Baylor Scott & White Health Plan ravulizumab Coverage

Coverage Criteria for Ravulizumab (Ultomiris)

Covered Indications and Criteria

Covered when ALL of the following universal criteria AND the indication-specific criteria are met:

Universal criteria: 1) Member received meningococcal vaccine at least 2 weeks prior to first dose OR as soon as possible with prophylactic antibiotics; 2) Ravulizumab will be dosed and administered according to FDA-approved labeling; 3) No active bacterial, viral, or fungal infection within 14 days of starting drug; 4) Provider attests that all REMS program requirements are met

Indication: PNH: Member is >=1 month old; diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH); ravulizumab prescribed by or in consultation with a hematologist; confirmed diagnosis by high-sensitivity flow cytometry with granulocyte or monocyte clone size >=5%; ravulizumab will not be used in combination with another complement inhibitor for PNH (examples: Empaveli, Fabhalta, PiaSky, Soliris) — concomitant use with Voydeya is allowed; initial documentation: if complement-inhibitor naïve LDH > 1.5 x ULN OR if complement-inhibitor experienced LDH < 1.5 x ULN, and >1 signs or symptoms of PNH (e.g., fatigue, hemoglobinuria, abdominal pain, dyspnea, anemia, history of thrombosis, dysphagia, erectile dysfunction, or need for transfusion); renewal requires LDH < 1.5 x ULN and reduced/no signs or symptoms and manageable or no side effects

Indication: aHUS: Member is >=1 month old; diagnosis of atypical hemolytic uremic syndrome (aHUS); ravulizumab prescribed by or in consultation with a hematologist or nephrologist; ravulizumab will not be used in combination with another complement inhibitor for aHUS (e.g., Soliris); initial documentation required: absence of Shiga toxin; ADAMTS13 activity > 5%; and signs or symptoms of aHUS (e.g., acute renal failure, thrombocytopenia, microangiopathic hemolysis, hemolytic anemia); renewal requires reduced/no signs or symptoms and manageable or no side effects

Indication: gMG: Member is >=18 years old; diagnosis of generalized myasthenia gravis (gMG); ravulizumab prescribed by or in consultation with a neurologist; ravulizumab will not be used in combination with another complement inhibitor (e.g., Soliris, Zilbrysq) or neonatal Fc receptor blocker (e.g., Vyvgart, Vyvgart Hytrulo, Rystiggo); initial documentation: anti-acetylcholine receptor (AChR) antibody positive; MGFA clinical classification II–IV; MG-ADL total score >=6; prior trial with inadequate response or intolerance to an acetylcholinesterase inhibitor and one or more immunosuppressive agents (including systemic corticosteroids or other non-steroidal immunosuppressants); renewal requires MG-ADL <6 and manageable or no side effects

Indication: NMOSD: Member is >=18 years old; diagnosis of neuromyelitis optica spectrum disorder (NMOSD); ravulizumab prescribed by or in consultation with a neurologist; ravulizumab will not be used in combination with any other biologics for NMOSD (examples: Soliris, Uplizna, Enspryng, rituximab, tocilizumab); initial documentation required: anti-aquaporin-4 (AQP4) antibody positive; history of >=1 relapse within 1 year; at least one sign or symptom of NMOSD (e.g., optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy or acute diencephalic syndrome with NMOSD-typical MRI lesions, or symptomatic cerebral syndrome with NMOSD-typical brain lesions); renewal requires reduced/no relapses or reduced/no signs or symptoms and manageable or no side effects

Initial therapy (AQP4+ NMOSD)

Covered when the following are met for adult patients with AQP4+ NMOSD:

Indication and evidence: Patient is an adult with aquaporin-4 antibody positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD), and ravulizumab is prescribed for reduction of relapse risk as supported by clinical studies; ravulizumab is indicated for treatment of NMOSD in adult patients and clinical trials demonstrated a significant reduction in relapse risk compared to placebo.

Concomitant administration of ravulizumab with other terminal complement inhibitors or overlapping biologic therapies is not permitted for the same indication. Examples include prohibition of concurrent use with Empaveli, Fabhalta, PiaSky, Soliris for PNH; with Soliris for aHUS; and with other complement inhibitors (for example Soliris, Zilbrysq) or neonatal Fc receptor blockers (for example Vyvgart, Vyvgart Hytrulo, Rystiggo) for gMG. For NMOSD, ravulizumab must not be used in combination with other biologics (for example Soliris, Uplizna, Enspryng, rituximab, tocilizumab). (Providers should follow indication-specific restrictions when documenting therapy.)

Requests to use ravulizumab for indications other than paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (AChR‑Ab positive), and aquaporin‑4 antibody positive neuromyelitis optica spectrum disorder (AQP4+ NMOSD) are considered experimental and investigational and will be denied because effectiveness for other indications has not been established.

Coding information in this policy is provided for reference only. An inclusive list of diagnosis codes may not be presented, and inclusion of a code does not guarantee reimbursement; payment requires that the member meets all applicable policy criteria and documentation requirements.

All other clinical uses of ravulizumab not specifically listed as covered in this policy are considered not medically necessary/experimental and investigational due to insufficient evidence of effectiveness. Such requests will be reviewed and are expected to be denied.

Some sections of the policy present coding and coverage guidance without explicit phrasing using the words 'not medically necessary.' When coverage is not supported by evidence or not included among the policy's listed indications, the policy treats those uses as investigational or non‑covered even if explicit 'not medically necessary' language is not repeated in every paragraph.

Billing and Coding

HCPCS CodesHCPCS

J1303

Injection, ravulizumab-cwvz, 10 mg

HCPCS CodesHCPCSCovered

J1303

Injection, ravulizumab-cwvz, 10 mg

CPT CodesCPT

No codes listed

ICD-10 codesICD-10

No codes listed

ICD10 Not coveredICD-10Not Covered

No codes listed

CPT CodesCPT

No codes listed

ICD-10 codesICD-10

No codes listed

ICD10 Not coveredICD-10Not Covered

No codes listed

LDH threshold for PNH (complement inhibitor naïve)

LDH entry criterion (complement inhibitor–naïve)LDH level > 1.5 x upper limit of normal (ULN)

ContextApplies to initial authorization documentation for PNH when patient is complement inhibitor–naïve.

Supporting renewal targetRenewal requires LDH < 1.5 x ULN with reduced or no signs/symptoms of PNH.

LDH threshold for PNH (complement inhibitor experienced)

LDH criterion (complement inhibitor–experienced)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for ravulizumab (J1303). Requests must include documentation that the member meets indication-specific and universal safety criteria; authorization will be granted only when all policy criteria are met.

Submit prior authorization for HCPCS J1303 (Injection, ravulizumab-cwvz, 10 mg). Inclusion of a code does not guarantee payment—member must meet all policy criteria.
Authorization duration: up to 12 months (the shortest of clinically appropriate duration, requested duration, or 12 months).

Documentation Required

Universal safety and documentation requirements

All requests must document universal safety requirements prior to initiation: meningococcal vaccination (either ≥2 weeks before first dose or given as soon as possible with prophylactic antibiotics), absence of active bacterial/viral/fungal infection within 14 days of starting therapy, and attestation that REMS program requirements are met.

Background and Indication Summary

Ravulizumab (Ultomiris®) is a long‑acting terminal complement C5 inhibitor indicated for several complement‑mediated disorders. It is approved for treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pediatric and/or adult patients, and for certain autoimmune neurological disorders including generalized myasthenia gravis (AChR‑Ab positive) and aquaporin‑4 antibody positive neuromyelitis optica spectrum disorder (AQP4+ NMOSD) in adults. The drug’s mechanism—blocking C5 cleavage and preventing membrane attack complex formation—reduces intravascular hemolysis in PNH and thrombotic microangiopathy in aHUS, and underlies its benefit in the listed neurologic indications where complement activation contributes to disease activity.

Definitions

PNH definition

DefinitionParoxysmal Nocturnal Hemoglobinuria (PNH) is a rare autoimmune disease in which hematopoietic cell membranes lack complement inhibitors, resulting in complement‑mediated intravascular hemolysis, hemoglobinuria, anemia, fatigue, and increased thrombotic risk.

PathophysiologyAbsence of membrane complement regulators permits MAC formation and destruction of affected blood cells.

Treatment noteRavulizumab is a terminal complement C5 inhibitor indicated for treatment of PNH in pediatric and adult patients.

aHUS definition

DefinitionAtypical Hemolytic Uremic Syndrome (aHUS) is a thrombotic microangiopathy caused by deficiency of complement regulatory proteins leading to uncontrolled complement activation, hemolytic anemia, thrombocytopenia, and acute kidney injury.

Clinical consequences

Policy Revision History

2026-02-26policy_updateLatest

Adjusted authorization duration to 12 months.

2025-12-08policy_creation

New policy created (Policy first listed as New).

OpenPayer

Ravulizumab (Ultomiris) coverage

Coverage Criteria for Ravulizumab (Ultomiris)

Billing and Coding

Prior Authorization, Documentation, and Provider Requirements

Background and Indication Summary

Definitions

Policy Revision History