CurrentAvMedPolicy N/A

Eculizumab Products IV - Generalized Myasthenia Gravis (gMG) (Medical)

Medical prior authorization form and clinical coverage criteria for IV eculizumab products (Soliris, Epysqli, Bkemv) for treatment of generalized myasthenia gravis (gMG), including initial authorization, reauthorization, dosing guidance, exclusions, administrative/REMS and documentation requirements.

Policy Summary

PayerAvMed

PolicyEculizumab Products IV - Generalized Myasthenia Gravis (gMG) (Medical)

Policy CodePolicy N/A

Change TypeClarified (administrative dates)

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form with prescriber signature, chart notes, baseline QMG and MG-ADL scores, documentation of prior therapies/trials, and vaccination status; fax to 1-877-535-1391.

SourceLink

POLICY UPDATE CHANGES

Approved by Pharmacy and Therapeutics Committee on multiple dates through 1/22/2026.

3Drug options listed

6Min age (years)

6Initial auth (months)

12Reauth interval (months)

Coverage Summary

Criteria for Approval

Initial Authorization (6 months)

All criteria must be met for approval. To support each line checked, documentation including lab results, diagnostics, and/or chart notes must be provided.

ALL of the following

Prescribing physician must be a neurologist
Prescriber must be enrolled in the Soliris® Risk Evaluation and Mitigation Strategy (REMS) program
Member must be 6 years of age or older
Member must have Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to IV disease and have a positive serologic test for anti-acetylcholine receptor (AchR) antibodies
chart notes must be submitted
Physician has assessed objective signs of neurological weakness and fatigability on a baseline neurological examination
chart notes must be submitted
Physician must have assessed and submitted a baseline Quantitative Myasthenia Gravis (QMG) score
Member has a MG-Activities of Daily Living (MG-ADL) total score of ≥ 6MG-ADL ≥ 6
results must be submitted
ONE of the following regarding pyridostigmine
- Member has tried and had an inadequate response to pyridostigmine
- Member has an intolerance, hypersensitivity or contraindication to pyridostigmine
ONE of the following regarding prior immunosuppressive therapy
- Member failed over 1 year of therapy with at least 2 immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate)
- Member failed at least 1 immunosuppressive therapy and required chronic plasmapheresis, plasma exchange (PE) or intravenous immunoglobulin (IVIG)
For Bkemv requests: ALL of the following must have inadequate response/contraindication/intolerance
- Rystiggo® (rozanolixizumab-noli) prior trial required
- Ultomiris® (ravulizumab-cwvz) prior trial required
- Epysqli® (eculizumab-aagh) prior trial required
- Uplizna® (inebilizumab-cdon) prior trial required
For Soliris requests: Member must meet ONE of the following (either prerequisite-drug failures OR pediatric criteria)
- Soliris prerequisite drug failures
  - Rystiggo® (rozanolixizumab-noli)
  - Ultomiris® (ravulizumab-cwvz)
  - Epysqli® (eculizumab-aagh)
  - Uplizna® (inebilizumab-cdon)
- Or member is under 18 years and meets ONE of the following pediatric criteria
  - Member with AChR+ disease: a minimum one-year trial of concurrent use with an oral corticosteroid plus another immunosuppressive therapy (e.g., azathioprine, cyclosporine, mycophenolate, etc.)
Member will avoid or use with caution medications known to worsen or exacerbate symptoms of MG (e.g., aminoglycosides, fluoroquinolones, beta-blockers, botulinum toxins, hydroxychloroquine)
Member does NOT have a systemic infection
Meningococcal vaccination requirement
- Member must be administered a meningococcal vaccine at least two weeks prior to initiation of eculizumab therapy and revaccinated according to current medical guidelines for vaccine use
- Member has NOT received a meningococcal vaccination at least two weeks prior to initiation and documented risks of delaying Soliris® therapy outweigh the risks of developing a meningococcal infection
Medication will NOT be used in combination with other immunomodulatory biologic therapies (e.g., ravulizumab, zilucoplan, efgartigimod products, rozanolixizumab-noli, rituximab, nipocalimab-aahu, inebilizumab-cdon)

ref

Reauthorization (12 months)

All criteria must be met for approval. Documentation including lab results, diagnostics, and/or chart notes must be provided.

ALL of the following

Member continues to meet all initial authorization criteria
Member has NOT experienced unacceptable toxicity from the drug (e.g., serious meningococcal infections (septicemia and/or meningitis), infusion reactions, serious infections)
Evidence of clinical improvement (one of)
- Member has demonstrated an improvement of at least 3 points from baseline in the Myasthenia Gravis-Specific Activities of Daily Living scale (MG-ADL)MG-ADL improvement ≥ 3 points from baseline
  total score must be documented

Exclusions (Not approved if any present)

Therapy will NOT be approved if member has history of any of the following:

ANY of the following

History of thymoma or other neoplasms of the thymus
History of thymectomy within 12 months prior to treatment
MGFA Class I or MG crisis at initiation of treatment (MGFA Class V)
Use of rituximab within 6 months prior to treatment
Use of IVIG or PE within 4 weeks prior to treatment

What Providers Must Do

Prior Authorization

Prior authorization required

Submit a completed prior authorization form with the prescriber signature, accompanying chart notes, baseline Quantitative Myasthenia Gravis (QMG) and MG-ADL scores, documentation of prior therapies/trials, and meningococcal vaccination status. Fax the completed materials to 1-877-535-1391.

Q5152
Q5151
J1299

Documentation Required

Baseline and follow-up objective measures required

Provide baseline neurological examination notes documenting objective signs of neurological weakness and fatigability, the baseline QMG score, the baseline MG-ADL total score, and documented follow-up QMG and MG-ADL scores demonstrating the required improvements for reauthorization.

Documentation Required

Prior therapy verification

Prior drug therapy trials and any use of IVIG or plasmapheresis/PE will be verified through pharmacy paid claims or submitted chart notes. Prerequisite biologic therapies listed on the form require prior authorization.

Billing Rule

Maximum quantity limit

Maximum Quantity Limit: 4 vials every 14 days. One 300 mg vial (30 mL) equals 150 billable units (1 billable unit per 2 mg).

Documentation Required

REMS enrollment requirement

The prescriber must be enrolled in the Soliris® Risk Evaluation and Mitigation Strategy (REMS) program to prescribe this therapy.

Denial Risk

Meningococcal vaccination timing

Therapy may be denied if documentation does not show the member received a meningococcal vaccine at least two weeks prior to initiation of eculizumab therapy, unless the provider documents that the risks of delaying therapy outweigh the risk of meningococcal infection.

Background and Definitions

Background: The clinical criteria emphasize that the prescribing physician must be enrolled in the Soliris® REMS program and that baseline objective measures must be documented (baseline neurological exam, Quantitative Myasthenia Gravis (QMG) score and MG‑ADL total score). Prior therapy requirements include trials or intolerance to pyridostigmine and specific prior immunosuppressive therapies or use of plasmapheresis/IVIG as detailed on the form. Members must receive meningococcal vaccination at least two weeks prior to initiation (or have documented reasons why delaying therapy is contraindicated). Exclusion criteria include history of thymoma or other thymic neoplasms, thymectomy within 12 months, recent use of rituximab (within 6 months) or IVIG/PE (within 4 weeks), unresolved meningococcal disease, active systemic infections, and MGFA class contraindications as listed.

Term	Definition
MG-ADL
Myasthenia Gravis - Activities of Daily Living scale
QMG
Quantitative Myasthenia Gravis score
MGFA
Myasthenia Gravis Foundation of America Clinical Classification
REMS
Risk Evaluation and Mitigation Strategy

name	type	number	effective date
Medicare Coverage for outpatient (Part B) drugs
NCD

Revision History

1/22/2026administrative_approvalLatest

Approved by Pharmacy and Therapeutics Committee on multiple dates through 1/22/2026.

11/20/2025administrative_approval

Approved by Pharmacy and Therapeutics Committee on multiple dates through 1/22/2026.

7/24/2025administrative_approval

Approved by Pharmacy and Therapeutics Committee on multiple dates through 1/22/2026.

5/22/2025administrative_approval

Approved by Pharmacy and Therapeutics Committee on multiple dates through 1/22/2026.

3/27/2025administrative_approval

Approved by Pharmacy and Therapeutics Committee on multiple dates through 1/22/2026.

9/21/2023administrative_approval

Approved by Pharmacy and Therapeutics Committee on multiple dates through 1/22/2026.

7/21/2022administrative_approval

Approved by Pharmacy and Therapeutics Committee on multiple dates through 1/22/2026.

8/15/2019administrative_approval

Approved by Pharmacy and Therapeutics Committee on multiple dates through 1/22/2026.

2/15/2018administrative_approval

Approved by Pharmacy and Therapeutics Committee on multiple dates through 1/22/2026.

OpenPayer

Eculizumab Products IV - Generalized Myasthenia Gravis (gMG) (Medical)

Coverage Summary

Criteria for Approval

Relevant Codes

What Providers Must Do

Background and Definitions

Medicare Determinations

Revision History

Q5152	Bkemv® (eculizumab-aeeb)
Q5151	Epysqli® (eculizumab-aagh)
J1299	Soliris® (eculizumab)