CurrentCignaPolicy IP0024

Dalfampridine (Ampyra) coverage for improving ambulation in multiple sclerosis

Policy Summary

PayerCigna

PolicyDalfampridine (Ampyra) coverage for improving ambulation in multiple sclerosis

Policy CodePolicy IP0024

Change TypeNo material change

Effective DateFeb 15, 2024

Next Review DateFeb 15, 2025

Key ActionPrior authorization may be required; document objective assessment of impaired ambulation and a trial of the preferred generic dalfampridine extended-release tablet unless contraindicated.

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this update.

6Key Medical Necessity Criteria

6/12Auth durations (initial/reauth months)

≤50 mL/minRenal function threshold (CrCl)

Coverage Summary

Defines medical necessity, prior authorization preferences, reauthorization, authorization durations, contraindications, and non-covered uses for dalfampridine (Ampyra and generic dalfampridine extended-release) for adults with multiple sclerosis to improve or maintain ambulation. Coverage stance: covered_with_criteria. Policy number: IP0024. Effective date: 2024-02-15. Next review date: 2025-02-15. Initial approval duration up to 6 months; reauthorization up to 12 months.

Medical Necessity Criteria

Initial Medical Necessity Criteria

Dalfampridine (Ampyra and dalfampridine extended-release tablet) is considered medically necessary when the individual meets ALL of the following criteria are met:

Age 18 years or older
Ambulatory status: Individual is ambulatory
Able to walk; policy requires individual to be ambulatory to be eligible for dalfampridine.
Indication: Used to improve or maintain ambulation in an individual with multiple sclerosis
Objective assessment: Prior to treatment, 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)
Prescriber requirement: Medication is prescribed by, or in consultation with, a neurologist or a physician who specializes in the treatment of multiple sclerosis
Preferred product requirement: Preferred products are required per plan-specific preferred alternative table (see code_groups/notes); documented trial of generic dalfampridine extended-release tablet required unless unable to take due to formulation difference causing significant allergy or serious adverse reaction

Reauthorization (Continuation) Criteria

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

Reauthorization Criteria

Ongoing initial criteria: Above initial medical necessity criteria continue to be met
Beneficial response: Documentation of beneficial response (for example, an increase in walking speed or a maintained level of ambulation)

Not Covered / Experimental

Conditions Not Covered:

Not covered / Experimental: Any use other than to improve walking/ambulation in adults with multiple sclerosis is considered experimental, investigational, or unproven

Contraindications / Safety Exclusions (clinical, not coverage criteria)

Dalfampridine is contraindicated in patients with:

Contraindications / Safety Exclusions

History of seizures
Renal impairment: Moderate or severe renal impairment (estimated creatinine clearance ≤ 50 mL/min)≤ 50 mL/min
renal function exclusion threshold
Hypersensitivity: History of hypersensitivity to dalfampridine or 4-aminopyridine

Coding

Preferred alternative (plan-specific) - genericNDC|mixedCovered

dalfampridine extended-release tablet (generic)

Preferred product; documented trial required per employer and individual/ family plan criteria; may require prior authorization. Receipt of sample product does not satisfy coverage criteria.

Brand productNDC|mixedCovered

Ampyra (dalfampridine)

Covered when medical necessity criteria are met; trial of the bioequivalent generic dalfampridine extended-release tablet is required per plan unless the individual cannot take the generic because of a formulation-related inactive ingredient allergy or serious adverse reaction.

Provider Actions

Prior Authorization

Prior authorization may be required

Prior authorization may be required for Ampyra; plans require trial of the preferred generic dalfampridine extended-release tablet and documentation if brand is needed due to formulation inactive ingredient allergy or serious adverse reaction.

Plan-specific preferred generic trial required; document allergy or serious adverse reaction to inactives if brand is needed.

Documentation Required

Assessment of ambulation required

Document objective assessment of impaired ambulation prior to treatment (for example, Timed 25-foot Walk test, Multiple Sclerosis Walking Scale-12 or another objective measure of gait).

Timed 25-foot Walk (Timed 25-foot Walk test)
Multiple Sclerosis Walking Scale-12 (MSWS-12)
Other objective gait measures (documented and reproducible)

Documentation Required

Specialist involvement required

Medication must be prescribed by, or in consultation with, a neurologist or a physician who specializes in treatment of multiple sclerosis.

Documentation Required

Reauthorization evidence of benefit

For continuation, document beneficial response such as increased walking speed or maintained ambulation.

Billing Rule

Authorization durations

Initial approval up to 6 months; reauthorization up to 12 months.

Initial approval up to 6 months
Reauthorization up to 12 months

Background & Evidence

Policy supports medical necessity review for dalfampridine (Ampyra and dalfampridine extended-release) indicated to improve walking in adults with multiple sclerosis, demonstrated by increased walking speed. Receipt of sample product does not satisfy coverage criteria.

Source	Reference
Prescribing information
Ampyra extended-release tablets prescribing information, Acorda; June 2022

Ambulatory: Able to walk; policy requires individual to be ambulatory to be eligible for dalfampridine.

OpenPayer

Dalfampridine (Ampyra) coverage for improving ambulation in multiple sclerosis

Coverage Summary

Medical Necessity Criteria

Coding

Provider Actions

Background & Evidence

Revision History