CurrentBlue Cross Blue Shield - IowaPolicy 05.02.86

Ultomiris (ravulizumab) coverage criteria

Covers indications, authorization criteria, required documentation, and continuation rules for Ultomiris (ravulizumab) for members of Blue Cross Blue Shield - Iowa when benefit and contract terms permit.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyUltomiris (ravulizumab) coverage criteria

Policy CodePolicy 05.02.86

Change TypeRevised

Effective DateMay 30, 2025

Next Review DateApr 1, 2025

Key ActionPrior authorization required; initial approvals may be granted for 6 months when indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

Reviewed and revised in April 2025 with current effective date May 30, 2025.

4FDA-approved indications listed

6 moInitial authorization (per indication)

12 moContinuation period

RequiredRequired testing

Coverage Criteria for Ultomiris (ravulizumab)

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Initial Therapy - PNH

Authorization of 6 months may be granted when ALL of the following are met:

PNH initial criteria

Diagnostic confirmation: Diagnosis confirmed by detecting a deficiency of glycosylphosphatidylinositol-anchored proteins (GPI-APs) demonstrated by either: (a) at least 5% PNH cells OR (b) at least 51% GPI-AP deficient polymorphonuclear cells; flow cytometry must be used.
Age for subcutaneous dosing: For subcutaneous dosing: member must be 18 years of age or older.

PNH initial criteria - note: The diagnosis of PNH was confirmed by detecting a deficiency of GPI-APs as demonstrated by either at least 5% PNH cells or at least 51% GPI-AP deficient polymorphonuclear cells; flow cytometry is used to demonstrate GPI-AP deficiency.

Initial Therapy - aHUS

Authorization of 6 months may be granted for aHUS not caused by Shiga toxin when ALL of the following are met:

aHUS initial criteria

Exclude Shiga toxin: Absence of Shiga toxin.
ADAMTS13 activity level above 5%.
Age for subcutaneous dosing: For subcutaneous dosing: member must be 18 years of age or older.

aHUS initial criteria - note: Authorization applies when aHUS is not caused by Shiga toxin and ADAMTS13 activity is >5%.

Initial Therapy - gMG

Authorization of 6 months may be granted for gMG when ALL of the following are met:

gMG initial criteria

Antibody status: Anti-acetylcholine receptor (AChR) antibody positive.
Clinical classification: Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV.
Symptom score: MG-ADL total score ≥6.
Prior therapy failure: Either: member failed treatment over at least one year with at least two immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate, tacrolimus, methotrexate, cyclophosphamide, rituximab) OR member failed at least one immunosuppressive therapy and required chronic plasmapheresis/plasma exchange or IVIG.

Initial Therapy - NMOSD

Authorization of 6 months may be granted for NMOSD in adults when ALL of the following are met:

NMOSD initial criteria

Antibody status: Anti-aquaporin-4 (AQP4) antibody positive.
Prescriber: Medication prescribed by, or in consultation with, a neurologist.
Core clinical characteristics: Member exhibits one of the NMOSD core clinical characteristics (e.g., optic neuritis; acute myelitis; acute brainstem syndrome; area postrema syndrome; symptomatic narcolepsy or acute diencephalic syndrome with NMOSD-typical lesions; symptomatic cerebral syndrome with NMOSD-typical brain lesions).
Recent relapse: Member experienced a relapse that required rescue therapy in the last 12 months prior to initiating therapy.

Ultomiris (ravulizumab) is not indicated for the treatment of patients with Shiga toxin E. coli–related hemolytic uremic syndrome (STEC‑HUS).

If a member does not meet the criteria outlined in this policy for initiation or continuation of Ultomiris, use of the drug is considered not medically necessary and coverage will not be provided.

Procedures, Diagnostic Thresholds, and Billing Guidance

Procedures and billing guidancemixed

No codes listed

PNH diagnostic cell percentage

PNH diagnostic thresholdAt least 5% PNH cells OR at least 51% GPI-AP–deficient polymorphonuclear cells (flow cytometry required)

Method of detectionGPI-AP deficiency demonstrated by flow cytometry

Subcutaneous dosing age requirementFor subcutaneous dosing: member must be 18 years of age or older

ADAMTS13 activity

ADAMTS13 activity thresholdADAMTS13 activity level above 5%

Indication contextRequired to consider aHUS not caused by Shiga toxin

Subcutaneous dosing age requirementFor subcutaneous dosing: member must be 18 years of age or older

MG-ADL score

MG-ADL score thresholdMG-ADL total score ≥6

Required antibody statusAnti-acetylcholine receptor (AChR) antibody positive (gMG indication)

Clinical classificationMGFA clinical classification II to IV required

Prior Authorization, Documentation, and Concomitant Therapy Rules

Prior Authorization

Prior authorization required

Prior authorization is required. Initial approvals may be granted for up to 6 months when indication-specific criteria are met.

Initial approval duration: up to 6 months when criteria met
Continuation/reauthorization: contingent on positive clinical response and absence of unacceptable toxicity or disease progression

Prior Authorization

Concomitant therapy restrictions

The requested medication must not be used concomitantly with specified therapies where prohibited. Confirm the member will not receive the requested drug at the same time as listed agents.

Prohibited concomitant therapies include other complement inhibitors (e.g., eculizumab), anti-CD20 therapies (e.g., rituximab), anti-CD19 antibody (e.g., inebilizumab), and IL-6 receptor antagonists (e.g., satralizumab).

Documentation Required

Required clinical documentation

Initial requests must include disease-specific objective testing and supporting documentation. Continuation requests must include documentation of ongoing clinical benefit.

Paroxysmal nocturnal hemoglobinuria (PNH): flow cytometry demonstrating deficiency of glycosylphosphatidylinositol-anchored proteins (GPI-APs).
Atypical hemolytic uremic syndrome (aHUS): ADAMTS13 level (to help exclude severe ADAMTS13 deficiency/TTP).
Generalized myasthenia gravis (gMG): positive anti-acetylcholine receptor (AChR) antibody (when applicable), clinical classification of myasthenia gravis score, MG Activities of Daily Living (MG-ADL) score, documentation of prior IVIG use or immunosuppressive therapies, and prior chronic plasmapheresis/plasma exchange if applicable.
Neuromyelitis optica spectrum disorder (NMOSD): immunoassay confirming anti–aquaporin-4 (AQP4) antibody positivity and documentation of core clinical characteristics (e.g., optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic diencephalic or cerebral syndrome) and relapse history (relapse requiring rescue therapy within prior 12 months when applicable).
For continuation/reauthorization: chart notes or medical record documentation supporting positive clinical response compared with baseline and absence of unacceptable toxicity or disease progression; medication prescribed by or in consultation with an appropriate specialist (e.g., neurologist for NMOSD).

Denial Risk

Not meeting listed criteria

Ultomiris is considered not medically necessary for members who do not meet the criteria set forth above.

Background on Ravulizumab (Ultomiris)

Ravulizumab (Ultomiris) is a terminal complement C5 inhibitor approved for multiple indications including atypical hemolytic uremic syndrome (aHUS), paroxysmal nocturnal hemoglobinuria (PNH), generalized myasthenia gravis (gMG) in AChR antibody–positive adults, and AQP4 antibody–positive neuromyelitis optica spectrum disorder (NMOSD). The policy ties authorization to indication‑specific objective diagnostic testing and defined clinical thresholds, and excludes use for STEC‑HUS. For NMOSD reauthorization the policy requires ongoing documentation of clinical benefit (for example, reduction in number or severity of relapses) and that the medication be prescribed by or in consultation with a neurologist.

OpenPayer

Ultomiris (ravulizumab) coverage criteria

Coverage Criteria for Ultomiris (ravulizumab)

Procedures, Diagnostic Thresholds, and Billing Guidance

Prior Authorization, Documentation, and Concomitant Therapy Rules

Key Definitions and Lab Thresholds

Background on Ravulizumab (Ultomiris)

Policy Revision History