CurrentallcareadvantagePolicy 109.3

Class Specific: myasthenia gravis agents (prior authorization and coverage criteria)

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Prior authorization and coverage criteria for specified myasthenia gravis agents for adults, including initial and renewal approval rules and required clinical documentation.

Policy Summary

Payerallcareadvantage

PolicyClass Specific: myasthenia gravis agents

Policy CodePolicy Policy 109.3

Change TypeNo material change

Effective DateMar 17, 2022

Last ReviewMar 14, 2024

Next Review DateMar 14, 2026

Key ActionObtain prior authorization; initial approvals up to 2 cycles and renewals up to 12 months when all criteria (age >18, neurology prescriber, MG-ADL ≥5, required serology/IgG thresholds, and FDA-consistent dosing) are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Agents listed in policy

Up to 2 cyclesInitial approval length

12 monthsRenewal approval length

≥5MG-ADL threshold

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CurrentallcareadvantagePolicy 109.3

Class Specific: myasthenia gravis agents (prior authorization and coverage criteria)

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Prior authorization and coverage criteria for specified myasthenia gravis agents for adults, including initial and renewal approval rules and required clinical documentation.

Policy Summary

Payerallcareadvantage

PolicyClass Specific: myasthenia gravis agents

Policy CodePolicy Policy 109.3

Change TypeNo material change

Effective DateMar 17, 2022

Last ReviewMar 14, 2024

Next Review DateMar 14, 2026

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Agents listed in policy

Up to 2 cyclesInitial approval length

12 monthsRenewal approval length

≥5MG-ADL threshold

Coverage Criteria for Myasthenia Gravis Agents

Initial Therapy

Covered when ALL of the following are met

Initial approval requirements

Serology/Agent-specific: If anti-AChR positive -> proceed to agent-specific branch; if anti-AChR negative and rozanolixizumab requested -> require MuSK-Ab+; other agents denied if required serology not met.
IgG thresholds: IgG ≥ 5.5 g/L required for rozanolixizumab OR IgG ≥ 6.0 g/L required for efgartigimod.

Renewal Therapy

Covered on renewal when ALL of the following are met

Renewal requirements: Member met initial PA criteria; sufficient interval since prior cycle (≥50 days for efgartigimod; policy notes minimum interval for other agents as specified); member experienced at least a 2-point reduction in MG-ADL total score from baseline; and dosing intervals and safety guidance for subsequent cycles are met.

Dosing

Dosing must match FDA labeling

FDA-consistent dosing: Requests for dosing that do not correspond to FDA labeling will be denied.

Patients under 18 years of age are not eligible for routine approval under this policy and will be routed for MD review or denied per policy rules. The policy requires serologic testing: a positive anti‑AChR antibody test is required for most agents; if anti‑AChR is negative and rozanolixizumab is requested, a positive MuSK antibody (MuSK‑Ab+) is required. Requests for agents that do not meet the specified serology requirements or that fail to meet the agent‑specific baseline IgG thresholds will be denied for that agent.

Requests that do not meet the stated initiation or renewal criteria will be denied or routed per the decision flow. Key triggers for denial or routing include: patient age ≤18, prescription not written by a neurology specialist, MG‑ADL total score < 5, member not established on the current MG therapy, lack of documentation supporting MGFA classification, missing or insufficient serology/IgG results, lack of required prior trial (or documented contraindication) of the specified therapy, or dosing that does not match FDA labeling. For renewals, failure to meet the renewal requirements—such as not meeting minimum interval rules (e.g., ≥ 50 days where applicable), or failure to demonstrate at least a 2‑point reduction in MG‑ADL from baseline—will result in denial.

Clinical Thresholds and Interval Key Values

inv-06: MG-ADL total score

MG-ADL total score (initiation)Required total score ≥ 5

UseServes as baseline disease-severity measure for initiation and to assess response on renewal

Action if not metRequests with MG-ADL < 5 are denied

inv-07: IgG level for rozanolixizumab

IgG threshold (rozanolixizumab)Required baseline IgG ≥ 5.5 g/L

RationalePolicy states IgG ≥5.5 g/L is required for rozanolixizumab

Action if not met

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior authorization required — initial and renewal rules

Prior authorization is required for these myasthenia gravis agents. Initial approvals are granted for up to 2 cycles; renewals may be approved for up to 12 months when all criteria are met, including age >18, prescription by a neurology specialist, MG-ADL ≥5, established on current MG therapy, documentation supporting MGFA class, applicable serology/IgG thresholds, required prior trial or contraindication to specified therapy, and dosing that corresponds to FDA labeling.

Initial approval length: up to 2 cycles
Renewal approval length: up to 12 months
Top-level eligibility: member >18 years old, neurology prescriber, MG-ADL ≥5, established on current MG therapy, MGFA documentation, serology/IgG thresholds, FDA-consistent dosing

Step Therapy

Step requirement — trial of one prior therapy required

Policy requires a prior trial of (or documented contraindication to) one specified therapy before approval of certain agents; absence of an adequate trial (or contraindication) will result in denial.

Background

Myasthenia gravis (MG) is an autoimmune disorder characterized by fluctuating skeletal muscle weakness. This policy covers class‑specific, antibody‑targeting therapies used for generalized MG in adults and defines clinical thresholds and documentation required for prior authorization, including disease severity measured by the MG‑ADL score, MGFA clinical classification, relevant autoantibody status (anti‑AChR and MuSK), baseline IgG where applicable, and adherence to FDA‑consistent dosing and cycle interval guidance (for example, minimum interval rules for subsequent cycles).

Definitions and Clinical Scales

inv-16: MG-ADL

DefinitionMyasthenia Gravis Activities of Daily Living (MG-ADL) profile is a patient-reported instrument measuring functional impact of MG; total score is used to assess disease severity and response

Policy useMG-ADL total score is required at initiation and used as baseline for measuring response on renewal

ThresholdRequired total MG-ADL score for initiation: ≥ 5

inv-17: MGFA

DefinitionMyasthenia Gravis Foundation of America (MGFA) clinical classification: categorical clinical staging used to describe disease severity

Policy requirementDocumentation of MGFA class is required to support clinical severity for coverage determinations

Policy Summary

Payerallcareadvantage

PolicyClass Specific: myasthenia gravis agents

Policy CodePolicy Policy 109.3

Change TypeNo material change

Effective DateMar 17, 2022

Last ReviewMar 14, 2024

Next Review DateMar 14, 2026

SourceLink

On This Page

Requests not meeting IgG threshold are denied for that agent

inv-08: IgG level for efgartigimod

IgG threshold (efgartigimod)Required baseline IgG ≥ 6.0 g/L

RationalePolicy lists IgG ≥6.0 g/L as the agent-specific requirement for efgartigimod

Action if not metRequests not meeting IgG threshold are not approved for that agent

inv-09: Minimum interval between cycles (efgartigimod)

Minimum interval between efgartigimod cyclesSubsequent cycles may not be initiated sooner than 50 days from the start of the prior cycle (≥ 50 days)

Renewal requirementRenewals require ≥50 days since prior cycle start for efgartigimod

Action if not metRenewal denied if interval < 50 days for efgartigimod

inv-10: Minimum interval between cycles (rozanolixizumab)

Minimum interval between rozanolixizumab cyclesSubsequent cycles should not be initiated sooner than 63 days from the start of the previous cycle (≥ 63 days)

Safety noteSafety of initiating subsequent cycles sooner than 63 days has not been established

Action if not metRequests to re-treat sooner than 63 days may be denied

See Criteria #10: adequate trial of (or contraindication to) one specified therapy is required

Documentation Required

Required documentation to support PA

Submit supporting clinical documentation with the prior authorization request to demonstrate eligibility.

Patient age >18 years
Prescription written by a neurology specialist
MG-ADL total score (baseline) with value (threshold ≥5)
Documentation that patient is established on current dose of MG therapy
MGFA clinical classification documentation
Relevant serologic antibody results (anti-AChR; if anti-AChR negative and requesting rozanolixizumab, MuSK-Ab+ required)
Baseline IgG level where applicable (≥5.5 g/L for rozanolixizumab; ≥6.0 g/L for efgartigimod)
Records of prior trials or documented contraindications to required therapies
Dosing schedule that corresponds to FDA labeling

Denial Risk

Common triggers for denial

Common reasons requests are denied include failure to meet age, prescriber, severity, treatment history, serology, or dosing requirements listed in the policy.

Patient is under 18 years of age (route to MD review or denial)
Prescription not written by a neurology specialist
MG-ADL total score < 5
Patient not established on current MG therapy
Documentation does not support MGFA clinical classification
Required serology results not met (anti-AChR or MuSK where specified) or IgG thresholds not met
Requested dosing does not correspond to FDA labeling
No adequate trial of (or documented contraindication to) the specified prior therapy

Action if missingRequests lacking MGFA documentation are denied