CurrentAvMedPolicy Pub. 100-2

Ultomiris (ravulizumab-cwvz) IV for generalized myasthenia gravis — Coverage Criteria

Prior authorization and step-edit requirements for outpatient/intravenous Ultomiris (ravulizumab-cwvz) for adults with generalized myasthenia gravis; applies to providers submitting medical (J-code) requests to AvMed.

Policy Summary

PayerAvMed

PolicyUltomiris (ravulizumab-cwvz) IV for generalized myasthenia gravis — Coverage Criteria

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionFax a signed medical prior authorization form with complete member/prescriber information and required documentation to AvMed to avoid delays.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Initial 6m / Reauth 12mTypical authorization durations

13 vials/56dMax quantity limit

≥18Minimum age

≥3 ptsReauth MG-ADL goal

≥5 ptsReauth QMG goal

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Initial Authorization Criteria

Covered when ALL of the following are met for initial authorization (6 months):

Provider and program requirements: Prescribing physician is a neurologist; prescriber enrolled in the Ultomiris REMS program; member is 18 years of age or older.

Disease confirmation: Member has MGFA Clinical Classification II–IV and positive anti‑AChR antibody test; objective signs of neurological weakness and fatigability on baseline neurological exam; baseline QMG score documented; baseline MG‑ADL total score ≥6.

Each item must be supported by chart notes and test results.

Prior therapy for symptomatic control: Member has tried and had an inadequate response to pyridostigmine OR has intolerance/hypersensitivity/contraindication to pyridostigmine.

Verified by chart notes or pharmacy paid claims.

Prior immunosuppressive therapy requirements: Either failed over 1 year of therapy with at least 2 immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate) OR failed at least 1 immunosuppressive therapy and required chronic plasmapheresis/plasma exchange or IVIG.

Safety and vaccine requirements: Member does not have a systemic infection; member must receive meningococcal vaccine at least 2 weeks prior to initiation OR documentation that risks of delaying therapy outweigh meningococcal infection risk; medication will not be used in combination with other immunomodulatory biologic therapies.

Exclusionary conditions: Member must not have history of thymoma or other thymus neoplasm; thymectomy within 12 months; MGFA Class I or MG crisis (Class V) at initiation; rituximab within 6 months; IVIG or PE within 4 weeks; unresolved meningococcal disease; or untreated systemic bacterial/significant infections.

Reauthorization Criteria

Reauthorization (12 months) — Covered when ALL of the following are met:

Continuation of initial criteria: Member continues to meet initial authorization criteria and has not experienced unacceptable toxicity from the drug (e.g., serious meningococcal infections, infusion reactions, serious infections).

Demonstrated clinical improvement: Either demonstrated improvement of at least 3 points from baseline in MG‑ADL OR at least 5 points from baseline in QMG (total scores must be documented).MG‑ADL ≥3 improvement OR QMG ≥5 improvement

Therapy will not be approved for members with any of the following exclusionary conditions: history of thymoma or other neoplasms of the thymus; history of thymectomy within 12 months prior to treatment; MGFA Class I disease or MG crisis (MGFA Class V) at initiation; use of rituximab within 6 months prior to treatment; use of IVIG or plasma exchange (PE) within 4 weeks prior to treatment; unresolved meningococcal disease; or any systemic bacterial or other significant infections that have not been treated with appropriate antibiotics.

Coding and Quantity Limits

Affected HCPCS codeHCPCS

J1303

Ultomiris (ravulizumab-cwvz)

Maximum Quantity

Maximum quantity limit13 vials every 56 days

Maximum dosing interval coveredMaintenance dosing once every 8 weeks (per weight-based regimen)

Applies to switching from SolirisLoading dose of Ultomiris given 2 weeks after last Soliris infusion; maintenance every 8 weeks thereafter

Weight-based dosing bands

Weight band 1≥40 kg to <60 kg — Loading dose 2,400 mg; Maintenance dose 3,000 mg

Weight band 2≥60 kg to <100 kg — Loading dose 2,700 mg; Maintenance dose 3,300 mg

Weight band 3≥100 kg — Loading dose 3,000 mg; Maintenance dose 3,600 mg

Provider Actions, Prior Authorization & Documentation

Denial Risk

Incomplete documentation triggers delay/denial

Prior authorization form must be signed by the prescribing physician (preprinted stamps not valid). All required member and prescriber information must be complete, correct, and legible. If the completed form or any required documentation is missing, incorrect, or illegible, the authorization may be delayed or denied.

Fax completed form to 1-877-535-1391
Prescriber signature required (no preprinted stamps)
Ensure phone and fax numbers are correct on the form

Documentation Required

Required supporting documentation

Provide the following supporting documentation with the prior authorization request; chart notes or pharmacy paid claims must verify items where indicated. Requests lacking these documents may be denied.

Baseline neurological exam chart notes documenting objective signs of weakness and fatigability
Baseline Quantitative Myasthenia Gravis (QMG) score
Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score (≥ 6) and baseline MG-ADL for comparison
Positive serologic test for anti-acetylcholine receptor (AChR) antibodies (lab report)
Documentation of prior therapies and treatment history (chart notes and/or pharmacy paid claims) including trials of pyridostigmine and immunosuppressive agents
Documentation of meningococcal vaccination status or clinical justification for initiating therapy without vaccination

Step Therapy

Step therapy / prior treatment requirements

Prior trials or intolerance must be documented before approval. Provide chart notes or pharmacy claims to verify prior treatments and reasons for failure/intolerance.

Documentation of trial and inadequate response to pyridostigmine OR documentation of intolerance, hypersensitivity, or contraindication to pyridostigmine
Either: failure of >1 year of therapy with at least two immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate); OR failure of at least one immunosuppressive therapy plus requirement for chronic plasmapheresis/plasma exchange (PE) or intravenous immunoglobulin (IVIG)
Do not combine Ultomiris with other immunomodulatory biologic therapies (e.g., eculizumab, zilucoplan, rituximab, efgartigimod, rozanolixizumab, nipocalimab, inebilizumab)

Definitions and Scales

REMS

REMS enrollment requirementPrescriber must be enrolled in the Ultomiris Risk Evaluation and Mitigation Strategy (REMS) program prior to prescribing

Prescriber specialtyPrescribing physician must be a neurologist (stated alongside REMS requirement)

Vaccination considerationEnsure meningococcal vaccination at least 2 weeks prior to initiation when possible (REMS-associated safety measures referenced in broader criteria)

MG-ADL

DefinitionMyasthenia Gravis–Activities of Daily Living (MG-ADL) scale — a patient-reported instrument used to document symptom severity and functional impact

Baseline requirementA baseline MG-ADL total score must be submitted and must be ≥6 for initial authorization

Role in reauthorizationReauthorization requires documented improvement of at least 3 points from baseline in MG-ADL

QMG

DefinitionQuantitative Myasthenia Gravis (QMG) score — an objective clinical measure of neuromuscular strength used to assess disease severity and response

Baseline requirementPhysician must assess and submit a baseline QMG score to support initial authorization

Role in reauthorizationReauthorization may be approved if there is documented improvement of at least 5 points from baseline in QMG

OpenPayer

Ultomiris (ravulizumab-cwvz) IV for generalized myasthenia gravis — Coverage Criteria

Coverage Criteria for Ultomiris (ravulizumab-cwvz)

Coding and Quantity Limits

Provider Actions, Prior Authorization & Documentation

Background on Ultomiris

Definitions and Scales