CurrentAvMedPolicy N/A

Eculizumab (Soliris) IV for Neuromyelitis Optica Spectrum Disorder (NMOSD)

Clinical prior authorization criteria for outpatient (medical benefit) use of Soliris (eculizumab) to treat adult members with NMOSD. Applies to providers requesting medical-administered Soliris through AvMed.

Policy Summary

PayerAvMed

PolicyEculizumab (Soliris) IV for Neuromyelitis Optica Spectrum Disorder (NMOSD)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization with documentation (positive AQP4-IgG serology, qualifying clinical history, relapse history, prior therapy trials, REMS enrollment, and meningococcal vaccination evidence) to AvMed to request Soliris approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6Initial authorization duration

12Reauthorization duration (months)

4Maximum quantity limit (vials/14 days)

18+Minimum member age required

Medical Necessity Criteria

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Initial Authorization — Medical Necessity Criteria

All of the following must be met for approval:

ALL of the following

Prescribing physician must be a neurologist
Member must be 18 years of age or older>= 18 years
Prescriber must be enrolled in the Soliris REMS program
ALL of the following
- Past medical history of one of: optic neuritis; acute myelitis; area postrema syndrome (otherwise unexplained hiccups or nausea/vomiting); acute brainstem syndrome; symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions; symptomatic cerebral syndrome with NMOSD-typical brain lesions
  At least one historic clinical syndrome consistent with NMOSD must be documented
- Positive serologic test for anti-aquaporin-4 immunoglobulin (AQP4-IgG) antibodies
  Lab results must be submitted
- Diagnosis of multiple sclerosis or other diagnoses have been ruled out
ONE of
- History of at least one relapse during the previous 12 months prior to initiating Soliris
- History of at least two relapses during the previous 24 months, with at least one relapse within the past 12 months
Documentation of inadequate response, contraindication, or intolerance to Enspryng (satralizumab) AND tried and failed at least one of: rituximab, inebilizumab (Uplizna)
Enspryng is a pharmacy benefit requiring prior authorization; prior trials of listed agents must be documented
Documentation of inadequate response, contraindication, or intolerance to Ultomiris (ravulizumab)
ANY of the following
- Member administered a meningococcal vaccine at least two weeks prior to initiation and revaccinated per guidelines
- Member has not received meningococcal vaccine at least two weeks prior but risks of delaying Soliris outweigh risk of meningococcal infection and this is documented
Member does NOT have a systemic infection
Medication will NOT be used in combination with disease-modifying therapies for multiple sclerosis (e.g., fingolimod, dimethyl fumarate, ocrelizumab)
Medication will NOT be used concurrently with other complement inhibitors (e.g., ravulizumab), IL-6 inhibitors (e.g., tocilizumab, satralizumab), anti-CD20 antibody therapy (e.g., rituximab) or anti-CD19 antibody therapy (e.g., inebilizumab)

Reauthorization Criteria

All of the following must be met for approval of continuing therapy:

ALL of the following

Member continues to meet all initial authorization criteria
Provider attests to absence of unacceptable toxicity from the drug (e.g., serious meningococcal infections, infusion reactions, serious infections)
Provider must submit clinical notes documenting clinical improvement (fewer relapses from baseline) or stabilization of patient relapses while on Soliris therapy
Add-on, dose escalation of immunosuppressive therapy, or additional rescue therapy from baseline to treat NMOSD or exacerbation while on therapy will be considered treatment failure

Exclusions / Not Approved Conditions

Therapy will NOT be approved if any of the following are present:

ANY of the following

Unresolved meningococcal disease
Any systemic bacterial or significant infections not treated with appropriate antibiotics
Treatment with rituximab or mitoxantrone within the 3 months prior to Soliris therapy
Treatment with IVIG within 3 weeks prior to Soliris therapy
Use of greater than 20 mg/day of oral glucocorticoids with or without other immunosuppressive therapy prior to treatment
Concurrent treatment with disease-modifying therapies for multiple sclerosis (e.g., fingolimod, dimethyl fumarate, ocrelizumab)

Relevant Codes and Referenced Drugs

Drug HCPCS Code (Medical benefit)HCPCSCovered

J1299

Injection, eculizumab, 1 mg (HCPCS code listed on form for Soliris)

Examples of referenced drugs (not exhaustive coding list)mixed

Enspryng	satralizumab — pharmacy benefit (requires prior authorization)
Rituximab	Rituxan — requires prior authorization
Uplizna	inebilizumab-cdon — requires prior authorization
Ultomiris	ravulizumab — requires prior authorization

Dosing & Quantity Limits

Maximum Quantity Limit4 vials every 14 days (one 300 mg vial = 150 billable units; 1 billable unit per 2 mg)

Induction and maintenance dosingInduction: 900 mg weekly x4; Maintenance: 1200 mg at week 5, then 1200 mg every 2 weeks

Age>= 18 years

What Providers Must Do

Prior Authorization

Submit prior authorization request

Prescribing physician must complete and sign AvMed's medical prior authorization form and fax all required documentation (medical records, laboratory results, weight, diagnosis, prior therapy history) to AvMed; incomplete or illegible information may delay authorization.

J1299

Documentation Required

Provide diagnostic and laboratory evidence

Submit supporting medical records including positive anti‑aquaporin‑4 (AQP4‑IgG) serology results, documentation of a qualifying NMOSD clinical syndrome (e.g., optic neuritis, acute myelitis, area postrema syndrome, brainstem/diencephalic/cerebral syndromes), detailed relapse history meeting the policy relapse criteria, and records showing multiple sclerosis and other alternative diagnoses have been ruled out.

Prior Authorization

REMS enrollment

Prescriber must be enrolled in the Soliris Risk Evaluation and Mitigation Strategy (REMS) program prior to approval of therapy.

Documentation Required

Meningococcal vaccination documentation

Document administration of a meningococcal vaccine at least two weeks prior to initiation of Soliris therapy, or provide documentation that the risks of delaying Soliris outweigh the risk of meningococcal infection if therapy is started sooner.

Denial Risk

Concurrent therapy and recent treatments exclusions

Requests will be denied if the member has recent use of excluded therapies, untreated active infections, or concurrent MS disease‑modifying therapy; ensure these exclusions are absent before submission to avoid denial.

Treatment with rituximab or mitoxantrone within 3 months prior to Soliris therapy
Treatment with IVIG within 3 weeks prior to Soliris therapy
Any systemic bacterial or significant infections not treated with appropriate antibiotics
Concurrent treatment with MS disease‑modifying therapies (e.g., fingolimod, dimethyl fumarate, ocrelizumab)

Clinical and Safety Context

Eculizumab (Soliris) is a monoclonal antibody that inhibits terminal complement and is indicated for the treatment of adult patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) to reduce the risk of relapse. The policy applies to outpatient, medical‑benefit administration of Soliris (J1299) and specifies induction and maintenance dosing with a maximum quantity limit of 4 vials every 14 days (one 300 mg vial = 150 billable units; 1 billable unit per 2 mg).

Because eculizumab increases susceptibility to serious infections—most notably meningococcal disease—prescribers must enroll in the Soliris REMS program and document meningococcal vaccination. Members must receive a meningococcal vaccine at least two weeks prior to initiation and be revaccinated per guidelines, or the provider must document that the risks of delaying therapy outweigh the risks of meningococcal infection.

Prior authorization requires submission of medical records supporting an NMOSD diagnosis, including documentation of at least one historic qualifying clinical syndrome (for example, optic neuritis or acute myelitis) and a positive AQP4‑IgG serologic test. The prescriber must be a neurologist and the member must be 18 years of age or older. Requests must also include relapse history and evidence that multiple sclerosis and other diagnoses have been ruled out.

The policy lists safety and prior‑treatment constraints: therapy will not be approved in members with unresolved meningococcal disease, untreated systemic bacterial infections, recent use of certain therapies (e.g., rituximab or mitoxantrone within 3 months, IVIG within 3 weeks), or concurrent use of multiple sclerosis disease‑modifying therapies or other complement/immune‑targeted biologics. These requirements and exclusions are enforced through the prior authorization process and REMS enrollment to mitigate infection risk.