CurrentUnitedHealthcarePolicy 2025 P 1275-8

Firdapse® (amifampridine) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy Summary

PayerUnitedHealthcare

PolicyFirdapse® (amifampridine) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 1275-8

Change TypeRevisions and clarifications (most recent: removal of concomitant-use restriction)

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization/notification for initial and reauthorization approvals; initial and reauthorization approvals are issued for 12 months and require documentation of positive clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Removed requirement for no concomitant use with similar potassium channel blockers from initial authorization criteria.

Updated background to include pediatric indication for patients 6 years of age and older.

Added 'Diagnosis of' to initial criteria wording with no change to clinical intent.

12Initial approval duration

12Reauthorization duration

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Coverage Summary

UnitedHealthcare prior authorization/notification policy for Firdapse (amifampridine) covering initial authorization and reauthorization criteria for commercial plans; includes program notes about automated approvals, supply limits, and state/federal mandates. Indication: treatment of Lambert-Eaton myasthenic syndrome (LEMS). Pediatric age: 6 years and older. Coverage stance: covered with criteria.

Key Policy Attributes

Initial approval duration12 months

Reauthorization duration12 months

Minimum pediatric age in indication6 years

Claim-based approvalAutomated approvals possible

Effective date2026-02-01

Last review2025-11

Initial Authorization Criteria

Initial Authorization

Firdapse will be approved based on the following criterion:

ALL of the following

Diagnosis of Lambert-Eaton myasthenic syndrome (LEMS)

Reauthorization / Continuation Criteria

Reauthorization

Firdapse will be approved based on the following criterion:

ALL of the following

Documentation of positive clinical response to Firdapse therapy

Provider Actions & Authorization Workflow

Prior Authorization

Prior Authorization Required

Initial and reauthorization approvals require prior authorization/notification per UnitedHealthcare policy; initial approval issued for 12 months and reauthorization issued for 12 months.

Documentation Required

Documentation for Reauthorization

Providers must document positive clinical response to Firdapse therapy to support reauthorization.

Applicable Codes

Diagnosis codes referencedICD-10

No codes listed

Clinical Evidence & References

Firdapse [package insert], Catalyst Pharmaceuticals, Inc., May 2024. This package insert is the primary referenced source in the policy background and references.

Background

Firdapse (amifampridine) is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years and older. UnitedHealthcare operates a prior authorization/notification program for this medication and may use program-specific automated approval/re-approval processes based on claim/medication history, diagnosis codes (ICD-10) and/or claim logic; supply limits and medical necessity reviews may also apply.

Revision History

11/2025revisionLatest

Removed requirement for no concomitant use with similar potassium channel blockers from initial authorization criteria.

11/2023revision

Added "Diagnosis of" to initial criteria wording with no change to clinical intent.

11/2022revision