CurrentCignaPolicy IP0290

Amifampridine Products

This Cigna coverage policy governs medical necessity criteria and coverage decisions for amifampridine products (Firdapse and historically Ruzurgi) for members with LEMS, affecting prescribers, reviewers, and pharmacy/medical benefit administrators.

Policy Summary

PayerCigna

PolicyAmifampridine Products

Policy CodePolicy IP0290

Change TypeRevisedClarified

Effective DateNov 1, 2024

Next Review Date

Key ActionSubmit prior authorization with documentation of age (≥6 years for initiation), confirmation of LEMS by electrodiagnostic study or antibody testing, absence of seizure history, and prescriber specialty or consultation.

SourceLink

POLICY UPDATE CHANGES

Updated coverage policy title from 'Amifampridine' to 'Amifampridine Products' and clarified diagnostic confirmation language.

Expanded indication language specifying Firdapse is indicated in adults and pediatric patients ≥ 6 years of age; noted Ruzurgi approval was withdrawn.

≥6minimum age for Firdapse indication

3 moinitial approval duration

1 yrcontinuing approval duration

7 yrorphan-drug exclusivity

withdrawn

Policy Summary

PayerCigna

PolicyAmifampridine Products

Policy CodePolicy IP0290

Change TypeRevisedClarified

Effective DateNov 1, 2024

Next Review Date

SourceLink

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Coverage Criteria for Amifampridine Products

Medical Necessity Criteria for LEMS

Amifampridine is considered medically necessary for LEMS when ONE of the following is met:

LEMS Indication: Patient meets either Initial therapy criteria (A) or Currently receiving therapy (B)

Approval durations differ for initial vs continuation

A) Initial therapy (approve 3 months)

Age: Patient is >= 6 years of age
Confirmed LEMS: Patient has confirmed LEMS based on at least ONE of: electrodiagnostic study (e.g., repetitive nerve stimulation) OR anti-P/Q-type voltage-gated calcium channel antibody testing (as reported by the prescriber)
Seizure history: Patient does not have a history of seizures
Contraindicated in patients with seizure history
Prescriber qualification: Amifampridine is being prescribed by or in consultation with a neurologist or a neuromuscular specialist

B) Currently receiving amifampridine (approve 1 year): Patient is continuing to derive benefit from amifampridine as assessed by the prescriber (examples: improved muscle strength, improved mobility)

Prescriber assessment documents continued benefit

Any use of amifampridine products other than for Lambert‑Eaton myasthenic syndrome (LEMS) is considered experimental, investigational, or unproven and is not covered under this policy.

Amifampridine products (Firdapse and historically Ruzurgi) are contraindicated in patients with a history of seizures; seizures have been observed with amifampridine and may be dose dependent. Use of amifampridine in patients with a seizure history or for indications other than LEMS is considered not medically necessary or unproven and may be denied.

Product and Coding Information

ProductsNDC | mixed

NDC (product-specific)

Firdapse (amifampridine tablets) and Ruzurgi (approval withdrawn)

Age threshold

Minimum age for Firdapse indication≥ 6 years

Age for Ruzurgi (historical)6 years to < 17 years (approval withdrawn)

Policy effective age rule sourceFDA‑approved indication language in policy: patient is ≥ 6 years of age for initial therapy

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required; duration differs for initial vs continuation therapy

Prior authorization is required with documentation that the patient meets either the Initial therapy or Currently receiving therapy criteria; approve initial therapy for 3 months when ALL initial criteria are met, and approve continuing therapy for up to 1 year if the prescriber documents continued benefit.

Initial therapy: approve 3 months when patient meets all listed conditions (age ≥ 6 years; confirmed LEMS; no history of seizures; prescribed by or in consultation with a neurologist/neuromuscular specialist).
Currently receiving amifampridine: approve up to 1 year when prescriber documents continued benefit (examples: improved muscle strength, improved mobility).

Step Therapy

No step therapy required

No step therapy requirements are specified for amifampridine; approvals are based on meeting the listed medical necessity criteria for initial or continuing therapy.

Clinical Background

Lambert‑Eaton myasthenic syndrome (LEMS) is a rare autoimmune disorder that impairs neuromuscular transmission, typically causing proximal muscle weakness, autonomic dysfunction, and areflexia due to antibodies targeting presynaptic P/Q‑type voltage‑gated calcium channels. Diagnosis is confirmed by electrodiagnostic testing (for example, repetitive nerve stimulation) or by detection of anti‑P/Q‑type voltage‑gated calcium channel antibodies. Amifampridine, a potassium channel blocker, is used to improve neuromuscular transmission and is indicated for treatment of LEMS when the medical necessity criteria in this policy are met.

Definitions and Contraindications

Confirmed LEMS

Diagnostic confirmation methodsElectrodiagnostic study (e.g., repetitive nerve stimulation)

Alternative diagnostic confirmationAnti‑P/Q‑type voltage‑gated calcium channels antibody testing

Documentation notePrescriber must state which test (electrodiagnostic study or antibody testing) confirms LEMS

Contraindication

Contraindication — seizure historyFirdapse and Ruzurgi are contraindicated in patients with a history of seizures

Seizure risk with amifampridineSeizures have been observed in patients with and without prior seizures; may be dose dependent