CurrentCignaPolicy N/A

Multiple Sclerosis - Dalfampridine Prior Authorization Policy

Defines prior authorization and medical necessity criteria for dalfampridine (Ampyra) prescription benefit coverage for adults with multiple sclerosis to improve or maintain ambulation, including initial and continuation therapy criteria and prescribing provider requirements.

Policy Summary

PayerCigna

PolicyMultiple Sclerosis - Dalfampridine Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of impaired ambulation for initial therapy and ensure prescribing by or consultation with a neurologist or MS specialist; approvals are provided for set durations (initial 4 months, continuation 1 year).

SourceLink

POLICY UPDATE CHANGES

Annual revision with no criteria changes noted for 11/08/2023, 10/09/2024, and 07/23/2025.

2Approval pathways (Initial / Continuation)

3Primary contraindications listed

2Example objective measures provided

Coverage Summary

Defines prior authorization and medical necessity criteria for dalfampridine (Ampyra) prescription benefit coverage for adults with multiple sclerosis to improve or maintain ambulation. Coverage stance: covered_with_criteria; approvals require meeting specified initial or continuation criteria and specialist involvement.

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Surface thresholds and quick facts

Age thresholdPatient must be ≥ 18 years of age

Renal function contraindication thresholdEstimated creatinine clearance ≤ 50 mL/minute (moderate or severe renal impairment)

Approval pathways (Initial / Continuation)2

Primary contraindications listed3 (history of seizures; moderate or severe renal impairment with CrCl ≤ 50 mL/min; hypersensitivity to dalfampridine/4-aminopyridine)

Example objective measures provided2 (Timed 25‑Foot Walk; Multiple Sclerosis Walking Scale‑12)

Prescriber requirementMust be prescribed by or in consultation with a neurologist or MS specialist

Provider Actions and Authorization

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of dalfampridine. All approvals are provided for the duration noted below. Because of the specialized skills required for evaluation and diagnosis of patients treated with dalfampridine as well as the monitoring required for adverse events and long-term efficacy, approval requires dalfampridine to be prescribed by or in consultation with a physician who specializes in the condition being treated. Approvals: initial therapy — 4 months; continuation therapy — 1 year. Prescriber must be a neurologist or in consultation with a physician who specializes in the treatment of multiple sclerosis.

Documentation Required

Objective measure of impaired ambulation required for initial therapy

For initial therapy, documentation of impaired ambulation using an objective measure must be provided. Examples of objective measures of ambulation include the Timed 25-Foot Walk and the Multiple Sclerosis Walking Scale-12.

Timed 25-Foot Walk
Multiple Sclerosis Walking Scale-12

Documentation Required

Improvement or maintenance of ambulation required for continuation

For continuation therapy, the prescriber must state that the patient has experienced improvement or maintenance in walking speed or other objective measures related to ambulation. Continuation approvals are provided for 1 year.

Denial Risk

Contraindications will preclude coverage

Claims may be denied if the patient has any of the following contraindications.

History of seizures
Estimated creatinine clearance ≤ 50 mL/minute (moderate or severe renal impairment)
History of hypersensitivity to dalfampridine or 4-aminopyridine

Background and Evidence

Dalfampridine is a potassium channel blocker indicated to improve walking in adults with multiple sclerosis; this effect was demonstrated by an increase in walking speed. Prior authorization is recommended and approvals are provided for specified durations because specialized skills are required for evaluation and diagnosis and monitoring for adverse events and long-term efficacy, so the medication must be prescribed by or in consultation with a neurologist or physician who specializes in MS. Safety exclusions include history of seizures, estimated creatinine clearance ≤ 50 mL/minute, and hypersensitivity to dalfampridine or 4-aminopyridine.

Primary reference: Ampyra extended-release tablets prescribing information, Acorda; June 2022.

Term	Definition
Objective measure of ambulation	Examples include the Timed 25-Foot Walk and Multiple Sclerosis Walking Scale-12.

Revision History

11/08/2023revision

Annual Revision — Summary of Changes: No criteria changes. Review Date = 11/08/2023.

10/09/2024revision

Annual Revision — Summary of Changes: No criteria changes. Review Date = 10/09/2024.

07/23/2025revisionLatest

Early Annual Revision — Summary of Changes: No criteria changes. Review Date = 07/23/2025.