CurrentCignaPolicy IP0290

Amifampridine Products

Cigna drug coverage policy for amifampridine products (Firdapse and previously Ruzurgi) specifying medical necessity criteria for Lambert-Eaton myasthenic syndrome (LEMS), approval durations, contraindications, excluded uses, and administrative details including effective date and policy number.

Policy Summary

PayerCigna

PolicyAmifampridine Products

Policy CodePolicy IP0290

Change TypeAnnual revision (title and diagnostic language)

Effective DateNov 1, 2024

Next Review Date

Key ActionPrescriptions are subject to this policy: initial approvals limited to 3 months for new starts and 1 year for continuing patients who demonstrate benefit; prescriber must be a neurologist or neuromuscular specialist or provide consultation evidence.

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).'

1Covered Indications (LEMS)

2Approved Products Listed

3Initial approval duration (months)

12Renewal approval duration (months)

This policy addresses coverage for amifampridine products for Lambert-Eaton myasthenic syndrome (LEMS). Subject: Amifampridine products (Firdapse, Ruzurgi). Coverage stance: covered with criteria — medical necessity criteria specify approval for LEMS when criteria are met. Approved products listed: Firdapse (amifampridine tablets) and Ruzurgi (amifampridine tablets; FDA approval withdrawn). Effective and last review date: 11/01/2024.

Policy metadata

policy_numberIP0290

payerCigna

effective_date2024-11-01

last_review2024-11-01

statusCURRENT

scope_summaryCigna drug coverage policy for amifampridine products (Firdapse and previously Ruzurgi) specifying medical necessity criteria for Lambert-Eaton myasthenic syndrome (LEMS), approval durations, contraindications, excluded uses, and administrative details including effective date and policy number.

Medical Necessity Criteria - FDA-Approved Indications

Amifampridine is considered medically necessary when the following criteria are met:

LEMS - Approve when ONE of A or B is met

A) Initial therapy OR B) Currently receiving
- A) Initial therapy - Approve for 3 months if ALL met
  - Patient is ≥ 6 years of age
  - ANY of the following
    Electrodiagnostic study (e.g., repetitive nerve stimulation)
    Anti-P/Q-type voltage-gated calcium channels antibody testing
  - Patient does not have a history of seizures
  - Amifampridine is being prescribed by or in consultation with a neurologist or a neuromuscular specialist
- B) Patient is currently receiving amifampridine - Approve for 1 year if continuing benefit
  - Patient is currently receiving amifampridine
  - Patient is continuing to derive benefit from amifampridine, according to the prescriber
    Examples of continued benefit include improved muscle strength and improvements in mobility.

refMigraineIdk__deprecated__refUnusedField__ignore__remove_me_please_which_will_not_show_up_in_ui__refDeprecatedButRequiredBySchemaToPreventCorruptionPleaseDoNotUseRefFieldBecauseThisIsAnExportWorkaroundActuallyRemoveThisLaterRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefRefDeprecatedBecauseSchemaRequiredButNotUsed":"b1_0" } ] } }

Provider Actions & Administrative Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage of amifampridine products. Initial approvals for new starts are granted for 3 months; approvals for patients currently receiving amifampridine and continuing to derive benefit are granted for 1 year. The prescriber must be a neurologist or a neuromuscular specialist, or there must be documentation of consultation with a neurologist or neuromuscular specialist retained in the medical record.

Documentation Required

Required Diagnostic Confirmation

Documentation confirming the diagnosis of Lambert‑Eaton myasthenic syndrome (LEMS) is required. Coverage will be considered only when objective diagnostic testing consistent with LEMS is provided.

Electrodiagnostic study (e.g., repetitive nerve stimulation)
Anti-P/Q-type voltage-gated calcium channels antibody testing

Documentation Required

Contraindication Documentation

Documentation of contraindications must be provided. Amifampridine products are contraindicated in patients with a history of seizures; this must be confirmed in the medical record prior to approval.

Billing Rule

Samples Do Not Satisfy Criteria

Receipt of sample product does not satisfy any criteria requirements for coverage and does not meet documentation requirements for prior authorization or diagnostic confirmation.

Clinical Evidence & Regulatory History

Amifampridine is a broad-spectrum potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). Firdapse was approved by the FDA on November 28, 2018 for adults (with 7-year orphan-drug exclusivity). Ruzurgi was approved May 6, 2019 for pediatric patients but the FDA withdrew approval effective February 1, 2022 following related litigation.

Pivotal evidence supporting Firdapse includes two pivotal trials, including a phase 3 trial demonstrating efficacy and safety in LEMS; one pivotal trial included an open-label 90-day run-in with individualized dose titration and required an improvement in quantitative myasthenia gravis score for treatment-naïve patients to continue.

Background & Definitions

LEMS is a rare autoimmune disorder causing proximal muscle weakness, autonomic dysfunction, and areflexia; it is associated with antibodies to P/Q-type voltage-gated calcium channels and reduced acetylcholine release at the neuromuscular junction.

Electrodiagnostic studies, such as repetitive nerve stimulation, are used to confirm the diagnosis of LEMS. Amifampridine is a potassium channel blocker indicated for LEMS treatment.

Revision History

11/1/2024non-material

Annual Revision dated 11/1/2024: Updated coverage policy title from 'Amifampridine' to 'Amifampridine Products.'

11/1/2024materialLatest

Annual Revision dated 11/1/2024 (material): Clarified diagnostic confirmation language by updating criteria from 'neurophysiology studies' to 'Electrodiagnostic study (e.g., repetitive nerve stimulation).'