety concern for infectious complications. Yartemlea carries warnings for serious infections including sepsis, viral infections, pneumonia, bacteremia, fungal infections, gastroenteritis, respiratory tract infections, and urosepsis. If administered to a patient with an active infection, the patient should be closely monitored for worsening infection and treated promptly.

No specific exclusions are listed in the provided document fragment. The codes and coding guidance note that inclusion or exclusion of a code in the document does not itself determine coverage — benefit determinations remain subject to the member-specific benefit plan and the formal written coverage position.

Requests for Yartemlea that do not meet the policy's stated initiation or continuation criteria may be denied. Typical reasons for denial include failure to document age ≥ 2 years, lack of documented TA-TMA diagnosis or post‑HSCT status, insufficient diagnostic confirmation (no biopsy or fewer than the required diagnostic features), failure to rule out alternative diagnoses, lack of specialist involvement or consultation, or a requested quantity that exceeds the policy limit (see dosing/quantity limits).

Within the text fragment provided there are no explicit statements listing conditions as not medically necessary. Coverage guidance emphasizes that determinations depend on whether the initiation and continuation criteria are satisfied and on member-specific plan terms.

Initial Therapy Details and Requirements

Initial Therapy Details — initial therapy criteria and dosing/limits

Initial therapy nodes: Patient ≥ 2 years of age; confirmed TA-TMA post-HSCT; diagnosis confirmed by biopsy or ≥4 diagnostic features (see Initial Therapy block); alternative diagnoses ruled out; TA-TMA triggers evaluated and managed; prescriber is specialist or consulted specialist; dosing: <50 kg = 4 mg/kg IV once weekly; ≥50 kg = 370 mg IV once weekly; increase frequency to twice weekly if inadequate improvement; quantity limit: 24 vials per 12 weeks.

Dosing and limits are per Dosing Information and Limits to treatment sections.

Initial therapy — 1 top-level node

Initial therapy: Intravenously administered Yartemlea may be authorized for initial treatment of TA-TMA when the policy's specified criteria are met.

Detailed criteria are provided in the Initial Therapy block elsewhere in the policy.

Criteria for Continuing Therapy

Continuation of Therapy — continuation may be approved when prior initiation criteria were met and patient shows clinical benefit

Continuation may be approved when prior initiation criteria were met and patient shows clinical benefit:

Continuation nodes: Prior initiation criteria met (or would have been met at therapy start); AND documentation of clinical benefit: improvement in TMA lab markers AND improvement in organ function; AND no unacceptable toxicity requiring discontinuation; AND prescriber is specialist or has consulted specialist; AND quantity limit not exceeded (24 vials per 12 weeks).

See Dosing Information and Limits to treatment for dosing and quantity limits.

Continuation therapy — 1 top-level node

Continuation therapy: Continuation/renewal criteria are referenced by the policy; detailed continuation criteria are included in the policy's Continuation Criteria section and require demonstration of clinical and laboratory improvement without unacceptable toxicity.

See full policy for detailed continuation criteria.

Quantity Limits and Dosing

Yartemlea (narsoplimab-wuug) — Quantity limit (24 vials)

Quantity limit24 vials per 12 weeks (maximum for initial or continuation treatment)

Per policy sectionListed as limits to treatment for both Initial Treatment and Continuation of Treatment

PurposeCovers maximum supplied vials for a course of therapy referenced in authorization and quantity checks

rUPCR for proteinuria threshold

rUPCR threshold≥ 1 mg/mg random urine to creatinine ratio (rUPCR)

ContextUsed as part of diagnostic features indicating renal dysfunction in TA-TMA criteria

Coding and Billing Information

Codes table referencedmixed

No codes listed

Covered CPT Codes (reference)CPT

C9399

Unclassified drugs or biologicals

HCPCS CodesHCPCS

J3490	Unclassified drugs
J3590	Unclassified biologics
J1289	Injection, narsoplimab-wuug, 1 mg Effective July 1 2026

ICD-10-CM DiagnosesICD-10

M31.11

Hematopoietic stem cell transplantation-associated thrombotic microangiopathy (TA-TMA)

ICD-10-PCS Procedure CodesICD-10

XW03357	Introduction of narsoplimab monoclonal antibody into a peripheral vein
XW04357	Introduction of narsoplimab monoclonal antibody into a central vein

Covered CPT Codes (reference)CPT

C9399

Unclassified drugs or biologicals

HCPCS CodesHCPCS

J3490	Unclassified drugs
J3590	Unclassified biologics
J1289	Injection, narsoplimab-wuug, 1 mg Effective July 1 2026

ICD-10-CM DiagnosesICD-10

M31.11

Hematopoietic stem cell transplantation-associated thrombotic microangiopathy (TA-TMA)

ICD-10-PCS Procedure CodesICD-10

XW03357	Introduction of narsoplimab monoclonal antibody into a peripheral vein
XW04357	Introduction of narsoplimab monoclonal antibody into a central vein

HCPCS effective date — J1289 effective July 1 2026

HCPCS codeJ1289 — Injection, narsoplimab-wuug, 1 mg

Effective date for J1289Effective July 1, 2026

Coding guidanceCodes listed for reference; inclusion does not guarantee coverage; verify member-specific benefits

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior authorization required — demonstrate initiation or continuation criteria (age ≥2 years and confirmed TA‑TMA)

Submit a prior authorization request demonstrating the patient meets the policy's initiation or continuation criteria, including that the patient is at least 2 years of age and has a documented diagnosis of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) with post‑HSCT status and diagnostic confirmation per policy.

Age ≥ 2 years required (Initial Treatment I).
Documented diagnosis of TA-TMA and that the patient is post‑HSCT (Initial Treatment II–III).
Provide evidence of diagnostic confirmation (histology or ≥4 diagnostic features) and that requested quantity does not exceed 24 vials/12 weeks.

Prior Authorization

Prior authorization required — IV Yartemlea requires prior auth and is medically necessary when criteria met

Prior authorization is required for intravenous Yartemlea (narsoplimab‑wuug); when the specified initiation or continuation criteria are met the therapy is considered medically necessary for TA‑TMA.

Place of Service and Administration

Note

Infusion: IV administration (FDA‑approved); site not restricted

IV administration is the approved route of administration for Yartemlea; the policy does not restrict specific infusion site of care in the provided text.

Yartemlea is the FDA‑approved IV monoclonal antibody for TA‑TMA in patients 2 years and older.
No site‑of‑care restriction is specified in the policy fragment.

Billing Rule

Infusion place of service and ICD‑10‑PCS coding guidance

Place of service for infusion may be outpatient or inpatient; ICD‑10‑PCS procedure codes reference introduction of narsoplimab into a peripheral or central vein for coding purposes.

Place of service listed includes outpatient and inpatient settings.

Definitions and Terminology

TA-TMA definition — hematopoietic stem cell transplant-associated thrombotic microangiopathy

DefinitionHematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA): a post-HSCT condition characterized by microangiopathic hemolytic anemia, thrombocytopenia, elevated LDH, schistocytes, hypertension, elevated sC5b-9, and renal dysfunction such as proteinuria.

Pathophysiology noteRelated to lectin-pathway-mediated endothelial injury; MASP-2 inhibition by narsoplimab prevents lectin-dependent activation of complement (C3 and C4).

Clinical features used in policyPolicy uses features including anemia, platelet abnormalities, LDH elevation, schistocytes, hypertension, elevated sC5b-9, and rUPCR-defined proteinuria to confirm diagnosis.

M31.11 — ICD-10-CM code for TA-TMA

ICD-10-CM codeM31.11 — Hematopoietic stem cell transplantation-associated thrombotic microangiopathy (TA-TMA)

Background on Yartemlea (narsoplimab-wuug)

Yartemlea (narsoplimab-wuug) is a humanized monoclonal antibody that functions as a MASP-2 inhibitor. By inhibiting mannan-binding lectin-associated serine protease‑2 (MASP‑2), it blocks activation of the lectin pathway of complement (reducing downstream C3/C4 activation), which is intended to prevent endothelial injury implicated in hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA). The agent is FDA‑approved for adults and pediatric patients aged 2 years and older for this indication.

Policy Revision History

2026-05-28policy_added

New policy added to the Prescription Drug section; Blue Cross of Idaho adopted the policy effective 2026-09-01 for intravenous Yartemlea (narsoplimab-wuug) for TA-TMA.

2026-09-01policy_effectiveLatest

Policy became effective for coverage of intravenously administered Yartemlea (narsoplimab-wuug) when specified criteria are met for TA-TMA.

Policy Summary

PayerBluecross Idaho

PolicyYartemlea (narsoplimab-wuug) for TA-TMA

Policy CodePolicy MP 5.01.677

Change TypeNew policy added

Effective DateSep 1, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

Key ActionSubmit prior authorization demonstrating patient is ≥2 years old, post-HSCT with confirmed TA-TMA and requested quantity ≤24 vials for 12 weeks.

SourceLink

On This Page

Role in authorization

One of the diagnostic features that can confirm TA-TMA for initiation/continuation approval

Infusion site of care note — IV administration

Route of administrationIntravenous (IV) administration — FDA-approved route

Site restrictionNo specific site-of-care restriction stated in provided text; place of service may include outpatient or inpatient

Implication for authorizationRequests should document IV administration; site (infusion center vs inpatient) is not restricted by this policy fragment

Listed HCPCS/CPT codes (e.g., J1289, J3490, J3590, C9399) are provided for billing reference but authorization must be obtained prior to infusion.
Policy states IV Yartemlea may be considered medically necessary when criteria are met.

Documentation Required

Required documentation for authorization — supply diagnostic, post‑HSCT, confirmation, and evaluation details

Include documentation with the authorization request showing TA‑TMA diagnosis, post‑HSCT status, diagnostic confirmation (histology or at least four diagnostic features), evaluation/management of alternative diagnoses and TA‑TMA triggers, specialist involvement, and requested quantity consistent with dosing limits.

Diagnostic confirmation: histological evidence of microangiopathy OR presence of ≥4 diagnostic features (e.g., anemia, thrombocytopenia, elevated LDH, schistocytes, hypertension, elevated sC5b‑9, renal dysfunction such as rUPCR ≥ 1 mg/mg).
Documentation that alternative diagnoses have been ruled out and TA‑TMA triggers have been evaluated and are being managed.
Evidence the prescriber is a specialist or that a specialist was consulted, and that the requested quantity does not exceed 24 vials for 12 weeks.

Billing Rule

Coding/documentation guidance — align codes with benefit plan; listed codes for reference

Ensure coding and claim documentation align with the member's benefit plan and this medical policy; the policy provides codes for reference but inclusion does not guarantee coverage or reimbursement.

Reference codes include CPT C9399; HCPCS J3490, J3590, J1289 (Injection, narsoplimab‑wuug, 1 mg effective July 1, 2026); ICD‑10‑CM M31.11; ICD‑10‑PCS XW03357 and XW04357.
Place of service may be outpatient or inpatient per coding guidance; verify member plan requirements before billing.

Denial Risk

Denial risk — requests not meeting initiation/continuation criteria may be denied

Requests that do not meet the policy's initiation or continuation criteria may be denied; this includes failures such as age <2 years, insufficient diagnostic confirmation, not post‑HSCT, lack of specialist involvement, or requested quantity exceeding limits.

Denials may be issued if diagnostic confirmation (histology or ≥4 features) is not provided.
Denials may be issued if requested quantity exceeds 24 vials per 12 weeks.

Note

Coverage subject to benefit plan — codes do not guarantee coverage or reimbursement

Inclusion of a code in the policy's coding section does not guarantee member coverage or provider reimbursement; coverage determinations remain subject to the member‑specific benefit plan and policy terms.

Verify member benefit plan documentation and any additional terms or requirements before assuming coverage.
Codes provided are for general reference and may not be all‑inclusive.

Documentation Required

Provider action — document specialist prescriber or specialist consultation

For authorization, ensure the prescriber is a specialist in the patient's diagnosis (e.g., hematologist) or document that a specialist consultation has occurred as required by the policy.

Specialist involvement is listed as a required element (Initial Treatment VII).
If the prescriber is not a specialist, include consult notes documenting specialist input.

Documentation Required

Provider action — verify and document dosing and quantity limits before authorization

Confirm and document that the requested quantity and proposed dosing conform to policy limits (maximum 24 vials for a 12‑week course and dosing per weight: 4 mg/kg IV once weekly if <50 kg; 370 mg IV once weekly if ≥50 kg).

Dosing: <50 kg = 4 mg/kg IV weekly; ≥50 kg = 370 mg IV weekly; increase to twice weekly if inadequate improvement.
Quantity limit: 24 vials for 12 weeks (initial treatment limit).

ICD‑10‑PCS codes: XW03357 (peripheral vein) and XW04357 (central vein) are provided for reference.

Listed in policy code table for reference; inclusion does not guarantee member coverage

UseReferenced as the diagnosis code for TA-TMA when submitting claims or documentation consistent with this policy