CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Dalfampridine

Defines coverage and approval criteria for dalfampridine (Ampyra) for members with multiple sclerosis to improve walking speed; includes initial (30-day) and continuation (12-month) authorization criteria and states that all other indications are experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDalfampridine

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization for an initial 30-day supply; document diagnosis of multiple sclerosis and sustained walking impairment prior to initiating therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Covered Indications (FDA-approved)

All other indicationsNot covered

Coverage Summary

Dalfampridine (Ampyra) is covered for the FDA-approved indication to improve walking in adult patients with multiple sclerosis, as demonstrated by an increase in walking speed. The policy limits use to this FDA-approved indication; all other uses are considered experimental/investigational and not medically necessary.

Initial Therapy Criteria (30-day authorization)

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Initial Authorization

Authorization of 30 days may be granted when ALL of the following are met:

ALL of the following

Member has a diagnosis of multiple sclerosis
Member has sustained walking impairment (prior to initiating therapy with the requested medication)

Prior Authorization

Prior authorization for initial therapy

Obtain prior authorization for an initial 30-day supply; document diagnosis of multiple sclerosis and sustained walking impairment prior to initiating therapy.

Continuation Therapy Criteria (Renewal / 12-month authorization)

Continuation of Therapy

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Member has a diagnosis of multiple sclerosis
Member has experienced an improvement in walking speed or other objective measure of walking ability since starting the requested medication

Prior Authorization

Prior authorization for continuation

For renewal, obtain authorization for up to 12 months by documenting improvement in walking speed or other objective measure of walking ability since starting dalfampridine.

Unproven / Non-covered Indications

Non-covered Indications

All other indications beyond the FDA-approved indication are considered:

Experimental/investigational and not medically necessary

Coverage status: covered with criteria. Initial authorization (up to 30 days) may be granted when all criteria are met, including a diagnosis of multiple sclerosis and documentation of sustained walking impairment prior to initiating dalfampridine. Continuation/renewal authorization (up to 12 months) may be granted when all criteria are met, including a diagnosis of multiple sclerosis and documentation of improvement in walking speed or other objective measure of walking ability since starting therapy. All non–FDA-approved uses are considered experimental/investigational and not medically necessary per the policy.

Clinical Evidence

Lancet 2009Key clinical trial: randomized double-blind controlled trial showing benefit in walking speed

Ampyra Jun 2022Package insert reference (Ampyra)

Dalfampridine Oct 2023Package insert reference (generic)

Key evidence includes a randomized, double‑blind, controlled trial published in Lancet (2009) demonstrating benefit in walking speed with sustained‑release fampridine. The policy also references product labeling: Ampyra package insert (June 2022) and dalfampridine package insert (October 2023) which support the indication for improving walking in adult patients with multiple sclerosis.

Provider Actions & Documentation Requirements

Documentation Required

Includes prior authorization requirements for both initiation and continuation of dalfampridine (Ampyra) for treatment of walking impairment in multiple sclerosis, and specifies required documentation.

Diagnosis of multiple sclerosis
Evidence of sustained walking impairment prior to initiation (baseline)
Objective measure of improvement in walking ability or walking speed for renewals