Narsoplimab-wuug (Yartemlea) — Coverage Criteria for TA-TMA
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Covers medical necessity and authorization criteria for narsoplimab-wuug (Yartemlea) IV infusion to treat hematopoietic stem cell transplant–associated thrombotic microangiopathy (TA-TMA) in patients aged 2 years and older; applies to Blue Cross Blue Shield - North Carolina.
Added requirement that the patient must be post-hematopoietic stem cell transplant for clarity.
Removed requirement that diagnostic features must be from two or more time points within 14 days.
Removed requirement that the patient must be classified as high-risk.
Duration of approval for both initial and continuation criteria was increased to 12 weeks.
Added requirement in continuation criteria that the patient has not experienced unacceptable toxicity with the requested agent.
Maximum units updated to reflect change (Maximum Units = 8,880).
Removed medical record documentation requirement from TA-TMA trigger evaluation.
Coverage & Medical Necessity Criteria
Initial Therapy
Covered when ALL of the following are met
Initial Approval - overall
- Age: Patient is 2 years of age or older>=2 years
- Diagnosis and timing: Diagnosis of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) and patient is post-hematopoietic stem cell transplant (HSCT)
Diagnostic confirmation
- Histology: Histological evidence of microangiopathy on biopsy of affected organ (e.g., kidney, intestines)
Diagnostic feature set
- Anemia: failure to achieve transfusion independence, hemoglobin decline >=1 g/dL from baseline, or new transfusion dependence
- Thrombocytopenia: higher than expected platelet transfusion needs, refractoriness to platelet transfusions, >=50% reduction from baseline after engraftment, or platelet count <150,000/µL
- Elevated LDH: Elevated lactate dehydrogenase (LDH)
- Schistocytes: Presence of schistocytes
- Hypertension
- Elevated sC5b-9: Elevated soluble complement 5b-9 (sC5b-9)
- Renal dysfunction (e.g., proteinuria defined as >= 1 mg/mg random urine to creatinine ratio [rUPCR])
- Alternative diagnosis and trigger management: Alternative diagnoses have been ruled out and TA-TMA triggers (e.g., calcineurin inhibitor toxicity, graft-versus-host disease, infections) have been evaluated and are being appropriately managed
- Prescriber is a specialist in the area of the patient's diagnosis (e.g., hematologist) or has consulted with such a specialist
- Quantity: Requested quantity does NOT exceed the maximum units allowed for the duration of approval
Continuation Therapy
Covered when ALL of the following are met
Continuation Approval - overall
- Prior approval or retrospective fit: Patient was approved through Blue Cross NC initial criteria OR would have met initial criteria at the time therapy started
Clinical response
- Laboratory improvement: Improvement in TMA laboratory markers (e.g., improvement in platelet counts; reduction in LDH and sC5b-9; resolution of schistocytes)
- Organ function improvement: Improvement in organ function (e.g., reduction in proteinuria, reduction in transfusion requirements, improved blood pressure control, resolution of GI manifestations)
- Toxicity: Patient has NOT experienced unacceptable toxicity or adverse events requiring discontinuation of the requested agent
- Prescriber is a specialist in the area of the patient's diagnosis (e.g., hematologist) or has consulted with such a specialist
- Quantity: Requested quantity does NOT exceed the maximum units allowed for the duration of approval
Before approval, alternative diagnoses that can mimic TA-TMA must be excluded. Examples specifically listed in the policy include autoimmune or alloimmune hemolytic anemia, thrombotic thrombocytopenic purpura (TTP), and Shiga toxin–producing Escherichia coli–induced hemolytic uremic syndrome. Medical record documentation that these alternative diagnoses have been evaluated and ruled out is required.
The policy also requires that common TA-TMA triggers be evaluated and appropriately managed prior to approval; triggers called out in the policy include drug toxicities such as calcineurin inhibitor toxicity, graft-versus-host disease (GVHD), and infections. Documentation that trigger evaluation and management are in progress is part of the pre-treatment assessment.
Requests that do not meet the policy criteria are considered not medically necessary. Common reasons include patients younger than 2 years, absence of a documented diagnosis of TA-TMA or lack of documentation that the patient is post-hematopoietic stem cell transplant (post‑HSCT), or failure to meet the required diagnostic confirmation (histology or the specified diagnostic feature set).
The prescriber must be a specialist (for example, a hematologist) or must have consulted a specialist; requests without appropriate specialist involvement may be denied. For continuation requests, documentation must show a positive clinical response (laboratory and organ-function improvement) and absence of unacceptable toxicity as specified in the continuation criteria.
Operational exceptions: prior authorization is required and approval is granted only when initial or continuation criteria are met, including adherence to quantity and duration limits. Medical record documentation should include the TA-TMA diagnosis, post‑HSCT status, diagnostic confirmation, evaluation/management of alternative diagnoses and triggers, and evidence of clinical response for continuation requests.
Dosing and Administration
| Weight/Population | Dose & Frequency | Instructions / Duration |
|---|---|---|
| ≥ 50 kg | 370 mg IV once weekly | Increase frequency to twice weekly if there is inadequate improvement in TA‑TMA signs and symptoms; duration per policy (approval duration updated to 12 weeks). |
| < 50 kg | 4 mg/kg IV once weekly | Increase frequency to twice weekly if there is inadequate improvement in TA‑TMA signs and symptoms; duration per policy (approval duration updated to 12 weeks). |
Billing Codes and Key Measurements
Prior Authorization, Documentation, and Pre-Treatment Evaluation
Prior authorization required — approval only if initial/continuation criteria are met
Prior authorization is required. Approval will be granted only when all applicable initial or continuation criteria are met, including documented diagnosis of TA-TMA in a patient aged 2 years or older, the patient is post-hematopoietic stem cell transplant (HSCT), required diagnostic confirmation is provided (histology or specified diagnostic feature set), prescriber is a specialist or has consulted a specialist, and the requested quantity does not exceed the maximum units for the approved duration (12 weeks).
- Initial criteria: patient ≥2 years, diagnosis of TA-TMA, post-HSCT status, diagnostic confirmation, alternative diagnoses ruled out, triggers evaluated/managed, specialist prescriber, quantity within maximum units (Duration = 12 weeks) [[see cited chunks]].
- Continuation criteria: prior Blue Cross NC approval or would have met initial criteria at therapy start, demonstrated clinical response, no unacceptable toxicity, specialist prescriber, quantity within maximum units (Duration = 12 weeks).
Pre-treatment evaluation — rule out alternatives and assess/manage TA-TMA triggers
Before authorization, alternative diagnoses must be ruled out and identified TA-TMA triggers must be evaluated and appropriately managed; this evaluation is required prior to approval.
- Alternative diagnoses to rule out include autoimmune or alloimmune hemolytic anemia, thrombotic thrombocytopenic purpura, Shiga toxin–producing E. coli–induced hemolytic uremic syndrome, etc.
- TA-TMA triggers to evaluate and manage include calcineurin inhibitor toxicity, graft-versus-host disease (GVHD), and infections.
Required medical record documentation for authorization
Medical record documentation must support the TA-TMA diagnosis, post-HSCT status, diagnostic confirmation (histology or specified diagnostic features), evaluation/management of alternative diagnoses and triggers, and evidence of clinical response for continuation.
- Documentation of age (≥2 years) and that the patient is post-hematopoietic stem cell transplant.
- Diagnostic confirmation: either histological evidence of microangiopathy on biopsy of an affected organ OR documentation showing presence of at least four diagnostic features (anemia, thrombocytopenia, elevated LDH, schistocytes, hypertension, elevated sC5b-9, renal dysfunction e.g., proteinuria ≥1 mg/mg rUPCR).
- Records showing alternative diagnoses were ruled out and TA-TMA triggers were evaluated and are being managed.
- For continuation: documentation of positive clinical response (improvement in TMA lab markers and organ function) and absence of unacceptable toxicity.
Denial triggers — when requests will be denied
Requests lacking required elements will be denied. Denial triggers include failure to meet initial or continuation criteria such as age <2 years, not having a post-HSCT TA-TMA diagnosis, missing diagnostic confirmation, failure to rule out alternative diagnoses or evaluate/manage triggers, lack of specialist prescriber or consult, evidence of unacceptable toxicity, or requests exceeding maximum units/duration.
- No documentation that the patient is ≥2 years of age.
- No documentation that the patient is post-hematopoietic stem cell transplant or does not have a TA-TMA diagnosis.
- Missing diagnostic confirmation (neither histology nor at least four specified diagnostic features documented).
- Alternative diagnoses not ruled out or TA-TMA triggers not evaluated/managed.
- Prescriber is not a specialist and no specialist consult is documented.
- Requested quantity exceeds the maximum units allowed for the 12-week approval period, or evidence of unacceptable toxicity/adverse events requiring discontinuation.
Key Terms and Limits
Clinical Background
Hematopoietic stem cell transplant–associated thrombotic microangiopathy (TA‑TMA) is a recognized complication after hematopoietic stem cell transplantation characterized by microangiopathic hemolytic anemia, thrombocytopenia or platelet transfusion dependence, elevated lactate dehydrogenase (LDH), schistocytes on peripheral smear, hypertension, evidence of complement activation (e.g., elevated sC5b‑9), and end‑organ dysfunction such as renal injury with proteinuria.
Because TA‑TMA presents with overlapping features seen in other post‑transplant complications, the policy requires either histological evidence of microangiopathy on biopsy or the presence of at least four specified diagnostic features (including anemia, thrombocytopenia, elevated LDH, schistocytes, hypertension, elevated sC5b‑9, or renal dysfunction such as proteinuria ≥ 1 mg/mg rUPCR) to confirm the diagnosis prior to initiating therapy.
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