CurrentAvMedPolicy Pub. 100-2

IV Eculizumab Products - Atypical Hemolytic Uremic Syndrome (aHUS)

Authorization and step-edit criteria for IV eculizumab products (Soliris, biosimilars) for treatment of atypical hemolytic uremic syndrome; applies to prescribers seeking medical prior authorization from AvMed.

Policy Summary

PayerAvMed

PolicyIV Eculizumab Products - Atypical Hemolytic Uremic Syndrome (aHUS)

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required chart notes and baseline labs (LDH, creatinine/eGFR, platelet count) and documentation that TTP and STEC-HUS have been ruled out.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

12 more-authorization duration

4 vials/14dmaximum quantity limit

≥2 months & ≥5 kgminimum age/weight

Coverage Criteria for IV eculizumab products (aHUS)

Initial Therapy

Policy Summary

PayerAvMed

PolicyIV Eculizumab Products - Atypical Hemolytic Uremic Syndrome (aHUS)

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required chart notes and baseline labs (LDH, creatinine/eGFR, platelet count) and documentation that TTP and STEC-HUS have been ruled out.

SourceLink

On This Page

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Initial Authorization Criteria: Prescribing physician is the treating physician or in consultation with a hematologist, oncologist, or nephrologist; prescriber is enrolled in the Soliris REMS program; member is at least 2 months of age and weighs at least 5 kg; confirmed diagnosis of atypical hemolytic uremic syndrome (aHUS) with chart notes and laboratory documentation submitted; thrombotic thrombocytopenic purpura (TTP) has been ruled out by ADAMTS-13 activity level (>10%); Shiga toxin E. coli–associated HUS (STEC-HUS) has been ruled out; other secondary causes (e.g., recent bone marrow or solid organ transplant, malignancy, autoimmune disorders, drug-induced malignant hypertension, HIV, Streptococcus pneumoniae or Influenza A (H1N1) infection, cobalamin deficiency) have been excluded; documented baseline laboratory values submitted including serum lactate dehydrogenase (LDH), serum creatinine/eGFR, platelet count, and plasma exchange/infusion requirement; for Bkemv and Soliris requests, documentation of inadequate response, contraindication, or intolerance to BOTH ravulizumab (Ultomiris) AND Epysqli (eculizumab-aagh); member does not have an active systemic infection; member has either received meningococcal vaccination at least 2 weeks prior to initiation OR documentation that the risks of delaying eculizumab therapy outweigh the risks of vaccination; medication will not be used concomitantly with other complement inhibitors.all items required

All documentation must be provided or request may be denied

Reauthorization/Continuation Therapy

Reauthorization covered when ALL of the following are met:

Reauthorization Criteria: Member continues to meet all initial authorization criteria; member has not experienced unacceptable toxicity from the drug (for example serious meningococcal infections such as septicemia or meningitis, infusion reactions, or other serious infections); provider submits clinical notes and laboratory results documenting positive clinical response or stabilization as evidenced by at least ONE of the following while on therapy: an increase in platelet count from baseline; maintenance of normal platelet counts and LDH levels for at least 4 weeks; a 25% reduction in serum creatinine for a minimum of 4 weeks; absence for at least 12 weeks of a decrease in platelet count >25% from baseline, plasma exchange/infusion, and new dialysis requirement.all items required plus at least one response measure

Documentation of response required

Therapy with IV eculizumab products will not be approved for members who have unresolved meningococcal disease. In addition, treatment is excluded when the member has any systemic bacterial infection or other significant infection that has not been treated with appropriate antibiotics. These infections must be resolved and appropriately managed prior to authorization to reduce the risk of serious infectious complications associated with complement C5 inhibition.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required for IV eculizumab products

Prior authorization is required for all IV eculizumab products (Soliris J1299, Epysqli Q5151, Bkemv Q5152) for aHUS; the prescribing physician must sign the request, be or consult with a hematologist/oncologist/nephrologist, and the prescriber must be enrolled in the Soliris REMS program.

Covered HCPCS codes: J1299, Q5151, Q5152
Prescribing physician must sign the request and be or consult with hematology/oncology/nephrology
Prescriber must be enrolled in the Soliris REMS program

Step Therapy

Step therapy: trial of ravulizumab and Epijkstra required

For Bkemv and Soliris requests, the member must have documentation of an inadequate response, contraindication, or intolerance to BOTH ravulizumab (Ultomiris) and Epysqli (eculizumab-aagh) prior to approval.

Ultomiris (ravulizumab) requires prior authorization
Epysqli (eculizumab-aagh) requires prior authorization

Documentation Required

Required clinical documentation and labs

Prescriber must submit supporting clinical documentation including chart notes and baseline laboratory values: serum LDH, serum creatinine/eGFR, platelet count, and records of plasma exchange/plasma infusion; documentation of diagnosis and ADAMTS-13 evaluation; and meningococcal vaccination status or justification for immediate therapy.

Confirmed diagnosis of aHUS with chart notes and labs
ADAMTS-13 activity level demonstrating TTP ruled out (ADAMTS-13 activity level >10%)
Meningococcal vaccination ≥2 weeks before initiation OR documentation that risks of delay outweigh vaccination risks
Documentation that medication will not be used with other complement inhibitors

Denial Risk

Incomplete or unsupported requests may be delayed or denied

Incomplete, incorrect, or illegible request information or missing supporting documentation (labs, diagnostics, chart notes) may delay review or result in denial; failure to meet clinical criteria or exclusions will result in denial.

Authorization may be delayed if the form is incomplete, incorrect, or illegible
Missing chart notes, baseline labs (LDH, creatinine/eGFR, platelet count), or ADAMTS-13 results may cause denial
Failure to document meningococcal vaccination status or justification for immediate therapy may delay or deny approval

Background

Atypical hemolytic uremic syndrome (aHUS) is a complement-mediated thrombotic microangiopathy characterized by uncontrolled complement activation leading to microangiopathic hemolytic anemia, thrombocytopenia, and acute kidney injury. Treatment with C5 complement inhibitors such as eculizumab and related products targets terminal complement activation to halt ongoing endothelial injury and thrombotic microangiopathy.

Because alternative causes of thrombotic microangiopathy (for example, thrombotic thrombocytopenic purpura or Shiga toxin–producing E. coli–associated HUS) require different management, the policy requires that these be excluded before initiating C5 inhibitor therapy. Providers must also follow enrollment and safety requirements (for example, Soliris REMS participation and meningococcal vaccination considerations) and supply baseline clinical and laboratory documentation when requesting prior authorization.

OpenPayer

IV Eculizumab Products - Atypical Hemolytic Uremic Syndrome (aHUS)

Coverage Criteria for IV eculizumab products (aHUS)

Coding and Quantity Limits

Provider Requirements, Prior Authorization, and Documentation

Definitions and Diagnostic Rules

Background

J1299	Soliris (eculizumab)
Q5151	Epysqli (eculizumab-aagh)
Q5152	Bkemv (eculizumab-aeeb)