CurrentCignaPolicy IP0024

Dalfampridine (Ampyra and generic dalfampridine extended‑release) coverage criteria

Cigna coverage policy for dalfampridine (Ampyra and generic dalfampridine extended‑release) specifying medical necessity, prior authorization preferences, reauthorization, and exclusions for use in patients with multiple sclerosis who have impaired ambulation.

Policy Summary

PayerCigna

PolicyDalfampridine (Ampyra and generic dalfampridine extended‑release) coverage criteria

Policy CodePolicy IP0024

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document objective assessment of impaired ambulation (e.g., Timed 25‑foot Walk) and trial of generic dalfampridine before covering Ampyra.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum age for coverage

Initial: up to 6 monthsauthorization duration (initial)

Reauth: up to 12 monthsauthorization duration (reauthorization)

Seizure history; CrCl ≤50key safety exclusions

Coverage Criteria for Dalfampridine (Ampyra)

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Initial Therapy

Dalfampridine is considered medically necessary when ALL of the following are met:

Initial medical necessity: A. Individual is 18 years of age or older; B. Individual is ambulatory; C. Dalfampridine (Ampyra or dalfampridine extended-release tablet) is being used to improve or maintain ambulation in an individual with multiple sclerosis; D. Prior to treatment, the individual has been assessed for impaired ambulation using an objective measure (for example, Timed 25‑foot Walk test, Multiple Sclerosis Walking Scale‑12 or another objective measure of gait); E. Medication is prescribed by, or in consultation with, a neurologist or a physician who specializes in the treatment of multiple sclerosis; F. Preferred products are required (refer to preferred product/step therapy requirements).

From policy medical necessity criteria.

Reauthorization / Continuation Therapy

Continuation is medically necessary when ALL of the initial criteria are met AND:

Reauthorization: Documentation of beneficial response to therapy (for example, an increase in walking speed or a maintained level of ambulation).

Continuation requirement.

Any use of dalfampridine outside of improving walking in multiple sclerosis is not covered by this policy and is considered experimental, investigational, or unproven.

Dalfampridine is contraindicated in individuals with a history of seizures. It is also contraindicated in patients with moderate or severe renal impairment, defined as an estimated creatinine clearance of ≤ 50 mL/min, and in those with a history of hypersensitivity to dalfampridine or 4‑aminopyridine.

Use of dalfampridine for indications other than improving walking in patients with multiple sclerosis is considered not medically necessary and may be denied as experimental or investigational.

Covered Products and Coding

Covered products / Preferred productsmixedCovered

Ampyra	Brand dalfampridine extended‑release tablet
dalfampridine extended‑release tablet	Bioequivalent generic dalfampridine extended‑release tablet

Estimated creatinine clearance

Contraindication thresholdEstimated creatinine clearance ≤ 50 mL/min — dalfampridine is contraindicated

Clinical implicationsDo not initiate or continue dalfampridine in patients with moderate or severe renal impairment (CrCl ≤ 50 mL/min)

Related safety exclusionContraindication listed alongside history of seizures and hypersensitivity to dalfampridine or 4-aminopyridine

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Preferred Product

Prior authorization may be required for Ampyra (dalfampridine). Generic dalfampridine extended‑release tablet is the preferred product; a trial of the generic is required before coverage of Ampyra unless an exception applies (e.g., documented allergy or serious adverse reaction to inactive ingredients).

Preferred product trial: Documented trial of dalfampridine extended‑release tablet (bioequivalent generic) is required prior to Ampyra.
Exception: Member cannot take the generic due to a formulation difference in inactive ingredients causing a significant allergy or serious adverse reaction.

Step Therapy

Preferred Product Trial (Step Therapy)

Step therapy requires a documented trial of the preferred generic dalfampridine extended‑release tablet prior to approving Ampyra, unless there is documentation of intolerance or allergy to the generic formulation.

Applies to Employer Group and Individual & Family Plans.
Trial must be documented in the medical record and submitted with the prior authorization request.

Documentation Required

Required Clinical Documentation

Objective assessment of impaired ambulation is required. Examples include the Timed 25‑Foot Walk test (T25FW), Multiple Sclerosis Walking Scale‑12 (MSWS‑12), or another validated gait assessment. Documentation must demonstrate impaired ambulation at initiation and, for reauthorization, evidence of beneficial response (e.g., increased walking speed or maintained ambulation).

Required at baseline: objective measure of impaired ambulation (e.g., T25FW, MSWS‑12).
Required for continuation: documentation of beneficial response (increase in walking speed or maintained ambulatory function).
Medication should be prescribed by or in consultation with a neurologist or MS specialist.
Include objective test results and dates in the prior authorization submission.

Denial Risk

Non‑Covered Uses

Use of dalfampridine (Ampyra or generic extended‑release) for indications other than improving walking in multiple sclerosis is considered experimental, investigational, or unproven and is not covered.

Non‑covered uses: any indication other than improving ambulation in MS.

Background

Dalfampridine is a selective potassium channel blocker indicated to improve walking (demonstrated by increased walking speed) in adults with multiple sclerosis. The policy governs use of dalfampridine to improve or maintain ambulation and outlines requirements for objective baseline assessment and safety screening prior to treatment.

Key safety considerations include a contraindication in patients with a history of seizures and in those with moderate or severe renal impairment (estimated creatinine clearance ≤ 50 mL/min), as well as hypersensitivity to dalfampridine or 4‑aminopyridine.