CurrentCignaPolicy IP0290

Amifampridine Products

Defines prior authorization, coverage criteria, documentation requirements, and approval durations for amifampridine products (Firdapse; Ruzurgi approval withdrawn) for treatment of Lambert-Eaton myasthenic syndrome (LEMS) under Cigna benefit plans.

Policy Summary

PayerCigna

PolicyAmifampridine Products

Policy CodePolicy IP0290

Change TypeCriteria clarification; documentation added

Effective DateOct 15, 2025

Next Review Date

Key ActionSubmit prior authorization with required documentation (electrodiagnostic study or anti-P/Q antibody testing) and ensure prescribing is by or in consultation with a neurologist or neuromuscular specialist.

SourceLink

POLICY UPDATE CHANGES

Updated coverage policy title from 'Amifampridine' to 'Amifampridine Products.'

Updated criteria for confirmation of diagnosis from 'neurophysiology studies' to 'Electrodiagnostic study (e.g., repetitive nerve stimulation).'

Added '[Documentation Required]' to diagnostic confirmation criteria.

1Covered Indication (LEMS)

≥6Minimum age (years)

3mo/1yrApproval durations

Coverage Summary

Coverage stance: covered with criteria for amifampridine products for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). The policy applies to FDA-approved product Firdapse (approved November 28, 2018) which is indicated in adults and pediatric patients ≥ 6 years. The policy notes that Ruzurgi had FDA approval but that approval was withdrawn. The scope defines that prior authorization is required, specifies documentation requirements to confirm diagnosis, and sets approval durations (initial approval 3 months; continuation approval 1 year) for covered use under Cigna benefit plans.

Quick coverage thresholds and facts

Minimum patient age for coverage≥ 6 years

Covered indication count1

Approval durationsInitial: 3 months; Continuation: 1 year

Policy coding/identifierIP0290

Initial Therapy Criteria

FDA-Approved Indications - Lambert-Eaton Myasthenic Syndrome (LEMS)

A) Initial therapy

Patient is ≥ 6 years of age
ANY of the following
- Electrodiagnostic study (e.g., repetitive nerve stimulation) [documentation required]
- Anti-P/Q-type voltage-gated calcium channels antibody testing [documentation required]
Patient does not have a history of seizures
Contraindicated in patients with a history of seizures
Medication is being prescribed by or in consultation with a neurologist or a neuromuscular specialist
Specialist prescribing requirement

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of amifampridine. Approvals are for the durations specified: initial approvals for 3 months and continuation approvals for 1 year. Initial approval requires prescription by or in consultation with a physician who specializes in the condition being treated.

Initial approval duration: 3 months
Continuation approval duration: 1 year

Documentation Required

Documentation required to confirm diagnosis

Documentation is required to confirm LEMS when relying on diagnostic testing. Acceptable documentation may include chart notes, laboratory tests, claims records, and/or other information that demonstrate results of an electrodiagnostic study (e.g., repetitive nerve stimulation) or anti-P/Q-type voltage-gated calcium channels antibody testing.

Electrodiagnostic study (e.g., repetitive nerve stimulation) [Documentation Required]
Anti-P/Q-type voltage-gated calcium channels antibody testing [Documentation Required]
Documentation examples: chart notes, laboratory tests, claims records, and/or other information

Documentation Required

Specialist prescribing requirement

Initial approval requires that amifampridine be prescribed by or in consultation with a neurologist or a neuromuscular specialist because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with amifampridine.

Prescriber: neurologist or neuromuscular specialist (or consult with one) for initial therapy

Denial Risk

Seizure history exclusion

Do not approve amifampridine for patients with a history of seizures; both Firdapse and Ruzurgi are contraindicated in patients with a history of seizures and seizures have been observed in patients with and without a seizure history taking amifampridine.

Contraindicated in patients with a history of seizures
Seizures have been reported in patients with and without prior seizure history; may be dose-dependent

Documentation Required

Continuation benefit documentation

For continuation approvals (1 year), the prescriber must attest that the patient is continuing to derive benefit from amifampridine. Examples of continued benefit include improved muscle strength and improvements in mobility.

Prescriber attestation of continued benefit required for 1-year continuation
Examples of benefit: improved muscle strength; improved mobility

Clinical Evidence

Key evidence summary: Firdapse was approved by the FDA on November 28, 2018 and received orphan-drug exclusivity through November 28, 2025. The FDA approval of Ruzurgi was withdrawn on February 1, 2022. Firdapse approval was supported by two pivotal trials (including an open-label run-in) and pediatric dosing is supported by pharmacokinetic modeling and safety data in patients ≥ 6 years.

Evidence summary

Firdapse FDA approvalApproved Nov 28, 2018 with orphan-drug exclusivity until Nov 28, 2025

Ruzurgi approval statusApproval withdrawn by FDA Feb 01, 2022

Pivotal trialsFirdapse approval supported by two pivotal trials including open‑label run‑in; pediatric dosing supported by PK modeling and safety data

Seizure contraindicationContraindicated in patients with a history of seizures; seizures observed with use

Background & Definitions

Background: Amifampridine is a potassium channel blocker indicated for treatment of Lambert-Eaton myasthenic syndrome (LEMS). Firdapse is FDA‑approved for adults and pediatric patients ≥ 6 years. Diagnosis of LEMS is confirmed by electrodiagnostic studies (for example, repetitive nerve stimulation) or by anti‑P/Q‑type voltage‑gated calcium channel antibody testing.

Definitions

LEMS (definition)Lambert‑Eaton Myasthenic Syndrome: a rare autoimmune disorder causing proximal muscle weakness, autonomic dysfunction, and areflexia; diagnosis confirmed by electrodiagnostic testing or anti‑P/Q‑type antibody testing

Documentation Required (definition)May include, but is not limited to, chart notes, laboratory tests, claims records, and/or other information to support the requested service

Revision History

11/1/2024administrative_update

Updated coverage policy title from 'Amifampridine' to 'Amifampridine Products.' (Administrative title update; non-material).

11/1/2024criteria_clarification

Clarified diagnostic test terminology: updated confirmation of diagnosis from 'neurophysiology studies' to 'Electrodiagnostic study (e.g., repetitive nerve stimulation).' (Material).

11/1/2024documentation_requirement_added

Added documentation requirement: '[Documentation Required]' added to diagnostic confirmation criteria (electrodiagnostic study or anti-P/Q-type antibody testing). (Material).

Policy Summary

PayerCigna

PolicyAmifampridine Products

Policy CodePolicy IP0290

Change TypeCriteria clarification; documentation added

Effective DateOct 15, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Amifampridine Products

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Applicable Codes

Provider Actions & Requirements

Clinical Evidence

Background & Definitions

Revision History