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    v1.0.28
    OpenPayerPolicy UpdatesNeurology/Neurosurgeryallcareadvantage dalfampridine Prior Auth Policy |…
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    CurrentallcareadvantagePolicy 052.2

    dalfampridine (Ampyra) prior authorization

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    Defines AllCare Advantage prior authorization, coverage criteria, and renewal requirements for dalfampridine (Ampyra) for adults with multiple sclerosis who have walking impairment.

    Policy Summary
    Payerallcareadvantage
    Policydalfampridine (Ampyra) prior authorization
    Policy CodePolicy 052.2
    Change TypeNo material change
    Effective DateMar 12, 2020
    Last ReviewMar 12, 2022
    Next Review DateMar 12, 2022
    Key ActionObtain prior authorization; initial approval up to 2 months and renewal up to 12 months contingent on documented ≥20% improvement in timed 25-foot walk.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    10 mg BIDmaximum recommended dosage
    2 monthsapproval length (initial)
    12 monthsapproval length (renewal)
    ≥20%required improvement

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    8–45 sec
    eligible baseline walk time

    Coverage criteria for dalfampridine (Ampyra)

    Initial Therapy

    Covered when ALL of the following are met:

    Initial criteria set: 1) Diagnosis of multiple sclerosis (FDA-approved indication).

    Deny if diagnosis of MS is not present.

    Prescriber requirement: 2) Medication is prescribed by or in consultation with a neurologist.

    Deny if not prescribed by or in consultation with a neurologist.

    Seizure history: 3) No history of seizures.

    Deny if there is a history of seizures due to increased seizure risk with dalfampridine.

    Renal function: 4) No moderate or severe renal impairment (based on estimated GFR).

    Deny if moderate or severe renal impairment is present because renal impairment increases drug concentration and seizure risk.

    Ambulatory status

    • Options

      • Uses walking aid: a) Requires use of a walking aid due to walking disability.

        Approve initial fill for up to 2 months if met.

      • Moderate dysfunction without aid: b) Has moderate ambulatory dysfunction, does not require a walking aid, AND is able to complete a baseline timed 25-foot walk between 8 and 45 seconds.baseline timed 25-foot walk 8–45 seconds

        Approve initial fill for a 2-month trial if met.

    Continuation / Renewal Therapy

    Renewal approval when ALL of the following are met:

    Renewal criteria set: 1) Member met the initial prior authorization criteria.

    If initial PA criteria were not met, deny renewal.

    Current ambulatory status: 2) Member is currently ambulatory.

    If not ambulatory, deny renewal.

    Response to therapy: 3) Member has been taking dalfampridine for ≥2 months with documented improvement in walking speed while on dalfampridine (≥20% improvement in timed 25-foot walk test).≥20% improvement

    If objective ≥20% improvement after ≥2 months is not documented, deny renewal.

    Coverage excludes patients with a history of seizures and those with moderate or severe renal impairment (based on estimated GFR). The FDA has issued safety communications noting an increased risk of seizures with dalfampridine that is concentration‑related and greatest in the weeks after starting therapy; seizures have occurred even in patients without a prior seizure disorder, and patients with any degree of renal dysfunction are at higher risk. These safety exclusions must be confirmed before authorization is granted.

    AllCare’s policy stance is limited coverage for new starts: because Ampyra (dalfampridine) demonstrated only a small clinical benefit in walking speed in trials and carries a real risk of seizures, AllCare does not broadly cover new initiations. Limited approval is allowed only when the policy’s specific eligibility and safety criteria are met and prior authorization requirements are satisfied.

    Codes and objective measures

    Drug codes (NDC)NDC
    NDC not listedNo NDC codes provided in document
    Timed 25-foot walk test improvement — renewal threshold value
    Renewal improvement thresholdMember must demonstrate ≥20% improvement in the timed 25-foot walk test after ≥2 months of therapy to qualify for renewal approval.
    Required duration before assessmentImprovement must be documented after the member has been taking dalfampridine for ≥2 months.
    Action on failure to meet thresholdIf ≥20% improvement is not documented, renewal is denied.
    Baseline timed 25-foot walk — eligible baseline window
    Eligible baseline windowBaseline timed 25-foot walk must be between 8 and 45 seconds to meet initial criteria.
    Purpose of baseline measurementEstablishes objective pre-treatment walking speed for comparison at renewal.

    Provider requirements and authorization rules

    Prior Authorization

    Prior authorization required

    Prior authorization is required for dalfampridine (Ampyra). Initial approvals are granted for up to 2 months; renewals may be approved for up to 12 months only if renewal criteria are met.

    • Initial: up to 2 months
    • Renewal: up to 12 months contingent on meeting renewal criteria
    Step Therapy

    No step therapy specified; follow eligibility & safety criteria

    No step therapy sequence is specified in this policy; providers must instead ensure patients meet the eligibility and safety criteria (MS diagnosis, neurologist prescribing or consultation, no seizure history, no moderate/severe renal impairment, and ambulatory criteria) before requesting authorization.

    • Policy explicitly states no step therapy sequence is specified
    • Focus is on eligibility and safety criteria for dalfampridine

    Background

    Dalfampridine (Ampyra) is an oral medication FDA‑approved to improve walking in adults with multiple sclerosis. Clinical trials supporting approval showed a small, responder‑dependent improvement in walking speed over 25 feet (the FDA review noted an absolute difference of about 2 seconds between responders and non‑responders), and fewer than 50% of treated patients were responders. Ampyra is not a disease‑modifying therapy for MS and has not been shown to improve relapse rate, disease progression, or quality of life. The drug’s safety profile includes a concentration‑related increased risk of seizures, particularly early in treatment and in patients with impaired renal function; the maximum recommended dosage is 10 mg twice daily.

    Key definitions

    Responder — definition and renewal requirement (≥20% improvement)
    Definition of ResponderA patient who demonstrates improvement in walking speed while on dalfampridine; for renewal, this is defined as ≥20% improvement in the timed 25-foot walk test.
    Renewal requirementDocumented ≥20% improvement in the timed 25-foot walk after ≥2 months of therapy is required for renewal approval.
    Consequence of not meeting requirementIf the ≥20% improvement criterion is not met, renewal is denied.
    Baseline timed 25-foot walk — definition and eligible baseline window
    Definition of baseline timed 25-foot walkAn objective timed measure of walking speed over 25 feet used to establish pre-treatment function.
    Eligible baseline time windowBaseline walk time must be between 8 and 45 seconds to meet initial therapy criteria.
    Policy Summary
    Payerallcareadvantage
    Policydalfampridine (Ampyra) prior authorization
    Policy CodePolicy 052.2
    Change TypeNo material change
    Effective DateMar 12, 2020
    Last ReviewMar 12, 2022
    Next Review DateMar 12, 2022
    Key ActionObtain prior authorization; initial approval up to 2 months and renewal up to 12 months contingent on documented ≥20% improvement in timed 25-foot walk.
    SourceLink
    On This Page
    Coverage criteria for dalfampridine (Ampyra)Codes and objective measuresProvider requirements and authorization rulesBackgroundKey definitions
    Action if baseline out of rangeIf baseline is not between 8 and 45 seconds, initial criteria are not met and the request is denied.
    Documentation Required

    Timed 25-foot walk documentation required for initial and renewal

    Document a baseline timed 25-foot walk between 8 and 45 seconds prior to initial authorization, and for renewal provide objective documentation showing ≥20% improvement in the timed 25-foot walk after ≥2 months of therapy.

    • Baseline timed 25-foot walk must be between 8 and 45 seconds
    • Renewal requires objective documentation of ≥20% improvement after ≥2 months on therapy
    Denial Risk

    Conditions that will trigger denial

    Requests will be denied if the patient does not have a diagnosis of multiple sclerosis, if the drug is not prescribed by or in consultation with a neurologist, if the patient has a history of seizures, or if the patient has moderate or severe renal impairment; absence of required baseline ambulatory criteria also triggers denial.

    • Deny if no MS diagnosis
    • Deny if not prescribed by or in consultation with a neurologist
    • Deny if patient has history of seizures
    • Deny if moderate or severe renal impairment (est. GFR)
    • Deny if baseline ambulatory criteria are not met
    Role in renewal evaluationBaseline measurement is compared to follow-up timed 25-foot walk to determine percent improvement for renewal (≥20% required).