CurrentAvMedPolicy N/A

Ultomiris IV - Neuromyelitis Optica Spectrum Disorder (NMOSD) (Medical)

Defines prior authorization clinical criteria, dosing guidance, exclusions, and reauthorization requirements for Ultomiris (ravulizumab-cwvz) IV when used to treat NMOSD under the medical benefit. Specifies prescriber, documentation, vaccination, prior-therapy, and safety requirements plus maximum quantity limits and dosing by weight.

Policy Summary

PayerAvMed

PolicyUltomiris IV - Neuromyelitis Optica Spectrum Disorder (NMOSD) (Medical)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionComplete and sign the AvMed medical prior authorization form and fax with supporting documentation (labs, diagnostics, chart notes) to 1-877-535-1391.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage criteria or policy content.

13Maximum Quantity Limit

18+Minimum Age (years)

6Initial Authorization (months)

12Reauthorization (months)

Coverage Summary

Overview: This policy covers Ultomiris (ravulizumab-cwvz) IV for Neuromyelitis Optica Spectrum Disorder (NMOSD) with a covered_with_criteria stance. Approval requires documentation supporting the NMOSD diagnosis, prescriber and safety requirements, and meeting prior-therapy and exclusion criteria.

Dosing summary: Ultomiris is administered as a weight-based loading dose followed by maintenance doses every 8 weeks. Members switching from eculizumab (Soliris) should receive the Ultomiris loading dose 2 weeks after the last Soliris infusion, then begin maintenance dosing every 8 weeks thereafter. The policy specifies a maximum quantity limit of 13 vials every 56 days.

Key requirements and transition guidance: Prescriber must be enrolled in the Ultomiris REMS program and meet documentation requirements (e.g., chart notes, AQP4-IgG lab results, MRI) to confirm NMOSD and relapse history. Members switching from Soliris follow the described 2-week transition interval to Ultomiris loading dose and then the 8-week maintenance schedule.

Quick facts (for reference): Minimum age requirement 18 years; initial authorization duration 6 months; reauthorization duration 12 months; maximum quantity limit 13 vials/56 days.

Quick policy facts and thresholds

Maximum Quantity Limit13 vials every 56 days

Age>= 18 years

Initial Authorization Duration6 months

Reauthorization Duration12 months

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization via AvMed is required for Ultomiris (ravulizumab-cwvz, J1303). Complete and sign the medical prior authorization form and fax with all supporting documentation to 1-877-535-1391.

Documentation Required

Submit documentation supporting NMOSD diagnosis

Submit medical records to support NMOSD diagnosis and relapse history. Required documentation includes chart notes, laboratory results showing AQP4‑IgG serology, MRI findings consistent with NMOSD, and documentation of relapses per the policy’s historical relapse definition.

Documentation Required

Meningococcal vaccination documentation

Document meningococcal vaccination at least two weeks prior to initiation and revaccination per current guidelines, or provide documented rationale that the risks of delaying Ultomiris outweigh the risk of meningococcal infection if vaccination has not been given ≥2 weeks prior.

Denial Risk

Denial if criteria not met

Requests may be denied if required information is incomplete, incorrect, or illegible, or if supporting documentation is not provided for each checked clinical criterion (diagnosis, labs, imaging, relapse history, prior therapies, vaccination, etc.).

Billing Rule

Maximum dosing and schedule guidance

Dosing is weight-based with a loading dose then maintenance every 8 weeks. Members switching from Soliris should receive the Ultomiris loading dose 2 weeks after the last Soliris infusion, then maintenance every 8 weeks. Maximum quantity limit is 13 vials per 56 days. (HCPCS code J1303.)

Documentation Required

REMS enrollment

Prescriber must be enrolled in the Ultomiris Risk Evaluation and Mitigation Strategy (REMS) program; enrollment is a required prescriber requirement on the form.

Step Therapy

Prior therapy requirements

Prior therapy requirements: member must have documentation of inadequate response, contraindication, or intolerance to Enspryng (satralizumab) and must have tried and failed at least one of rituximab (Rituxan) or inebilizumab (Uplizna) prior to initiation of Ultomiris.

Background

Background: Ultomiris (ravulizumab-cwvz) is an intravenous complement C5 inhibitor indicated for Neuromyelitis Optica Spectrum Disorder (NMOSD).

Dosing and schedule: The recommended regimen is a weight-based loading dose administered intravenously, followed by maintenance doses once every 8 weeks (maintenance timing depends on body weight). Specific example weight bands and doses are provided in the policy.

Transition and safety requirements: Members switching from eculizumab (Soliris) should receive the Ultomiris loading dose 2 weeks after the last Soliris infusion, then begin maintenance doses every 8 weeks. Prescribers must be enrolled in the Ultomiris Risk Evaluation and Mitigation Strategy (REMS) program. The policy also requires documentation of meningococcal vaccination at least 2 weeks prior to initiation or documentation that risks of delaying therapy outweigh the infection risk.

Definitions

Historical relapse (definition)A new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change on neurologic examination (clinical findings, MRI findings, or both) that persist for more than 24 hours and/or require treatment.

OpenPayer

Ultomiris IV - Neuromyelitis Optica Spectrum Disorder (NMOSD) (Medical)

Coverage Summary

Medical-Necessity Criteria

Coding

Provider Actions & Requirements

Background

Revision History