CurrentCignaPolicy N/A

Amifampridine (Firdapse, Ruzurgi) Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for amifampridine products (Firdapse and Ruzurgi) for treatment of Lambert-Eaton myasthenic syndrome (LEMS) under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAmifampridine (Firdapse, Ruzurgi) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJul 23, 2025

Key ActionPrior authorization is required for amifampridine products; initial approvals require prescription by or consultation with a neurologist or neuromuscular specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial approval duration

1 yearcontinuation approval duration

≥6 yrsminimum age for initial therapy

approval withdrawnRuzurgi status

seizurescontraindicated population

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Medical Necessity Criteria

FDA-Approved Indication: LEMS

Covered when ONE of the following is met for LEMS:

LEMS indication: Approve for the duration noted if the patient meets ONE of the following (A or B)

A) Initial therapy (approve 3 months): Initial therapy: Approve amifampridine for 3 months if the patient meets ALL of the following (i, ii, iii, and iv)3 months

i: Patient is ≥ 6 years of age≥ 6 years

ii: Confirmed LEMS based on at least ONE of the following: (a) electrodiagnostic study (e.g., repetitive nerve stimulation) OR (b) anti-P/Q-type voltage-gated calcium channels antibody testing

iii: Patient does not have a history of seizures

Contraindicated in patients with a history of seizures; seizures reported in prescribing information

iv: Medication is prescribed by or in consultation with a neurologist or a neuromuscular specialist

B) Currently receiving amifampridine (approve 1 year): Patient is currently receiving amifampridine: Approve for 1 year if the prescriber reports the patient is continuing to derive benefit from amifampridine1 year

Examples of continued benefit include improved muscle strength and improvements in mobility.

Amifampridine products (including Firdapse® and Ruzurgi®) are considered not medically necessary for uses other than those specified in this policy. Coverage is limited to indications and criteria explicitly described in the policy; criteria will be updated as new published data become available.

Any use of amifampridine outside the FDA‑approved indication for Lambert‑Eaton myasthenic syndrome (LEMS) and other uses specifically supported in this policy is considered not medically necessary and is not covered.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for amifampridine products. Initial approvals require the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist or neuromuscular specialist). Approvals are provided for the durations noted in the policy; where duration is expressed in months, 1 month = 30 days.

Affected products: Firdapse (amifampridine tablets) and Ruzurgi (approval withdrawn) for prescription benefit coverage under Cigna.
Initial prior authorization: Required; prescriber must be a neurologist or neuromuscular specialist or consult with one.
Initial approval duration: 3 months for new starts (see clinical criteria).
Continuation approval duration: 1 year for patients currently receiving therapy who continue to derive benefit.

Documentation Required

Required Clinical Documentation

Prescriber must document a confirmed diagnosis of Lambert-Eaton Myasthenic Syndrome (LEMS) using at least one of the following: electrodiagnostic testing (e.g., repetitive nerve stimulation) OR anti-P/Q-type voltage-gated calcium channel antibody testing. Prescriber must also confirm the patient is age ≥ 6 years and has no history of seizures for initial therapy.

Confirmation of LEMS: electrodiagnostic study (e.g., repetitive nerve stimulation) or anti-P/Q-type voltage-gated calcium channel antibody testing.
Initial therapy eligibility: patient ≥ 6 years of age and no history of seizures.
Continuation therapy: prescriber attestation that the patient is continuing to derive clinical benefit (examples: improved muscle strength or mobility).

Denial Risk

Denial Triggers

Requests will be denied if the request lacks a covered diagnosis (LEMS), does not meet the medical necessity criteria outlined in this policy (including age, diagnostic confirmation, prescribing specialist requirement), or is not supported by the required documentation from the prescriber. Claims submitted with codes/diagnoses not covered under this policy will be denied as not covered.

Denial triggers: missing documentation of diagnostic testing or antibody testing.
Denial triggers: patient does not meet age or seizure-history criteria for initial therapy.
Denial triggers: medication not prescribed by or in consultation with a neurologist/neuromuscular specialist.

Note

Provider Actions and Documentation Checklist

Provider action: ensure prior authorization is submitted with documentation of diagnostic confirmation (electrodiagnostic study or anti-P/Q antibody testing), prescriber specialty or consultation note, patient age, seizure history, and rationale for continuation of therapy when applicable.

Include copies or summaries of electrodiagnostic testing or antibody test results.
For continuation requests, include clinical progress notes demonstrating continued benefit (e.g., improved strength, mobility).
If using prior authorization forms, attach documentation showing neurologist consultation when the prescriber is not a specialist.

Definitions and Key Terms

LEMS — Definition

DefinitionLambert-Eaton myasthenic syndrome (LEMS) is a rare autoimmune disorder affecting neuromuscular transmission characterized by proximal muscle weakness, autonomic dysfunction, and areflexia.

PathophysiologyAutoantibodies against presynaptic P/Q-type voltage-gated calcium channels lead to diminished acetylcholine release at the neuromuscular junction.

Diagnostic confirmationDiagnosis is confirmed by electrodiagnostic studies (e.g., repetitive nerve stimulation) or anti-P/Q-type voltage-gated calcium channel antibody testing.

Typical clinical featuresProximal muscle weakness, autonomic dysfunction (eg, dry mouth, constipation), and reduced or absent deep tendon reflexes (areflexia).

Age considerationsFirdapse is indicated in adults and pediatric patients ≥ 6 years of age; Ruzurgi previously had pediatric indication but FDA approval was withdrawn (see policy).

OpenPayer

Amifampridine (Firdapse, Ruzurgi) Prior Authorization Policy

Coverage and Medical Necessity Criteria

Provider Requirements, Prior Authorization, and Documentation

Clinical Background

Definitions and Key Terms